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October 22, 2021

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The weekly global report provides brief updates on COVID-19 related activity and policy development in AdvaMed’s priority markets. For additional information, please contact Ralph Ives at Rives@AdvaMed.org.

    COVID-19 Outbreak: Weekly Global Report for Friday, October 22, 2021

     

    AdvaMed recognizes that its members, particularly those with global government affairs responsibilities, are tracking COVID-19 related developments around the world to assess the public health and economic impacts on their businesses. Knowing that companies are consuming information from a variety of sources, AdvaMed's global team would like to provide members with a weekly snapshot of the key statistics, policy developments and advocacy initiatives underway in our priority markets.  If you have any suggestions, we welcome your feedback.

     

    Global

    • Weekly COVID-19 statistics. Global cases reached 242 million. Deaths around the world have almost reached 5 million. Around 6.7 billion vaccines have been administered.
    • U.S. cases exceeded 45.2 million with deaths increasing to 721,000.
    • Staff Contact: Ralph Ives (rives@advamed.org).

                                                                    China

                                                                    • The latest: Parts of northern China are bracing for more COVID-19 curbs as a wave of cases raises concerns of a broader outbreak, with three areas enforcing lockdowns, some schools halting classes, and an aerospace firm delaying work on a rocket project. The latest cluster, involving mostly northern and northwestern China, has reached the capital, Beijing, and the neighbouring Hebei province, where officials pledged stringent measures against the virus as they stepped up preparations for the 2022 Winter Olympics Games in February. Many of the recent cases are contacts of an elderly couple who had travelled in the provinces of Shaanxi and Gansu and the Chinese region of Inner Mongolia before being confirmed as COVID-19 patients last Sunday. It remains unclear whether the married couple were the source of the outbreak, or where they had contracted the virus.
                                                                    • Will Beijing soften it zero-tolerance approach? In recent and separate interviews with Chinese state media outlets last week, China’s top health officials hinted that the country would reopen its borders once approximately 85% of its population has been vaccinated, suggesting that China may have to forego its stringent zero-tolerance COVID-19 policy and learn to “coexist” with the virus as it becomes endemic and its fatality rate becomes more akin to the seasonal flu. In an interview, Gao Fu, the head of the Chinese Center for Disease Control and Prevention, appeared to indicate that China would start to “open up” by early 2022 if it reached an 85% inoculation rate. Separately, China’s top infectious disease expert Zhong Nanshan also gave similar remarks over the National Day holiday, stating that China would “completely reopen” its borders after “the vast majority of the population [80%-85%] has been vaccinated,” adding: “In the long run, adopting the strictest pandemic control measures are not feasible, and will be a huge burden on China.” According to official numbers, China has fully vaccinated (double dose) 78% of its population, having administered 2.22 billion doses of vaccines as of yesterday. Still, given the upcoming Winter Olympics in Beijing next February and the 20th Party Congress next fall, many observers are uncertain how far China may go in softening its containment measures.
                                                                    • Beijing to offer booster shots: Beijing on Thursday reported one newly confirmed COVID-19 case linked to the recent epidemic flare-up in Northwest China, which has been identified as caused by the Delta variant, local health authorities said. The capital city has launched booster shot services for residents, targeting key groups including people going abroad and staff working at ports and medical services.
                                                                    • Despite a massively efficient vaccine roll-out since May, the Chinese government has given no indication it intends to change its current COVID playbook of closed borders, strict two-week quarantine for foreign arrivals, and aggressive lockdowns and mass testing when flareups arise. Beijing remains ever cautious as the Delta variant circulates worldwide and the efficacy of China’s vaccines is questioned. Many businesses expect that China may retain stringent travel restrictions through at least February 2022, when Beijing will host the Winter Olympics.
                                                                    • Status of the vaccination campaign: 1.09 billion Chinese citizens (77% of the population) have received at least one COVID vaccine dose as of this Monday, according to the National Health Commission (NHC). Among them, nearly 970 million have been fully vaccinated with two shots. About 162 million doses of Covid vaccines have been given to minors ages 12 to 17. The NHC recently said it would allow some groups of people at higher risk, including those 60 or older, to take a booster shot six months after full vaccination. The decision was based on data from domestic vaccine makers Sinovac and Sinopharm on the performance of their inactivated-virus vaccines after six months.
                                                                    • China to build permanent quarantine centers for foreign arrivals: Health authorities have ordered cities in China to build or convert facilities into permanent quarantine centers for overseas arrivals, as Beijing pushes ahead with its zero-tolerance policy on COVID-19.City governments have been told to move away from using hotels for quarantine and instead provide dedicated facilities. There should be 20 quarantine rooms per 10,000 people available by the end of October, according to National Health Commission official Cui Gang.
                                                                    • Weekly COVID-19 statistics: China’s total COVID cases now stand at 109,010, an increase of 160 cases over the previous week. The number of reported deaths remained unchanged at 4,849.
                                                                    • China’s vaccines and approval date: Sinopharm (approved Dec. 31, 2020); Sinovac’s CoronaVac (approved on Feb. 5); CanSino Biologics and a second Sinopharm vaccine (both approved in April). Three other vaccines have been approved in May and June.
                                                                    • China updates its mass testing protocol: In a city with a population greater than 5 million people, mass testing shall now be completed within three days, according to the updated protocol issued by the National Health Commission. The time limit was set at three to five days for cities of the same size in the previous protocol introduced in February. For cities with less than 5 million people, the time limit for completing city-wide testing remains unchanged at two days.
                                                                    • Chinese airports toughen up quarantine rules: Airports around China are lengthening the amount of time some international aircrews and ground staff must spend in quarantine, after containment breaches sparked community spread of the highly infectious delta variant in several regions. Some regional regimes will see airport workers judged to be a higher risk isolated for up to 28 days after two weeks of work. These represent far tougher restrictions than those currently mandated by the country’s national aviation authority.
                                                                    • Post-COVID healthcare system upgrade: China will provide funding to build new institutions and infrastructure to fight infectious diseases and improve healthcare, the state planning body said in a "five-year plan" for the sector. The central government will subsidize the construction of new "prevention bases" for infectious disease and new grassroots medical facilities across the country, the National Development and Reform Commission (NDRC) said in the plan, published this Thursday. It said China was facing difficult healthcare challenges, including new emerging infectious diseases, the increasingly heavy burden of chronic illnesses as well as the growing need for mental health services. "The public health system is in urgent need of improvement, and the ability to prevent, control and treat major epidemics is not strong," it warned. High-quality medical resources are also insufficient and not evenly distributed, and there are also gaps when it comes to treating women and children, it added.
                                                                    • BioNTech vaccine: Chinese regulators completed an expert review of a COVID-19 mRNA vaccine developed by Germany's BioNTech and Fosun Pharma and the shot is now in the administration review stage, Caixin reported. China hasn't approved any COVID-19 vaccine developed overseas but has greenlighted several domestic brands. Chinese authorities plan to use the vaccine, which goes by the brand name Comirnaty, as a booster shot for people who have received inactivated-virus vaccines, people close to regulators told Caixin. Most people in China have received inactivated-virus vaccines made by Sinovac and state-owned Sinopharm Group that have demonstrated lower efficacy than mRNA vaccines.
                                                                    • China’s own mRNA vaccine: China’s first messenger RNA (mRNA) COVID-19 vaccine, is expected to start phase three tests in many overseas countries soon, the chief executive officer of Suzhou Abogen Biosciences, the vaccine’s developer, said this week. Together with Chinese clinical contract research organization Tigermed, Abogen is preparing to conduct overseas Phase III clinical trials using 28,000 volunteers in countries including Mexico, Columbia and Pakistan. The vaccine can be stored at temperatures of between two and eight degrees centigrade for at least seven months, making it convenient for mass distribution. The clinical trials will not select specific variants, and will also not reject any strains, Ying told Yicai Global. The Suzhou, eastern Jiangsu province-based firm is also developing a separate mRNA vaccine candidate that will target the variants that were first found in South Africa and India.
                                                                    • Vaccine diplomacy: CCP General Secretary Xi Jinping pledged to provide two billion doses of COVD-19 vaccines to the world by the end of this year. Xi also declared that the COVAX global vaccine distribution initiative would receive a donation from China of $100mln. China has already supplied over 770 million vaccine doses to other countries, according to the Ministry of Foreign Affairs.
                                                                    • China’s economy: China's factory and retail sectors faltered in August with output and sales growth hitting one-year lows as fresh coronavirus outbreaks and supply disruptions threatened the country's impressive economic recovery. Industrial production rose 5.3% in August from a year earlier, narrowing from an increase of 6.4% in July and marking the weakest pace since July 2020, data from the National Bureau of Statistics showed on Wednesday. Output growth missed the 5.8% increase tipped by analysts. Consumer spending also took a big hit from rising local COVID-19 cases and floods with sales rising only 2.5% in August from a year ago, much lower than the forecast 7.0% rise and the slowest clip since August last year.
                                                                    • China’s response to a new WHO investigation into COVID’s origins: Beijing has called on the World Health Organization to uphold an “objective, scientific” approach as the UN body prepares to launch the next phase of research into the origins of the coronavirus. The comments came after the WHO on Wednesday revealed the group of international scientists who will lead future research to try to trace the emergence of the virus, which was first identified in China nearly two years ago. Speaking on Thursday, Chinese foreign ministry spokesman Zhao Lijian also appeared to leave the door open to future field missions in the country. “China will continue to support and participate in the global scientific origins tracing, and resolutely oppose any form of political manipulation,” Zhao said, when asked whether China would allow further missions if asked by the WHO group. The new group – Scientific Advisory Group for the Origins of Novel Pathogens, or Sago – comprising 26 scientists from six continents, is the WHO’s attempt to defuse political tensions around the research.
                                                                    • China’s Economy: China's economy hit its slowest pace of growth in a year in the third quarter, hurt by power shortages and wobbles in the property sector, highlighting the challenge facing policymakers as they seek to prop up a faltering recovery while reining in the real estate sector. Gross domestic product expanded 4.9% from a year ago, missing forecasts, as attempts by Beijing to curb lending to the property sector exacerbated the fallout from electricity shortages which sent factory output back to levels last seen in early 2020, when heavy COVID-19 curbs were in place. The world's second-largest economy had staged an impressive rebound from last year's pandemic slump but the recovery has lost steam from the blistering 18.3% growth clocked in the first quarter.
                                                                    • S.-China relations: President Joe Biden’s pick to be ambassador to China drew sharp lines with Beijing over its “aggressive” actions in the Indo-Pacific but said “American strength” gives the U.S. key advantages in the relationship between the world’s two largest economies. Nicholas Burns, a longtime diplomat who previously served as U.S. ambassador to NATO and Greece, said in his Senate confirmation hearing that China has been the aggressor in its relationship with Taiwan, Vietnam, Japan and the Philippines. He also said he’s skeptical about Chinese intentions on issues like 5G technology. But he emphasized his view that the U.S. has the upper hand. “Beijing proclaims that the East is rising and the West is in decline,” Burns said. “I’m confident in our own country,” he added, citing the U.S. military, foreign service and educational system as advantages over China. “The People’s Republic of China is not an Olympian power.”
                                                                    • Staff Contact: Kyle Churchman (kchurchman@advamed.org)

