COVID-19 Outbreak: Weekly Global Report for Friday, September 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 a new milestone of 223 million cases. Deaths around the world have exceeded 4.6 million. The countries with the most reported cases continue to be the U.S. (40.6 million), India (33.1 million) and Brazil (20.9 million).
• U.S. cases exceeded 40.6 million with deaths increasing to 654,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: The highly transmissible Delta variant has posed the most severe test of Beijing’s “zero tolerance” policy to date. Confronted with its largest COVID outbreak since the initial outbreak in Wuhan beginning last month, Beijing credits the sharp decline in case counts in recent weeks to its “strict, scientific, and swift measures.” All travel into Beijing from hotspots remains cut off. Mass testing is still underway in a few Chinese cities. The world’s third largest container port, in Ningbo, fully re-opened last week after COVID cases were reported there a few weeks prior. Some observers outside and inside China worry that Beijing’s “zero tolerance” policy approach could have economic downsides.
• 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 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 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,
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 107,329, an increase of 227 cases over the previous week. The number of reported deaths remained unchanged over the previous week, at 4,848.
• 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 reopens terminal at world’s third-busiest port: The Meishan terminal at Ningbo port reopened last Wednesday following a two-week shutdown that further snarled already stressed shipping routes in Asia. The terminal, representing a quarter of the Ningbo-Zhoushan port’s capacity, was shut from Aug. 11 after a worker was found to be infected with COVID-19. This was the second closure of part of a port in China this year due to a COVID outbreak, after the month-long shutdown of Yantian port in Guangdong from late May. With demand for vessels and containers rising this year and companies ramping up exports to Europe and the U.S. for the year-end holiday shopping season, even a limited closure of part of a port is costly for both shoppers and shippers.
• 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.
• Revised U.S. intelligence agency community report on COVID’s origins: U.S. President Joe Biden received a copy of the updated findings and was briefed on the classified report last Tuesday. The intelligence community has been "working expeditiously" to prepare an unclassified version for the public, Psaki said without giving a timeline for its release. U.S. officials say they do not expect the review to lead to firm conclusions after China stymied earlier international efforts to gather key information on the ground. The U.S. report is intended to resolve disputes among intelligence agencies considering different theories about how the coronavirus emerged, including a once-dismissed theory about a Chinese laboratory accident.
• As China continues to push its own lab-leak theory: The South China Morning Post reports that Beijing, in seeking to counter the hypothesis that the virus may have escaped from the Wuhan Institute of Virology, is pushing its own hypothesis that the virus originated from Fort Detrick, about an hour’s drive from Washington and the original home of the US biological weapons program. While most Americans may be unfamiliar with Fort Detrick, hundreds of millions of Chinese netizens are familiar with the Detrick name and its supposed links to COVID-19, mostly thanks to China’s so-called Wolf Warrior diplomats. They have said dozens of times in social media posts and press conferences that Fort Detrick, half a world away from China in the state of Maryland, needs to be investigated as a potential source of the virus.
• China’s economy: China's exports unexpectedly grew at a faster pace in August thanks to solid global demand, helping take some of the pressure off the world's second-biggest economy as it navigates its way through headwinds from several fronts. The Asian giant staged an impressive recovery from a coronavirus-battered slump, but economic momentum has weakened recently due to the Delta variant-driven COVID-19 outbreaks, high raw material prices, slowing factory activity, tighter measures to tame hot property prices and a campaign to reduce carbon emissions. Shipments from the world's biggest exporter in August rose 25.6% year-on-year, picking up speed from a 19.3.% gain in July, customs data showed on Tuesday, pointing to some resilience in China's industrial sector. Analysts polled by Reuters had forecast growth of 17.1%.
• US will limit some Chinese passenger air carriers to 40% capacity: The US Transportation Department on Wednesday 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.
• U.S.-China relations: President Joe Biden spoke by telephone with President Xi Jinping on Thursday evening to underscore U.S. frustration with Beijing’s lack of seriousness in its engagement with American officials to date. The call was the second between the two leaders and comes as the relationship is becoming increasingly adversarial. The American president initiated the conversation after meetings involving his cabinet officials and Chinese counterparts over the past months remained unfruitful, a senior administration official told reporters before the call. Biden’s goal was to see whether personal engagement with Xi could set the relationship on a more serious path and help advance issues where both sides can cooperate, the official said.
  Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – :  33,139,981 total cases, 393,614 active cases/441,749 deaths/ discharged 32,304,618 (John Hopkins & MoHFW) as compared to 32,810,845 total cases, 389,583 active cases/439,529 deaths/ discharged 32,028,825 (John Hopkins & MoHFW) last week. 716,597,428 people have been vaccinated.
• India administered 18 crore doses of Covid-19 vaccines in August, more than what all G7 nations put together did during the month. Japan administered 4 crore doses, USA 2.3 crore, France 1.3 crore, Germany 90 lakh, Italy 80 lakh, UK 50 lakh and Canada 30 lakh, according to data shared by the Union health ministry.
• Stressing that the government if focusing on swiftly ramping up Covid vaccination coverage across the country, Prime Minister Narendra Modi on Monday, September 06 urged healthcare workers to reduce wastage of jabs as it can help save 10% of expenditure on inoculation. The PM was interacting with healthcare workers and beneficiaries of Covid vaccination programme of Himachal Pradesh, which has inoculated 100% of its adult population with at least the first dose.
• Telangana will from Thursday, September 09, start a trial run for delivering vaccines by drones, eventually paving the way for taking this route to healthcare centres in remote parts of the country. Delhi based drone delivery tech firm Skye Air Mobility has tied up with Blue Dart to initiate a three-phase trial for the Telangana government’s “Medicine from the sky” project.
• Data from Indian states, including the latest and fourth national sero survey, shows that children have already got Covid-19 infection at a similar or even higher rate than adults (mostly asymptomatic and with far lower rate of moderate to severe disease). Therefore, they are already protected and not at additional risk,” the advisory says.
• The Indian Association of Preventive and Social Medicine (IAPSM), a consortium of some of the leading public health experts in the country, has strongly advocated reopening all schools in the country. It issued an advisory stating that gains from resumption of academic activities far outweigh the risks involved, and that the government must not wait for vaccination among kids to resume classes.
• The Russian Direct Investment Fund (RDIF) and Panacea Biotec have announced the supply of the first shipment out of one million doses of the second component (human adenovirus serotype 5) of the Russian Sputnik V coronavirus vaccine manufactured by Panacea Biotec for sale in India
• Government released the number of COVID samples that were sequenced every month amidst reports that alleged a decline in genome sequencing and analysis of Covid-19 as cases of disease continued to rise. It was further stated by the authorities that the sequences analyzed in the Institute of Genomics and Integrated Biology are as per the collection date of samples and does not depict the number of samples sequenced in a particular month.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,616,826 reported cases and 16,652 reported deaths compared to 1,232,459 reported cases and 15,555 total deaths three weeks ago.
• Japan’s case numbers appear to have peaked and are now starting to decline. However, they remain high compared to early August.
• The Japanese government extended the COVID-19 state of emergency covering Tokyo and 18 other prefectures to September 30.
• Japan’s Prime Minister indicated that only patients with severe cases of COVID-19 can be admitted to hospitals, based on concerns about growing hospital bed shortages.
• 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.
• After a comparatively slow start, Japan's vaccination program has picked up speed, with around 48 percent of the population now fully vaccinated.
• Japan had been making good progress ramping up its vaccination efforts, but it now faces a shortage of vaccines. About 40% of the population is fully vaccinated. Prime Minister Suga said that his goal is to complete all vaccinations by November.
• 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.
• Moderna will provide 50 million doses of the vaccine by September. It is being used at mass vaccination centers in Tokyo and Osaka, as well as elsewhere. AstraZeneca has contracted to provide 120 million doses, which the government will stockpile for later use.
• The central government has asked companies to reduce the number of workers going to the office by 70% and facilitate telecommuting and staggered commuting hours.
• Prefectural governments are urging hospitals to open up more Covid-19- dedicated beds, which is putting further pressure on patients to avoid elective surgeries.
