COVID-19 Outbreak: Weekly Global Report for Friday, November 19, 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 256 million. Deaths around the world have exceeded just over 5.1 million. Around 7.6 billion vaccines have been administered.
• U.S. cases exceeded 47.5 million with deaths increasing to 768,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: China is facing several new—albeit small—COVID-19 flare-ups that have spread to more than half of its provinces and municipalities, mostly in Northern China. Health officials say this wave is more "complicated" than the Nanjing airport coronavirus cluster spread that began in the summer, as there are multiple sources—many of which remain unknown—and the onset of winter which makes it easier for the virus to propagate. China is pursuing a zero-tolerance approach to these flare-ups: aggressive contact tracing and testing couples with partial lockdowns. More recently, there has been a push for boosters and the vaccination of children aged 3-11. The PRC government remain defensive against external and internal criticism of its zero-tolerance approach.
• Flare up in Northern port city: China has linked the coronavirus outbreak in Dalian, a major port city that has become the country’s latest hotspot, to cold-chain foods and authorities are stepping up scrutiny of imported products. The northeastern city is battling the biggest flareup in the country’s current virus wave, placing tens of thousands of university students under lockdown. The first identified case was linked to a cold-storage facility and several other infections were reported among employees in the cold-chain industry, local media said, adding that this is the third cold-chain related outbreak in the city. Dalian is an important cold-chain storage and transportation base, handling about 70% of China’s total imported cold-chain products. Cities across the country have stepped up investigation of cold-chain foods from Dalian in recent days. Shopping centers and food companies were asked to suspend sales and conduct nucleic acid tests on these products immediately.
• Mixing of booster shots to be permitted: China will allow the mixing of Covid-19 vaccines for its booster shots drive, with an “an optimal immunization combination” to be introduced very soon, a senior health official said. The new strategy will help to reduce severe illness and deaths from Covid-19 and win the country time to adjust its strict pandemic controls, National Health Commission official Zheng Zhongwei told state broadcaster CCTV on Monday. China has thus far prohibited the mixing and matching of vaccines, or sequential immunization, despite studies around the world on its effectiveness and some countries recommending such a regimen. CanSino is likely to benefit from the possible strategy change on booster doses, as its single-dose shot is the only approved vaccine to use a different technology from the inactivated varieties. Zheng’s remarks also offer hope for possible regulatory approval for an mRNA vaccine jointly developed by Germany’s BioNTech and China’s Fosun Pharma.
• Approval of COVID therapeutics: China is on track to approve its first drug for Covid-19, possibly within weeks. This comes as Chinese scientists race to find an effective treatment for the disease, crucial for the country with a zero-tolerance strategy before it can consider reopening its borders, even as vaccination remains a priority. Conditional approval may be given to a neutralising monoclonal antibody treatment co-developed by Chinese and US researchers by the end of the year, according to an official publication of the Ministry of Science and Technology. Brii Biosciences, a multinational pharmaceutical firm based in the US and China, developed the therapy with scientists at Tsinghua University and the Third People’s Hospital of Shenzhen. Interim data from an international trial showed the medication could reduce the risk of hospitalisation and death for Covid-19 patients by 78 per cent. If approved, the company would first target the China and US markets, while it would also prioritise countries where it has held clinical trials, including Brazil, South Africa, Mexico, Argentina and the Philippines. The interim results also showed that the drug was effective against Covid-19 variants such as Delta.
• Entry rules from Hong Kong eased: Travelers from Hong Kong will be allowed to enter mainland China without having to undergo COVID-19 quarantine starting from the first week of December, earlier than expected, although the initial quota will be limited to only a few hundred per day. The first phase of the much-anticipated border reopening revealed on Thursday is the result of weeks of negotiations between the two sides and is likely to coincide with China’s Olympic medalists visiting the city.
• Vaccination program for children aged 3-11: China has launched a nationwide COVID-19 vaccination campaign for minors aged three to 11, in a bid to increase mass vaccine coverage and accelerate the building of herd immunity, as a new rebound in cases hits almost one-third of the country and becomes one of the worst since the initial outbreak in 2020. Furthermore, local city and provincial-level governments in at least five provinces issued notices in recent days announcing that children aged from three to 11 will be required to get vaccinated. China in June had approved two vaccines – Sinopharm’s from the Beijing Institute of Biological Products and Sinovac – for children aged three to 17, but it has only been vaccinating those aged 12 and older.