                                                                                                                                                                                India

                                                                                                                                                                                • Weekly COVID-19 statistics:  34,126,682 total cases, 178,098 active cases/452,651 deaths/discharged 33,478,247 (John Hopkins and MoHFW) as compared to 34,019,680 total cases, 206,586 active cases/451,435 deaths/discharged 33,362,709 (John Hopkins and MoHFW) last week. 991,282,283 people have been vaccinated.
                                                                                                                                                                                • India logged 14,623 new coronavirus infections, taking the total tally of COVID-19 cases to 34,108,996, while the active cases declined to 178,098, the lowest in 229 days , according to the data released by Health Ministry on Wednesday, October 20. The daily rise in coronavirus infections has been below 30,000 for 26th straight days and less than 50,000 daily new cases have been reported for 115 consecutive day now.
                                                                                                                                                                                • Coming very close to the 100 crore mark, India has administered 99.12 crore (99,12,82,283) total cases under its vaccination drive against Covid-19 with the administration of 4,136,142 vaccine doses in the last 24 hours, the Union Health Ministry said. Out of the total doses administered in the last 24 hors, the maximum of over 51 crore doses have gone to the 18-44 age group followed by people from the 45-59 age group.
                                                                                                                                                                                • The chances of a third Covid-19 wave appear remote under the “present circumstances” with only the Delta and its derivatives as the main SARS-CoV-2 variants in circulation and the weekly caseload dropping steadily, according to the experts.
                                                                                                                                                                                • India has delayed committing supplies of vaccine to the COVAX global sharing platform, two sources told Reuters on Tuesday, October 19, a day after one of its key backers, the WHO, said the agency could not “cut corners” to approve a domestically developed vaccine. The world’s biggest vaccine maker resumed exports of Civid-19doses this month for the first time since April. It has sent about 4 million to countries such as neighbouring Bangladesh and Iran, but none to COVAX.
                                                                                                                                                                                • India’s Covid-19 cumulative vaccination coverage on Tuesday, October 19 crossed 99 crore. This include more than 70 crore people who have been administered the first dose and 28.9 crore who have received the second dose. As India gets closer to the one billion mark, the health ministry urged state governments to step up the vaccination drive and also focus on the second dose coverage as a sizeable number of people     eligible for the second shot have not got it yet.
                                                                                                                                                                                • Indian drug manufacturers who have signed up with Russia's RDIF to produce Sputnik V are struggling to scale up production of the second component of the Covid-19 vaccine, and are now counting on the approval for the single-shot Sputnik Light to salvage the situation. A top executive of the drug maker, which has signed a pact with RDIF to manufacture and supply up to 200 million doses of Sputnik V, told ET that with the existing technology, it is not viable to manufacture the second dose at scale. 
                                                                                                                                                                                • The WHO said on Monday, October 18, it was “aware that many people are waiting for WHO’s recommendation for Covaxin  to be included in the Covid-19 emergency use listing that it “cannot cut corners”. It added that “before adding a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective.
                                                                                                                                                                                • Hyderabad-based Bharat Biotech, the manufacturer of indigenous Covid-19 vaccine, is aiming to produce 70-80 million doses monthly from December, lagging way behing the government’s 400 million production estimate between April-December. AT present the company is producing 30-40 million per month.
                                                                                                                                                                                • Mixing and matching using two different Covid vaccines for immunization has a long way to go in the country, as experts here are determined to find the “best possible combination”. N.K Arora, who heads the Covid-19 working group of the Centre’s National Technical Advisory Group on Immunization (NTAGI), told TOI on Sunday that in addition to the Covishield-Covaxin trials currently under way at Christian Medical College in Vellore.
                                                                                                                                                                                • India's vaccination campaign has slowed despite amassing record stockpiles of vaccines, health ministry data showed on Monday, October 18, as authorities maintain a wider than usual gap between doses in a strategy that has boosted coverage. Domestic production of the Astra Zeneca vaccine, which accounts for nearly 90% of the doses administered, has more than tripled since May, when a supply shortage prompted India to double the period between doses to between 12 and 16 weeks.
                                                                                                                                                                                • With COVID-19 cases coming down in the country, the government on Friday, October 15, removed export curbs on all diagnostic kits and reagents including instruments, which are used in detection of coronavirus infections. The daily rise in new coronavirus infections has been below 30,000 for 21 straight days and less than 50,000 daily cases have been reported for 110 consecutive days.
                                                                                                                                                                                • WHO's technical advisory group will meet on October 26 to consider granting Emergency Use Listing (EUL) to Bharat Biotech’s  Covaxin, WHO Chief Scientist Soumya Swaminathan said on Sunday. “WHO has been working closely with Bharat Biotech to complete the dossier, she tweeted”.
                                                                                                                                                                                • India will have a vaccine capacity of 28 crore doses this month, which includes 22 crore Serum Institute of India’s Covishield and 6 crore doses of Bharat Biotech’s Covaxin and production of 60 lakh doses of Zydus Cadila’s ZyCov-Ddoses are also ready, said the government sources. India will have a capacity of more than 30 crores by next year per month, which includes Covishield, Covaxin, ZyCov-D and Biological-E.
                                                                                                                                                                                • Staff Contact: Abby Pratt (apratt@advamed.org).

                                                                                                                                                                                                                                  Japan

                                                                                                                                                                                                                                  • Weekly COVID-19 statistics – 1,716,477 total reported cases and 18,187 total reported deaths compared to 1,713,684 total reported cases and 18,069 total reported deaths last week.
                                                                                                                                                                                                                                  • Japan has seen a remarkable drop in new cases. Daily cases nationwide have dropped from a peak of around 25,000 in August to under 400 this week.
                                                                                                                                                                                                                                  • The Japanese government lifted the COVID-19 state of emergency covering 19 prefectures including Tokyo at the end of September. The emergency mainly involved requests for restaurants and bars to reduce their hours and not serve alcohol. With the lifting, Japan is free of emergency requirements for the first time in more than six months.
                                                                                                                                                                                                                                  • After a comparatively slow start, Japan's vaccination program has picked up speed, with 68.8% of the population now fully vaccinated.
                                                                                                                                                                                                                                  • Japan plans to start administering third doses of COVID-19 vaccine in December to those who had their second doses at least 8 months ago.
                                                                                                                                                                                                                                  • Japan is easing its quarantine restrictions for travelers entering the country who been fully vaccinated with the Pfizer, Moderna, or Astra Zeneca vaccines. They will no longer be required to self-isolate in designated facilities for 3 days before completing a 14-day quarantine. Instead, they will need to self-quarantine at home for 10 days and then pass a PCR test.
                                                                                                                                                                                                                                  • Japan has agreed to buy 150 million doses of Novavax's coronavirus vaccine, with Japanese firm Takeda expecting to manufacture the formula for distribution early next year.
                                                                                                                                                                                                                                  • Japan provided final approval to the Moderna vaccine and the Astra Zeneca vaccine on May 21. The Pfizer vaccine was approved in February. J&J submitted its application for approval of its vaccine on May 24. It is expected to be approved and available for use around the beginning of 2022.
                                                                                                                                                                                                                                  • The Japanese government continues to maintain its controls on foreign nationals entering the country. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam remain suspended. Tokyo’s restrictions on foreign entries except for returning nationals remain in place.
                                                                                                                                                                                                                                  • Staff Contact: Phil Agress (PAgress@AdvaMed.org).

