COVID-19 Outbreak: Weekly Global Report for Friday, September 24, 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 230 million cases. Deaths around the world have exceeded 4.72 million. The countries with the most reported cases continue to be the U.S. (42.6 million), India (33.5 million) and Brazil (21.3 million).
• U.S. cases exceeded 41.7 million with deaths increasing to 682,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: China's northeastern city of Harbin went into semi-shutdown this week after reporting new locally transmitted COVID-19 cases for the first time since early February. Harbin, with a population of more than 10 million, launched citywide nucleic acid testing on Tuesday afternoon and plans to complete the campaign by Friday. Meanwhile, hopes that China’s Fujian province had turned the corner of its COVID-19 outbreak were put on hold on Tuesday, with a surge of 42 new cases in the midst of Mid-Autumn Festival celebrations. Still, the outbreaks in Harbin and Fujian appear to remain localized. China’s wide-scale domestic outbreak occurred in late July to August.
• 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 108,126, an increase of 421 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.
• 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.
• 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.
• S.-China relations: Last week, President Joe Biden denied media report that his Chinese counterpart, Xi Jinping, last week turned down an offer from Biden for a face-to-face meeting. The Financial Times cited multiple people briefed on a 90-minute call between the two leaders last week as saying Xi did not take Biden up on the offer and instead insisted that Washington adopt a less strident tone toward Beijing. "It's not true," Biden said when asked by reporters if he was disappointed that Xi did not want to meet with him. Biden's national security adviser, Jake Sullivan, said in a statement earlier on Tuesday that the report was "not an accurate portrayal of the call. Period." A source who was among those briefed on the call confirmed the report was accurate. "Xi apparently intimated that the tone and atmosphere of the relationship needed to be improved first," the source told Reuters.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics:  33,531,498 total cases, 301,640 active cases/446,050 deaths/ discharged 32,815,731 (John Hopkins & MoHFW) as compared to 33,316,755 total cases, 342,923 active cases/443,928 deaths/ discharged 32,560,474 (John Hopkins & MoHFW). 833,990,049 people have been vaccinated.
• R-value, which reflects how rapidly coronavirus pandemic is spreading, dropped to 0.92 by mid-September after spiralling over 1 by August-end, according to researchers. However, the R-values of major cities, Mumbai, Kolkata, Chennai, Bengaluru, are over 1. The R-value of Delhi and Pune are below 1. The R-values of Maharashtra and Kerala are below 1, giving a much needed relief to these two states with the highest number of active cases.
• Indian travellers vaccinated with two doses of Covishield will still have to undergo 10 days of quarantine in the UK even as the vaccine has been approved under the revised British guidelines for travel, according to UK officials. They said the main issue is vaccine certification and not the Covishield vaccine and that both India and the UK are holding talks to mutually resolve the matter.
• Bharat Biotech, the developer of indigenously developed Covid-19 vaccine Covaxin, has completed the Phase II/III trials on children in the 2-18 years age group and is all set to submit the data to the drug regulator, Drugs Controller General of India (DCGI), soon, the company’s chairman & managing director Dr Krishna Ella said on Tuesday. “The paediatric trial we have just completed. The Phase II/III is all completed.
• Suchitra Ella, joint managing director at Bharat Biotech, on Tuesday, September 21, said the choice of vaccine should not become a barrier to enter any country. She was responding to the United Kingdom's decision to not ease travel restrictions on people fully vaccinated in India. Vaccines which are approved and licensed by the national regulatory authorities should not be restricted by other countries to ban entry of travellers, Ella said.
• Drug Firm AstraZeneca is stepping on the gas in the fight against the Covid-19 virus with plans to launch a next generation jab to address emerging strains, a cocktail of two monoclonal antibodies for prevention-to-treatment, and a booster shot of its existing vaccine. The Covid therapies including the vaccines are expected to be rolled out in India next year, and could be manufactured at the Serum Institute.
• India expects to get its first Johnson & Johnson Covid-19 vaccine doses from next month, filled and finished in India by a partner of the US drugmaker, a source with knowledge of the matter told Reuters on Monday. It could receive as many as 43.5 million doses of the single-shot vaccine in October, said the source - a big step towards helping India meet its target of producing more than 300 million doses in the month.
