COVID-19 Outbreak: Weekly Global Report for Friday, December 10, 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:  34,666,241 total cases, 94,742 active cases/474,111 deaths/ discharged 34,097,388 (John Hopkins & MoHFW) as compared to 34,606,541 total cases, 99,976 active cases/470,115 deaths/ discharged 34,056,666 (John Hopkins & MoHFW). 1,303,932,286 doses have been administered.
• Indian Covid-19 vaccine makers are lobbying the government to authorize boosters as supplies have so outstripped demand that one drugmaker told Reuters it had suspended a plan to produce more than 100 million doses of Russia’s Sputnik shot. The Serum Institute of India (SII), the world’s biggest vaccine maker, and Sputnik’s India distributor, Dr. Reddy’s Laboratories, have both said they have approached health authorities about boosters.
• With the Union health ministry asking people not to bolster their immunity guards against Omicron, sales of health supplements and vitamins have increased by nearly 25% in city pharmacies. According to pharmacy owners, there is an increase in queries about any protocol treatment regarding Omicron infection. While the Omicron variant can potentially spread faster than the Delta variant of Covid-19, there is less clarity among patients about the treatment protocol for the variant so far.
• About 50% of Indians favour suspension of international flights from countries, where omicron infections are high, shows a survey by local circles. “The survey received more than 18,000 responses from citizens residing in 317 districts of India. 68% respondents were men while 32% respondents were women, 41% respondents were from tier 1, 30% from tier 2 and 29% respondents were from tier 3, 4 and rural districts,” local circles said in a release. India had announced to resume international flights from December 15, 2021, but then decided to defer it due to rising Omicron cases across the world. India has introduced more checks for people from at-risk countries that includes African countries.
• In a finding that would help boost confidence in vaccines. A study has revealed that people hospitalized with breakthrough infection after taking either Covaxin or Covishield have similar outcome-very low mortality rate. The death and recovery rates are similar for people vaccinated with either Covishield or Covaxin as both offer equal and similar protection in cases of breakthrough infection. “We found no difference in occurrence of severe disease at admission, need for mechanical ventilation or in hospital mortality between patients with breakthrough Covid-19 who received either of the two vaccines,’’ said researchers from All-India Institute of Medical Sciences (AIIMS), New Delhi.
• The government has included treatment of Covid-19 and Dengue under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY)., the Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar stated in a written reply in the Rajya Sabha. Laboratory test and treatment for Covid-19 infection are both under health benefit packages for Covid-19. The tests for Covid-19 reimbursement level package is as per the ICMR guidelines. Treatment of vector borne diseases like dengue fever, dengue hemorrhagic fever, dengue shock syndrome would be included in the health benefit package under the AB-PMJAY.
• With not enough orders for Covishield from the Centre, Serum Institute of India CEO Adar Pooniwala on Tuesday, December 07 said the company is looking at slashing monthly production of vaccines by at least 50%. SII has written to the government to seek clarity on its requirement, if any, for normal two doses for eligible people and also on booster doses. I’m actually in a dilemma that I never imagined we are producing 250 million doses a month but the good news is that India has covered up a large part of its population and we would have completed all our orders to the health ministry in a week’s time…on a monthly basis until the orders again pick up either in India or the world.
• Informing about the deployment of Covid vaccine for children in India’s vaccination drive, Minister of State (MoS) for Health & Family Welfare Dr. Bharati Pawar told Rajya Sabha that the National Expert Group on Vaccine Administration for Covid (NEGVAC) and National Technical Advisory Group on Immunization (NTAGI) are deliberating  and considering scientific evidences related to vaccination for children aged less than 18 years. The vaccination drive for children will begin once enough safety data from clinical trials is made available to the regulatory authorities. Dr. Pawar further highlighted that Cadila Healthcare’s ZyCoV-D has already received approval for Restricted Use in Emergency Setting for children aged 12 years and above.
