COVID-19 Outbreak: Weekly Global Report for Friday, December 3, 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 263 million. Deaths around the world have exceeded just over 5.2 million. Around 8 billion vaccines have been administered.
• U.S. cases exceeded 48.7 million with deaths increasing to 782,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: As the world grapples with the Omicron variant, the Chinese government is confident its “zero-Covid” strategy can prevent a major outbreak across the nation. On Sunday, Zhang Wenhong, director of China’s National Center of Infectious Diseases, said on his official Weibo account that “there will be no major impact on China at present,” as the country’s “rapid response and dynamic clearing strategy can cope with all types of new coronavirus variants.” Zhang’s views were supported by Wu Zunyou, chief epidemiologist at the Chinese Center for Disease Control and Prevention, who told the Caijing Annual Conference on Sunday that such a policy is a “magic weapon” for China to control any domestic outbreaks. At times defensive against external and internal criticism of its zero-tolerance approach, the Chinese government believes recent developments vindicate zero-tolerance. China’s CDC recently published an article that predicts that, if China adopts the epidemic prevention strategy of some countries like the US, UK, Israel, Spain and France, the number of new infections is likely to reach hundreds of thousands per day with about 10,000 seriously ill cases. The same article says that zero-COVID has prevented at least 200 million COVID-19 infections and 3 million deaths.
• China to supply Africa will more vaccines: Chinese President Xi Jinping pledged to supply another 1 billion doses of vaccines to African countries, as the world’s poorest continent grapples with the emergence of a new and potentially more transmissible Covid-19 variant.  Xi said 600 million doses will be donated while the rest will be jointly produced by Chinese enterprises and African countries, without providing details. He was speaking via video at the eighth triennial Forum on China-Africa Cooperation in the Senegalese city of Diamniadio on Monday. “We need to put people and their lives first, be guided by science, support waiving intellectual property rights on COVID-19 vaccines, and truly ensure the accessibility and affordability of vaccines in Africa to bridge the immunization gap,” Xi said in a speech. China has already sold 136 million vaccine doses to Africa and pledged 19 million in donations, according to the Beijing-based Bridge Consulting, which tallies deliveries through government press releases and news reports. Beijing has delivered 107 million of those doses, and another 11.6 million through the Covax initiative, the consulting firm said Monday.
• Shaanxi province’s strict containment measures for domestic travelers: The northwestern province of Shaanxi has imposed some of the strictest entry control measures for domestic travelers, mandating at least 14-day quarantine — similar to international arrivals in China — for anyone coming from locations designated “medium- and high-risk” in the country, the provincial government said last week. Authorities said the policy would be kept in place from “this winter to next spring” for visitors or returning residents from areas with at least one confirmed or asymptomatic infection.
• 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 111,436, an increase of 535 cases over the week of Nov. 15. 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: China’s economy is facing multiple risks heading into next year, with a property slump lingering and a new virus variant possibly upending the global recovery. Economists expect Chinese authorities to boost fiscal and monetary support next year after a relatively restrained approach for most of this year. The People’s Bank of China last week signaled an easing bias, while the State Council, China’s cabinet, urged local governments to speed up spending. All eyes are on two key political meetings in December -- the Communist Party’s Politburo and the Central Economic Work Conference -- for clues on next policy steps.
• S.-China relations: China has urged American business groups to “speak up and speak out” for Beijing as the White House considers a diplomatic boycott of the Winter Olympics and to impose additional tariffs on China. Foreign vice-minister Xie Feng, who is in charge of US affairs, laid out Beijing’s requests during a virtual meeting on Tuesday with key US business lobby groups, including the American Chamber of Commerce in China. Representatives from the American Chamber of Commerce in Shanghai, the US-China Business Council and various state-level bilateral associations were also present, according to an account posted on the Chinese foreign ministry’s website. Xie praised the American groups for their commitment and contribution to friendly relations in the past, especially when bilateral ties were in trouble, and urged them to be the “guardians” of US-China cooperation. “It’s good to enjoy the shade under the big tree,” he said. But warned that if relations between the two countries deteriorate, the business community could not expect to make money while remaining silent.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics:  34,606,541 total cases, 99,763 active cases/ 469,714 deaths/discharged 34,037,054 (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) two weeks back. 1,249,619,515 people have been vaccinated. India in November recorded the lowest number of new Covid-19 cases in 18 months since May 2020. A drop of 40% from 5.2 lakhs infections logged during October. This was the sixth consecutive month of falling coronavirus cases in India since its peak of the second wave in May.
