COVID-19 Outbreak: Weekly Global Report for Friday, October 15, 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 240 million. Deaths around the world have exceeded 4.9 million. Around 6.5 billion vaccines have been administered.
• U.S. cases exceeded 44.7 million with deaths increasing to 721,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Overview of China’s containment strategy: Despite a massively efficient vaccine roll-out since May, the Chinese government has given no indication it intends to change its current COVID playbook of closed borders, strict two-week quarantine for foreign arrivals, and aggressive lockdowns and mass testing when flareups arise. Beijing remains ever cautious as the Delta variant circulates worldwide and the efficacy of China’s vaccines is questioned. Many businesses expect that China may retain stringent travel restrictions through at least February 2022, when Beijing will host the Winter Olympics.
• Status of the vaccination campaign: 1.09 billion Chinese citizens (77% of the population) have received at least one COVID vaccine dose as of this Monday, according to the National Health Commission (NHC). Among them, nearly 970 million have been fully vaccinated with two shots. About 162 million doses of Covid vaccines have been given to minors ages 12 to 17. The NHC recently said it would allow some groups of people at higher risk, including those 60 or older, to take a booster shot six months after full vaccination. The decision was based on data from domestic vaccine makers Sinovac and Sinopharm on the performance of their inactivated-virus vaccines after six months.
• Adolescent vaccinations: China has fully vaccinated 91% of students aged 12-17 against the coronavirus, state television reported on Wednesday, although authorities said schools need to be vigilant. China's two main vaccines have been approved for use in children from the age of three but authorities in charge of the vaccination rollout have yet to make children under 12 eligible. The education ministry said in a statement that schools should not be complacent and implement anti-COVID measures in a more efficient and targeted manner.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 108,661, an increase of 124 cases over the previous week. The number of reported deaths remained unchanged at 4,849.
• China’s vaccines and approval date: Sinopharm (approved Dec. 31, 2020); Sinovac’s CoronaVac (approved on Feb. 5); CanSino Biologics and a second Sinopharm vaccine (both approved in April). Three other vaccines have been approved in May and June.
• China updates its mass testing protocol: In a city with a population greater than 5 million people, mass testing shall now be completed within three days, according to the updated protocol issued by the National Health Commission. The time limit was set at three to five days for cities of the same size in the previous protocol introduced in February. For cities with less than 5 million people, the time limit for completing city-wide testing remains unchanged at two days.
• Chinese airports toughen up quarantine rules: Airports around China are lengthening the amount of time some international aircrews and ground staff must spend in quarantine, after containment breaches sparked community spread of the highly infectious delta variant in several regions. Some regional regimes will see airport workers judged to be a higher risk isolated for up to 28 days after two weeks of work. These represent far tougher restrictions than those currently mandated by the country’s national aviation authority.
• Post-COVID healthcare system upgrade: China will provide funding to build new institutions and infrastructure to fight infectious diseases and improve healthcare, the state planning body said in a "five-year plan" for the sector. The central government will subsidize the construction of new "prevention bases" for infectious disease and new grassroots medical facilities across the country, the National Development and Reform Commission (NDRC) said in the plan, published this Thursday. It said China was facing difficult healthcare challenges, including new emerging infectious diseases, the increasingly heavy burden of chronic illnesses as well as the growing need for mental health services. "The public health system is in urgent need of improvement, and the ability to prevent, control and treat major epidemics is not strong," it warned. High-quality medical resources are also insufficient and not evenly distributed, and there are also gaps when it comes to treating women and children, it added.
• BioNTech vaccine: Chinese regulators completed an expert review of a COVID-19 mRNA vaccine developed by Germany's BioNTech and Fosun Pharma and the shot is now in the administration review stage, Caixin reported. China hasn't approved any COVID-19 vaccine developed overseas but has greenlighted several domestic brands. Chinese authorities plan to use the vaccine, which goes by the brand name Comirnaty, as a booster shot for people who have received inactivated-virus vaccines, people close to regulators told Caixin. Most people in China have received inactivated-virus vaccines made by Sinovac and state-owned Sinopharm Group that have demonstrated lower efficacy than mRNA vaccines.
• China’s own mRNA vaccine: China’s first messenger RNA (mRNA) COVID-19 vaccine, is expected to start phase three tests in many overseas countries soon, the chief executive officer of Suzhou Abogen Biosciences, the vaccine’s developer, said this week. Together with Chinese clinical contract research organization Tigermed, Abogen is preparing to conduct overseas Phase III clinical trials using 28,000 volunteers in countries including Mexico, Columbia and Pakistan. The vaccine can be stored at temperatures of between two and eight degrees centigrade for at least seven months, making it convenient for mass distribution. The clinical trials will not select specific variants, and will also not reject any strains, Ying told Yicai Global. The Suzhou, eastern Jiangsu province-based firm is also developing a separate mRNA vaccine candidate that will target the variants that were first found in South Africa and India.
• Vaccine diplomacy: CCP General Secretary Xi Jinping pledged to provide two billion doses of COVD-19 vaccines to the world by the end of this year. Xi also declared that the COVAX global vaccine distribution initiative would receive a donation from China of $100mln. China has already supplied over 770 million vaccine doses to other countries, according to the Ministry of Foreign Affairs.