• The Japanese government continues to maintain its controls on foreign nationals entering the country. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam remain suspended. Tokyo’s restrictions on foreign entries except for returning nationals remain in place.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org).

Korea

• South Korea has 2,047 new COVID cases, which is an increase but consistent with their levels over the last few weeks. The country has not been able to get lower numbers over the summer, but neither has it seen dramatic spikes. The number are slightly increasing, which is a concern, but remain overall low.
• Korea now has 267,470 total cases, 26,207 active with 2,343 deaths. Total cases per million population have remained low compared to most of the world but Korea is now above the 5K threshold with 5,212 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 46.
• South Korea officials credit strict social distancing measures as the reason they are not seeing greater or more dramatic spikes.
• The Seoul metropolitan area, home to half of the nation's 51.3 million population, has emerged as the hotbed of the country's latest wave of the pandemic, accounting for around 70 percent of the total. Health authorities have expressed concerns over a further surge in cases during the fall harvest Chuseok holiday, set for Sept. 20-22, when millions of South Koreans travel nationwide.
• Ahead of the holiday, authorities decided to extend the current virus curbs ― Level 4 in the greater Seoul area, which is the highest in the four-tier system, and Level 3 in other regions ― for another four weeks through Oct. 3, limiting the size of private gatherings and restaurant business hours.
• 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.
• A total of 31.7 million people, or 61.8 percent of the country's population, have received their first shots of COVID-19 vaccines, and 19.1 million people, or 37.2 percent, have been fully vaccinated, the KDCA said.
• The country plans to provide at least one jab to 70 percent of the population by the end of September with hopes of reaching herd immunity in November.
• While 97 percent of people in Beijing have received COVID-19 vaccine injections, Korean diplomats in the Chinese capital seem reluctant to receive the shots. More than half of them, including Ambassador Jang Ha-sung, have not been vaccinated yet, leading to speculation that they are shunning Chinese vaccines.
• According to Ministry of Foreign Affairs data submitted to Rep. Thae Yong-ho of the main opposition People Power Party, only 35 out of 79 diplomats working at the Korean Embassy in Beijing have been vaccinated so far.
• The low vaccination rate there contrasts with that of the Korean Consulate General in Hong Kong. Among 10 Korean diplomats working there, nine have been vaccinated, while the remaining one person also plans to receive the shot within this month.
• As Hong Kong offers Pfizer vaccines unlike mainland China, where Sinopharm or Sinovac vaccines are available, the low vaccination rate of the Korean Embassy in Beijing is leading to speculation that diplomats there are reluctant to receive Chinese vaccines.
• Foreigners arriving at South Korean airports face a mandatory 14-day quarantine procedure and must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation. However, some people who have been vaccinated against COVID-19 in countries other than Korea will be exempt from the 14-day self-quarantine requirement, meaning they can move around freely as soon as they enter the country. A similar exemption has been in place since May for those who were vaccinated in Korea.
• The new exemption applies only to people who were fully vaccinated at least two weeks before traveling to Korea. It also applies only to those who have received a COVID-19 vaccine that is approved for emergency use by the World Health Organization. The list includes those from Pfizer, Janssen, Moderna, AstraZeneca, Sinopharm and Covishield. All international arrivals still have to show a negative result from a COVID-19 test taken within 72 hours of departing for Korea. Without one, you can still be refused entry.
• The exemption also only applies to those visiting Korea for business or academic purposes, for the public interest or to visit immediate family members. Otherwise, you still have to self-quarantine for two weeks upon entry. Immediate family members are defined as spouses, lineal ascendants or descendants, and lineal ascendants or descendants of spouses. You will have to fill out forms and prove your intent to visit them. The necessary forms are available online from Korean embassies and consulates abroad or other government agencies.
• Those coming from countries experiencing the spread of certain COVID-19 variants are also ineligible for this exemption.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

 

Cases

• ASEAN now has 10,740,240 reported cases compared to 9,044,491 reported cases three weeks ago. It has a total of 238,461 reported deaths compared 198,463 reported deaths three weeks ago.
• The number of new cases across the ASEAN region has declined for the past three weeks.