• Amid Omicron concerns, the Ministry of Health and Family Welfare (MoHFW) has extended the recently released guidelines for international travellers entering India, further added the list of molecular testing units approved by ICMR for Covid testing along with additional information for people travelling from countries at risk. Recently released guidelines for incoming passengers from countries at-risk included compulsory testing on arrival, seven day mandatory home quarantine and further genomic testing of positive samples in view of the detection of new, possibly more transmissible variant Omicron.
• The vaccine effectiveness of Covishield against Covid-19 infection in fully vaccinated individuals was found to be 63% between April and May when the second wave was at its peak in India, according to a new study. It was published in ‘The Lancet infectious Diseases Journal’ and it included a comparison between 2,379 cases of confirmed SARS CoV-2 infection and 1,981 controls.
• Around 8.3 lakh Covid patients have been treated under the Ayushman Bharat-PMJAY scheme over the past two years, the Centre informed the Rajya Sabha on Wednesday, December 01. In a written reply, Minister of State Dr. Bharati Pravin Pawar said: “Around 8.3 lakh Covid-19 cases were treated under Ayushman Bharat-PMJAY in the last two years.” In the past two years, approximately 8.3 lakh hospital admissions have been authorized for the treatment of Covid-19 under Ayushman Bharat-PMJAY.
• Out-of-hospital consumer healthcare company, Portea Medical, informed that they have provided home isolation services to 4,00,308 Covid positive patients pan India since May 2020 and it has reduced the rate of hospitalization to about 3%. Nearly 45 percent of the patients were above 60 years and with co-morbidities and were classified as high risk. The home healthcare company informed that they had introduced home care solutions like Oxygen therapy for Covid patients, ICU care, chemotherapy for cancer patients.
• Some passengers flying in from at-risk countries will need to wait for up-to six hours for the on-arrival RT-PCR test report at Indira Gandhi International Airport from Wednesday, December 01, when new rules to contain the Omicron variant of the Covid Coronavirus kick in. People coming in from South Africa, Bostwana and Hong Kong will be allowed to leave IGIA only if they test negative for Covid. Else, they have to go to designated Covid centres. Other people arriving from countries at-risk of the Omicron variant will be allowed to take connecting domestic flights only after a negative result on testing at the airport.
• Hospitals across the country are on high alert and gearing up to handle any possible future surge in Covid-19 cases amid growing concerns about the heavily mutated Omicron variant that has triggered travel bans across the globe, industry officials said on Monday, November 29. Besides reserving isolation wards and ICUs for Covid-19 patients, hospitals have decided to scale up screening of patients arriving with travel history.
• The Omicron variant does not escape RT-PCR and rapid antigen testing (RAT), the Centre has underlined while advising states to immediately ramp up testing. A senior official said 764 samples were genome-sequenced between November 26 and November 30 and no case of the Omicron variant was detected till Tuesday. Genome sequencing is crucial not only to ascertain whether the new variant has entered the country, but also to identify and analyse its characteristics, behaviour and severity.
• The National Technical Group on Immunization (NTAGI) and National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) are deliberating and considering scientific evidence for the need and justification for booster dose, Rajya Sabha was told on Tuesday, November 30. Responding to a query on the stand of the Indian Government on booster doses, Union Minister of State for Health Bharati Pravin Pawar in a written reply said some countries are providing booster doses of Covid-19 vaccine.
