COVID-19 Outbreak: Weekly Global Report for Friday, October 8, 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 230 million cases. Deaths around the world have exceeded 4.8 million. The countries with the most reported cases continue to be the U.S. (44.1 million), India (33.9 million) and Brazil (21.5 million).
• U.S. cases exceeded 44.1 million with deaths increasing to 708,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Overview of China’s containment strategy: 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.
• Adolescent vaccinations: China has fully vaccinated 91% of students aged 12-17 against the coronavirus, state television reported on Wednesday, although authorities said schools need to be vigilant. China's two main vaccines have been approved for use in children from the age of three but authorities in charge of the vaccination rollout have yet to make children under 12 eligible. The education ministry said in a statement that schools should not be complacent and implement anti-COVID measures in a more efficient and targeted manner.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 108,661, an increase of 124 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.
• US will limit some Chinese passenger air carriers to 40% capacity: The US Transportation Department said it will limit some flights from Chinese carriers to 40% passenger capacity for four weeks after China imposed similar limits on four United Airlines flights. China told United on August 6 it was imposing sanctions after it alleged five passengers who traveled from San Francisco to Shanghai tested positive for COVID-19 on July 21. The US order said the department will limit over a four-week period each of four Chinese carriers to 40% capacity on a single China-US flight. United Airlines said it was "pleased to see this action by the (Transportation Department) in pursuit of fairness in this important market." The US government says China's "circuit breaker" policy violates the nations' air services agreement and "places undue culpability on carriers with respect to travelers that test positive for COVID-19 after their arrival in China." The limits come as many Chinese students are headed to the US for the start of fall classes.
• USTR unveils its China trade strategy: S. Trade Representative (USTR) Katherine Tai in public remarks this Monday said the United States and China would soon resume formal engagement on trade. In her first major speech on China trade policy, Tai said Washington and Beijing would revisit the Phase One trade deal – due to expire at the end of the year – and said the administration planned to press China on its purchase and structural reform commitments under the deal. USTR is also now expected to commence a "targeted" tariff exclusion process, focused initially on tariffs that most directly harm U.S. economic interests. The administration left open the possibility of further tariff exclusion processes, but the tariffs imposed by the Trump administration will remain in place for the time being.
• S.-China relations: The United States and China have reached an agreement in principle to hold a virtual summit before the end of the year, U.S. officials told reporters yesterday. The comments on a prospective virtual summit between U.S. President Joe Biden and Chinese President Xi Jinping came after a six-hour meeting between White House National Security Advisor Jake Sullivan and senior Chinese diplomat Yang Jiechi in Zurich. U.S. officials described the Zurich meeting as more meaningful and substantive than previous engagements with Chinese counterparts, and Chinese state media characterized the talks as "constructive, and conducive to enhancing mutual understanding." Officials have not yet suggested a date for the proposed virtual summit.
  Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics:  33,894,312 total cases, 244,198 active cases/449856 deaths/discharged 33,200,258 (John Hopkins and MoHFW) as compared to 33,716,451 total cases, 277,020 active cases/448,062 deaths/ discharged 33,014,898 (John Hopkins & MoHFW). 926,368,608 people have been vaccinated. The total vaccine doses crossed 92 crore (92,17,65,405) mark as India administered 59,48,360 vaccine doses in the last 24 hours. Out of the total doses administered in the last 24 hours, the maximum of over 46 crore doses have gone to the 18-44 age group followed by people from the 45-59 age group.
• Bharat Biotech said on Wednesday, October 06, it had submitted data from its COVID-19 vaccine trial in children aged 2 to 18 years to India's drug regulator, becoming the country's first company to have tested its shot in very young children. The South Asian country is turning its focus towards vaccinating children against the coronavirus, having already administered more than 920 million doses to adults among its population of nearly 1.4 billion.
• Prime Minister Narendra Modi will inaugurate 35 Pressure Swing Adsorption (PSA) Oxygen Plants established under PM CARES in an event to be held on October 07, at AIIMS Rishikesh. These are amongst the oxygen plants being set up across 35 states and Union Territories in an attempt to cover all districts of the country with commissioned PSA Oxygen Plants.
• A new report by Unicef shows that with restricted movement, school closures, increase in stress, anxiety, screen time and impact of digital technologies on young minds, there is wide concern about the impact of the Covid-19 pandemic on mental health. Around 14% of 15 to 24-year-olds in India are reporting often feeling depressed or having little interest in doing things.