• 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 110,901, an increase of 443 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.
• New progress in China’s own mRNA vaccine: Chinese regulators took a step toward clearing the use of mRNA vaccines as booster shots to protect against Covid-19. An mRNA vaccine jointly developed by Chinese biotech company Walvax Biotechnology Co. and Suzhou Abogen Biosciences won administrative approval to conduct a Phase 3b clinical trial of the shot. Approval was granted to assess the efficacy and safety of using the mRNA vaccine as booster shots for adults inoculated with inactivated-virus vaccines, according to public records on the Ministry of Science and Technology website. 
• 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.
• COVID’s origins: U.S. intelligence agencies said last Friday they may never be able to identify the origins of COVID-19, as they released a new, more detailed version of their review of whether the coronavirus came from animal-to-human transmission or leaked from a lab. The Office of the U.S. Director of National Intelligence (ODNI) said in a declassified report that a natural origin and a lab leak are both plausible hypotheses for how SARS-COV-2 first infected humans. But it said analysts disagree on which is more likely or whether any definitive assessment can be made at all. The report issued on Friday is an update of a 90-day review that President Joe Biden's administration released in August, amid intense political infighting over how much to blame China for the effects of the global pandemic rather than governments that may not have moved quickly enough to protect citizens.
• Energy crunch: Electricity supplies in China have largely stabilised after the recent power crunch but winter will still be a challenge and localised shortages are still a possibility, the state electric corporation has warned. It said high power consumption, the demand for heating in the north with the onset of winter and a shortage of water for hydropower production were among the challenges it faced. “During this winter and spring next year, there will be ‘tight overall balancing and regional shortages’ in the grid, and the grand challenge to supply electricity will continue,” the State Grid Corporation said in a statement. The country is currently facing its worst power crunch in decades after the electricity supply was hit by coal shortages and aggressive energy consumption curbs to meet emissions targets. These shortages also pushed up the price of coal, but because power companies are only allowed to pass some of the costs on to consumers, they resorted to cutting their output to remain profitable.
• China’s economy: Retail sales growth in China bounced back in October, data released on Monday showed, while industrial production also beat expectations. Retail sales, a key measurement of consumer spending in the world’s most populous nation, grew by 4.9 per cent in October compared with a year earlier, and up from the 4.4 per cent increase in September. Industrial production, a gauge of activity in the manufacturing, mining and utilities sectors, grew by 3.5 per cent in October from a year earlier after a 3.1 per cent gain in September, according to the National Bureau of Statistics (NBS). The figure was also above the median forecast in the Bloomberg survey for a rise of 3 per cent.
• S.-China relations: On Nov. 15, President Joe Biden and President Xi Jinping held a first virtual meeting, following direct phone calls between the leaders in February and September. The priority was to have a frank discussion and, as President Biden noted, the value of “common sense guardrails” to manage competition in the relationship. The meeting covered a broad range of specific topics, including trade, climate change, energy and foreign policy, with a broadly warmer tone than in the past. The dialogue resulted in few immediate outcomes, with a Chinese commitment to update its “fast track” procedures to approve business travel and broader joint references to hold additional dialogues on unspecified priority areas. See U.S. readouts here and here; and a Chinese readout here. Trade and economic issues were raised, but largely within the bounds of bilateral discussions already being led by U.S. Trade Representative Katherine Tai with Chinese Vice Premier Liu He.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics:  34,478,517  total cases, 128,762 active cases/464,623 deaths/discharged 33,885,132 (John Hopkins and MoHFW) as compared to 34,401,670 total cases, 138,556 active cases/462,189 deaths/discharged 33,800,925 (John Hopkins and MoHFW). 1,144,632,851 people have been vaccinated.
• Urging people to come forward for the second dose, Union Health Minister assured that there is no shortage of vaccine doses in the country. Informing that the number of fully vaccinated individuals in the country has surpassed the partially vaccinated eligible population for the first time  in the country, Mandaviya noted that this feat has been made possible by people’s faith and confidence in the government, and the ongoing ‘Har Ghar Dastak’ campaign which has seen tremendous response from various parts of the country.