• A soon to be introduced and visually interpreted rapid Covid test-developed by the Indian Council of Medical Research-National Institute of Virology and transferred to Chennai and Delhi based companies for production-could cut down the cos and the turnaround time by almost 40%, ICMR-NIV officials said. The test would be made available within two weeks at the airports in India and other places. The companies have been asked to scale up production amid Omicron concerns. The molecular based technology used in this rapid test kit neither requires expensive machines like RTPCR, high-speed centrifuges nor a skilled workforce to conduct the test. The test, RT-LAMP, has 100% sensitivity and 100% specificity.
• The National Technical Advisory Group on Immunization (NTAGI), the Covid-19 advisory group in India, is likely to contemplate key issues like the need for a booster dose to the eligible population, additional dose for the immunocompromised and opening vaccination for children in a meeting to be held on Monday, December 06. NTAGI chair NK Arora will give a presentation on a status report, detailing the share of children in the total active Covid-19 cases, impact of Covid-19 on children and the need for the vaccination in children, they said.
• After keeping a close eye on the symptoms of nine cases of the Omicron variant of Covid-19, doctors at the Sawai Man Singh (SMS) Medical College have said that they did not find any complications and the symptoms were mild. The doctors said that the symptoms of the Omicron variant were mostly different from that of the Delta variant, which dominated the second wave of Covid-19. The doctors claimed that the criticality is much less in Omicron than in the Delta variant. “All nine patients are stable. While some of them are asymptomatic, others have mild symptoms.
• The scientific advisory group on Covid Immunization has deferred any decision on whether there is a need to administer a ‘booster’to those at high-risk of infection or severe illness caused by the coronavirus. “No recommendation has been made by the NTAGI yet,” a senior official said. Experts remain more keen on protecting immunocompromised children with vaccination, for which guidelines are likely to be submitted by end of this week. Sources said the National Technical Advisory Group o Immunization (NTAGI) for Covid-19 has assessed data, which shows high seropositivity in the country’s population.
• India’s tally of confirmed Covid-19 cases linked to the newly discovered Omicron variant shot  up five ties overnight as nine people in Rajasthan, including a four member NRI family from South Africa, seven in Maharashtra’s Pune  and one in Delhi tested positive for that strain of the virus. The total count currently stands at 21. As of Saturday, December 04, the tally was four, after Maharashtra and Gujarat reported a case each to add to the two detected first in Karnataka. Delhi’s first Covid patient found to have been infected with the Omicron variant is a 33 year old man who returned from Tanzania recently.
• Amid growing concerns over the Omicron variant of SARS-Cov-2, a parliamentary committee has recommended that he efficacy of Covid vaccines must be evaluated and the government conduct more research to examine the need for booster doses to contain the new strain. The Parliamentary Standing Committee  on Health, which presented its report on Friday, also said that concerns with regard to the new strain developing immunoescape mechanism should be critically addressed.
• The Indian SARS-CoV-2 Consortium on Genomics (INSACOG) in its recent weekly bulletin has said that many more specific experiments are needed to assess the impacts of booster dose, which are being guided and monitored by National Technical Advisory Group on Immunization (NTAGI) and National Expert Group on Vaccine Administration (NEGVAC) for Covid-19. However, in its previous weekly bulletin dated on November 29, INSACOG has recommended a booster dose for those 40 years of age and over, first targeting the most high-risk/ high-exposure “may be considered”.
• The Union Health Ministry on Saturday, December 04 wrote to Karnataka, Kerala, Tamil Nadu, Jammu and Kashmir, Odisha and Mizoram to take necessary steps under the “Test-Track-Treat-Vaccinate-Covid Appropriate Behaviour” strategy to control the spread of Covid-19 and reduce fatality. The move comes in view of rising cases of the infection, weekly positivity rates and weekly deaths in some districts. Referring to a letter sent to all states/UTs on November 27 in the context of the new Omicron variant, Union Health Secretary Rajesh Bhushan on Saturday said all states have been advised to undertake enhanced surveillance of international travellers, monitor emerging hotspots, prompt contact tracing of positive people, besides sending all positive samples for genomic sequencing, early identification of cases and review of health infrastructure preparedness, and most importantly to focus on IEC and community sensitization.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,728,780 total reported cases and 18,383 total reported deaths compared to 1,727,920 total reported cases and 18,375 total reported deaths last week.