• The emergence of the Omicon strain could lead drug companies scrambling to the drawing board to tweak their Covid-19 vaccine plans, US firm Novavax and Russia’s Gamaleya Institute said on Monday, November 29 that they had initiated work on developing new versions of their respective vaccines adapted to the mutant strain. Pfizer and Moderna too said they were racing to tweak their vaccines.. Other companies that are expected to modify their vaccines include the Pune based Gennova Biopharmaceuticals and the Hyderabad based Bio-E.
• Amid mounting fear over the new SARS-COV-2 variant Omicron, an expert committee on Covid immunization is considering to recommend an “additional dose’’ to those who are immunocompromised or are elderly and at high risk of infection or death due to Covid-19 infection, an official source said. A final decision on the issue, however, will be taken by the National Technical Advisory Group on Immunization (NTAGI) next week, which can be then considered by the health ministry for approval. It would be too early as yet to speculate on just when the doses will be given.
• Covishield and Covaxin jabs can prevent hospitalization or death that may result from the new Bostwana variant Omicron (B.1.1.529), the Covid-19 virus’s most mutated variant as yet, virologists and infectious diseases experts have said. Senior Scientist Raman Gangakhedkar, former head of Epidemiology and communicable diseases division of the Indian Council or Medical Research (ICMR), said, “Theoretically, it is possible that the new variant of concern (Omicron) may challenge vaccines’ efficacy. But, we know that our vaccines prevent hospitalization and death.
• The new Omicron variant of Coronavirus has reportedly got over 30 mutations in the spike protein region giving it the potential to develop a immunoescape mechanism, and thus the efficacy of vaccines against it needed to be evaluated critically, AIIMS chief Dr. Randeep Guleria has said. The presence of spike protein facilitates a virus’ entry into the host cell and is responsible for making it transmissible and causing infection. “The new variant of coronavirus reportedly has got more than 30 mutations at the spike protein region and therefore has the potential of developing immunoescape mechanisms.
• In view of the possible threat that the new Covid-19 variant can pose to the nation, the Centre has asked all states and UTs to focus on intensive containment, active surveillance, enhanced testing, monitoring of hot-spots, increased coverage of vaccination and augmentation of health infrastructure. Listing a series of measures which states and UTs should undertake, Union Health Secretary Rajesh Bhushan also stressed on rigorous surveillance of international passengers ensuring prompt dispatch of samples for genome sequencing and strict enforcement of  Covid-appropriate behaviour to effectively manage this Variant of Concern (VoC).
• All international passengers, except those under five years of age, flying into India from Covid-at-risk countries must undergo RT-PCR test on arrival, starting from 12.01 am (IST) of December 01,2021. This will include those transiting from these places too. Those testing negative must home quarantine for seven days and then re-test on the eighth day. Thse who are testing positive will be admitted to separate isolation facility and their sample sent for genomic testing and would be discharged if found not infected with the Omicron variant.
• An expert panel of India’s Central Drug Authority, which recently reviewed Serum Institute’s  application seeking emergency authorization of Covid-19 vaccine Covovax, has sought additional data from the firm, while noting the jab has not yet been approved in the country of origin, official sources said. The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorization covovax for restricted use in emergency situations.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,727,920 total reported cases and 18,375 total reported deaths compared to 1,726,421 total reported cases and 18,354 total reported deaths two weeks ago.
• Japan continues to see an extremely low number of new cases and deaths. It is averaging fewer than 100 new cases and fewer than 2 deaths per day. New daily cases had reached a peak of around 25,000 in August.
• Japan has placed a daily cap on arrivals from overseas at 3,500, with no in priority between Japanese citizens and foreign residents. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam remain suspended.
• 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 77.4% of the population now fully vaccinated.
• Japan started administering third doses of COVID-19 vaccine in December to medical workers who had their second doses at least 8 months ago. It will make boosters available to the general population in January and is considering shortening the 8 month period between second doses and boosters.
• 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.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org).