• The subject expert committee (SEC) under India’s drug regulator is expected to review the EUA applications of drug companies seeking approval for Merck’s antiviral pill Molnupiravir, on Thursday. Several companies including Natco, Dr. Reddy’s , Cipla, Sun Pharma, Hetero and BDR Pharma are awaiting regulatory nod to introduce the generic antiviral in India, which is expected to be available at affordable prices. The drug, being considered a potential game changer in treating mild Covid-19 infections, could become the first oral anti-viral pill to be launched here in India.
• Inoculation of children against Covid-19 should be started at the earliest, feel health experts, especially now that the schools have reopened for in-person classes. One vaccine has already received Emergency Use Authorization (EUA) and another is awaiting the approval, but the government is yet to announce the roll-out of an inoculation drive for children. But with schoold reopening their campuses in phases, doctors as well as parents want vaccine protection for the paediatric population.
• The Association of Healthcare Providers (India) or APHI, a body that represents small and medium hospitals has urged the government to consider allowing the eligible population to get a booster dose on a voluntary basis. APHI is of the view that the stock of Covid-19 vaccines available with the private sector may be effectively utilized for this purpose. The APHI Director General Girdhar Gyani said that they have proposed to the government  to utilize the surplus vaccine for booster shots.
• Myanmar, Bangladesh, Nepal and Iran have been the first recipients  of resumed vaccine exports from India almost eight months after they were halted due to rising cases of Covid-19.  The government had stopped vaccines exports as the brutal second wave hit India in April-May this year. It’s only after India had administered close to a billion doses of vaccines did the  government relax restrictions. Commercial contracts were also kept in abeyance as production was procured for domestic use.
• With focus shifting to the treatment of Covid-19 through oral pills, domestic companies, including Cipla, Dr. Reddy’s Sun Pharma and BDR Pharma, are eyeing antivirals- including Pfizer’s new drug, Paxlovid. Most of these antivirals are expected to be manufactured in the country and will be available  at a fraction of the global prices. With coronavirus heading to the epidemic stage in some countries, the oral pills are expected to get a huge market.
• Eight weeks after the government imposed a hold on all major exports of Covid-19 vaccines, Pune based Serum Institute of India(SII) is likely to start supplying Covishield this week to the Covax international vaccine facility. The company is expected to supply 25 million doses to the Covax facility led by the Gavi vaccine alliance, World Health Organization and the Coalition for Epidemic Preparedness Innovations till the end of December, the people said.
• Union Health Minister Mansukh Mandaviya cycled his way to inaugurate the health pavilion at the India International Trade Fair (IITF) 2021 organized in the National capital to generate awareness and promote a healthy active lifestyle in view of the rising burden of NCDs in the country. He informed that the purpose of health pavilion is to create awareness regarding Non-Communicable Diseases (NCDs) and importance of preventive health.
• Soon, you may have your Covid vaccination status printed on your flight boarding pass, making your travel hassle free and smooth. The government is working on providing APIs for vaccination status at the time of web check-in with a mobile number. It is also exploring possibilities of having the vaccination status printed on all boarding passes-including the ones issued on spot. An application programming interface (API) is needed to bring applications together in order to perform a designed function built around sharing data and executing pre-defined processes.
• India on Monday, November 15 allowed fully vaccinated (with approved jabs) arrivals from 99 countries- including US, UK, UAE, Qatar, France and Germany- to travel quarantine-free in the country. The decision comes as the country allowed foreign tourists on non-charters. India had suspended tourist visas last March and resumed them from October 15 by allowing them in on charters. Apar from a Covid negative report within 72 hours of departure to India, travellers from these 99 countries (called Category A) will also need to upload their fully vaccinated certificate on the Air Suvidha Portal.
• Bharat Biotech’s Covaxin has immunological memory to Covid and its variants of concern for at least up to six months, National Institute of Immunology (NII) director in-charge Pushkar Sharma said on Monday, November 15, It means the vaccine can provide protection from the virus for a minimum of that duration. Immunological memory is the ability of the immune system to respond more rapidly and effectively to pathogens that have been encountered previously.
• Like street vendors calling attention to their wares, two women health workers from Assam were recently seen in a viral video carrying a blue box strapped to a bamboo pole and shouting. “First dose. Second dose. Corona vaccine. Anybody “left out? The act may have amused many, but seen in the context of India’s imposing inoculation target and the anxiety of the health establishment over unused vaccine going past their expiry date, there is suspicion this goes beyond comic relief.