• China’s economy: China's factory and retail sectors faltered in August with output and sales growth hitting one-year lows as fresh coronavirus outbreaks and supply disruptions threatened the country's impressive economic recovery. Industrial production rose 5.3% in August from a year earlier, narrowing from an increase of 6.4% in July and marking the weakest pace since July 2020, data from the National Bureau of Statistics showed on Wednesday. Output growth missed the 5.8% increase tipped by analysts. Consumer spending also took a big hit from rising local COVID-19 cases and floods with sales rising only 2.5% in August from a year ago, much lower than the forecast 7.0% rise and the slowest clip since August last year.
• US will limit some Chinese passenger air carriers to 40% capacity: The US Transportation Department said it will limit some flights from Chinese carriers to 40% passenger capacity for four weeks after China imposed similar limits on four United Airlines flights. China told United on August 6 it was imposing sanctions after it alleged five passengers who traveled from San Francisco to Shanghai tested positive for COVID-19 on July 21. The US order said the department will limit over a four-week period each of four Chinese carriers to 40% capacity on a single China-US flight. United Airlines said it was "pleased to see this action by the (Transportation Department) in pursuit of fairness in this important market." The US government says China's "circuit breaker" policy violates the nations' air services agreement and "places undue culpability on carriers with respect to travelers that test positive for COVID-19 after their arrival in China." The limits come as many Chinese students are headed to the US for the start of fall classes.
• USTR unveils its China trade strategy: S. Trade Representative (USTR) Katherine Tai in public remarks this Monday said the United States and China would soon resume formal engagement on trade. In her first major speech on China trade policy, Tai said Washington and Beijing would revisit the Phase One trade deal – due to expire at the end of the year – and said the administration planned to press China on its purchase and structural reform commitments under the deal. USTR is also now expected to commence a "targeted" tariff exclusion process, focused initially on tariffs that most directly harm U.S. economic interests. The administration left open the possibility of further tariff exclusion processes, but the tariffs imposed by the Trump administration will remain in place for the time being.
• S.-China relations: The United States and China have reached an agreement in principle to hold a virtual summit before the end of the year, U.S. officials told reporters yesterday. The comments on a prospective virtual summit between U.S. President Joe Biden and Chinese President Xi Jinping came after a six-hour meeting between White House National Security Advisor Jake Sullivan and senior Chinese diplomat Yang Jiechi in Zurich. U.S. officials described the Zurich meeting as more meaningful and substantive than previous engagements with Chinese counterparts, and Chinese state media characterized the talks as "constructive, and conducive to enhancing mutual understanding." Officials have not yet suggested a date for the proposed virtual summit.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics:  34,019,680 total cases, 206,586 active cases/451,435 deaths/discharged 33,362,709 (John Hopkins and MoHFW) as compared to 33,894,312 total cases, 244,198 active cases/449856 deaths/discharged 33,200,258 (John Hopkins and MoHFW) last week. 968,220,997 people have been vaccinated. The total COVID-19 vaccine doses administered in the country crossed 95.82 crore on Monday as 59 lakh more jabs were given during the day, the Union Health Ministry said. The daily vaccination tally for Monday is expected to increase with the compilation of the final reports for the day by late night, the ministry said.
• World Health Organization (WHO) has recommended that all immune-compromised patients should get a third dose or booster shot of a vaccine against Covid-19. According to Subject Advisory Group of Experts (SAGE) of the UN health body, moderately and severely immunocompromised people should be offered an additional dose since they are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of contracting severe Covid-19.
• Covid vaccinations for children and adolescents can turn out to be a game changer and enable return to normalcy among the young population, said public health experts. The Drugs Controller General of India on Tuesday, October 12, granted the Hyderabad-based drug maker Bharat Biotech's Covaxin an emergency use approval for children in the age group of 2 to 18 years. The Subject Expert Committee (SEC) gave positive recommendation for use of Covaxin in the 2-18 years age group. The decision comes after a thorough review of Bharat Biotech’s submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO.
• The recommendation of the subject expert committee (SEC) for the grant of marketing authorisation for Bharat Biotech's Covaxin for 2-18-year-old children has put the fate of Zydus Cadila vaccine rollout in question, as the price of the vaccine seems to be holding up its induction in the vaccination programme. Zydus Cadila has the drug regulator's emergency use authorisation to administer its Covid vaccine, ZyCoV-D, in children aged 12-18 years.
• India's Everest Organics Ltd on Tuesday, October 12, said that it had started making the active pharmaceutical ingredient (API) for a generic version of Merck & Co's experimental antiviral drug molnupiravir to treat mild to moderate COVID-19. Shares of Everest Organics jumped as much as 11.6% after the news came in, and were last up 9.9% at 330 rupees in a weak Mumbai market.
• Hyderabad-based pharmaceutical company Biological E has sought permission from India's drug regulator to conduct the phase-3 clinical trial for its COVID-19 vaccine Corbevax as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin. Currently, phase 2/3 clinical trials of the second indigenously developed Corbevax, an RBD protein sub-unit vaccine to be administered in adults aged 18 years to 80 years, is underway and the results are likely to be declared this month.