                                                                                                                                                                                                                                                                                                                                                                      Korea

                                                                                                                                                                                                                                                                                                                                                                      • South Korea has 1,441 new COVID cases, which is a decrease of about 500 from last week. The country has not seen dramatic spikes recently, but the persistence of cases in the current ranges is a concern. The numbers remain overall low.
                                                                                                                                                                                                                                                                                                                                                                      • Korea now has 337,529 total cases, 27,065 active with 2,709 deaths. Total cases per million population have remained low compared to most of the world but Korea is now above the 6K threshold with 6,771 cases per million. (S. Korea ranks still as one of the lowest among the more highly populated countries). Deaths per million remain comparatively low as well at just 53).
                                                                                                                                                                                                                                                                                                                                                                      • South Korea officials credit strict social distancing measures as the reason they are not seeing greater or more dramatic spikes.
                                                                                                                                                                                                                                                                                                                                                                      • Some restrictions have been eased to give leeway to vaccinated people and allow more students to take in-person classes to mitigate the prolonged pandemic's impact on the local economy.
                                                                                                                                                                                                                                                                                                                                                                      • The government is pushing to introduce its "Living with COVID-19" phase Nov. 1 at the earliest, as the nation's vaccination rate is expected to reach 70 percent in the coming days, according to Minister of Health and Welfare.
                                                                                                                                                                                                                                                                                                                                                                      • The Ministry said the government was "considering" beginning the plan that day, under which the health authorities will ease social distancing measures and focus more on managing critically ill patients rather than all virus cases. The minister made the remarks during the National Assembly's audit of the health ministry and the Korea Disease Control and Prevention Agency (KDCA), Wednesday.
                                                                                                                                                                                                                                                                                                                                                                      • Korea continues to improve its vaccination numbers. A total of 73,716,800 doses have been administered. 67.4% of the population is now fully vaccinated, and another 11.7% have received their first dose.
                                                                                                                                                                                                                                                                                                                                                                      • Moderna has approved the domestic use of its COVID-19 vaccines to be produced by its South Korean business partner Samsung Biologics.
                                                                                                                                                                                                                                                                                                                                                                      • While chances are low the mRNA-based biotech Moderna will let Samsung Biologics handle the total distribution process of its vaccines to be manufactured at Samsung's facility in Incheon's Songdo, Moderna's approval for the domestic use of its vaccines will be a huge plus in terms of backing Seoul's efforts to increase the local vaccination rate, and plans for initiating a round of booster shots for people in their 60s after their initial immunization.
                                                                                                                                                                                                                                                                                                                                                                      • Foreigners arriving at South Korean airports face a mandatory 14-day quarantine procedure and must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation. However, some people who have been vaccinated against COVID-19 in countries other than Korea will be exempt from the 14-day self-quarantine requirement, meaning they can move around freely as soon as they enter the country. A similar exemption has been in place since May for those who were vaccinated in Korea.
                                                                                                                                                                                                                                                                                                                                                                      • The exemption applies only to people who were fully vaccinated at least two weeks before traveling to Korea. It also applies only to those who have received a COVID-19 vaccine that is approved for emergency use by the World Health Organization. The list includes those from Pfizer, Janssen, Moderna, AstraZeneca, Sinopharm and Covishield. All international arrivals still have to show a negative result from a COVID-19 test taken within 72 hours of departing for Korea. Without one, you can still be refused entry.
                                                                                                                                                                                                                                                                                                                                                                      • The exemption also only applies to those visiting Korea for business or academic purposes, for the public interest or to visit immediate family members. Otherwise, you still have to self-quarantine for two weeks upon entry. Immediate family members are defined as spouses, lineal ascendants or descendants, and lineal ascendants or descendants of spouses. You will have to fill out forms and prove your intent to visit them. The necessary forms are available online from Korean embassies and consulates abroad or other government agencies.
                                                                                                                                                                                                                                                                                                                                                                      • Those coming from countries experiencing the spread of certain COVID-19 variants are also ineligible for this exemption.
                                                                                                                                                                                                                                                                                                                                                                      • For a list of current travel and entry restrictions, see the following link: https://www.koreaonlinevisa.com/travel-restrictions/.
                                                                                                                                                                                                                                                                                                                                                                      • Resources: http://ncov.mohw.go.kr/en/. 
                                                                                                                                                                                                                                                                                                                                                                      • Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          ASEAN

                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Cases

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • ASEAN now has 12,893,187 total reported cases compared to 12,667,771 total reported cases last week. It has a total of 274,010 reported deaths compared to 270,661 reported deaths reported deaths last week.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Cases continue to drop significantly across the ASEAN region with the exception of Singapore, which has recently suffered from a renewed outbreak. ASEAN added its lowest number of new cases last week since the end of June.  The region added 225,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Indonesia: New cases continue to fall rapidly to extremely low levels. Indonesia recorded fewer than 6,000 new cases last week, the lowest since June 2020. Indonesia is now reporting 4,237,834 total cases and 143,120 total deaths compared to 4,232,099 total cases and 142,848 total deaths the previous week. Indonesia accounts for 52% of total deaths in ASEAN since the start of the pandemic.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Malaysia: Malaysia is preparing to shift into an endemic COVID-19 phase where it will not impose wide lockdowns again if cases rise. The number of new cases is at the lowest since late June. Those vaccinated may now dine in restaurants, reopen businesses, and visit salons. Total reported cases have grown from 2,361,529 to 2,407,382 over the past week. Total deaths have grown from 27,593 to 28,138 over that time.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Thailand: The number of new cases is holding steady. Total reported cases grew from 1,751,704 to 1,821,579 over the past week and reported deaths have increased from 18,029 to 18,559 over that time.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Philippines: Cases in the Philippines are moderating slightly and the country is starting to ease restrictions on some businesses. The Philippines is now reporting 2,740,111 total cases, up from 2,698,232 total cases the previous week. Total reported deaths have increased from 40,221 to 41,237 over that time.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Vietnam: Total reported cases of COVID-19 infection grew from 849,691 to 873,901 over the past week. Total reported deaths grew from 20,869 to 21,416 over that time. Authorities have permitted Ho Chi Minh City to carefully begin relaxing social distancing measures and to gradually reopen. The city will also license businesses and production facilities to resume operations provided that they meet safety requirements.  
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Singapore: The number of new cases in Singapore continues to grow and has more than doubled since early September. The country has paused the easing of social restrictions amid growing case numbers, despite an 80%+ vaccination rate. Total reported cases increased from 135,395 to 158,587 over the past week. The total number of deaths increased rose from 192 to 264 over that period.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Cambodia: Cambodia has experienced nearly three weeks of drastically lower case counts. Total reported cases increased from 115,875 to 117,352 over the past week. Total reported deaths grew from 2,584 to 2,704 over that period.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Laos: Laos reported a growth in total cases from 30,615 to 33,998 over the past week. It reported 49 total deaths, up from 36 last week.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Vaccinations

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Indonesia is now vaccinating 2 million people daily. The country authorized the Pfizer vaccine for emergency use on July 15. It will be given to Indonesians aged 12 years and up. It has been administering the Sinovac and AstraZeneca vaccines. Only 23.6% of the population is fully vaccinated.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Malaysia has increased its vaccination rate sharply in recent weeks. The government announced this week that civil servants may face disciplinary action or termination if they fail to complete the COVID-19 vaccination process. Malayia has fully vaccinated 71.9% of its population.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The Philippines began its immunization program after receiving its first batch of the COVID-19 vaccine (600,00 doses of Sinovac Biotech's CoronaVac, donated by China). It is due to receive another 25 million doses of CoronaVac this year. 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • However, there is little public support for the inoculation drive. Polls show that fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 22.2% of the population is fully vaccinated.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Singapore has one of the highest vaccination rates in the world. Currently, 84% of the population is fully vaccinated.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 36.2% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Thailand's Food and Drug Administration has approved Siam Bioscience as a manufacturing facility for the COVID-19 AstraZeneca vaccine. Thailand plans to export the vaccines to eight Southeast Asian countries.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Vietnam has fully vaccinated only 19.6% of its population to date. A Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Cambodia: According to the Cambodian authorities, the government has vaccinated over 98% of the target adult population of 10 million and 88% of the 12-17 age group of nearly two million, which is 72% of the country’s population. It just kicked off a campaign to vaccinate 6–11-year-olds. According to third party sources, 76.5% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Travel