Korea

• Korea added 5,266 cases on Thursday to reach 457,612. 5,242 of the total cases (99.54%) were locally transmitted while 24 (0.46%) originated overseas. The country is now experiencing consistent spiking COVID rates but still remains at a lower rate than many other countries. 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.
• South Korea has administered 85,609,485 doses 42,593,798 first doses (82.9% of the population) and 41,129,620 second doses (80.1% of the population) of the COVID-19 vaccine 80.1% of the population is 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 (delayed as indicated below)
    • 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 (delayed as indicated below).
    • ​ Lift restrictions on private gatherings.
• Due to the recent surge in COVID-19 cases, Korea will maintain Phase One of its “Living with COVID-19 Strategy” until December 26 and will reassess the situation then.
• Starting December 3, all international arrivals into Korea will undergo a 10-day quarantine regardless of their nationality and vaccination status. This new mandate will last until December 16 given the concerns surrounding the new Omicron COVID-19 variant.
• The latest entry and exit requirements for travel between the U.S. and Korea can be found on the US Embassy website.
• On Wednesday, Korea confirmed its first Omicron infections ― a married couple returning to Incheon after visiting Nigeria, their Uzbek friend who gave them a ride home from the airport and separate cases of two women in their 50s in Gyeonggi Province, who also returned recently from Nigeria. Subsequently, additional new Omicron infections have been confirmed, totaling 6 confirmed cases.
• South Korea's economy grew at the same pace as earlier forecast in the third quarter of the year despite better-than-expected private consumption and robust exports, central bank data showed Thursday.
• The country's gross domestic product adjusted for inflation grew 0.3 percent in the July-September period, compared with three months earlier, according to the preliminary data by the Bank of Korea (BOK).
• South Korea has clinched the top spot in Asia in a United Nations agency’s global innovation rankings, coming in fifth globally. In the World Intellectual Property Organization’s Global Innovation Index 2021, Korea was ahead of Singapore, Japan and China. It was behind Switzerland, Sweden, the United States and the United Kingdom. Korea, Asia’s fourth-biggest economy, was in 10th place last year.
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

 

Cases

• ASEAN now has 14,148,373 total reported cases compared to13,698,735 total reported cases two weeks ago. It has a total of 292,648 total reported deaths compared to 286,385 total reported deaths two weeks ago.
• ASEAN continues to experience a relatively low level of new cases, with the exception of Vietnam and Laos.
• Indonesia: New cases and fatalities continue to fall to extremely low levels. Indonesia is now reporting 4,256,998 total cases and 143,850 total deaths compared to 4,252,345 total cases and 143,709 total deaths two weeks ago. Indonesia accounts for 49% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: Total reported cases grew from 2,563,153 to 2,638,221 over the past two weeks. Total deaths have grown from 29,837 to 30,474 over that time.
• Thailand: Total reported cases grew from 2,044,125 to 2,152,729 over the past two weeks and reported deaths have increased from 20,252 to 20,845 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 2,833,743 total cases, up from 2,821,753 total cases two weeks ago. Total reported deaths have increased from 46,422 to 48,752 over that time.
• Vietnam: Total reported cases grew from 1,065,469 to 1,266,288 over the past two weeks. Total reported deaths grew from 23,476 to 25,658 over that time.
• Singapore: The number of new cases in Singapore remains relatively high. Total reported cases increased from 244,815 to 266,049 over the past two weeks. The total number of deaths increased rose from 619 to 726 over that period.
• Cambodia: Cambodia has experienced nearly five weeks of drastically lower case counts. Total reported cases increased from 119,741 to 120,183 over the past two weeks. Total reported deaths grew from 2,887 to 2,949 over that period.
• Laos: Laos reported a growth in total cases from 57,397 to 76,496 over the past week. It reported 186 total deaths, up from 112 two weeks ago.

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 35.3% of the population is fully vaccinated.