• After almost nine months since India began inoculating its adult population for Covid, the wait for childrens’ vaccines seems to be over. But without any guidelines from the Centre for vaccinating the paediatric age group, the wait could be a bit longer, say experts.
• Scientists working in a public laboratory in Mumbai have come up with a rapid test to ascertain if a person has silicosis, a progressive lung disease caused by exposure to silica. The kit – which detects levels of serum CC16 in blood — is the result of a collaboration between the Mumbai team of the National Institute of Virology (NIV) and the National Institute for Occupational Health.
• India has exported Covid vaccine doses to Myanmar, Nepal, Bangladesh, and Iran, sources informed on Sunday. According to sources, Myanmar, Nepal, and Bangladesh received ten lakh doses of Covishield each, while Iran received three lakh doses of Covaxin. Earlier, on September 20, the Government of India had announced its decision to resume the export of vaccines against the coronavirus disease (Covid-19) from October.
• The government has permitted the export of Russia's single-dose Covid-19 vaccine Sputnik Light domestically produced here as the jab has not yet been approved for emergency use in India, sources said on Sunday, October 10. Indian drug firm Hetero Biopharma Limited has been allowed to export 40 lakh doses of Sputnik Light to Russia
• With the Centre having told all states to ramp up testing, the Indian Council of Medical Research (ICMR), which has approved three home-based test kits, has left it upon states to take a call on them. While these kits are being used, many states have continuously been stressing on RT-PCR and antigen tests ahead of the festive season.
• If the regulations on a 12-16 week gap between the first and second shots of Covishield remain unchanged, at least around a quarter of India’s adult population will not be able to get fully vaccinated by the end of this year. As of 7pm on Friday, October 08 over 26 crore of the 94 crore adults or about 28% had not got even their first shot. Almost 90% of vaccination has been through Covishield, and there are only 12 weeks left in the year.
• India has informed the UN that it will ramp up its production capacity as new Indian vaccines come on stream, emphasising that the supply chains of raw materials must be kept open as Covid-19 vaccines need to reach every corner of the globe. India's Permanent Representative to the UN Ambassador T S Tirumurti on Friday said that India has provided medical related assistance and subsequently, vaccines to numerous countries all over the world.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,713,684 total reported cases and 18,069 total reported deaths compared to 1,709,214 reported cases and 17,874 reported deaths last week.
• Japan’s new case numbers are declining rapidly. Serious cases have fallen by half over the last month, and hospitalizations have plummeted from a high of just over 230,000 in late August to around 31,000.
• The Japanese government lifted the COVID-19 state of emergency covering 19 prefectures including Tokyo at the end of September. The emergency mainly involved requests for restaurants and bars to reduce their hours and not serve alcohol. With the lifting, Japan is free of emergency requirements for the first time in more than six months.
• After a comparatively slow start, Japan's vaccination program has picked up speed, with 66.2% of the population now fully vaccinated.
• Japan plans to start administering third doses of COVID-19 vaccine in December to those who had their second doses at least 8 months ago.
• Japan is easing its quarantine restrictions for travelers entering the country who been fully vaccinated with the Pfizer, Moderna, or Astra Zeneca vaccines. They will no longer be required to self-isolate in designated facilities for 3 days before completing a 14-day quarantine. Instead, they will need to self-quarantine at home for 10 days and then pass a PCR test.
• Japan has agreed to buy 150 million doses of Novavax's coronavirus vaccine, with Japanese firm Takeda expecting to manufacture the formula for distribution early next year.
• Japan provided final approval to the Moderna vaccine and the Astra Zeneca vaccine on May 21. The Pfizer vaccine was approved in February. J&J submitted its application for approval of its vaccine on May 24. It is expected to be approved and available for use around the beginning of 2022.
• The Japanese government continues to maintain its controls on foreign nationals entering the country. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam remain suspended. Tokyo’s restrictions on foreign entries except for returning nationals remain in place.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org).

Korea

• South Korea has 1,937 new COVID cases, which is a decrease from last week. The country has not seen dramatic spikes recently, but the persistence of cases in the current ranges is a concern. The numbers remain overall low.
• Korea now has 337,679 total cases, 31,3423 active with 2,618 deaths. Total cases per million population have remained low compared to most of the world but Korea is now above the 6K threshold with 6,579 cases per million. (S. Korea ranks still as one of the lowest among the more highly populated countries). Deaths per million remain comparatively low as well at just 51.
• South Korea officials credit strict social distancing measures as the reason they are not seeing greater or more dramatic spikes.
• Some restrictions have been eased to give leeway to vaccinated people and allow more students to take in-person classes to mitigate the prolonged pandemic's impact on the local economy.
• Korea continues to improve its vaccination numbers. A total of 70,348,260 doses have been administered. 61.6% of the population is now fully vaccinated, and another 16.7% have received their first dose.
• With the country's vaccinations gathering pace, the government is considering a gradual shift to a phase of "living with COVID-19" starting in November, under which COVID-19 is treated as an infectious respiratory disease, like seasonal influenza, with eased distancing being implemented.