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Singapore is allowing quarantine-free entry as of October 19 for fully vaccinated travelers from eight countries - Britain, Canada, Denmark, France, Italy, the Netherlands, Spain and the United States. The latest easing of restrictions expanded vaccinated air travel lanes open to Germany and Brunei that began last month. The U.S. government, however, has raised its COVID-19 travel advisory level for Singapore to the highest risk category and is asking visitors to avoid travel to the country.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Singapore and Hong Kong agreed to drop their travel bubble that had been scheduled to start May 26 due to an outbreak of cases in Singapore.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Indonesia: The quarantine period for international visitors has been cut from eight days to five days. Indonesia reopened international flights to Bali on October 14 for foreign visitors from countries with a positivity rate of less than 5% and who have been fully vaccinated against COVID-19.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Thailand approved a plan to end quarantine for vaccinated air travelers from the U.S., U.K, China, Germany, and Singapore starting November 1, in a bid to boost tourism ahead of the year-end holiday season. The tourists would be allowed to enter all regions in Thailand by air with no quarantine requirements.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Vietnam is planning to reopen key tourist destinations to fully vaccinated visitors from countries deemed low COVID-19 risk, including the U.S., in December, ahead of a full resumption targeted for June next year. Vietnam had recently announced it would reopen the resort island of Phu Quoc to vaccinated travelers beginning November. In December, the country plans to allow tourists from approved countries to visit the UNESCO World Heritage site Halong Bay and Hoi An, the highlands town of Dalat, and beach destination Nha Trang.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Philippines: Fully-vaccinated international travelers from countries classified as “green” (low-risk) will no longer be required to undergo facility-based quarantine if they provide a negative COVID-19 test result taken within 72 hours of their departure.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Staff Contact: Phil Agress (PAgress@AdvaMed.org)