• Indonesia: The pace of new infections in Indonesia has fallen considerably in recent weeks to its lowest level since June. Cases have declined 79% from their July peak nationwide. Indonesia is now reporting 4,153,355 total cases and 138,116 total deaths compared to 3,930,300 total cases and 122,633 total deaths three weeks ago. Indonesia accounts for 58% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: The number of new cases dropped by one-third last week. Companies with 40-59% fully vaccinated workers may now operate at 60% capacity, while companies with 60-79% fully vaccinated workers may operate at 80% capacity, and companies with 80-100% fully vaccinated workers may now operate at full capacity. Fully vaccinated individuals may now quarantine at home following overseas travel, visit long-distance spouses, travel within the country to meet children under 18 years old, and visit houses of worship. Reported cases have grown from 1,489,460 to 1,900,467 over the past three weeks. Total deaths have grown from 13,480 to 19,163 over that timeframe.
• Thailand: The number of total cases has started to trend downward, falling about 30% from two weeks ago. Reported cases grew from 989,859 to 1,338,550 over the past three weeks and reported deaths have increased from 8,586 to 13,731 over that time.
• Philippines: The Philippines added a record number of new cases last week. Manila is under the strictest enhanced community quarantine (ECQ) until September 15 to stem the rise in COVID-19 cases. Under ECQ, only essential sectors such as health, food production, and distribution, banks, energy, telecommunications, airlines, etc. can operate fully. The movement of all persons will be limited to accessing goods and services from and working in permitted establishments.  The Philippines is now reporting 2,161,892 total cases, up from 1,791,003 total cases three weeks ago. Total reported deaths have increased from 30,881 to 34,733 over that time.
• Vietnam: Vietnam continues to experience a high number of new cases. Hanoi extended the city’s COVID-19 restrictions for an additional two weeks. Ho Chi Minh City (HCMC) has extended its tight social distancing rules until September 15. HCMC accounts for half of the infections and 80% of the fatalities. Cases of COVID-19 infection grew from 312,611 to 576,096 over the past three weeks. The total number of deaths doubled from 7,150 to 14,470 over that period.
• Singapore: The number of new cases is rising, and Singapore’s seven-day rolling average of 34 new cases per million is now higher than Indonesia’s (28) and India’s (29). The country announced further restrictions on workplace gatherings, increased testing, and aggressive contact tracing measures. Based on high vaccination rates, up to 50% of Singapore’s workforce can return to in-person working. Reported cases increased from 66,334 to 69,582 over the past three weeks. The total number of deaths increased rose from 46 to 56 over that period.
• Cambodia: Total reported cases increased from 87,190 to 96,935 over the past three weeks. Reported deaths grew from 1,730 to 1,987 over that period.
• Laos: Laos reported a growth in total cases from 11,029 to 16,576 over the past three weeks. It has reported 16 deaths from COVID since the outset of the pandemic, including 7 over the past three weeks.

Vaccinations

• Indonesia authorized the Pfizer vaccine for emergency use on July 15. It will be given to Indonesians aged 12 years and up. The country is currently in the second stage of vaccinations following the vaccination of medical workers in the first stage. It reportedly has 76 million doses of the vaccine on hand. It has been administering the Sinovac and AstraZeneca vaccines. Only 14.7% of the population is fully vaccinated.
• The government revoked its ill-received self-paid COVID-19 vaccination program, following demands that the vaccine should be free for all.
• Malaysia announced that it will stop using China’s Sinovac vaccine in favor of the Pfizer shot. The country approved both AstraZeneca and Sinovac vaccines for emergency use on March 2 after previously approving the Pfizer vaccine. It has granted conditional approval to the J&J vaccine manufactured in Belgium, and on July 16 it granted conditional approval for emergency use to the Sinopharm vaccine. 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 51.6% of its population. One million doses of the Pfizer vaccine donated by the U.S. arrived in Malaysia on July 5.
• The Philippines began its immunization program after receiving its first batch of the COVID-19 vaccine (600,00 doses of Sinovac Biotech's CoronaVac, donated by China). It is due to receive another 25 million doses of CoronaVac this year. 