• Moderna has approved the domestic use of its COVID-19 vaccines to be produced by its South Korean business partner Samsung Biologics, two sources directly involved with the matter said, Thursday.
• While chances are low the mRNA-based biotech Moderna will let Samsung Biologics handle the total distribution process of its vaccines to be manufactured at Samsung's facility in Incheon's Songdo, Moderna's approval for the domestic use of its vaccines will be a huge plus in terms of backing Seoul's efforts to increase the local vaccination rate, and plans for initiating a round of booster shots for people in their 60s after their initial immunization, they said.
• A major umbrella labor union said Thursday it will hold a large-scale rally in central Seoul next week when its members walk off their jobs for a one-day general strike to call for the enhancement of labor rights. The Korean Confederation of Trade Unions (KCTU), one of the country's two umbrella labor organizations, said it will push ahead with its plan to stage a strike on Wednesday next week.
• Wrongly administering COVID-19 vaccines into blood vessels instead of the muscles could be behind the serious side effects, some studies have suggested.
• An Aug. 2 report published by the Journal of Korean Medical Sciences is one of the first in the country to suggest that technique known as aspiration -- which is pulling back on the syringe plunger before injecting the vaccine to ensure no blood vessel is accidentally punctured -- may provide better chances of avoiding side effects.
• The report looked at Korea’s first and only fatal case of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome, or TTS, in a 33-year-old man who received AstraZeneca’s vaccine. He died 19 days following his first vaccination in June, after developing blood clots in the brain called cerebral venous sinus thrombosis.
• Foreigners arriving at South Korean airports face a mandatory 14-day quarantine procedure and must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation. However, some people who have been vaccinated against COVID-19 in countries other than Korea will be exempt from the 14-day self-quarantine requirement, meaning they can move around freely as soon as they enter the country. A similar exemption has been in place since May for those who were vaccinated in Korea.
• The exemption applies only to people who were fully vaccinated at least two weeks before traveling to Korea. It also applies only to those who have received a COVID-19 vaccine that is approved for emergency use by the World Health Organization. The list includes those from Pfizer, Janssen, Moderna, AstraZeneca, Sinopharm and Covishield. All international arrivals still have to show a negative result from a COVID-19 test taken within 72 hours of departing for Korea. Without one, you can still be refused entry.
• The exemption also only applies to those visiting Korea for business or academic purposes, for the public interest or to visit immediate family members. Otherwise, you still have to self-quarantine for two weeks upon entry. Immediate family members are defined as spouses, lineal ascendants or descendants, and lineal ascendants or descendants of spouses. You will have to fill out forms and prove your intent to visit them. The necessary forms are available online from Korean embassies and consulates abroad or other government agencies.
• Those coming from countries experiencing the spread of certain COVID-19 variants are also ineligible for this exemption.
• For a list of current travel and entry restrictions, see the following link: https://www.koreaonlinevisa.com/travel-restrictions/.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

 

Cases

• ASEAN now has 12,667,771 total reported cases compared to 12,401,505 total reported cases last week. It has a total of 270,661 reported deaths compared to 266,709 reported deaths last week.
• Cases continue to drop significantly across the ASEAN region with the exception of Singapore, which has recently suffered from a renewed outbreak. ASEAN added its lowest number of new cases last week since the end of June.  The region added 266,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: New cases continue to fall rapidly to extremely low levels. Indonesia is now reporting 4,232,099 total cases and 142,848 total deaths compared to 4,224,487 total cases and 142,494 total deaths the previous week. Indonesia accounts for 53% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: Malaysia is preparing to shift into an endemic COVID-19 phase where it will not impose wide lockdowns again if cases rise. The number of new cases has dropped significantly in the past month. Those vaccinated may now dine in restaurants, reopen businesses, and visit salons. Total reported cases have grown from 2,303,837 to 2,361,529 over the past week. Total deaths have grown from 26,981 to 27,593 over that time.
• Thailand: The number of new cases is holding steady. Total reported cases grew from 1,678,297 to 1,751,704 over the past week and reported deaths have increased from 17,418 to 18,029 over that time.
• Philippines: Cases in the Philippines are moderating slightly.  The Philippines is now reporting 2,698,232 total cases, up from 2,632,881 total cases the previous week. Total reported deaths have increased from 38,937 to 40,221 over that time.
• Vietnam: Total reported cases of COVID-19 infection grew from 826,837 to 849,691 over the past week. Total reported deaths grew from 20,223 to 20,869 over that time. Authorities have permitted Ho Chi Minh City to carefully begin relaxing social distancing measures and to gradually reopen. The city will also license businesses and production facilities to resume operations provided that they meet safety requirements.  
• Singapore: The number of new cases in Singapore continues to grow, and is up nearly 50% since early September. The country has paused the easing of social restrictions amid growing case numbers, despite an 80%+ vaccination rate. Total reported cases increased from 113,381 to 135,395 over the past week. The total number of deaths increased rose from 133 to 192 over that period.
• Cambodia: Total reported cases increased from 114,148 to 115,875 over the past week. Total reported deaths grew from 2,441 to 2,584 over that period.