• Researchers from BJ Government Medical College and Sassoon General Hospital observed in a recent study that Covid symptoms in children underwent changes during the second wave of the pandemic. In a study conducted among 84 children infected with severe Covid, researchers found that the clinical symptoms of Covid-19 in kids were now wider than previously described, often with nonspecific signs and manifestations, including a wider prevalence of gastrointestinal symptoms.
• People infected with the original strain of the coronavirus that caused Covid-19 early in the pandemic produced a consistent antibody response, making two main groups of antibodies to bind to the spike protein on the virus's outer surface. However, those antibodies don't bind well to newer variants, a new study has shown. The finding, published in the journal Nature Communications, has implications for the ability of new variants to reinfect people who contracted earlier versions of the virus, as well as for the continuing efficacy of vaccines -- that were developed to fight the original strain -- and the design of possible vaccine boosters.
• World Health Organisation's (WHO) approval for the emergency use authorisation (EUA) to COVID-19 vaccine Covaxin, developed by the Hyderabad-based Bharat Biotech, is likely to be delayed till October 5. As per WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to granting EUA to Covaxin. Hanna Nohynek, SAGE member will be introducing session objective setting, an update on regulatory decisions and an overview of Working Group deliverables.
• India will resume export of surplus Covid-19 vaccines next month under the 'Vaccine Maitri' programme and to meet its commitment to the COVAX global pool, but vaccinating its own citizens remains the topm priority of the government, Health Minister Mansukh Mandaviya said on Monday, September 20. He said the government will receive over 30 crore doses of vaccines in October and over 100 crore doses in the next three months.
• Molecular diagnostics company Mylab Discovery Solutions acquired a majority stake in Swayam developer, Sanskritech giving it access to potentially utilize Sanskritech’s point of care testing system. Mylab is planning to establish Sanskritech’s point of care (POC) testing systems at doctor offices, nursing homes, community health centers, airports amongst other centres through lab partners in an attempt to provide faster results to patients.
• Immunologist Satyajit Rath said that less than 15 per cent of Indian adults have been vaccinated with two doses, and this clearly means that all Indians "who are more vulnerable to infection" have not yet necessarily gotten two doses. "I therefore think that it is ethically premature to begin planning a third dose to a fortunate category of people at this stage," Rath, from New Delhi's National Institute of Immunology (NII), told PTI. "It is also pragmatically premature to do so, since we have no really clear idea of who is 'more vulnerable to infection'.
• City-to-City COVID-19 Vaccination Learning Exchange (CoVLEx) initiative to build a global COVID-19 vaccination knowledge management platform and initiate an exchange of ideas and learnings on pandemic response was launched by the Ministry of Health and Family Welfare (MoHFW) and NITI Aayog, a initiative supported by USAID. CoVLEx will span across Delhi, Mumbai, Ahmedabad, Indore, Bhubaneswar, and ten cities in South Asian and African countries.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,688,630 reported cases and 17,400 reported deaths compared to 1,657,004 reported cases and 16,959 reported deaths last week.
• Japan’s new case numbers are declining fairly rapidly. Japan’s top COVID-19 advisor said that the peak of the 5^th wave has passed.
• The COVID-19 state of emergency covering Tokyo and 18 other prefectures will remain in place until September 30. The Japanese government is leaning toward at least partially lifting the COVID-19 state of emergency covering 19 prefectures including Tokyo at the end of the month.
• The Japanese government hopes to ease the scope of COVID-19 restrictions under a state of emergency around November, when it aims to complete vaccinating all people who wish to be inoculated. The plan includes letting eateries provide alcohol and allowing people to travel across prefectural borders and hold big events with more attendees even if the state of emergency is still in force.
• After a comparatively slow start, Japan's vaccination program has picked up speed, with 55.3% of the population now fully vaccinated.
• Japan plans to start administering third doses of COVID-19 vaccine to the elderly early next year.