• However, there is little public support for the inoculation drive. Polls show that fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 14.6% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 79.1% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 15.7% 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 3.9% of its population to date. Meanwhile, a Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
• Cambodia has fully vaccinated more of its population than the U.S. Currently, 55.1% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore 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 and Hong Kong agreed to postpone their travel bubble that had been scheduled to start May 26 due to an outbreak of cases in Singapore.      
• Indonesia has closed its border to foreign nationals to mitigate the increased spread of COVID-19. The policy provides exemptions for holders of diplomatic visas and official visas related to foreign officials at the ministerial level, holders of limited stay permits, and permanent resident permits. 
• Thailand’s Prime Minister announced in mid-June his goal of fully opening the country to foreign visitors within 120 days to pave the way for economic recovery. As of April, Thailand reduced its mandatory quarantine from 14 to seven days for foreigners arriving in the country who have been vaccinated against the coronavirus. Vaccinations must be administered within three months of the travel period and visitors will still be required to show negative COVID-19 test results within three days of their departure. Those not yet inoculated but with coronavirus-free certificates would be quarantined for 10 days.
• Vietnam has temporarily restricted the entry of foreigners and overseas Vietnamese to focus on COVID-19 preventative measures. It has also increased the quarantine period for incoming travelers and close contacts of confirmed cases to 21 days.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

• Europe is having mixed results. As far as increases in cases, we are seeing sharp increases in the UK, Russia and German, and some persistence in elevated numbers in France, albeit at a significantly reduced rate from the prior week. The remainder of Europe appears to have slowed recently in terms of new cases.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 12,828 (17,621); Spain 5,619 (6,818); Russia 18,024 (18,368); UK 38,974 (35,693); Italy 5,919 (6,503); Germany 14,683 (14,615); and Belgium 1,847 (1,854).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed by Germany, France, Italy, Serbia, and Spain. Switzerland, Netherlands and Ukraine round out the top ten.
• In terms of cases per million in Europe, Czech Republic is the 5^th highest in Europe with 156,689. Netherlands is 8^th with 114,179; Sweden is 10^th with 111,710. France, Spain and UK are 12 – 14 (see numbers in chart below). Italy continues to be a winner in this group with just 75,973 cases per million.
• Russia's reported numbers on COVID remain problematic, now just over 7 million, the second most in Europe and fifth worst in the world, behind USA, India, Brazil and UK. Russia deaths per day remain very high compared to the rest of Europe, at 797. The official COVID-19 death toll in Russia now stands at over 189,000, fifth highest in the world behind US, Brazil, India, Mexico and Peru. The real tally for Russia is likely to be much higher. By comparison, Germany, with roughly 3 million fewer cases, reports 92,988 deaths.

• In terms of deaths per million, Belgium is the 15^th worst in the world with 2,183. Italy is 16^th, with 2,149. The UK is 24^th with 1,957. Other rankings in this category are Spain, 28th, and France 30^th. (The US ranks 20^th with 2,014 deaths per million).
• The figures for new deaths per day, (which tend to lag any increased infection rates) are as follows:  Russia 797, UK 191; France 100; Spain 81; Italy 69; Germany 39; Belgium 7.
• Germany continues to lead Europe in the number of vaccine doses administered with over 103 million doses administered, and over 61% fully vaccinated. The UK is second with almost 92 million doses, 64% fully vaccinated. France has now administered over 90 million doses, with just under 62% fully vaccinated. Italy has administered over 80 million does, and is just under 63% fully vaccinated. Spain is now over 66 million doses, (74.3% fully vaccinated). These numbers continue to rapidly 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.
• Though the EU first lifted travel restrictions on Americans in June, the US has kept their ban on European non-essential travel in place since March 2020.
• The European Union has ended its legal dispute with AstraZeneca, announcing a deal to secure the delivery of the remaining doses of the company's COVID-19 vaccine to EU countries.
• AstraZeneca committed to providing 135 million doses by the end of 2021 with the remaining 65 million doses delivered by the end of March 2022. That's in addition to the almost 100 million already distributed throughout this year. In total, the company will provide the bloc with 300 million doses – the figure initially agreed when it signed the contract with the European Commission in August 2020.