• Laos: Laos reported a growth in total cases from 26,462 to 30,615 over the past week. It reported 36 total deaths, up from 23 last week.

Vaccinations

• Indonesia is now vaccinating 2 million people daily. The country authorized the Pfizer vaccine for emergency use on July 15. It will be given to Indonesians aged 12 years and up. It has been administering the Sinovac and AstraZeneca vaccines. Only 21.7% of the population is fully vaccinated.
• Malaysia has increased its vaccination rate sharply in recent weeks. It announced that it will stop using China’s Sinovac vaccine in favor of the Pfizer shot. Mass vaccinations began on February 24 using the Pfizer vaccine and the government aims to vaccinate 80% of its 32 million population by next February. So far, it has fully vaccinated 67.2% of its population. One million doses of the Pfizer vaccine donated by the U.S. arrived in Malaysia on July 5.
• The Philippines began its immunization program after receiving its first batch of the COVID-19 vaccine (600,00 doses of Sinovac Biotech's CoronaVac, donated by China). It is due to receive another 25 million doses of CoronaVac this year. 
• However, there is little public support for the inoculation drive. Polls show that fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 22.4% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 84% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 34.8% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available.
• Thailand's Food and Drug Administration has approved Siam Bioscience as a manufacturing facility for the COVID-19 AstraZeneca vaccine. Thailand plans to export the vaccines to eight Southeast Asian countries.
• Vietnam’s health ministry said the country will have nearly 125 million doses of Covid-19 vaccines this year. The total includes 5 million doses from Moderna, 20 million doses of the Sputnik V vaccine, and 31 million doses of the vaccine developed by Pfizer. Vietnam will also acquire 30 million AstraZeneca doses and 38.9 million doses through the Covax initiative.  The U.S. shipped 2 million doses of the Moderna vaccine to Vietnam in July. The country has fully vaccinated only 16.9% of its population to date. Meanwhile, a Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
• Cambodia: According to the Cambodian authorities, the government has vaccinated over 98% of the target adult population of 10 million and 88% of the 12-17 age group of nearly two million, which is 72% of the country’s population. It just kicked off a campaign to vaccinate 6-11 year-olds. According to third party sources, somewhere between 72.6% and 78.2% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore debuted its vaccinated travel lane, opening up quarantine-free visits to travelers from Germany and Brunei (travelers from China, Taiwan, and Hong Kong were already eligible for quarantine-free travel).  Singapore will ease quarantine requirements for visitors from other selected countries, including the U.S. and U.K., from 14 days to 10 days.
• Singapore and Hong Kong agreed to drop their travel bubble that had been scheduled to start May 26 due to an outbreak of cases in Singapore.
• Indonesia: The quarantine period for international visitors has been cut from eight days to five days. Indonesia reopened international flights to Bali on October 14 for foreign visitors from countries with a positivity rate of less than 5% and who have been fully vaccinated against COVID-19.
• Thailand announced it will waive its mandatory quarantine requirement in Bangkok and nine regions beginning this November to vaccinated arrivals. Authorities will also reduce the quarantine time nationwide for visitors arriving in October. The Prime Minister indicated that he is aiming to fully reopen Thailand on November 1st to vaccinated foreign tourists from at least ten countries, including the United States and Singapore. The tourists would be allowed to enter all regions in Thailand by air with no quarantine requirements. He pledged to target additional low-risk countries to join in the following months. 
• 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.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

• Europe is trending overall positive in most of its larger countries. However, the UK and Russia are notable exceptions. The UK’s early COVID success has now deteriorated to where is consistently in the lead for new cases in the EU, by a wide margin. Increasing deaths per day in the UK are also concerning. Russia remains high as well, second worst in the EU, and its deaths per day are now consistently the worst reported figures in Europe.
• The UK’s deaths per day and death rate (deaths per million) have also increased substantially. France and Italy’s improvements can be said to be a solid trend. Spain continues to look good as well. Experts believe the situation in Russia is worse than reported due to significant under-reporting.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 5,187 (4,946); Spain 1,931 (2,303); Russia 31,299 (25,133); UK 45,066 (39,851); Italy 2,668 (3,230); Germany 3,129 (11,604); and Belgium 3,667 (1,730).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed by France, Spain, Italy and Germany. Poland, Ukraine, Netherlands and Czech Republic round out the top ten.
• In terms of cases per million in Europe, Czech Republic is the 5^th highest in Europe with 158,003. The UK has risen to 10^th, with 121,701. Netherlands is 12^th with 118,522; Sweden is 13^th with 114,073. Belgium, France and Spain are 14 – 16. (see numbers in chart below). Italy continues to be a winner in this group with just 78,043 cases per million (30th).
• The UK is now fourth worst in the world in terms of total cases, behind USA, India, and Brazil. Russia is fifth worst in the world in total cases.
• In terms of deaths per day, Russia remains very high compared to the rest of Europe, at 986. Russia’s consistent lead in deaths per day is in contrast to some of its other reported numbers, and is one factor experts cite to indicate the Russian numbers are being significantly under reported. Ukraine, Romania, UK and Poland comprise the remaining top 5 countries in Europe in deaths per day.