• India's top court ordered state authorities to pay $672 (50,000 rupees) as compensation for each death caused by COVID-19, as a way to help families cope with the loss, according to its order reviewed by Reuters on Tuesday, October 05. In major cities including the capital New Delhi, experts said a large number of deaths were unreported as hospitals ran out of beds and oxygen supplies.
• India on Monday, October 04, restricted the export of syringes with or without needles which means their exports would now require a licence. The Directorate General of Foreign Trade (DGFT) said that the export policy for syringes with or without needles has been amended from “free” to “restricted”.
• Drug firm Cadila Healthcare on Tuesday, October 05, said it has received permission from the Indian drug regulator for conducting phase III trials for its two-dose Covid-19 vaccine ZyCoV-D. The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20.
• India will roll out this month the next phase of the World Health Organization's Solidarity trial - Solidarity PLUS - which aims to assess the effectiveness of new drugs in treating hospitalised Covid-19 patients. The India trial will study two drugs - Imatinib and Infliximab - which are already in use for other conditions. Imatinib is used for treating certain cancers while infliximab is used for diseases of the immune system, including Crohn's disease and rheumatoid arthritis.
• Health Minister Mansukh Mandaviya launched ICMR’s Drone Response and Outreach in North East (i-Drone) on October 04, as a part of ‘Antyodaya’, an initiative taken up by the government to make healthcare accessible to all. This delivery model will be used to provide life-saving medications and vaccines in otherwise inaccessible areas with tough terrains.
• In a bid to detect a Covid-19 outbreak in densely populated areas or a probable third wave, India will employ sewage surveillance programme which involves testing the sewage water reaching treatment plants for SARS-CoV-2 virus through the standard RT-PCR test. The department of biotechnology has drawn up a detailed sewage surveillance plan. This plan will be rolled out through the Indian SARS-CoV-2 Genomics Consortium (INSACOG), a network of 35 genome sequencing laboratories.
• India is entering another phase in the anti-Covid fight with daily aggregate second doses on the verge of outnumbering first doses nationally and already exceeding first doses in many states. Most states now have single-dosed at least 50% of adults; Himachal became the first state to cross 50% adult coverage on both doses. Cumulative vaccination doses have also crossed 90 crore, signalling a sort of a halfway mark in vaccinations given the total adult population of 94 crore.
• With talks underway between the central government and Zydus Cadila over the pricing of the Covid-19 vaccine ZyCov-D, the pharma company is learnt to have proposed a price of Rs 1,900 for its three-dose jab that can be given to those above 12 years of age.
• India’s drug regulator has given permission to Zydus Cadila for conducting Phase III trial on the two-dose regimen of its needle-free Covid-19 vaccine, ZyCoV-D. In a meeting held last month, the Subject Expert Committee (SEC), which advises the drug regulator-granted permission to the company for conducting Phase III trials on its Covid-19 vaccine.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,709,214 reported cases and 17,874 reported deaths compared to 1,701,897 reported cases and 17,666 reported deaths last week.
• Japan’s new case numbers are declining rapidly.  Serious cases have fallen by half over the last month, and hospitalizations have plummeted from a high of just over 230,000 in late August to around 31,000.
• 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 63.1% of the population now fully vaccinated.
• Japan plans to start administering third doses of COVID-19 vaccine to the elderly early next year.
• 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 2,425 new COVID cases, which is a slight decrease 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 325,804 total cases, 34,438 active with 2,544 deaths. Total cases per million population have remained low compared to most of the world but Korea is now above the 6K threshold with 6,348 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 48.
• 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.
• Korea continues to improve its vaccination numbers. A total of 66,876,735 doses have been administered. 55.61% of the population is now fully vaccinated, and another 22.1% have received their first dose.
• Over 30 percent of eligible recipients among teenagers aged 16 and 17 have made an appointment for a COVID-19 vaccination during the first two days of their reservation period, against earlier expectations that many parents would be hesitant to have their children vaccinated. The government began to receive the reservations for those born between 2004 and 2005, from 8 p.m., Tuesday.
• Health authorities remain on alert over further rises in new cases after another extended weekend ending Oct. 11 due to Hangeul Day, which celebrates the proclamation of the Korean alphabet.