• Japan plans to ease 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 central government 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 1,716 new COVID cases, which is a slight decrease from last week’s numbers, and consistent with their levels over the last few weeks. 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 292,699 total cases, 27,430 active with 2,427 deaths. Total cases per million population have remained low compared to most of the world but Korea is now above the 5K threshold with 5,703 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 47.
• 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 57,359,308 doses have been administered. 43.3% of the population is now fully vaccinated, and another 28% have received their first dose.
• Authorities have extended 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.
• The Korea Centers for Disease Control and Prevention said it would announce new immunization plans on Monday afternoon for those who have until now been left out of the vaccination drive. The plan will include inoculating pregnant women, children and adolescents. Details on booster shots will also be unveiled.
• In August, a vaccination committee recommended that pregnant women and teens aged 12 to 17 be included on the vaccination list, after it concluded that the vaccines would not pose any safety or efficacy issues. The government has reviewed the plans with the related ministries and relevant stakeholders since.
• South Korea is halving the minimum amount of time until a second dose of AstraZeneca’s COVID-19 vaccine to four weeks from eight weeks, in the hopes of accelerating the drive for full vaccination coverage.
• The number of medical tourists to South Korea dropped over 76% in 2020 due to COVID concerns and restrictions. Other countries with large scale medical tourism faced similar reductions.
• 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 11,697,460 reported cases compared to 11,244,298 reported cases last week. It has a total of 256,502 reported deaths compared to 248,283 reported deaths last week.
• The overall number of new COVID-19 cases in Southeast Asia has been declining in recent weeks.  The region added 453,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: The situation continues to improve dramatically in Indonesia as it recorded its lowest daily case count in a year last Sunday. Indonesia is now reporting 4,201,559 total cases and 141,114 total deaths compared to 4,181,309 total cases and 139,919 total deaths the previous week. Indonesia accounts for 55% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: The number of new cases is dropping in Malaysia. 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 2,030,935 to 2,142,924 over the past week. Total deaths have grown from 22,009 to 24,565 over that time.
• Thailand: The number of new cases is trending downward. Reported cases grew from 1,434,237 to 1,524,613 over the past week and reported deaths have increased from 14,953 to 15,884 over that time.
• Philippines: Cases in the Philippines are moderating slightly.  The Philippines is now reporting 2,434,753 total cases, up from 2,304,192 total cases the previous week. Total reported deaths have increased from 36,018 to 37,405 over that time.
• Vietnam: The spread of the virus in Ho Chi Minh City has begun to slow, which may allow relaxed restrictions. City authorities had announced the extension of the current COVID-19 movement restrictions until at least October 1, 2021. Hanoi will further ease its coronavirus restrictions this week, given that new cases are on the decline and the majority of its adult population is partially vaccinated. Cases of COVID-19 infection grew from 656,129 to 728,435 over the past week. The total number of deaths grew from 16,425 to 18,017 over that period.
• Singapore: With daily cases hitting over 1,000 multiple times over the past week, officials are keeping close watch on ICU capacity and warning citizens that the next few weeks will be critical in evaluating Singapore’s strategy of learning to live with COVID-19.   The country has adopted 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 73,938 to 81,356 over the past week. The total number of deaths increased rose from 58 to 68 over that period.
• Cambodia: Total reported cases increased from 102,136 to 106,619 over the past week. Reported deaths grew from 2,078 to 2,176 over that period.
• Laos: Laos logged 467 new COVID-19 cases last Saturday, including 383 local transmissions, the highest daily tally since the pandemic broke out in the country.  Laos reported a growth in total cases from 17,905 to 19,952 over the past week. It has reported 16 deaths from COVID since the outset of the pandemic, with no new deaths reported last week.

Vaccinations

• Indonesia is now vaccinating 1.3 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 17.2% 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 59.4% 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 17.2% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 79.9% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 21,7% 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 only 7.2% 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, 64.4% 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 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: The Indonesian government announced that it plans to gradually reopen its borders to foreigners once 70% of the target population of 208 million have received at least one vaccine dose.