• In terms of deaths per million, Belgium is the 19th worst in the world with 2,200. Italy is 20th, with 2,178. The UK is now 25^th with 2,023. Other rankings in this category are Spain, 30th, and France 33rd. (The US ranks 18^th with 2,219 deaths per million).
• The figures for new deaths per day (which tend to lag any increased infection rates) are as follows:  Russia 984 (929); UK 136 (143); France 23 (34) Spain 42 (57); Italy 37 (39); Germany 82 (80)); Belgium 18 (8).
• Germany continues to lead Europe in the number of vaccine doses administered with over 109 million doses, and 64.8% fully vaccinated. France is second in Europe with over 96 million doses administered and 66.9% fully vaccinated. The UK is third in Europe with almost 95 million doses, just over 66% fully vaccinated. Italy has administered almost 87 million doses and is 69.5% fully vaccinated. Spain is now at almost 71 million doses, just over 79% fully vaccinated. These numbers continue to increase.
• European Union guidance (nonbinding) has recommended a pause on all non-essential travel from the US as Covid-19 cases surge. The recommendation is nonbinding, meaning individual countries will be allowed to decide if they still wish to allow US visitors with proof of vaccination, negative tests, or quarantine.
• The World Health Organization (WHO) has suspended the approval process for Russia's Sputnik V COVID vaccine. A regional WHO official said the manufacturing process of the jab had not met the necessary standards. Russia first applied for approval from the WHO for their vaccine in February but has not yet received an Emergency Use Listing (EUL).
• Here is a link to a regularly updated article describing in detail the latest on EU travel restrictions: https://www.euronews.com/travel/2021/09/30/what-s-the-latest-on-european-travel-restrictions.
• All EU Member States are issuing and verifying a COVID Digital Certificate in a bid to boost tourism across the region this summer and beyond. The pass is proof that a person has:
  • Been vaccinated against COVID-19
  • Tested negative for COVID-19
  • Recovered from COVID-19
• The certificate is an EU-wide scheme for travel within the EU, and is available in digital or paper form, free of charge. https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en. EU citizens and their families, and legal EU residents, may use it. There are discussions underway to allow US and UK citizens to obtain and use the digital certificates.
• The European Medicines Agency has back Pfizer or Moderna booster shots for people with weak immunity.
• Eastern European countries with below-average COVID vaccination rates are facing a surge in infections, data from the European Centre for Disease Prevention and Control (ECDC) show. According to the latest data released on Thursday, the 14-day incidence rate for COVID-19 infections amongst the 31 countries of the EU/EEA is 166.5 cases per 100,000 inhabitants.
• The rates are well above average in eastern European countries, including in the Baltics — where they range from 859 cases per 100,000 inhabitants to 972.2 — and in Romania, Slovenia, and Bulgaria, where the rates respectively stand at 858, 555, and 403 cases per 100,000 population.
• All these countries have below-average vaccination rates. Some 74.7 % of adults in the EU/EEA are fully vaccinated, according to the ECDC. In the Baltics, Lithuania has the highest vaccination rate with 70.2% of the population aged 18 and over now fully protected while neighbour Latvia has the lowest at 52.2%.
• Slovenia has also fully inoculated over half of its adult population but in Romania and Bulgaria, the rates fall to just 34.8% and 23.6% respectively.
• The European Parliament has voted to approve reforms to the EU's Blue Card Directive, designed to facilitate the employment of highly skilled workers from outside the bloc and help plug the gap where labour shortages exist in certain sectors. In what will be the only changes to EU migration law in recent years, MEPs voted 556 in favour of the revisions, 105 against and 31 abstained. Brussels wants to make it easier to attract highly skilled non-EU workers in sectors like healthcare and information and communication technologies (ICT) where significant shortfalls exist.
• 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.
• The UK and EU are starting negotiations on the Northern Ireland Protocol today.
  • On Wednesday, the European Commission published a response to the Brexit Minister, Lord Frost’s requests to change the trade deal with Northern Ireland.
  • Vice President of the European Commission, Maros Sefcovic said  the EU had ‘gone to the limits’ of what it can offer the UK.
• Figures from NHS Digital have revealed that the NHS has a £9.2 billion maintenance backlog, which has grown from £6.5 billion two years ago.
• The NHS and DHSC have published a ‘blueprint’ to help improve patient access to GPs. GPs in England have been told they must meet more patients face-to-face.
• Chief Medical Officer, Chris Whitty has said the NHS is facing an ‘exceptionally difficult’ winter.
• A massive shortage of butchers has led to a backlog of pigs on UK farms. Pig farmer Sophie Hope told Euronews the industry is on the brink of disaster unless the British government acts soon. With EU workers quitting the UK because of Brexit and the COVID pandemic, there is a shortage of butchers in processing plants.
• From Oct. 4, the UK is scrapping its ‘traffic light” system and will implement a two-tier system, with several dozen countries where COVID-19 is widespread classed as red, and the remainder as open.
• There are now just two lists, “red” and “rest of the world.” The UK’s red list has been reduced from 54 to only seven countries, Panama, Peru, Colombia, Dominican Republic, Haiti, and Venezuela.