• For another two weeks starting Monday, South Korea extended the toughest social distancing rules in the greater Seoul area, home to half of the population of 51 million.
• Since July 12, the greater Seoul area has been under the Level 4 measures, which include business restrictions and a ban on private gatherings of three or more people after 6 p.m.
• With the country's vaccinations gathering pace, the government is considering a gradual shift to a phase of "living with COVID-19" starting in November, under which COVID-19 is treated as an infectious respiratory disease, like seasonal influenza, with eased distancing being implemented.
• South Korea has halved the minimum amount of time until a second dose of AstraZeneca’s COVID-19 vaccine to four weeks from eight weeks, in the hopes of accelerating the drive for full vaccination coverage.
• South Korea says that proof of COVID-19 vaccination may soon be necessary for people to enjoy more freedoms as it journeys toward normal.
• The digitized vaccine passport would help minimize the disease circulating among the unvaccinated, the Ministry of Health and Welfare’s spokesperson Son Young-rae told reporters Tuesday, “which will determine the success of our ability to contain the pandemic as vaccination rates rise.” The pass, meant to first and foremost incentivize vaccinations, will be instrumental as Korea shifts to “living with COVID-19,” slated for later this fall, he said.
• However, the announcement has since drawn some protest online in the form of petitions posted on the presidential and parliamentary websites, although an Oct. 1 survey showed nearly strong support for the idea of having a pass. A former head of the Kora Centers for Disease Control has warned against a vaccine pass working as a tool to punish those who aren’t vaccinated.   
• 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 new 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.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

 

Cases

• ASEAN now has 12,401,505 total reported cases compared to 12,078,952 last week. It has a total of 266,709 reported deaths compared to 262,239 last week.
• ASEAN added its lowest number of new cases last week since the end of June.  The region added 322,553 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: New cases are at their lowest level since August 2020. Indonesia is now reporting 4,224,487 total cases and 142,494 total deaths compared to 4,213,414 total cases and 141,826 total deaths the previous week. Indonesia accounts for 53% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: The number of new cases has dropped significantly in the past month. Those vaccinated may now dine in restaurants, reopen businesses, and visit salons. Total reported cases have grown from 2,232,960 to 2,303,837 over the past week. Total deaths have grown from 26,143 to 26,981 over that time.
• Thailand: The number of new cases is trending downward. Total reported cases grew from 1,603,475 to 1,678,297 over the past week and reported deaths have increased from 16,727 to 17,418 over that time.
• Philippines: Cases in the Philippines are moderating slightly.  The Philippines is now reporting 2,632,881 total cases, up from 2,549,966 total cases, the previous week. Total reported deaths have increased from 38,294 to 38,937 over that time.
• Vietnam: Total reported cases of COVID-19 infection grew from 779,398 to 826,837 over the past week. Total reported deaths grew from 19,098 to 20,223 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: Singapore reported its highest single-day new COVID-19 case total on October 5, with 3,486 cases and nine deaths. The country has paused the easing of social restrictions amid growing case numbers, despite an 80%+ vaccination rate. Total reported cases increased from 94,043 to 113,381 over the past week. The total number of deaths increased rose from 93 to133 over that period.
• Cambodia: Total reported cases increased from 112,651 to 114,148 over the past week. Total reported deaths grew from 2,319 to 2,441 over that period.
• Laos: Laos logged 467 new COVID-19 cases last Saturday, including 383 local transmissions, the highest daily tally since the pandemic broke out in the country.  Laos reported a growth in total cases from 23,488 to 26,462 over the past week. It reported 23 total deaths, up from 17 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 19.9% of the population is fully vaccinated.
• Malaysia has increased its vaccination rate sharply in recent weeks. It announced that it will stop using China’s Sinovac vaccine in favor of the Pfizer shot. Mass vaccinations began on February 24 using the Pfizer vaccine and the government aims to vaccinate 80% of its 32 million population by next February. So far, it has fully vaccinated 64.6% of its population. One million doses of the Pfizer vaccine donated by the U.S. arrived in Malaysia on July 5.