• "Today's settlement agreement guarantees the delivery of the remaining 200 million COVID-19 vaccine doses by AstraZeneca to the EU," said Stella Kyriakides, EU Commissioner for health, in a statement. "While this week we reached the important milestone of 70% full vaccination of the EU's adult population, there are significant differences in vaccination rates between our Member States, and the continued availability of vaccines, including AstraZeneca's, remain crucial."
• European Union member states should not make vaccinations compulsory for teachers, according to one of the continent's largest teachers' unions. Despite shots being widely available, Susan Flocken, director of the European Trade Union Committee for Education (ETUCE), told Euronews that not all teachers have had theirs and that they should not be mandatory in any situation. "Vaccination should always be voluntary. We shouldn't force vaccinations. It is important to have the offer to vaccinate and that was one of the main issues at the beginning [of the pandemic]," Flocken said.
• The European Union will return to Africa millions of doses of Johnson & Johnson ’s Covid-19 vaccine that it received from a plant in South Africa, following criticism by health activists that the bloc was taking away shots from a continent that has the lowest immunization rate in the world.
• The EU Digital COVID Certificate is now live. All EU Member States are issuing and verifying the pass 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 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, the Implications for the medical technology industry from the failure of the EU and Switzerland to reach an agreement on a mutual recognition agreement (MRA) include the following:  
  • For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
  • Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognized as valid in the EU.
  • For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorized representative was previously established in Switzerland, must designate an authorized representative established in the EU.
  • On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.
• The following links may be of interest on the Swiss/EU MRA issue
  • EU Commission Announcement and Notice to Stakeholders on the failure to reach agreement-- mdcg_eu-switzerland_mra_en.pdf (europa.eu)
  • Swiss MedTech statement on the ‘downgrade’ of Switzerland to third country status: Swiss medtech downgraded to «third country» status | Swiss Medtech (swiss-medtech.ch).
  • Swiss Medtech summary of current state of play for devices moving into and out of Switzerland from the EU: pdf (swiss-medtech.ch).
  • Swiss schedule for Swiss importers to meet requirements to continue to place devices on the market in Switzerland (initial date is December 2021 for Class III);
    https://www.swiss-medtech.ch/sites/default/files/2021-04/20210401_Brancheninformation_MDR_eMepV_EN.pdf.
    • • While the schedule says ‘not yet passed’ it became effective when the MRA was not renewed on May 26.

• The EU currently allows all travelers with proof of vaccination into the EU, with some restrictions. Please check if you intend to travel as these situations can change rapidly. See link for full explanation: COVID-19: travel from third countries into the EU - Consilium (europa.eu). For incoming US travelers, EU countries in most instances now allow entry with proof of vaccination and/or a negative COVID-19 test result. Those showing proof of vaccination can enter in most instances without restrictions. Again, please check before you travel as situations can change.
• In the UK, Prime Minister, Boris Johnson has announced a new Health and Social Care tax which will be introduced to pay for reforms to the social care sector and NHS funding in England.
• The reforms also include an extra £36 billion over the next 3 years to address the elective backlog.
• The Department of Health and Social Care have announced an additional £5.4 billion to be spent on the NHS’s response to covid-19 over the next 6 months.
• The Health and Social Care Committee held an evidence session on reducing the backlog of care for patients.
• The UK has extended the Brexit grace period for trade into Northern Ireland.
• Trade talks between the UK and India are being boosted by a £1 billion deal with an energy company to end a long running tax row.
• EU nationals living in the UK who apply to change their status risk being rejected by landlords, employers and mortgage lenders because of an anomaly on the digital residency permits issued by the government. Before they can access public or financial services, EU nationals have to prove that they have been granted either settled or pre-settled status by the Home Office. In many cases, there has been a lapse in this documentation, making it impossible to prove one’s status. Paper residency permits were never issued when the UK was part of the EU.
• The UK’s medicines regulator has granted emergency approval for the Pfizer and AstraZeneca vaccines to be used as third booster shots to tackle potentially waning immunity, adding pressure on the government’s vaccination watchdog to approve a new jab program.