• Malaysia has increased its vaccination rate sharply over the past several months. The government announced this week that civil servants may face disciplinary action or termination if they fail to complete the COVID-19 vaccination process. Malaysia has fully vaccinated 78.4% 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 33.6% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 87% 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, 59.4% 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 52.3% of its population to date. A Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
• Cambodia: 80.1% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore is not allowing visitors who have a 14-day travel history to Botswana, Eswatini, Lesotho, Mozambique, Namibia, South Africa and Zimbabwe are not allowed to enter or transit through Singapore.
• Singapore’s 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: Effective 29 November, all travelers who have been physically present or have transited Botswana, Eswatini, Lesotho, Mozambique, Namibia, South Africa, Zimbabwe, Malawi, Angola, and Zambia are prohibited entry into Cambodia.
• Other than the above, those who have 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 and in some cases dramatically negative COVID trends continue in Europe, with spiking and persistent numbers. Case numbers as well as deaths are overall increasing rapidly. In previous weeks, there had been increasing cases but deaths were remaining at prior levels or increasing only incrementally. The current trend shows more significant deaths and death rates well above prior levels. 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, France and Russia are also continuing negative trends.
• Germany’s new cases continue to be highest in Europe, followed by France, the UK and Russia. 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 our last reported week prior to Thanksgiving. France 49,610 (20,294); Spain 10,536 (6,667); Russia 32,837 (36,626); UK 48,374 (38,314); Italy 15,085 (10,165); Germany 71,887 (60,753); and Belgium 16,566 (12,388).
• 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 202,304. The UK is 12^th highest with 150,254. Netherlands is 9^th with 154,853; Belgium, is 10^th with 151,448.
• The UK continues to be fourth worst in the world in terms of total cases, behind USA, India, and Brazil. Russia is fifth worst in the world in total cases.
• In terms of deaths per day, Russia remains by far the highest in Europe, at 1,226. Germany has been increasing over the last few weeks and is now 4^th in Europe with 415. The UK is sixth with 171. Russia’s consistent lead in deaths per day is in contrast to some of its other reported numbers, and is one indicator that its numbers are likely under reported. Along with Russia, Poland, Ukraine, Germany, Hungary and the UK comprise the top 6 countries in Europe in deaths per day.

• In terms of deaths per million, Belgium is the 21 worst in the world with 2,317. Italy is 28th, with 2,220. The UK is 29^th with 2,122. Other rankings in this category are Spain, 36th, and France 39th. (The US ranks 20^th with 2,412 deaths per million).
• The figures for deaths per day (which tend to lag any increased infection rates) are as follows:  Russia 1,226 (1,247); UK 171 (201); France 96 (50); Spain 28 (30); Italy 93 (72); Germany 415 (248); Belgium 49 (41)).
• Germany continues to lead Europe in the number of vaccine doses administered with over 124 million doses and 68.1% fully vaccinated. German authorities expected their numbers to be higher, but are encountering resistance from many Germans who do not want to be vaccinated. ICU beds in many parts of Germany are full of unvaccinated COVID patients. The UK is second in Europe in vaccine doses administered with over 116 million administered and 68% fully vaccinated. Russia has provided over 127 million doses, but has only 39.1% fully vaccinated. France is at over 105 million doses administered and almost 69.8% fully vaccinated. Italy has administered over 96 million doses and is 73% fully vaccinated. Spain is now over 76 million doses and just under 81% fully vaccinated. These numbers continue to increase, but the rate of increase has slowed in some countries due to population segments who refuse to get vaccinated.
  
• 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.
• In Europe, tens of millions of eligible adults are still not vaccinated. The sad and avoidable reality is that this increases the risk of those who reject the vaccine ending up in an ICU if they contract COVID-19, unnecessarily limiting some of society’s most valuable finite resources: ICU beds and medical staff.
• This translates into adverse outcomes for both COVID-19 patients for whom ICU beds might be lacking, but also for non-COVID-19 patients whose medical and surgical care could be delayed or even cancelled.