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Europe

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Europe is trending overall positive in most of its larger countries, but Germany has seen a spike in new cases. The UK and Russia continue negative trends. The UK’s early COVID success has now deteriorated to where is consistently in the lead for new cases in the EU, by a wide margin. Increasing deaths per day in the UK are also concerning. Russia remains high as well, second worst in the EU, and its deaths per day are now consistently the worst reported figures in Europe.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The UK’s deaths per day and death rate (deaths per million) have also increased substantially. France and Italy’s improvements can be said to be a solid trend. Spain continues to look good as well. Experts believe the situation in Russia is 7 to 10 times worse in terms of reported fatalities due to significant under-reporting.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 6,036 (5,187); Spain 2,528 (1,931); Russia 34,073 (31,299); UK 49,139 (45,066); Italy 3,702 (2,668); Germany 18,687 (3,129); and Belgium 3,874 (3,667).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed France, Spain, Italy and Germany. Poland, Ukraine, Netherlands and Czech Republic round out the top ten.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • In terms of cases per million in Europe, Czech Republic is the 5th highest in Europe with 159,810. The UK has risen to 9thh, with 125,673. Netherlands is 12th with 119,850; Sweden is 13th with 114,446. Belgium, France and Spain are 14 – 16. (see numbers in chart below). Italy continues to be a winner in this group with just 78,313 cases per million (33rd).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The UK continues to be fourth worst in the world in terms of total cases, behind USA, India, and Brazil. Russia is fifth worst in the world in total cases.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • In terms of deaths per day, Russia remains very high compared to the rest of Europe, at 1,028. Russia’s consistent lead in deaths per day is in contrast to some of its other reported numbers, and is one factor experts cite to indicate the Russian numbers are being significantly under reported. Ukraine, Romania, UK, and Bulgaria comprise the remaining top 5 countries in Europe in deaths per day. Germany is now 6th in Europe in deaths per day.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          EU Chart for October 22 2021
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • In terms of deaths per million, Belgium is the 20th worst in the world with 2,213. Italy is 22nd, with 2,182. The UK is now 26th with 2,034. Other rankings in this category are Spain, 30th, and France 34th. (The US ranks 16th with 2,254 deaths per million).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The figures for new deaths per day (which tend to lag any increased infection rates) are as follows:  Russia 1028 (984); UK 179 (136); France 21 (23) Spain 31 (42); Italy 33 (37)); Germany 80 (82); Belgium 17 (18).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Vladimir Putin ordered workers across Russia to stay home to curb soaring COVID-19 fatalities as the daily death toll reached yet another record high. The non-working week will start on October 30 and run until November 7. Vladimir Putin also urged Russians to "be responsible" and get vaccinated. Authorities recorded 1,028 new COVID-19 deaths on Wednesday — the highest number observed since the beginning of the pandemic, and the second consecutive over the 1,000 threshold.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany continues to lead Europe in the number of vaccine doses administered with over 110 million doses, and 65.4% fully vaccinated. France is second in Europe with over 97 million doses administered and 67.4% fully vaccinated. The UK is third in Europe with almost 95 million doses, almost 67% fully vaccinated. Italy has administered almost 88 million doses and is just under 71% fully vaccinated. Spain is now over 71 million doses, almost 80% fully vaccinated. These numbers continue to increase.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • European Union guidance (nonbinding) has recommended a pause on all non-essential travel from the US as Covid-19 cases surge. The recommendation is nonbinding, meaning individual countries will be allowed to decide if they still wish to allow US visitors with proof of vaccination, negative tests, or quarantine.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The World Health Organization (WHO) has suspended the approval process for Russia's Sputnik V COVID vaccine. A regional WHO official said the manufacturing process of the jab had not met the necessary standards. Russia first applied for approval from the WHO for their vaccine in February but has not yet received an Emergency Use Listing (EUL).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Here is a link to a regularly updated article describing in detail the latest on EU travel restrictions: https://www.euronews.com/travel/2021/09/30/what-s-the-latest-on-european-travel-restrictions.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • All EU Member States are issuing and verifying a COVID Digital Certificate in a bid to boost tourism across the region this summer and beyond. The pass is proof that a person has:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Been vaccinated against COVID-19
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Tested negative for COVID-19
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Recovered from COVID-19
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The certificate is an EU-wide scheme for travel within the EU, and is available in digital or paper form, free of charge. https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en. EU citizens and their families, and legal EU residents, may use it. There are discussions underway to allow US and UK citizens to obtain and use the digital certificates.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Eastern European countries with below-average COVID vaccination rates are facing a surge in infections, data from the European Centre for Disease Prevention and Control (ECDC) show.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Ukraine has hit an all time COVID death rate based in part on reluctance to take vaccines. Ukrainian authorities reported 22,415 new confirmed infections and 546 deaths in the past 24 hours, the highest numbers since the start of the pandemic. Overall, the country has registered over 2.7 million infections and 62,389 deaths.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Morocco has banned all flights to UK, Germany and the Netherlands in response to increases in COVID cases in these countries.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The European Parliament has approved reforms to the EU's Blue Card Directive, designed to facilitate the employment of highly skilled workers from outside the bloc and help plug the gap where labour shortages exist in certain sectors. In what will be the only changes to EU migration law in recent years, MEPs voted 556 in favour of the revisions, 105 against and 31 abstained. Brussels wants to make it easier to attract highly skilled non-EU workers in sectors like healthcare and information and communication technologies (ICT) where significant shortfalls exist.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • A powerful autumn storm, named Aurore, blasted parts of western Europe on Thursday, knocking out power to a quarter of a million French homes and damaging buildings in at least four countries.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Train services were disrupted by uprooted trees littering tracks in France, Germany and the Netherlands and roofs were ripped off many buildings, including at part of the stadium used by the professional soccer club in the Belgian port city of Antwerp. 250,000 homes in France were left without power.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The Swiss Federal Council has indicated that there remain "substantial differences between Switzerland and the EU on key aspects of the agreement" and "the conditions are thus not met for the signing". The main stumbling blocks were freedom of movement, the level playing field and state aid rules.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The Swiss government argues that incorporating a 2004 EU law called Citizens' Rights Directive (CRD), which gives citizens from the European Economic Area (an area that includes the 27 EU countries, Iceland, Norway and Liechtenstein) the right of free movement and residence, could entail "higher social security costs" and "effectively constitute a paradigm shift in Switzerland's migration policy".
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Among the particular objections, Switzerland didn't want to incorporate the notion of permanent residence for EU citizens and access to social security for non-employed residents, such as job-seekers and students. Switzerland was not comfortable either with the concept of EU citizenship, although Brussels insisted that this aspect was not part of the deal.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • While discussions could be restarted at any time, this has not occurred. The Implications for the medical technology industry from the failure of the EU and Switzerland to reach an agreement on a mutual recognition agreement (MRA) include the following:  
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognized as valid in the EU.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorized representative was previously established in Switzerland, must designate an authorized representative established in the EU.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The following links may be of interest on the Swiss/EU MRA issue
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • EU Commission Announcement and Notice to Stakeholders on the failure to reach agreement-- mdcg_eu-switzerland_mra_en.pdf (europa.eu)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Swiss MedTech statement on the ‘downgrade’ of Switzerland to third country status: Swiss medtech downgraded to «third country» status | Swiss Medtech (swiss-medtech.ch).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Swiss Medtech summary of current state of play for devices moving into and out of Switzerland from the EU: pdf (swiss-medtech.ch).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Swiss schedule for Swiss importers to meet requirements to continue to place devices on the market in Switzerland (initial date is December 2021 for Class III);