• Japan continues to see an extremely low number of new cases and deaths. It is averaging around 100 new cases and barely over one death 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 7,102 cases today to reach 496,584. 7,082 of 7,102 (99.72%) were locally transmitted while 20 (0.28%) originated overseas.
• 42,822,222 first doses (83.4% of the population), 41,509,745 second doses (80.8% of the population) and 4,843,497 third doses (9.4% of the population) of the COVID-19 vaccine have been administered in Korea.
• Please note the following updates regarding COVID-19-related policies in Korea:
  • Stricter Social Distancing Measures (December 6, 2021 – January 2, 2022): Due to the recent surge in COVID-19 cases and the new omicron COVID-19 variant, the Korean Government will limit private gatherings to maximum 6 people in the Greater Seoul Metropolitan area and 8 people elsewhere until January 2, 2022.
  • International Arrival Quarantine Measures (December 3 – 16, 2021): All international arrivals into Korea now undergo a 10-day quarantine regardless of their nationality and vaccination status. Quarantine exemption certificates can be issued for important business trips, diplomatic visits, and other humanitarian reasons.
  • Latest entry and exit requirements for travel between the U.S. and Korea can be found at the US Embassy website..
• 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.
• Korea will recognize foreign nationals' vaccination history abroad so they can be verified as "vaccinated" against COVID-19, according to the Korea Disease Control and Prevention Agency (KDCA), Thursday.
• This move is aimed at including them in the "vaccine pass" program and facilitating their receiving of booster shots in Korea.
• The KDCA said foreign nationals who have been vaccinated abroad will be able to register their overseas vaccination records on the COOV COVID-19 vaccine app by visiting a local health center with ID and vaccination certificates issued overseas.
• To dater, such registration for overseas vaccinations was allowed only for Korean nationals, and non-Koreans could complete the registration only if they had quarantine exemption certificates, which are issued for urgent and inevitable entry for business, academic, public or humanitarian reasons.
• This measure has left many fully vaccinated foreign nationals categorized as "unvaccinated" in the government system, bringing criticism that the government discriminates against foreigners.
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

 

Cases

• ASEAN now has 14,308,411 total reported cases compared to 14,148,373 total reported cases last week. It has a total of 296,055 reported deaths compared to 292,648 total reported deaths last week.
• The ASEAN region continues to experience a steady decline in new cases, with the growth in cases at its lowest level last week since June 2021. Vietnam is the exception, with case levels continuing to rise considerably.
• Indonesia: New cases and fatalities continue to fall to extremely low levels. Indonesia is now reporting 4,258,560 total cases and 143,918 total deaths compared to 4,256,998 total cases and 143,850 total deaths last week. Indonesia accounts for 49% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: Total reported cases grew from 2,638,221 to 2,673,019 last week. Total deaths have grown from 30,474 to 30,746 over that time.
• Thailand: Total reported cases grew from 2,152,729 to 2,156,587 last week and reported deaths have increased from 20,845 to 21,082 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 2,835,996 total cases, up from 2,833,437 last week. Total reported deaths have increased from 48,752 to 49,936 over that time.
• Vietnam: Total reported cases grew from 1,266,288 to 1,367,433 last week. Total reported deaths grew from 25,658 to 27,146 over that time.
• Singapore: The number of new cases in Singapore moderated last week. Total reported cases increased from 266,049 to 271,297 last week. The total number of deaths increased rose from 619 to 726 over that period.