• The severe consequences of low vaccine uptake are reflected in intensive care admission statistics published by many EU member states: at least 80 per cent of critically ill COVID-19 patients are now the unvaccinated.
• As COVID-19 cases surge in Europe there's been more focus on convincing the unvaccinated to get the jab.
• So far the measures have ranged from COVID passes to lockdowns targeting those without the vaccine.
• But now more countries are considering mandatory vaccination. On Wednesday, European Commission President Ursula von der Leyen called for an EU discussion on the topic.
• Scientists believe they may have the answer as to why some coronavirus vaccines are associated with extremely rare cases of blood clots. In a peer-reviewed paper published in the international journal Science Advances on Wednesday, the team behind the research say they think they have pinpointed a "molecular mechanism" behind the clots linked to adenovirus vaccines, such as AstraZeneca and Johnson & Johnson.
• Brussels has announced plans to raise up to €300 billion to counter China's infrastructure spending around the world. The money will help poorer countries build highways, pipelines and broadband networks. The move is a response to China’s Belt and Road Initiative (BIR), a massive collection of infrastructure projects across the globe that has served to fortify Beijing’s foreign policy and soft power.
• The United Nations needs a record $41 billion (€36 billion) to address skyrocketing aid demands worldwide, as the pandemic continues to rage, and climate change and conflicts push more people to the brink of famine, the UN Under-Secretary-General for Humanitarian Affairs Martin Griffiths said on Thursday.
• The UN warned that the need for humanitarian aid was skyrocketing around the world, as its humanitarian agency OCHA estimated that 274 million people worldwide would need some form of emergency assistance next year, up from 17% on an already record-breaking 2021.
• Existing COVID-19 vaccines are likely to be much less effective against the Omicron variant of the virus than previous variants, the CEO of drugmaker Moderna has warned. Speaking to the Financial Times, Stéphane Bancel said the large number of mutations in the variant suggested that the world's COVID-19 vaccines may need to be adjusted to retain their effectiveness against the virus, should Omicron become dominant. "There is no world, I think, where [the effectiveness] is the same level...we had with Delta," Bancel told the FT on Tuesday.
  A World Health Organization technical brief describes the Omicron variant as having an unprecedented number of spike mutations. The high number of spike mutations - believed to be between 26 and 32 - raise concerns about its ability to evade vaccines and to spread, virologist Tulio de Oliveira told an online press conference last week. The spike protein is what helps the virus to invade the body’s cells.
• "Omicron is a highly divergent variant with a high number of mutations," the WHO said, adding that some of the mutations were "concerning and may be associated with immune escape potential and higher transmissibility".   "However, there are still considerable uncertainties," the WHO said.
• 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, they have noted that the US has expressed concerns in the UK government’s threat to revoke the Northern Ireland protocol and further the US has indicated such action could threaten peace in Ireland and hinder any UK-US trade deal. The US is planning to keep tariffs on UK metal products in place until the UK agrees to not apply Article 16.
• Commenting on the Irish border issue, French President, Emmanuel Macron has said the rules of Brexit are a matter of ‘war and peace’ for Ireland.
• The World Trade Organization launched a deal to improve licensing and qualification procedures for global services trade.  
• An NHS Trust has apologised for accidently sharing the data of patients in a covid-19 vaccine trial.
• NHS Providers has published it’s latest Digital Boards development programme on how the NHS boards can excel the digital transformation agenda.
• The National Audit Office has revealed up to 12 million patients could be on NHS waiting lists by 2025.
• Senior Doctors in the NHS have warned the government to implement ‘Plan B’ before hospitals become overwhelmed by Omicron.
• The BBC has written a piece on the threat Omicron could have on the NHS.
• Health Secretary, Sajid Javid has announced a review of the pay for medical directors and senior ICS managers in the NHS.
• The UK’s trade deal with Norway, Iceland and Liechtenstein comes has now come into effect.
• International Trade Secretary, Anne-Marie Trevelyan has said the government will start looking at digital trade deals for UK businesses.