• Nearly 80%ofo India’s eligible adult population has been administered the first dose of Covid-19 vaccine while 38%has been fully vaccinated, the Union Health Ministry said on Friday, November 12. During an interactive webinar on the ongoing “HarGhar Dastak” campaign, Additional Secretary in the Union Health Ministry Manohar Agnani said that under the campaign, by November 30, the government wants the first dose coverage of Covid-19 vaccination in the country to reach at least 90 per cent.
• The Supreme Court on Friday, November 12 asked the Centre to sort out the dispute over non-inclusion of doctors and health workers who have lst their lives battling Covid-19 in private clinics, dispensaries and non-recognized hospitals in the Centre’s insurance scheme promising Rs. 50 Lakh to their families. A Bench of Justices DY Chandrachud and AS Bopanna said, “ You must sort it out.
• Zydus Cadila’s Covid-19 vaccine ZyCod-D, which has been cleared by India’s Drug regulator for those aged 12 years and above, will only be administered to adults as of now under the government’s national anti-coronavirus vaccination programme, sources said on Sunday, November 14. The health ministry has given a go ahead to initiate the preparatory work for the inclusion of indigenously developed, needle free jab in the national Covid inoculation drive and it can be introduced in the programme anytime soon.
• Children under five years of age are exempted from both pre-and post-arrival testing upon arrival in India, according to the Ministry of Health & Family Welfare. However, if they are found to be symptomatic for Covid-19 on arrival or during the home quarantine period, they shall undergo testing and treatment as per protocols. “Children under 5 years of age are exempted from both pre-and post-arrival testing.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,726,421 total reported cases and 18,354 total reported deaths compared to 1,725,302 total reported cases and 18,335 total reported deaths last week.
• Japan has seen a remarkable drop in new cases. Daily cases nationwide have averaged between 100-200 for the past few days, the lowest since June 2020. New daily cases had reached a peak of around 25,000 in August.
• The Japanese government lifted the attendance cap of 10,000 at large-scale events such as concerts and sports events. The 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 76.2% 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

• Korea added 3,292 on Thursday to reach 406,065. 3,272 of the total cases 3,292 (99.39%) were locally transmitted while 20 (0.61%) originated overseas. The country is now experiencing a significant trend in spiking COVID rates but still remains at a lower rate than many other countries. However, the case numbers on Thursday hit an all-time high for any period since the start of the pandemic amid eased social distancing rules, putting health authorities on alert over further upticks.
• 42,110,652 first doses (82.0% of the population) and 40,312,386 second doses (78.5% of the population) of the COVID-19 vaccine have been administered in Korea. 78.5% are now fully vaccinated.
• Please note the following COVID-19-related policies that may be of interest to those traveling to and from Korea, with links:
  • Starting November 1, Korea has entered Phase One of its “Living with COVID-19 Strategy “
  • Some of the highlights are as follows:
    • ​Phased One Starting November 1, 2021
    • ​Maximum 10 people could gather for private meetings without an​y time restriction.
    • ​Allow up to 99 attendees at events (maximum 499 if all attendees are fully vaccinated or present negative PCR test results).
    • ​ Lift restrictions on business hours for "multi-purpose facilities," except entertainment facilities which will be allowed to operate until midnight.
    • ​ Introduce "Vaccine Pass" system, requiring people to show a full COVID-19 vaccination certificate (via "COOV" app or paper-based) or a negative PCR test result to enter multi-purpose facilities.
    • ​Phase Two Starting in mid-December, 2021
    • Under "Vaccine Pass" system, large-scale concerts and street rallies will be allowed.
    • Lift restrictions on business hours for entertainment facilities.
    • ​Phase Three Starting in Late January, 2022
    • ​ Lift restrictions on private gatherings.
• Starting November 8, the US has implemented a new international air travel policy requiring a proof of full vaccination and a negative COVID-19 test result to enter the U.S.
• South Korea and Japan clashed with each other during a U.S.-hosted trilateral vice-ministerial meeting, as the vice ministers from Seoul and Tokyo did not participate in a scheduled joint press conference due to the latter's insistence on Japan's territorial claims on South Korea's easternmost islets of Dokdo.