• Cambodia: Cambodia has experienced nearly six weeks of drastically lower case counts. Total reported cases increased from 120,183 to 120,312 last week. Total reported deaths grew from 2,949 to 2,974 over that period.
• Laos: Laos reported a growth in total cases from 76,496 to 84,503 last week. It reported 224 total deaths, up from 186 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 36.7% of the population is fully vaccinated.
• Malaysia now has one of the highest vaccination rates in the region. 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 78.6% 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 36.1% 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, 60.9% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available.
• Thailand's Food and Drug Administration has approved Siam Bioscience as a manufacturing facility for the COVID-19 AstraZeneca vaccine. Thailand plans to export the vaccines to eight Southeast Asian countries.
• Vietnam has fully vaccinated 57.0% of its population to date. A Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
• Cambodia: 80.2% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore and Malaysia reopened one of the world's busiest land borders to vaccinated travelers after nearly two years.
• 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 trends remain significant in Europe, but are less severe this week. As noted below, the WHO noted Wednesday that Europe as a whole recorded a slight drop in COVID cases and deaths after a long string of weekly increases. The WHO is speaking in terms of total numbers in Europe, so many countries do continue increasingly negative trends even if Europe as a whole levelled off a bit this week. The UK and France experienced increases in new cases per day.
• 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 61,340 (49,610); Spain 10, 952 (10,536); Russia 30,752 (32,837); UK 51,050 (48,374); Italy 17,948 (15,085); Germany 68,832 (71,887); and Belgium 10,878 (16,566).
• 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, Spain and Italy. Poland, Ukraine, Netherlands and Czech Republic round out the top ten.
• In terms of cases per million in Europe, Czech Republic is the 4th highest in Europe with 212,551. The UK is 12^th highest with 155,124. Netherlands is 9^th with 163,410; Belgium, is 10^th with 161,189.
• 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 2,346. Italy is 28th, with 2,229. The UK is 29^th with 2,134. Other rankings in this category are Spain, 36th, and France 39th. (The US ranks 20^th with 2,438 deaths per million).
• The figures for deaths per day (which tend to lag any increased infection rates) are as follows:  Russia 1,179 (1,226); UK 161 (171); France 133 (96); Spain 18 (28); Italy 88 (93); Germany 448 (415); Belgium 43 (49).
• Germany continues to lead Europe in the number of vaccine doses administered with over 129 million doses and 68.6% fully vaccinated. German authorities are encountering resistance from many Germans who do not want to be vaccinated. The UK is second in Europe in vaccine doses administered with over 119 million administered and 3% fully vaccinated. Russia has provided over 132 million doses, but has only 40.8% fully vaccinated. France is over 109 million doses administered and over 70% fully vaccinated. Italy has administered over 100 million doses and is over 73% fully vaccinated. Spain is now over 77 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.
• BioNTech and Pfizer said on Wednesday a three-shot course of their Covid-19 vaccine was able to neutralize the new Omicron variant in a laboratory test and they could deliver an Omicron-based vaccine in March 2022 if needed. In the first official statement from vaccine manufacturers on the likely efficacy of their shot against Omicron, BioNTech and Pfizer said that two vaccine doses resulted in significantly lower neutralizing antibodies but that a third dose of their vaccine increased the neutralizing antibodies by a factor of 25.
• Vaccine plants in the European Union are expected to produce 3.6 billion COVID-19 shots next year, out of a global output of more than 20 billion, two senior EU officials said on Wednesday. EU countries are administering boosters after having completed the primary vaccination of nearly 70% of the EU population, whereas in Africa only 7% have been immunized against the coronavirus, EU data show.
• The World Health Organization’s European region has recorded a slight drop in both COVID-19 cases and deaths last week after facing a string of weekly increases. The WHO also noted European Center for Disease Prevention and Control figures showing that as of Monday, all the 212 confirmed cases of the omicron variant identified across 18 European Union countries up to that point had turned up asymptomatic or mild disease. WHO cautioned that its understanding of the omicron variant will “continue to evolve” as more data comes in about its impact.