• 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 22.4% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 83% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 30.9% 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’s health ministry said the country will have nearly 125 million doses of Covid-19 vaccines this year. The total includes 5 million doses from Moderna, 20 million doses of the Sputnik V vaccine, and 31 million doses of the vaccine developed by Pfizer. Vietnam will also acquire 30 million AstraZeneca doses and 38.9 million doses through the Covax initiative.  The U.S. shipped 2 million doses of the Moderna vaccine to Vietnam in July. The country has fully vaccinated only 12.6% of its population to date. Meanwhile, 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, somewhere between 66.6% and 73.8% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore debuted its vaccinated travel lane, opening up quarantine-free visits to travelers from Germany and Brunei (travelers from China, Taiwan, and Hong Kong were already eligible for quarantine-free travel).  Singapore will ease quarantine requirements for visitors from other selected countries, including the U.S. and U.K., from 14 days to 10 days.
• 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 country allow international flights to begin landing in Bali next week. Carriers from countries including China, Japan, New Zealand, South Korea, and the United Arab Emirates could resume flights to Bali on October 14, with eligible passengers including Indonesian citizens and foreigners with a work permit or business visa. They would be subject to eight days quarantine at a hotel at their own expense. 
• Thailand announced it will waive its mandatory quarantine requirement in Bangkok and nine regions beginning this November to vaccinated arrivals. Authorities will also reduce the quarantine time nationwide for visitors arriving in October. 
• Vietnam has temporarily restricted the entry of foreigners and overseas Vietnamese to focus on COVID-19 preventative measures. It has also increased the quarantine period for incoming travelers and close contacts of confirmed cases to 21 days.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

• Europe is trending overall positive in its larger countries. However, the UK is proving to be the exception. The UK’s early COVID success has now deteriorated to where it has more than triple the daily cases of Germany. The UK’s deaths 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. Russia continues to report high numbers, with experts believing there is significant under-reporting in Russia.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 4,946 (5,835); Spain 2,303 (2,761); Russia 25,133 (22,430); UK 39,851 (36,722); Italy 3,230 (3,212); Germany 11,604 (12,209); and Belgium 1,730 (1,874).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed by 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 5^th highest in Europe with 158,003. Netherlands is 10th with 117177; the UK is close behind at 11^th with 117,166; Sweden is 12^th with 113,676. Belgium, France and Spain are 14 – 16. (see numbers in chart below). Italy continues to be a winner in this group with just 77,703 cases per million (29^th).
• Russia's reported numbers on COVID remain problematic, continuing at over 7.6 million total cases, the second most in Europe, behind only UK.
• The UK is now fourth worst in the world in terms of total cases, behind USA, India, and Brazil and UK. 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 929. 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. Romania, Ukraine, UK and Bulgaria comprise the remaining top 5 countries in Europe in deaths per day.

• In terms of deaths per million, Belgium is the 18th worst in the world with 2,200. Italy is 20th, with 2,173. The UK is 24^th with 2,.009. Other rankings in this category are Spain, 29th, and France 33rd. (The US ranks 19^th with 2,182 deaths per million).
• The figures for new deaths per day, (which tend to lag any increased infection rates) are as follows:  Russia 929 (817); UK 143 (150); France 34 (42) Spain 57 (39); Italy 39 (63); Germany 80 (70); Belgium 8 (13).
• Germany continues to lead Europe in the number of vaccine doses administered with over 108 million doses administered, and 64.4% fully vaccinated. France is second in Europe with over 95.5 million doses administered and 66.3% fully vaccinated. The UK is third in Europe with over 94 million doses, approximately 66% fully vaccinated. Italy has administered almost 86 million doses and is almost 69% fully vaccinated. Spain is now over 70.5 million doses, almost 79% 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.
• The conclusions from the inaugural EU-US Trade and Technology Council (TTC) that occurred this week present a detailed and ambitious range of topics that the EU and the US vow to tackle together. The topics include microchips, robotics, forced labor, disinformation, counterfeit, algorithm transparency, cloud infrastructure, cyber-security and digitalization of SMEs, together with wider and more complex challenges, such as climate change, fair competition, regional peace and human rights.
• The European Union has urged member states to provide relief funds to consumers affected by rising gas and electricity prices. EU Energy Commissioner Kadri Simson said the bloc should provide "targeted support" to citizens and small businesses that were hardest hit. "Direct payments to those most at risk of energy poverty, cutting energy taxes, shifting charges to general taxation, are all measures that can be taken very swiftly under EU rules," Simson told the European Parliament on Wednesday.