• Testing requirements will be eased for fully vaccinated arrivals to England from open countries, who will no longer have to take a COVID-19 test before traveling. Travelers will still need a test after landing, but from the end October an inexpensive lateral flow test will suffice, rather than a more sensitive - but pricier - PCR test.
• Unvaccinated travelers will still have to self-isolate for 10 days, as well as taking coronavirus tests before and after their trips. In a boost to tourism, Britain said it will recognize vaccinations given in 17 more countries, including Australia, Canada, Japan and South Korea. It previously had recognized only shots given in the U.K., the U.S. and the European Union.
• A wide range of waiting times data has been released by the British government as part of its return to treatment initiative. The number of people waiting for over a year for treatment in England has reached its highest levels since 2008. The official and detailed data from NHS England on waiting times can be found here: https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/.
• ABHI has conducted a comprehensive analysis of the re-start of elective procedures in each Trust and Health Board in the UK. The results can be found here: https://www.abhi.org.uk/membership/members-area/updates/2020/july/the-restart-of-planned-care/.
• If you are experiencing issues with exporting goods to the UK from the EU, or to the EU from the UK, please let us know immediately and advise the UK’s Border and Protocol Delivery Group at this e-mail address: enquiries@cabinetoffice.gov.uk.
• In Germany, after a messy Election Day that saw ballots moved around the German capital during a marathon, the results are to be reviewed — focusing on two districts.
• In a sitting of the state election committee, Berlin's state returning officer, Petra Michaelis, who has already handed in her resignation, said violations of election rules in two districts could affect the results, and referred the issue to Berlin's state Constitutional Court. The court will now decide whether the elections need to be repeated in the two districts.
• The three parties that made big gains in Germany's national election aim by Friday to have a basis on which to decide whether to move to full coalition talks, the Free Democrats said on Tuesday.
• The Social Democrats (SPD), who came first in last month's election, the Greens and the pro-business FDP have held exploratory talks on whether they have enough in common to form a government together.
• Olaf Scholz has emerged as a leading candidate to succeed Angela Merkel as German chancellor after the Greens and liberals announced their readiness to enter formal coalition talks with his Social Democratic party (SPD).
• The Berlin Senate has voted in sweeping changes to its COVID rules, including new exceptions that will allow certain groups of unvaccinated people into venues that have opted for a 'vaccinated-only' rule. From Sunday, October 10th, people who are unable to get vaccinated for medical reasons will be allowed into so-called ‘2G’ venues, which are usually only open to those who are vaccinated or recovered.
• Germany’s top economic institutes cut their joint forecast for 2021 growth in Europe’s largest economy to 2.4% on Thursday as supply bottlenecks hamper manufacturing, but they raised their prediction for next year.
• BVMed, the German MedTech association, expects the new German government to ensure that the core topics of the future-oriented medical technology industry are also reflected in the coalition agreement for the new legislative period. In the EU Medical Device Regulation (MDR), BVMed is lobbying for an "addendum" in order to establish solutions for the transition periods as well as existing and niche products. In order to strengthen Germany as a medical technology location, BVMed is proposing a "Medtech 2030 Initiative" to the new German government to coordinate measures between research, economic, labor, and health policy.
• According to a recent industry survey by BVMed, the MDR is already having a dramatic impact on the medtech market. More than 70 percent of BVMed member companies have discontinued individual medical devices or entire product lines due to the new MDR regulations. This is the result of a BVMed survey in which 88 member companies participated. More than 55 percent of the companies indicated that previous suppliers have already discontinued their business activities due to the MDR.
• If you are interested in the latest travel, testing and quarantine regulations for Germany, please see the following link: https://www.auswaertiges-amt.de/en/coronavirus/2317268.
• Germany’s version of the EU-wide digital vaccine pass certificates was launched earlier this summer and these can be used as proof of vaccination. Although authorities have stressed that the pass with a QR code does make travel into the country and around the EU easier, it is not compulsory. For activities where some kind of immunity or proof of not having Covid is required, people can also show a paper copy of their vaccine certificate, recovery or test.
• To access the German version of the EU digital pass, people have to be fully vaccinated and can get it from most pharmacies, a doctor or the vaccination centre they got their jabs. People can also get it if they’ve recovered from Covid recently and therefore received one shot. People can use the paper certificate with a QR code on it, or scan it into an app.
• France will take "retaliatory" measures within eight days if the UK does not grant more licenses to French fishermen, the government has warned.
• Secretary of State for European Affairs Clément Beaune told senators on Wednesday evening that "in the next eight days or so, we will announce response measures, retaliation measures, if necessary, national or European, if we do not have concrete British signals on the issue of licences".
• France is threatening to cut electricity supplies to Jersey — an autonomous dependency of the British Crown — and to take action in the financial services and research sectors.
• The French government has proposed to extend the country's COVID-19 state of emergency until July 31 next year. A draft law for the extension will be submitted to France's parliament for a vote, government spokesman Gabriel Attal said on Wednesday.
• The current state of emergency bill in France - allowing the government to impose coronavirus-related restrictions - is set to expire on November 15.
• Under current rules, citizens must use a COVID-19 health pass to access bars, restaurants, cinemas, theatres, and other venues. Speaking after a cabinet meeting, Attal told reporters that the extended state of emergency would help France deal with the health crisis.