• Korea's role in the global semiconductor supply chain is expected to be a top issue in talks between Minister of Trade Yeo Han-koo and U.S. Trade Representative (USTR) Katherine Tai slated for Friday. Tai arrived in Seoul, Thursday, as part of a trip to U.S. allies in Asia. Prior to her visit to Seoul, the U.S. trade chief agreed in Tokyo to set up a forum to boost the two countries' trade partnership. This is the first time in a decade for the chief U.S. trade negotiator to officially visit Seoul, since 2011 when discussions for the Korea-U.S. FTA (KORUS FTA) were taking place.
• Tai is expected to ask Korea to confirm its commitment for an increased trade alliance amid the ongoing dispute between the U.S. and China regarding supply chain issues, and ask Seoul to play a key role in ensuring stability in the global semiconductors supply chain, given Samsung Electronics and SK hynix's weight in the chip industry.
• U.S. Secretary of Commerce Gina Raimondo and her South Korean counterpart, Moon Sung-wook, have agreed to cooperate on enhancing their countries' supply chain resiliency, the Department of Commerce said. The leaders also agreed to expand the countries' commercial forum to jointly tackle other issues, such as setting global standards for key industrial sectors, according to a press release released last Tuesday.
• "Today, we reaffirm our commitment to collaborate through the U.S. ― Korea Commercial Forum. We celebrate our early progress and look forward to holding discussions on semiconductor supply chains with U.S. and Korean firms in the future as the first step in this engagement," Raimondo said after her Tuesday meeting with Moon, minister of trade, industry and energy. "Our teams also agreed to share information on reducing the risk of supply and demand imbalance of chips capacity, including technology and investment priorities, and work together to coordinate our efforts to resolve the current supply chain crisis and position the supply chain to minimize future bottlenecks," she added, according to the press release. Moon arrived here Tuesday on a three-day visit that also included a meeting with Energy Secretary Jennifer Granholm.
• The Moon-Raimondo meeting came one day after some 200 global chipmakers and other businesses, including South Korea's Samsung Electronics Co. and SK hynix Inc., were asked to submit information on their business to the U.S. to resolve the ongoing semiconductor shortage. Raimondo said the U.S. and South Korea will continue to work through their joint commerce forum to tackle supply chain issues and others.
• 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 13,698,735 total reported cases compared to 13,502,173 total reported cases last week. It has a total of 286,385 total reported deaths compared to 283,135 total reported deaths last week.
• ASEAN continues to experience a relatively low level of new cases, with the exception of Vietnam and Laos. The region added just under 200,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: New cases and fatalities continue to fall to extremely low levels. New COVID-19 cases in Indonesia dropped 31% over the past week, with fatalities declining to an average of 15 per day. Indonesia is now reporting 4,252,345 total cases and 143,709 total deaths compared to 4,249,758 total cases and 143,608 total deaths the previous week. Indonesia accounts for 50% 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. Those vaccinated may now dine in restaurants, reopen businesses, and visit salons. Total reported cases have grown from 2,522,498 to 2,563,153 over the past week. Total deaths have grown from 29,486 to 29,837 over that time.
• Thailand: The number of new cases is declining slightly. Total reported cases grew from 1,996,969 to 2,044,125 over the past week and reported deaths have increased from 19,883 to 20,252 over that time.
• Philippines: New case numbers in the Philippines are moderating and the country is starting to ease restrictions on some businesses.  The Philippines is now reporting 2,821,753 total cases, up from 2,811,248 total cases the previous week. Total reported deaths have increased from 44,866 to 46,422 over that time.
• Vietnam: Total reported cases grew from 1,000,897 to 1,065,469 over the past week. Total reported deaths grew from 22,849 to 23,476 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 remains relatively high and has grown 2 ½ times since October 1. Total reported cases increased from 227,681 to 244,815 over the past week. The total number of deaths increased rose from 540 to 619 over that period.
• Cambodia: Cambodia has experienced nearly three weeks of drastically lower case counts. Total reported cases increased from 119,358 to 119,741 over the past week. Total reported deaths grew from 2,850 to 2,887 over that period.
• Laos: Laos reported a growth in total cases from 50,031 to 57,397 over the past week. It reported 112 total deaths, up from 91 last week.

Vaccinations

• Indonesia 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 31.5% of the population is fully vaccinated. The country announced its intention to achieve a 100% vaccination rate for those aged 12 and above by year’s end.