• WHO said in its weekly epidemiological released late Tuesday that the weekly number of new cases in its 53-country European region fell 2% to more than 2.6 million new cases reported over the last week — with Germany and Britain recording the most — and 29,000 new deaths over the period — a decline of 3% from the previous week. The incidence of cases in Europe had been rising since mid-October, WHO said.
• European Union countries are expected to agree to limit to nine months the duration of COVID-19 certificates for travel around the bloc, three EU sources told Reuters, but some states are concerned that such a limit could hinder travel.
• The EU executive proposed at an internal meeting with health experts from member states on Thursday to impose PCR tests on all incoming travelers from outside the bloc, two of the sources said, a step prompted by a lack of firm information so far on the risks posed by the Omicron coronavirus variant. The EU introduced COVID-19 passes in July to facilitate travel for people who are fully vaccinated against coronavirus, have recovered from the disease or have a negative PCR test. As evidence increased about the waning protection from vaccines, in November the European Commission proposed a nine-month validity limit for COVID-19 passes from the time a person has received two doses (or one in the case of the Johnson & Johnson vaccine).
• France's upcoming presidency of the European Union will aim to "move towards a powerful Europe in the world, a fully sovereign Europe, free to make its own choices and able to master its destiny," said French president Emmanuel Macron. The six-month tenure, due to start on January 1, overlaps with the country's presidential election.
• Here are six key themes outlined in Macron's speech on Thursday.
  • Reform of the Schengen free-movement area to give the EU more integrity over its borders;
  • Defend Europe’s social model, to focus on growth, investment and civic service;
  • Reconciliation of climate ambitions with economic development;
  • Transform Europe into a digital power;
  • Focus on non-negotiable, existential issues in support of the rule of law;
  • No formal declaration of his intention to seek re-election as President of France.
• Brussels has taken the first steps to ensure Europe's gig workers -- which include Uber drivers and Deliveroo riders -- enjoy the same labour rights as other traditional employees. The European Commission unveiled draft rules on Thursday that would see digital platforms automatically reclassified as employers.
• That would compel them to ensure staff have the right to a minimum wage, paid leave and unemployment insurance. Up to 4.1 million gig workers could be affected by the legal change.
• Greece is facing its fifth and deadliest wave of the pandemic, with unprecedented numbers of people testing positive and the number of COVID-related deaths soaring. Last Monday, the daily number of cases hit a record 7,335 — the highest since the beginning of the pandemic. Yet unlike other European countries facing a spike in cases, Greece has a relatively high overall vaccination rate of around 63 per cent. A region-by-region comparison, however, shows wildly fluctuating rates in different parts of the country. In the north, for example, the percentage is well below 50 per cent. Vaccination skepticism, conspiracy theories, and a disdain for authority are thought to be the main culprits. Members of the anti-vaccine movement in Greece are exceptionally vocal and have not hesitated to take matters to the street.
• 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.
• Under proposed new legislation in the UK, non-Irish EU citizens living in the Republic of Ireland will have to apply online for pre-travel clearance to cross the Irish border. The bill, now working its way through Westminster and due to come into effect in 2025, has been criticized by Sinn Féin, the SDLP and Alliance. It is part of the UK's attempt to control immigration post-Brexit. It has passed the House of Commons but has yet to be voted on by the Lords.
• The measure would require all non-Irish EU citizens - and those from Norway, Liechtenstein and Iceland - living in the Republic of Ireland to apply for an electronic travel authorization (ETA) to cross the border.   They will require a US-style waiver known as an Electronic Travel Authorisation (ETA) to cross the border as part of the new post-Brexit immigration nationality and borders bill. The scheme is expected to come into force in 2025 but has already been denounced as “unworkable” on the Irish border, where thousands of people commute in both directions for schools, work and shopping.
• The International Trade Committee have met to review the impact of the Northern Ireland Protocol on trade between Britain and Northern Ireland.