• France’s introduction of the health pass has proved a success in dealing with threats posed by both high rates of vaccine skepticism and the Delta variant – while offering Emmanuel Macron a useful political card to play ahead of April’s presidential elections.
• The French government is extending the requirement for a health pass (pass sanitaire) to access most public spaces, possibly until July 31, 2022. The pass is required for anyone seeking to access long-distance transport or venues like restaurants, cafés, bars, cinemas, museums and sports stadiums.
• COVID screening tests in France will no longer be free for unvaccinated people starting on Oct. 15, according to the French authorities, a change that signals a new phase in the government’s strategy to quell coronavirus infections by encouraging people to get inoculated.
• Unvaccinated people will now essentially have to pay to enter cafes, restaurants and theaters, because under a law enacted this summer, entering many indoor venues requires proof of being fully vaccinated, of a recent negative test or of a recent Covid-19 recovery. Tests will remain free for vaccinated people.
• France has made it mandatory to show the health pass – proving that you are vaccinated or have tested negative for Covid-19 – for access to public venues for more than 50 people since July 21. On August 9 the health pass requirements were extended to a range of new settings, including long-distance transport, restaurants and cafés – even France’s outdoor terraces.  
• Any of the following documents can be used as a health pass in France:
  • Proof of having completed a vaccination program (two doses of an EU-approved vaccine: Pfizer, Moderna, AstraZeneca or Johnson & Johnson)
  • A negative PCR or antigen test taken within the last 48 hours
  • A Covid-19 recovery certificate that is less than six months old
  • Anyone who enters an establishment without showing a valid pass can be fined €135 for a first offence.
• Workers who work face to face with the public – for instance at cafés, cinemas or on public transport – are now required to show proof that they are fully vaccinated or have tested negative for the coronavirus in the last 72 hours. It will apply to some 1.8 million workers across the country. Members of the public are already required to carry health passes in order to access eateries and cultural or leisure venues.
• Here is a link to policies related to entry and travel to France: https://www.diplomatie.gouv.fr/en/coming-to-france/coronavirus-advice-for-foreign-nationals-in-france/. (Also see EU section above for updated travel restriction information for any country in the EU, including France).
• Meanwhile, vaccinated tourists from France's "orange" list, which includes the UK, and most countries in Africa and Asia, will no longer need an essential reason to travel. These visitors will be exempt from quarantine but must still present a negative COVID-19 test. Here is a description of the categories and how they work:
  • Red
  • Vaccinated: Inoculated visitors from red countries must provide results of a PCR or antigen test no more than 48 hours old, provide an essential reason for travel, self-isolate for seven days and take a mandatory antigen test upon arrival.
  • Unvaccinated: Those who haven’t gotten their shots have the same requirements as vaccinated travelers from red countries, but their isolation time is increased to 10 days, and their compliance is checked by authorities.
  • Orange
  • Vaccinated: If you’re vaccinated and coming from an orange/amber country, you will need a PCR test no more than 72 hours prior to departure or an antigen test that’s no more than 48 hours old. Travelers can visit for any reason, such as tourism, provided they meet these other requirements.
  • Unvaccinated: Unvaccinated arrivals must observe the same testing requirements as vaccinated travelers under the orange/amber category, but they must also provide a “pressing reason” for travel (i.e., essential travel), take additional tests on arrival and self-isolate for seven days.
  • Green
  • Vaccinated: There are no restrictions if you are vaccinated, and arriving from a country labeled green.
  • Unvaccinated: If you are not vaccinated, you need a PCR or antigen test within 72hrs before departure.
• An online calculator has been launched which will allow people in France to see when they will be able to get the COVID vaccine. The tool was developed by the University of Vienna. https://www.omnicalculator.com/health/queue-pour-vaccin-france.
• If you are experiencing difficulties with exporting PPE from the EU, please let us know immediately. We have not seen any instances of this occurring since an initial incident was resolved.
• If you are having any issues moving medical supplies or medical products from the EU to the UK, or vice versa, please let us know immediately.
• AdvaMed's joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation.
• Resources: https://www.ecdc.europa.eu/en
• https://www.europarl.europa.eu/news/en/headlines/priorities/eu-response-to-coronavirus;
• https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public;
• https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/economy_en;
• https://www.abhi.org.uk/what-we-do/abhi-covid-19-hub/;
• https://ec.europa.eu/commission/presscorner/detail/en/IP_20_582;
• https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html;
• https://www.medtecheurope.org/covid-19-information-hub;
• https://www.medtecheurope.org/resource-library/european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/;
• https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
• https://www.medtecheurope.org/resource-library/eu-materials-covid-19/.
• Med Tech Europe White Paper on Companion Diagnostics under the IVDR: https://www.medtecheurope.org/resource-library/joint-medtech-europe-efpia-white-paper-on-companion-diagnostics-under-the-ivdr/
• Staff Contact:  Joe Gatewood (jgatewood@advamed.org)

Latin America

 

Reuters COVID-19 Tracker – Latin America

 

WHO/PAHO COVID-19 Information