• 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 76.9% 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 36.7% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 86% of the population is fully vaccinated. The country announced that it will cease covering the medical costs of patients who are eligible to get vaccinated but choose not to. Costs for partly vaccinated patients will be covered through the end of the year to allow time for second shots.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 53.8% 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 37.8% 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, 79.1% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore is expanding quarantine-free travel to visitors from Australia and Switzerland, beginning November 8. The Vaccinated Travel Lane (VTL) is now available to fully vaccinated visitors from nearly a dozen countries, including Brunei, Britain, Canada, Denmark, France, Germany, Italy, the Netherlands, Spain, and the United States. 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 Malaysia announced that they will launch a vaccinated travel lane (VTL) between Changi Airport and Kuala Lumpur International Airport on Nov 29.
• 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 foreign ministers of Indonesia and Singapore to continue discussions on a bilateral vaccinated travel lane (VTL), a day after Singapore announced that vaccinated travelers from Indonesia could travel quarantine-free to Singapore beginning November 29. Indonesia remains closed to general travel from Singapore. Sponsored business visas are once again available, though a five-day quarantine in a designated hotel is still required.    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.
• Malaysia hopes to reopen to international tourists in November, starting with the resort of Langkawi. Singapore and Malaysia announced that they will launch a vaccinated travel lane (VTL) between Changi Airport and Kuala Lumpur International Airport on Nov 29.
• 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.
• Cambodia: Anyone who has received a second COVID-19 vaccine shot of any sort can now travel anywhere in Cambodia. Travelers will have to show their negative test 72 hours before travel and have two vaccine doses. Cambodia has lifted all quarantine requirements for vaccinated inbound travelers entering Cambodia by air, waterway, or land border checkpoints. Travelers will be required to take a rapid antigen test on arrival. Those who are unvaccinated will be quarantined for 14 days.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

• Negative COVID trends continue in Europe, with spiking and persistent numbers. Germany continues to have very high numbers and dramatic spiking attributable to relaxed social distancing and a stubborn but surprisingly large portion of its population who refuse to be vaccinated. The UK and Russia are also continuing negative trends, although the hospitalization rate in the UK appears to be lower than that in Germany. The UK’s early COVID success has now deteriorated to be consistently in the top range for new cases in Europe. Russia’s COVID numbers remains high as well, but seem to hover around a specific range. Russia has the second worst numbers in Europe, and its deaths per day are consistently the worst reported figures in Europe.
• Germany’s new cases continue to be highest in Europe, followed by the UK and Russia. Numbers are persistent in most countries in the EU, with many seeing increases. Experts believe the situation in Russia is 7 to 10 times worse in terms of 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 20,294 (11,883); Spain 6,667 (3,594); Russia 36,626 (38,058); UK 38,314 (39,326); Italy 10,165 (7,891); Germany 60,753 (45,416); and Belgium 12,388 (10,132).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK has the most COVID cases, followed by Russia, France, Germany (now 4^th), Spain and Italy. Ukraine, Poland, 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 179,789. The UK is 9^th highest with 141,496. Netherlands is 11^th with 137,035; Belgium, is 15^th; Sweden is 17^th and France is 18^th. Italy continues to be a winner in this group with just 80,930 cases per million (37th).
• 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 million, Belgium is the 21 worst in the world with 2,268. Italy is 25th, with 2,204. The UK is 29^th with 2,097. Other rankings in this category are Spain, 33rd, and France 38th. (The US ranks 20^th with 2,32 deaths per million).
• The figures for deaths per day (which tend to lag any increased infection rates) are as follows:  Russia 1,247 (1,239); UK 201 (214); France 50 (33); Spain 30 (33); Italy 72 (62); Germany 248 (244); Belgium 41 (30).
• Germany continues to lead Europe in the number of vaccine doses administered with over 116 million doses and 67.2% fully vaccinated. The UK is second in Europe in vaccine doses administered with over 110 million administered and 5% fully vaccinated. Russia has provided over 116 million doses, but has just under 36% fully vaccinated. France is at over 101 million doses administered and almost 69% fully vaccinated. Italy has administered over 92 million doses and is 72.8% fully vaccinated. Spain is now over 74 million doses and over 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 reported on Tuesday (November 16) that coronavirus deaths in Europe rose 5% in the previous week, making it the only region in the world where COVID-19 deaths increased.