• No 10 is expecting to host a number of gatherings this Christmas and insisted it was not suggesting parties should be cancelled, after two government ministers said big gatherings and “snogging under the mistletoe” should be avoided. The controversy comes amid anger over reports that Downing Street staff held multiple gatherings over the Christmas period last year when the UK was under lockdown.
• 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.’
• The Cabinet Office has been fined £500,000 by the UK’s data watchdog after the postal addresses of the 2020 New Year honours recipients were disclosed online. The Information Commissioner’s Office (ICO) found officials failed to put in place “appropriate technical and organisational measures” to prevent the unauthorised disclosure of personal information in breach of data protection law.
• 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.
• 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 moved on Thursday (December 2) to tighten restrictions for those unvaccinated against COVID-19. People without the jab won't be able to access non-essential shops, restaurants, places of culture or leisure. The decision was announced after a meeting between outgoing Chancellor Angela Merkel, her successor Olaf Scholz and the leaders of the country's 16 regions.
• A draft law on mandatory vaccination is to be submitted to parliament for entry into force in February or March. Masks are to be required in schools, and new limits imposed on private meetings. The moves follow a ruling from a top German court upholding government measures to tackle all-time high COVID-19 infections. The Federal Constitutional Court found that a curfew and school closures were in line with the country's constitution.
• Scientists and doctors have warned that medical services in Germany could become overstretched in the coming weeks unless drastic action is taken. Some hospitals in the south and east have already transferred patients to other parts of the country.
• Germany is now recommending a COVID booster shot for everyone over the age of 18.
• Finance Minister Olaf Scholz is expected to be officially elected German chancellor on December 8th, replacing Angela Merkel after 16 years at the helm, parliament said in a planning statement on Thursday. “Chancellor election day expected on Wednesday, December 8th, 2021”, the Bundestag said in the note. The election of Social Democrat Scholz, 63, would officially end Merkel’s 16 years in office. Scholz’s SPD last week announced a coalition tie-up with the Greens and liberal Free Democrats (FDP), putting the centre-left in charge for the first time in 16 years.
• 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.
• Mainland France’s first Omicron-variant case has been detected in the greater Paris region, according to the local health authority. The infected person had recently returned from Nigeria.
• The fifth wave of Covid-19 infections has swept through France, leaving no corner untouched. French authorities are setting down new pandemic measures to stem the tide – expediting booster shots, tightening the health pass and widening mask mandates. But one paradox stands out: While cases are higher than ever and rising fastest in children, the last of the unvaccinated, France is loosening protection measures at schools.
• The surge led Health Minister Oliver Véran last week to announce an extension of vaccine booster shots to all French adults, under threat of having their health pass, which grants access to restaurants, culture venues and travel, voided. Mask mandates are back for all indoor public spaces, even with a health pass, and some local authorities like Paris now require masking in crowds also outdoors. "This fifth wave will be without contest stronger and longer than the summer's fourth wave," Véran warned during a press conference last Thursday.
• Meanwhile, as striking as the surge has been nationwide – despite more than 75 percent of France 's population aged 12 and up completely vaccinated – the spread is outsized among the country's unvaccinated youngest. The European Medicines Agency has recommended approval of Pfizer-BioNTech's vaccine for 5-to-11-year-olds last week. But Véran said vaccinating this age group would not begin in France until January at the earliest, pending the advice of France's own ethics and health authority.
• On Tuesday, France issued a first green light only for a subset of "fragile" 5-to-11-year-olds, or those living with immune-compromised or vulnerable unvaccinated people. And yet last Thursday, in a dissonant break from Véran's stark warning moments earlier, from his own podium just steps away, Education Minister Jean-Michel Blanquer, went on to declare a loosening of the Covid-19 protocol in schools: no additional restrictions and no more closing school classes automatically when a Covid-19 infection is detected. The announcement drew reactions of dismay from health and education professionals.
• 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.
• COVID screening tests in France are 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 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