                                                                                                                                                                                                                                                                                                                                                                                                                                                                              https://www.swiss-medtech.ch/sites/default/files/2021-04/20210401_Brancheninformation_MDR_eMepV_EN.pdf.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                • While the schedule says ‘not yet passed’ it became effective when the MRA was not renewed on May 26.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The EU currently allows all travelers with proof of vaccination into the EU, with some restrictions. Please check if you intend to travel as these situations can change rapidly. See link for full explanation: COVID-19: travel from third countries into the EU - Consilium (europa.eu). For incoming US travelers, EU countries in most instances now allow entry with proof of vaccination and/or a negative COVID-19 test result. Those showing proof of vaccination can enter in most instances without restrictions. Again, please check before you travel as situations can change.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • In the UK, global leaders are hoping to make positive steps toward combating climate change, as the UK gets ready to host COP26 in Glasgow from October 31 to November 12.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The summit hopes to fast-track the goals of the 2015 Paris Agreement and the UN Framework Convention on Climate Change and make significant strides forward. This includes achieving net zero emissions by 2050 and keeping global temperature rises to well below 2 degrees, preferable to 1.5 degrees Celsius.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Vaccine centres in England are to be open to children during school holidays.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The UK recorded 49,156 cases of covid-19 on Tuesday, the highest figure since March 2021. Reduced mask wearing and slow update of booster jabs are among the contributing factors.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Many scientists and public officials are calling on the British government to reimpose social restrictions and speed up booster vaccination as COVID infections rates in the UK continue to rise. The UK continues to be the leader in reported COVID cases in Europe. Last week, the Office for National Statistics estimated that one in 60 people in England had the virus, one of the highest levels seen in Britain during the pandemic.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • At the Global Investment Summit, the Prime Minister, Boris Johnson announced that the UK has secured £9.7 billion worth of trade and investment deals.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The Wall Street Journal has written an article on the impact of Brexit on the UK
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • GPs in England are threatening to take industrial action in protest at the government’s attempt to force them to see any patient who wants a face-to-face appointment. The British Medical Association’s GPs committee voted unanimously to reject the plan by the health secretary, Sajid Javid, that included “naming and shaming” surgeries that see too few patients in person. The doctors’ union said it had decided to hold a ballot on possible industrial action, which could result in family doctors at the 6,600 practices in England reducing the work they undertake.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • “GPs have been left with no alternative but to take this action. All efforts to persuade the government to introduce a workable plan that will bring immediate and longer-term improvement,“ said Dr Richard Vautrey, the chair of the BMA’s GPs committee.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Jeremy Hunt has called for the government to cut the time required between Covid vaccine doses to allow more booster jabs to be given as concern grows about the pace and organisations of the latest rollout. Speaking in the Commons, the former health secretary said: “If you look at the higher hospitalisations, cases and death rates [in the UK] compared to countries like France and Germany, the heart of it is not actually things like mask-wearing and Covid passports, it is their higher vaccine immunity.”
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • From Oct. 4, the UK is scrapping its ‘traffic light” system and will implement a two-tier system, with several dozen countries where COVID-19 is widespread classed as red, and the remainder as open.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • There are now just two lists, “red” and “rest of the world.” The UK’s red list has been reduced from 54 to only seven countries, Panama, Peru, Colombia, Dominican Republic, Haiti, and Venezuela.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Testing requirements will be eased for fully vaccinated arrivals to England from open countries, who will no longer have to take a COVID-19 test before traveling. Travelers will still need a test after landing, but from the end October an inexpensive lateral flow test will suffice, rather than a more sensitive - but pricier - PCR test.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Unvaccinated travelers will still have to self-isolate for 10 days, as well as taking coronavirus tests before and after their trips. In a boost to tourism, Britain said it will recognize vaccinations given in 17 more countries, including Australia, Canada, Japan and South Korea. It previously had recognized only shots given in the U.K., the U.S. and the European Union.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • A wide range of waiting times data has been released by the British government as part of its return to treatment initiative. The number of people waiting for over a year for treatment in England has reached its highest levels since 2008. The official and detailed data from NHS England on waiting times can be found here: https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • ABHI has conducted a comprehensive analysis of the re-start of elective procedures in each Trust and Health Board in the UK. The results can be found here: https://www.abhi.org.uk/membership/members-area/updates/2020/july/the-restart-of-planned-care/.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • If you are experiencing issues with exporting goods to the UK from the EU, or to the EU from the UK, please let us know immediately and advise the UK’s Border and Protocol Delivery Group at this e-mail address: enquiries@cabinetoffice.gov.uk.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany's Social Democrats (SPD), Greens and Liberals (FDP) announced on Thursday that they aim to finish coalition negotiations by the end of November and for a new government to come into force on December 6. The government would be helmed by Olaf Scholz, from the centre-left SPD.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany needs an extra 860 billion euros ($1 trillion) in investment if it is to achieve its 2030 climate target, a study conducted by the Federation of German Industries (BDI) with the Boston Consulting Group said on Thursday.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany is seeing high COVID19 incidence rates in children and teenagers. In eight areas of the country, the incidence rate crossed 500 per 100,000 people in 10 to 19-year-olds, according to the country's public health institute.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Daily COVID-19 infections in Germany rose significantly as 17,015 new cases were registered within one day, around 5,100 more than a week ago. Germany's seven-day incidence rate rose for the seventh day in a row and climbed to 80.4 cases per 100,000 inhabitants, the Robert Koch Institute (RKI) announced on Wednesday.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Daily COVID-19 infections in Germany rose significantly as 17,015 new cases were registered within one day, around 5,100 more than a week ago, according to the RKI, the federal agency and research institute responsible for disease control and prevention.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany is currently debating whether to extend the epidemic situation of national scope that is expiring at the end of November. After the outbreak of COVID-19, the state of emergency was first declared by the Bundestag in March 2020.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The Berlin Senate has voted in sweeping changes to its COVID rules, including new exceptions that will allow certain groups of unvaccinated people into venues that have opted for a 'vaccinated-only' rule. From Sunday, October 10th, people who are unable to get vaccinated for medical reasons will be allowed into so-called ‘2G’ venues, which are usually only open to those who are vaccinated or recovered.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany’s top economic institutes cut their joint forecast for 2021 growth in Europe’s largest economy to 2.4% on Thursday as supply bottlenecks hamper manufacturing, but they raised their prediction for next year.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • BVMed, the German MedTech association, expects the new German government to ensure that the core topics of the future-oriented medical technology industry are also reflected in the coalition agreement for the new legislative period. In the EU Medical Device Regulation (MDR), BVMed is lobbying for an "addendum" in order to establish solutions for the transition periods as well as existing and niche products. In order to strengthen Germany as a medical technology location, BVMed is proposing a "Medtech 2030 Initiative" to the new German government to coordinate measures between research, economic, labor, and health policy.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • According to a recent industry survey by BVMed, the MDR is already having a dramatic impact on the medtech market. More than 70 percent of BVMed member companies have discontinued individual medical devices or entire product lines due to the new MDR regulations. This is the result of a BVMed survey in which 88 member companies participated. More than 55 percent of the companies indicated that previous suppliers have already discontinued their business activities due to the MDR.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • If you are interested in the latest travel, testing and quarantine regulations for Germany, please see the following link: https://www.auswaertiges-amt.de/en/coronavirus/2317268.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Germany’s version of the EU-wide digital vaccine pass certificates was launched earlier this summer and these can be used as proof of vaccination. Although authorities have stressed that the pass with a QR code does make travel into the country and around the EU easier, it is not compulsory. For activities where some kind of immunity or proof of not having Covid is required, people can also show a paper copy of their vaccine certificate, recovery or test.