• Italy has tightened its green pass rules in an attempt to slow down the infection rate before the December holiday season. According to the new set of restrictions, trains can now be stopped in case any of the passengers appear to have covid symptoms, while all taxi drivers are required to have a valid green pass, with the limit of two passengers seated in the back also becoming mandatory.
• Italy has already updated its international travel rules in late October. The five-grade system can effectively ban entry for anything except work and family reasons depending on the tier of the country of origin, but most European countries are still in the middle “C” tier. However, this might change by December 15, when the rules are supposed to be updated.
• Italy’s authorities reported 44 covid-related deaths on Monday (November 15), an uptick from 36 the day before. The number of infections went down, from 7,569 on Sunday to 5,144. Italy still has the second-highest overall death toll on the continent, placing it right after the UK.
• Italy is expanding the number of people eligible for a booster vaccine as the 4th wave in the COVID-19 pandemic grips Europe. Health Minister Roberto Speranza told lawmakers in the Chamber of Deputies on Wednesday that anyone 40 years or older can get the booster shot starting Dec. 1. Italy has already offered boosters to those 60 years old and older who received their last vaccine dose at least six months earlier. The country hasn’t been hit as hard in the latest wave of the coronavirus pandemic as some northern countries including Austria and Germany as well as several nations in eastern Europe. Italian authorities are scrambling to keep it that way. Experts credit in large part Italy’s vaccination rate. Nearly 84% of those 12 and older and eligible for the shots are fully vaccinated.
• There is "serious intent" in the EU to solve post-Brexit difficulties over the Northern Ireland border, Irish Prime Minister Micheál Martin has said. Speaking to the BBC, he said the "mood music" surrounding EU-UK negotiations had improved in recent weeks. But he admitted feeling "frustrated" that the issue had hindered the "full flowering" of the two sides' alliance. And he warned the UK against acting unilaterally, saying it would "undermine" relationships.
• 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 EU’s COVID Digital 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 pass is proof that a person has: Been vaccinated against COVID-19; Tested negative for COVID-19; and/or Recovered from COVID-19.
• 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, A report from the Royal College of Emergency Medicine found that overcrowding in NHS hospitals has killed ‘more than 4,500 patients last year’.
• The Welsh NHS Confederation has found up to 15% of hospital beds are used by patients waiting for care.
• Health Secretary, Sajid Javid has described the leadership of digital technology in the NHS as ‘odd’.
• Leaders in the NHS are calling for new measures to replace the four hour emergency standards target.
• The Infrastructure and Projects Authority have raised concerns over the progress on the government’s New Hospitals Programme.
• The European Commission believe a tougher stance on the UK has helped them engage in more productive trade discussions.
• A “shambolic” rollout of third Covid vaccinations has left an unknown number of immunocompromised people still without proper protection going into winter, and in other cases even given the wrong type of injection, a leading charity has said. Blood Cancer UK said poor planning and confusing messaging meant “many thousands” of people with weakened immune systems might have missed out, leaving them at greater risk of serious consequences if they catch COVID.
• In a lengthy statement, the charity said NHS England had repeatedly failed to acknowledge the problem, while Sajid Javid, the health secretary, incorrectly said more than six weeks ago that the “vast, vast majority” of eligible people had already been invited for a third jab.
• COVID passes may be used over Christmas in order to keep pubs and restaurants open, the Welsh government has said. But First Minister Mark Drakeford said no decision would be made on introducing the pass to the hospitality sector until early December. Mr Drakeford made the comments as he unveiled the latest 21-day review of Covid regulations. He said there would be no rule changes in the next three weeks, following the latest review on Thursday.
• Covid case rates in England are now highest among children aged five to nine, latest weekly surveillance figures reveal. The data, up to 14 November, shows this younger age group has overtaken older, secondary school aged children for the first time.
• In recent months, the 10 to 19 age group maintained the highest rate of infections per 100,000 tested. It is too soon to say what is behind the change and if it will continue. In recent weeks, children aged 12 and over have started being offered Covid jabs.
• Although the UK’s ‘traffic light” system has been officially scrapped, the UK will retain a two-tier system, with high-risk countries classified as red, and the remainder as ‘open.’