• 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. 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 trending overall positive in its larger countries, although the UK and Germany have persistently high numbers for new cases. The UK has by far the highest number of new daily cases in Europe. Russia continues to report consistently high numbers.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 6,794 (9,144); Spain 2,840 (3,723); Russia 19,706 (18,841); UK 34,460 (30,402); Italy 3,970 (4,830); Germany 11,165 (13,047); and Belgium 1,797 (1,725).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed by Germany, 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 157,216. Netherlands is 9th with 115,812; Sweden is 11^th with 112873. UK, France, and Spain and 12 – 14 (see numbers in chart below). Italy continues to be a winner in this group with just 76,978 cases per million (28^th).
• Russia's reported numbers on COVID remain problematic, continuing over 7 million, the second most in Europe (the UK is worst in this category) 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 817. The second place country, the UK, is reporting only 166 deaths per day. The official COVID-19 death toll in Russia now stands at over 200,000, but there are concerns with chronic under reporting. By comparison, Germany, with roughly 3 million fewer cases, reports just over 93,000 deaths.

• In terms of deaths per million, Belgium is the 15^th worst in the world with 2,191. Italy is 18th, with 2,162. The UK is 25^th with 1,985. Other rankings in this category are Spain, 28th, and France 31st. (The US ranks 20th with 2,099 deaths per million).
• The figures for new deaths per day, (which tend to lag any increased infection rates) are as follows:  Russia 817; UK 166; France 58; Spain 102; Italy 49; Germany 51; Belgium 7.
• Germany continues to lead Europe in the number of vaccine doses administered with over 106 million doses administered, and 63% fully vaccinated. The UK is second in Europe with over 93 million doses, just over 65% fully vaccinated. France has now administered over 92 million doses, with almost 64% fully vaccinated. Italy has administered over 83 million doses and is just over 66% fully vaccinated. Spain is now over 69 million doses, over 77% 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).
• The WHO says they have delayed approving the jab until a new inspection can be carried out at one of the plants where Sputnik V was manufactured.
• Portugal is now the country with the world's highest vaccination rate, according to figures from Our World In Data. About 84% of the country's 10.3 million population is now fully vaccinated. This is the highest rate in the world, ahead of the UAE (80.8%) and Singapore (77.3%) and well ahead of the 61.6% for the 27 member states of the European Union. Portugal was hit very hard by the first wave of COVID.
• Portugal's goal to fully inoculate 85% of its population is now within reach and the country is expected to relax some of the measures imposed to curb the spread of the disease.
• An Italian MEP has left the far-right League party over its decision to back so-called "green" COVID health passes. Francesca Donato, who was elected to the European Parliament in 2019, announced her departure on Tuesday. The Eurosceptic MEP has long been opposed to obligatory vaccinations and has regularly criticized the COVID-19 restrictions enforced by Italy's government.
• The European Union's chief executive Ursula von der Leyen pledged to accelerate the rate of Covid-19 vaccinations around the world, offering another 200 million jabs for low-income countries in her annual State of the European Union speech on Wednesday.
• "Our first and most urgent priority is to speed up global vaccination," von der Leyen told the European Parliament in Strasbourg. "We have already committed to share 250 million doses of vaccine. I can announce today that our mission will add a new donation of another 200 million doses until the middle of next year," she said.
• 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 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, the UK’s announced intention to attempt to join the USMCA trade pact between the US, Mexico and Canada appears to have been premature, and to have occurred with little in the way of diplomatic preparation.  
• US President Joe Biden has said he had no intention of ‘handing’ the Prime Minister, Boris Johnson a trade deal.
• The UK government has published guidance for businesses to better understand the UK’s internal market system.
• The Health and Social Care Committee have held another oral evidence session on clearing the backlog.
• The outgoing Chief Inspector of Hospitals for the Care Quality Commission has said ICS leads need to ‘be courageous’ in putting quality first.
• Boris Johnson’s national insurance hike to fund health and social care will hit NHS and care workers with a £900m tax bill. The prime minister announced this month that contributions are to increase by 1.25 percentage points to pay for his plan to tackle the NHS backlog and pay for social care changes. Now an official analysis of the impact of the tax rise, performed by the House of Commons library, shows it will inflict a “terrible” financial toll on health and social care workers and their families.