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • To access the German version of the EU digital pass, people have to be fully vaccinated and can get it from most pharmacies, a doctor or the vaccination centre they got their jabs. People can also get it if they’ve recovered from Covid recently and therefore received one shot. People can use the paper certificate with a QR code on it, or scan it into an app.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • France's train operator SNCF has announced that several high-speed TGV trains in the west of the country will be cancelled this weekend, as rail workers strike. According to SNCF, 1 in 10 of the TGV Atlantique trains will be cancelled on Friday October 22nd, while one in three trains will not be running on Saturday and Sunday, AFP has reported.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Paris had 6,000 fewer primary and nursery school pupils this year than 2020 due to the COVID-19 pandemic and remote reworking, the mayor's office said.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The number of primary school pupils in the French capital has been falling steadily for a decade, but this year-on-year decrease of 5% — from 119,000 to 113,000 pupils — is two to three times greater than in previous years. The acceleration of this trend was already noticeable in 2020, after the first lockdown, with 3,700 fewer pupils. Patrick Bloche, deputy mayor in charge of education and families, attributed the fall to "the structural phenomenon of a drop in the birth rate", combined with "the COVID effect and the telecommuting effect" which allows Parisians "to keep their jobs without being forced to come to work every morning."
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • French president Emmanuel Macron unveiled a €30 billion plan to create the "high tech champions of the future". Dubbed "France 2030," the aim is to invest the funds over five years in sectors such as robotics, semiconductors, electric cars, and nuclear and renewable energy sources. "I want us to look ahead and see our weaknesses and strengths. We need the country to produce more," Macron said. The main focus will be on "decarbonising" French industry, building small reactors, and becoming leaders in green hydrogen, he added.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The plan will include €8 billion being spent on renewables, nuclear and hydrogen. But €4 billion will be spent on transport and mobility, with a target to produce 2 million electric and hybrid vehicles and the first low emission aircraft.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The French government has proposed to extend the country's COVID-19 state of emergency until July 31 next year. A draft law for the extension will be submitted to France's parliament for a vote, government spokesman Gabriel Attal said on Wednesday.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The current state of emergency bill in France - allowing the government to impose coronavirus-related restrictions - is set to expire on November 15.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Under current rules, citizens must use a COVID-19 health pass to access bars, restaurants, cinemas, theatres, and other venues. Speaking after a cabinet meeting, Attal told reporters that the extended state of emergency would help France deal with the health crisis.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • France’s introduction of the health pass has proved a success in dealing with threats posed by both high rates of vaccine skepticism and the Delta variant – while offering Emmanuel Macron a useful political card to play ahead of April’s presidential elections.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • The French government is extending the requirement for a health pass (pass sanitaire) to access most public spaces, possibly until July 31, 2022. The pass is required for anyone seeking to access long-distance transport or venues like restaurants, cafés, bars, cinemas, museums and sports stadiums.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • COVID screening tests in France will no longer be free for unvaccinated people starting on Oct. 15, according to the French authorities, a change that signals a new phase in the government’s strategy to quell coronavirus infections by encouraging people to get inoculated.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Unvaccinated people will now essentially have to pay to enter cafes, restaurants and theaters, because under a law enacted this summer, entering many indoor venues requires proof of being fully vaccinated, of a recent negative test or of a recent Covid-19 recovery. Tests will remain free for vaccinated people.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • France has made it mandatory to show the health pass – proving that you are vaccinated or have tested negative for Covid-19 – for access to public venues for more than 50 people since July 21. On August 9 the health pass requirements were extended to a range of new settings, including long-distance transport, restaurants and cafés – even France’s outdoor terraces.  
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Any of the following documents can be used as a health pass in France:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Proof of having completed a vaccination program (two doses of an EU-approved vaccine: Pfizer, Moderna, AstraZeneca or Johnson & Johnson)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • A negative PCR or antigen test taken within the last 48 hours
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • A Covid-19 recovery certificate that is less than six months old
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Anyone who enters an establishment without showing a valid pass can be fined €135 for a first offence.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Workers who work face to face with the public – for instance at cafés, cinemas or on public transport – are now required to show proof that they are fully vaccinated or have tested negative for the coronavirus in the last 72 hours. It will apply to some 1.8 million workers across the country. Members of the public are already required to carry health passes in order to access eateries and cultural or leisure venues.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Here is a link to policies related to entry and travel to France: https://www.diplomatie.gouv.fr/en/coming-to-france/coronavirus-advice-for-foreign-nationals-in-france/. (Also see EU section above for updated travel restriction information for any country in the EU, including France).
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Meanwhile, vaccinated tourists from France's "orange" list, which includes the UK, and most countries in Africa and Asia, will no longer need an essential reason to travel. These visitors will be exempt from quarantine but must still present a negative COVID-19 test. Here is a description of the categories and how they work:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Red
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Vaccinated: Inoculated visitors from red countries must provide results of a PCR or antigen test no more than 48 hours old, provide an essential reason for travel, self-isolate for seven days and take a mandatory antigen test upon arrival.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Unvaccinated: Those who haven’t gotten their shots have the same requirements as vaccinated travelers from red countries, but their isolation time is increased to 10 days, and their compliance is checked by authorities.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Orange
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Vaccinated: If you’re vaccinated and coming from an orange/amber country, you will need a PCR test no more than 72 hours prior to departure or an antigen test that’s no more than 48 hours old. Travelers can visit for any reason, such as tourism, provided they meet these other requirements.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Unvaccinated: Unvaccinated arrivals must observe the same testing requirements as vaccinated travelers under the orange/amber category, but they must also provide a “pressing reason” for travel (i.e., essential travel), take additional tests on arrival and self-isolate for seven days.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Green
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Vaccinated: There are no restrictions if you are vaccinated, and arriving from a country labeled green.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                            • Unvaccinated: If you are not vaccinated, you need a PCR or antigen test within 72hrs before departure.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • An online calculator has been launched which will allow people in France to see when they will be able to get the COVID vaccine. The tool was developed by the University of Vienna. https://www.omnicalculator.com/health/queue-pour-vaccin-france.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • If you are experiencing difficulties with exporting PPE from the EU, please let us know immediately. We have not seen any instances of this occurring since an initial incident was resolved.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • If you are having any issues moving medical supplies or medical products from the EU to the UK, or vice versa, please let us know immediately.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • AdvaMed's joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Resources: https://www.ecdc.europa.eu/en
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.europarl.europa.eu/news/en/headlines/priorities/eu-response-to-coronavirus;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/economy_en;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.abhi.org.uk/what-we-do/abhi-covid-19-hub/;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://ec.europa.eu/commission/presscorner/detail/en/IP_20_582;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.medtecheurope.org/covid-19-information-hub;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.medtecheurope.org/resource-library/european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • https://www.medtecheurope.org/resource-library/eu-materials-covid-19/.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Med Tech Europe White Paper on Companion Diagnostics under the IVDR: https://www.medtecheurope.org/resource-library/joint-medtech-europe-efpia-white-paper-on-companion-diagnostics-under-the-ivdr/
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Staff Contact:  Joe Gatewood (jgatewood@advamed.org)