• Testing requirements are 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.
• UK regulator MHRA has issued a consultation on the future of medical devices in the United Kingdom. The consultation is available here: https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom. Member companies are strongly encouraged to make their views known regarding the future of the UK’s regulatory system. AdvaMed and ABHI will be providing responses as well, but we believe MHRA most urgently wants to hear directly from those companies who are currently or who plan to provide medical technology to the UK market. The consultation closes November 25, 2021.
• 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 lower house of parliament the Bundestag voted on Thursday (November 18) in favor of new restrictions to curb a surge in coronavirus cases. The plans need to be approved by the upper house, the Bundesrat. They include new restrictions for the workplace and public transport. People will need to prove they are vaccinated, recovered from COVID-19 or have tested negative for the virus in order to gain access.
• In regions where there are more than three COVID-19 patients in hospital per 100,000 inhabitants, only the vaccinated and those who have recovered from the virus will be able to access public places such as restaurants or concert halls. Most regions in the country are currently above that threshold.
• Under the new German rules, unvaccinated people -- even if they tested negative for COVID-19 -- will see their access to many public venues restricted.
• The measures were proposed by the three parties expected to form the next coalition: the Social Democrats (SPD), the liberals and the greens.
• Lothar Wieler, director of the Robert Koch Institute, Germany's disease control agency has publicly stated that -- "We are going to have a really terrible Christmas if we don't take countermeasures now." He called for a significant increase in vaccination rates to well above 75%, from 67.7% at present. In some German regions rates are as low as 57.6%. Wieler also urged the closure of bars and clubs, an end to large-scale events and for many other places to be restricted to those with vacccine or recovery certificates.
• Angela Merkel this week stated that the fourth wave of COVID-19 is hitting Germany with "full force". She has continued meetings with state leaders to monitor and address the situation.
• Germany is now recommending a COVID booster shot for everyone over the age of 18.
• 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, individuals must be fully vaccinated.   It is obtainable 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. The paper certificate with a QR code can be used or it can be scanned into an app.
• France is going through its fifth wave with the number of infections steadily climbing. There were 20,294 new cases confirmed on Wednesday (November 17), the highest daily tally since late August. The number of daily cases has risen by 60% in a week, with hospitalizations up by over 10%.
• But the government and its scientific advisers believe that the measures already put in place are sufficient for now. Spokesman Gabriel Attal cited "the efficiency of the vaccine", the health pass and respect for social distancing. "We are holding up better today than other countries not only because our vaccination coverage is higher and the booster shot is progressing, but also because we implemented the health pass very early on," he argued. Nearly 75% of France's 67.4 million people are fully vaccinated. "There are nine times more critical care admissions and deaths among the unvaccinated than among the vaccinated," Attal said.
• In a bid to encourage older people to come forward for a third dose of the vaccine, President Macron has said that from mid-December, a booster jab will be needed in order for people aged over 65 to have their health passes extended.
• Despite high vaccination rates, France is seeing a spike in daily infections. On Tuesday, the country reported 12,476 new confirmed infections within 24 hours - the highest level since early September. Covid has claimed the lives of more than 118,000 people in France since the start of the outbreak.
• President Macron stated that all the evidence showed that six months after a person was vaccinated "immunity decreases and therefore the risk of developing a serious form [of Covid] increases". "The solution to this decrease in immunity is an additional vaccine shot," he said.
• The president said that next month booster jabs would be also made available to those aged between 50 and 64, stressing that more than 80% of Covid patients currently being treated in intensive care units were aged over 50.
• France has slammed the Channel Island of Jersey amid an ongoing post-Brexit row over fishing licences. Annick Girardin, the country's sea minister, said it had shown a lack of willingness to cooperate on the controversial issue. "It is definitely obvious that Jersey does not respect the Brexit agreement, worse, it shows a non-willingness to cooperate with us," she said.
• Girardin added that 46 applications for authorisation were still unanswered and that 52 licences had expired on 31 October, "including 13 priority ones, depriving these fishermen of access to Jersey waters". The minister also said she was preparing a plan to compensate French fishermen who would not obtain a licence.
• COVID screening tests in France is no longer free. This change signals a new phase in the government’s strategy to quell coronavirus infections by encouraging people to get inoculated.
• Unvaccinated people in France 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.
• 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 IVDR and 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