• The report reveals they will pay 12% of the £7.4bn expected to be raised from employees through the tax rise. Nurses, care home staff and other health and social care workers will pay an additional £900m in tax, according to the analysis. The figures do not include those working in the NHS or care who are self-employed, which point to the real impact being potentially even greater.
• The UK’s MHRA has published its consultation on the New UK Regulatory Framework (including the CA mark). AdvaMed will provide information to members as this develops. https://tinyurl.com/7cjkcb9n. We have sent a communication to the UK WG and will be providing direct input through our MTG advocacy group and in consultation with ABHI.
• According to recent estimates, higher energy prices will send the annual inflation rate in the UK above 4% by the end of the year and keep it there well into 2022.
• The British government announced a major simplification of its rules for international travel on Friday, heeding complaints from travelers and businesses that its regulations aimed at staving off the spread of COVID-19 were cumbersome and ineffective.
• Transport Secretary Grant Shapps said the “simpler, more straightforward system” would allow “more people to travel, see loved ones or conduct business around the world while providing a boost for the travel industry.” He said the changes were possible because of Britain's high vaccination rate. Almost 82% of people 16 and up in the U.K. are fully vaccinated.
• Shapps said the U.K. is scrapping its "traffic light” system that ranks countries as red, amber or green — high, medium or low risk from the coronavirus. The categories have been criticized as unfair, and sudden changes to countries’ status have caused headaches for thousands of travelers.
• From Oct. 4, there will be a two-tier system, with several dozen countries where COVID-19 is widespread classed as red, and the remainder as open. Eight countries will be removed from the red list on Wednesday: Turkey, Pakistan, the Maldives, Egypt, Sri Lanka, Oman, Bangladesh and Kenya.
• 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.
• Until October 4, 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 voters will go to the polls this weekend and vote to determine who will be Germany’s next Chancellor (and which party will have the majority, or whether Germany will require a coalition government).
• According to a recent poll, 74% of German voters know who they are going to vote for. Social Democrats are at 25%, CDU at 21%. Greens at 14%.
• 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.
• Germany’s economic recovery from the COVID-19 pandemic lost momentum in September as activity in both the manufacturing and services sectors slowed amid supply bottlenecks and waning catch-up effects, a survey showed on Thursday.
• Data from IHS Markit’s flash Purchasing Managers’ Index (PMI) showed growth in the manufacturing sector slowed to an eight-month low reading of 58.5 from 62.6 in August. The subindex for the services sector slipped to a four-month low of 56.0 from 60.8 in August.
• 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.
• The way out of a diplomatic crisis between France and the US over a mega submarine deal will "take time and require actions", French Foreign Minister Jean-Yves Le Drian told his US counterpart Antony Blinken Thursday.
• Le Drian's meeting with Blinken in New York came a day after French President Emmanuel Macron had a phone conversation with President Joe Biden in a bid to restore "confidence" between the two allies following a crisis triggered by Australia's cancellation of a submarine contract with Paris.
• French officials said on Wednesday they had identified health workers suspected of leaking the vaccination status and personal details of President Emmanuel Macron.
• Social media in France this week was exploding with a story about the arrest of a French doctor in French Polynesia, with video footage. It was claimed the doctor was arrested for prescribing hydroxychloroquine to treat COVID 19. But this was not true, his arrest was unrelated to prescribing hydroxy to treat COVID.
• The details of his "health pass", a QR code that acts as proof of vaccination or immunity and allows access to cafes and cultural life, has been shared on social media recently. The health pass shared on social media also showed his full name and date of birth.
• About 3,000 health workers were suspended because they have not been vaccinated against Covid-19. A new rule, which came into effect last week, made vaccination mandatory for the country's 2.7 million health, care home and fire service staff. But French Health Minister Olivier Véran said on Thursday that "most of the suspensions are only temporary". Many are now agreeing to get jabbed because "they see that the vaccination mandate is a reality", he said. The rule applies to all doctors, nurses, office staff and volunteers.
• 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.
• 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.
• 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.
• 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.
• 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