• The National Audit Office has warned government trade negotiators to not be ‘stretched too thin’ to ensure the UK gets the best out of post-Brexit agreements.
• The Department of International Trade has published an overview of the meeting between the International Trade Secretary, Anne-Marie Trevelyan and US Trade Representative, Katharine Tai.
• Government advisers have warned that the Omicron variant could lead to 1,000 hospital admissions a day.
• Downing Street has said the Omicron variant is more transmissible than the current Delta strain.
• The NHS is expected to employ 52,000 vaccinators and volunteers to help administer booster vaccines across the country.
• Three major cancer hospital trusts saw waiting time standards hit a new recorded low.
• The NHS has struggled to increase the rate of private sector activity to support the response to the elective backlog.
• Cases of the Omicron variant could be spreading even faster in England than in South Africa, according to a senior scientific adviser, who warned that the variant was a “very severe setback” to hopes of bringing the pandemic under control. Prof John Edmunds, an epidemiologist at the London School of Hygiene and Tropical Medicine and a member of the government’s Scientific Advisory Group for Emergencies (Sage), said that plan B measures announced by the prime minister were “absolutely not an overreaction” even if Omicron turned out to be milder than the current dominant variant.
• 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.
• In Germany, Karl Lauterbach has been appointed as new health minister. The SPD health politician, physician and health economist Prof. Dr. Karl Lauterbach is the successor to Jens Spahn (CDU). Lauterbach has been a member of the Bundestag since 2005 and has gained widespread public recognition since the start of the COVID 19 pandemic.
• On November 24, 2021, the leaders of the SPD, the Greens, and the FDP presented the coalition agreement for the new “traffic light” (red-yellow-green) federal government without CDU participation. The title of the 177-page contract is “Daring More Progress.” The new federal government wants to be an “alliance for freedom, justice, and sustainability.”
• Olaf Scholz, the current vice chancellor and SPD top candidate, was elected German chancellor on December 8, 2021. SPD politician Bärbel Bas is the new president of the German Bundestag.
• The German Standing Vaccines Commission (STIKO) has provisionally recommended that five to 11-year-old children with pre-existing conditions be given Covid shots - though healthy children should also be able to get vaccinated. In a draft resolution released on Thursday, STIKO said the Covid vaccine would be recommended both for younger children with vulnerabilities and those who have contact with at-risk individuals, such as a parent with health problems.
• If five to 11-year-olds don’t fall into either of these groups, it will still be possible to get vaccinated against COVID on request and after a medical consultation with a doctor, the draft stated. The experts’ resolution is now due to be circulated among states and clinical societies before it is finalized, so changes are still possible at this stage.
• Germany moved on 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.
• This week, December 9, another round of talks is being held by new Chancellor Scholz and state leaders. Topics of focus include speeding up booster vaccinations and response to the Omicron variant. Germany is recommending a COVID booster shot for everyone over the age of 18.
• 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.
• 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.
• German Chancellor Scholz’s first official trip outside of Germany will be to Paris.
• Far-right French presidential candidate Eric Zemmour has been attacked at his first campaign rally. As the 63-year-old moved through the crowd to the stage, a man briefly grabbed him by the neck before security officers intervened. Local media report his wrist was injured and that his doctors have ordered nine days of rest. The former journalist and pundit is known for his controversial views on migrants and World War Two.
• Jersey has given permanent licenses to more French fishing vessels in a move that should ease tensions that have bubbled up between France and the UK. A further nine French boats have moved from temporary to permanent licences, following the receipt of more data. France, which had given Jersey an ultimatum, was previously frustrated by a decision by the UK and Jersey to deny fishing licences to dozens of French boats. "We have always been clear that this process is based purely on data and evidence," said deputy John Young. Previously these nine boats had temporary licences, but this changed when they gave the authorities more information, meaning 125 French boats can now fish in and around Jersey.
• Recent figures place the number of Omicron variant cases in France at only 40.
• 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