• Spain’s COVID-19 rate is now at a ‘low risk level’ for the first time in 15 months. According to Spain’s Health Ministry, this means incidence of below 50 cases per 100,000 people. More than 75% of the Spanish population has now been fully vaccinated.
• 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.
• 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.
• European Commission Vice President Maros Šefčovič has said the EU plans to introduce new proposals for the Northern Ireland Protocol next week. The UK promises a ‘robust reaction’ if the EU starts a trade war over Northern Ireland. The EU counters that the UK should tone down its rhetoric in advance of next week’s talks.
• Private hospitals in the UK only treated an average of 8 covid-19 patients per day during the height of the pandemic, a report from the Centre for Health and Public Interest has revealed.
• Data from HSJ has shown that the NHS in England saw more covid-19 patients admitted to hospital during the summer months than in winter in 2021.
• Health unions have warned that the Health Secretary’s review of management in the NHS will be ‘very counterproductive’.  The acting chair of the General Medical Council has said the record high waiting lists for treatment are ‘deeply distressing’ for medical professionals.
• Prime Minister, Boris Johnson has delivered his first in person speech since the pandemic began on the last day of the Conservative Party Conference.
• Health Secretary, Sajid Javid has said medical device manufacturers should ensure their products work well for people of all ethnic backgrounds. The Health Secretary also made note that poor leadership could be to blame for some trusts being ‘in trouble all the time’.
• The Department of Health and Social Care is expected to announce that all front line staff are to be fully vaccinated, unless they are medically exempt.
• Data from Pantheon Economics’ UK monitor has shown that the UK could miss out on a global upswing in trade, due to post-Brexit regulatory issues.
• 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.
• Olaf Scholz has come a step closer to succeeding Angela Merkel as German chancellor after the Greens and liberals announced their readiness to enter formal coalition talks with his Social Democratic party (SPD).
• Scholz, who is also the serving finance minister, welcomed the agreement, triggered by an invitation from the Greens to the Free Democrats (FDP) for the three parties to start talks on Thursday. It makes the prospect of a centre-left government replacing the centre-right-led one which has been in power for 16 years more likely than at any time since the 26 September election.
• 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.
• Like almost all other German states, Berlin allows the owners of bars, restaurants, cinemas and various other indoor venues to operate a strict ‘2G’ entry policy that excludes people who don’t have any immunity from Covid. Along with the scrapping of free rapid tests on October 11th, the rule is intended to encourage people who are on the fence about getting vaccinated to get their jabs as soon as possible.
• That means that those who are unable to get vaccinated – such as young children and people with weak immunity – aren’t intended to be disadvantaged by the rules. But although senators made exceptions for unvaccinated minors, state health minister Dilek Kalayci (SPD) originally said that people who could not get vaccinated for medical reasons would still be unable to access ‘2G’ venues.
• German health experts say it is highly likely that more residents are vaccinated against Covid-19 than the official statistics indicate. The Robert Koch Institute (RKI) for disease control believes the real number of vaccinations carried out in Germany is up to five percentage points higher than the official reporting data shows. Five percentage points in the adult population corresponds roughly to 3.5 million people.
• The RKI believes up to 84 percent of over 18s in Germany have received at least one jab, and up to 80 percent are already fully vaccinated (up to Tuesday October 5th). The estimate is based on citizen surveys and reporting data.
• 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.
• In the ongoing post-Brexit dispute over fishing around the Jersey islands, the EU could hit Britain and Jersey’s energy supply over the UK’s failure to provide sufficient fishing licences to French fishers, France’s EU affairs minister has said.
• Clément Beaune, who is a close ally of the French president, Emmanuel Macron, said action would be decided on within days and discussions were already in motion. France’s prime minister, Jean Castex, echoed the sentiment, telling the national assembly that the EU had to be firmer with the UK. “The [European] Commission is moving, it must do more”, he said.
• The high-profile falling-out between the U.S. and France over the AUKUS agreement shouldn't "cause a rift" in the transatlantic alliance, the head of NATO said on Thursday.
• 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 famed outdoor terraces. This week’s mandate adds to the number of people who are required to carry the health pass in order to engage in various public activities.
• 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.
• In France, vaccinated people traveling from the EU and countries on France's "green" list, including South Korea, Japan, and Israel, can avoid COVID-19 testing requirements altogether. Unvaccinated travelers from these regions can enter with a negative test.
• 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