• Under UK travel rules, there are three categories of countries, Red, Green and Amber. All countries are placed on the amber list unless there is specific evidence they should be on green or red lists. The UK requires the use of a high accuracy test, such as PCR or antigen test, as supporting evidence. Failure to provide proof of a negative test before travelling to England could result in a £500 fine.
• Very few countries are on the green list, and those include Israel, Singapore and Iceland. If you are coming into the UK from a green list country, you must still 1) take a COVID 19 test before departure and have proof of a negative result; 2) book a test for the second day of your return; and 3) complete a passenger locator form. You do not need to quarantine unless your day two test is positive.
• If returning from an Amber country (most countries are categorized as Amber), you must take a COVID-19 test before departure and have proof of a negative result; 2) book a COVID-19 test on days two and eight after you return; 3) complete a passenger locator form; and 4) quarantine for 10 days. The government advises not to travel to Amber countries, although this is a suggestion and people still travel to amber listed countries. It may be possible to end the amber quarantine early in England if you pay for an additional test under the test to release scheme, which would occur on day 5.  
• Red list countries are those the UK government says are at the highest risk from Covid and should not be visited "except in the most extreme of circumstances". Dozens of countries are on the red list, including India, Pakistan, Turkey, Brazil and South Africa. If you have been in a red list country in the last 10 days, you can only enter the UK if you are a UK or Irish national, or UK resident. If you're returning from a red list country, you must 1) take a Covid-19 test before departure and have proof of a negative result; 2) complete a passenger locator form; 3) self-isolate for 10 days in a government-approved quarantine hotel, which you must book and pay for in advance (Rates are as follows: 10 days (11-nights) for one adult - £1,750; Additional adult (or child over 11) - £650; Children aged five to 11 - £325).
• 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.
• German Health Minister Jens Spahn has said more people need to receive COVID jabs to ensure a safe fall and winter. He said vaccinations were the key to a return of "freedom and normality." He urged people to receive their COVID vaccinations to keep health care services from being overwhelmed in the fall and winter.
• In Germany, an annual study has again asked people what they fear the most. After almost two years of COVID pandemic, somewhat surprisingly, health issues do not top the list. The top 5 issues of most concern to Germans are 1) tax hikes due to COVID; 2) rise in the cost of living; 3) tax hikes due to EU debt; 4) refugees; and tied for 5^th are two issues pollutants in food/care for the elderly.
• The German government has pledged to donate at least 30 million vaccine doses of the AstraZeneca and Johnson & Johnson vaccines by the end of 2021 to an international vaccine relief effort.
• Germany, as well as Switzerland and Canada have been reclassified by the US as high-risk countries "due to a high level of COVID-19." The decision comes as the EU calls for reimposing restrictions on American tourists.
• Kids in Germany are heading back to school amid the fourth wave of the coronavirus pandemic. But relaxed quarantine rules for the mostly unvaccinated schoolchildren have parents and teachers fearing that the recovered sense of normalcy won't last long.
• Opinion polls indicate that there is no two-party coalition that would manage to secure a majority following the general election in September 26. However, several three-party options would be possible.
• 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.
• The German Medtech Association BVMed considers the MDR not yet fit for practice. There are still too few Notified Bodies, too bureaucratic regulations, and a lack of clarification. BVMed is therefore in favour of quick and pragmatic solutions and better support for small and medium-sized companies. Among other things, BVMed calls for Notified Bodies to be notified more quickly, for remote audits to be permitted, for the transition period for old certificates to be extended, and for pragmatic solutions to be established for proven existing devices and niche devices.
• France stressed on Thursday it will not tolerate any "financial blackmail" or flouting of international law after the UK said it planned to turn back migrant boats crossing the English Channel. French Interior Minister Gérald Darmanin wrote on Twitter that "France will not accept any practice contrary to the law of the sea, nor any financial blackmail". "Britain's commitment must be kept," he said, adding: "The friendship between our two countries deserves better than posturing that undermines cooperation between our services."
• The warning comes after Darmanin met with his British counterpart, Priti Patel, on the sidelines of a meeting of G7 interior ministers in London on Wednesday, during which Patel demanded French authorities do more to stem the flow of migrants reaching UK shores.