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Latin America

                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Reuters COVID-19 Tracker – Latin America

                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          WHO/PAHO COVID-19 Information

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          LATAM Chart for October 22 2021

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          WEEKLY HIGHLIGHTS – COVID 19

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Prospectiva COVID-19 LATAM Weekly Updated for October 19, 2021

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Argentina: Government is negotiating an agreement to freeze prices of 1,650 food products and mass consumer goods for 90 days to contain inflation.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Bolivia: Government announced booster vaccines for those over 18 years old.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Brazil: Pandemic CPI will conclude work this week and vote on the final report.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Brazil: Covid inquiry accuses Bolsonaro of multiple crimes
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Colombia: President Duque visited Brazil amid a diplomatic visit to the country.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Chile: Joint commission approved the 2022 Health budget.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Ecuador: President Lasso declares a state of exception to tackle drug-related violence.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Mexico: Packaging of the Sputnik V vaccine will start in November.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Paraguay: Government announces a decrease in coronavirus cases while the number of vaccines in the country expands.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Peru: President Castillo decreed the General Government Policy 2021-2026.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Uruguay: Ministry of Health authorized the non-use of masks in open spaces and public roads.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          AFRICA

                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Reuters COVID-19 Tracker – Africa

                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          WHO COVID-19 – Africa Dashboard

                                                                                                                                                                                                                                                                                                                                                                                                                                                                          • Staff Contact: Steven Bipes (sbipes@advamed.org)

                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

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                                                                                                                                                                                                                                                                                                                                                                                                                                                                          AdvaMed, 701 Pennsylvania Ave, Suite 800, Washington, DC 20004, US, 202-783-8700