• Several British news outlets reported on Thursday that British Border Force staff were to receive training on how to turn back migrant boats before they reach the coast.
• Former French Health Minister Agnes Buzyn was summoned to appear before judges on Friday to face questions over whether her response to the coronavirus pandemic was inadequate, newspaper Le Monde reported.
• Buzyn, health minister from May 2017 to February 2020, had to step down at the start of the pandemic under pressure from President Emmanuel Macron to replace Benjamin Griveaux, the LREM party candidate for Mayor of Paris who was forced to withdraw after a sex-tape scandal. She lost her bid for the Paris city hall and ended up being appointed in January to the World Health Organization (WHO) in Geneva, in charge of monitoring multilateral issues.
• France has granted citizenship to over 12,000 foreign-born health workers, security guards, checkout assistants and other front-line workers to thank them for their services during the Covid-19 crisis, the government said on Thursday (Sept 9).
• Marlene Schiappa, junior interior minister in charge of citizenship, said over 16,000 people had applied for a French passport over the past year under a special scheme allowing workers in essential services to apply for citizenship after just two years in France, instead of the usual five. Of these, 12,012 became French, she said.
• France has made it obligatory to show the health pass – proving that you are vaccinated or have tested negative for Covid-19 – for access to public venues for more than 50 people since July 21. On August 9 the health pass requirements were extended to a range of new settings, including long-distance transport, restaurants and cafés – even France’s famed outdoor terraces. This week’s mandate adds to the number of people who are required to carry the health pass in order to engage in various public activities.
• Any of the following documents can be used as a health pass in France:
  • Proof of having completed a vaccination program (two doses of an EU-approved vaccine: Pfizer, Moderna, AstraZeneca or Johnson & Johnson)
  • A negative PCR or antigen test taken within the last 48 hours
  • A Covid-19 recovery certificate that is less than six months old
  • Anyone who enters an establishment without showing a valid pass can be fined €135 for a first offence.
• The new measure means staff who work face to face with the public – for instance at cafés, cinemas or on public transport – are now required to show proof that they are fully vaccinated or have tested negative for the coronavirus in the last 72 hours. It will apply to some 1.8 million workers across the country. Members of the public are already required to carry health passes in order to access eateries and cultural or leisure venues.
• In France, vaccinated people traveling from the EU and countries on France's "green" list, including South Korea, Japan, and Israel, can avoid COVID-19 testing requirements altogether. Unvaccinated travelers from these regions can enter with a negative test. 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.
• The US and Canada have been reclassified as “green” under France’s traffic light classification for Covid travel restrictions, which means Covid-19 cases are low enough to allow for people to travel more freely. However, this could change given the EU’s reclassification of the US this week. The US had been classed as orange when the traffic light system was first announced on June 9th, but an announcement in the government’s Journal official signaled the change. Arrivals from the two North American countries will now no longer have to go into quarantine on arrival in France and will be able to enter the country without an “essential reason”, even if they have not been vaccinated.
• 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/.
• 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.
• The proposed one-year suspension of implementation of the EU's MDR is final and extends until May 26, 2021, the date of application of the current regulation but does not extend every target deadline referenced in the law.  It also creates the possibility of EU-wide derogations for specific medical devices. https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718; https://www.medtecheurope.org/news-and-events/press/medtech-europe-welcomes-the-amendment-of-the-medical-devices-regulation-and-urges-similar-action-for-the-ivd-regulation/.
• The EU Commission has published a document that permits Notified Bodies to perform virtual audits under IVDR and MDR on a temporary basis. While this Notice does not modify the legal text of the Regulations, it recognizes that Member States – who are responsible for monitoring of Notified Bodies – may exercise discretion in allowing (case-by-case, and temporarily) QMS audits under the IVDR/MDR to take place virtually/remotely, in cases where this is justified, e.g., because continued supply of devices to the market is otherwise at stake. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2021.008.01.0001.01.ENG&toc=OJ%3AC%3A2021%3A008%3ATOC.
• AdvaMed's joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation.
• 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