COVID-19 Outbreak: Weekly Global Report for Friday, September 17, 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 226 million cases. Deaths around the world have exceeded 4.68 million. The countries with the most reported cases continue to be the U.S. (41.7 million), India (33.3 million) and Brazil (21.0 million).
• U.S. cases exceeded 41.7 million with deaths increasing to 669,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: New local COVID-19 infections more than doubled in China's southeastern province of Fujian this week, prompting officials to quickly roll out measures including travel restrictions to halt the spread of the virus. In just four days, a total of 102 community infections have been reported in three Fujian cities, including Xiamen, a tourist and transport hub with a population of 5 million. The infections come ahead of the week-long National Day holiday starting on Oct. 1, a major tourist season. The last domestic outbreak in late July to August disrupted travel, hitting the tourism, hospitality, and transportation sectors. China's air passenger traffic plunged 51.5% in August from a year earlier, data released on Tuesday showed, highlighting the vulnerability of Chinese airlines to repeated outbreaks even though COVID-19 is largely under control in the country.
• 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,
• 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 107,705, an increase of 376 cases over the previous week. The number of reported deaths increased by 1 over the previous week to reach 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.
• 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 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 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.
• S.-China relations: President Joe Biden denied on Tuesday a 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:  33,316,755 total cases, 342,923 active cases/443,928 deaths/ discharged 32,560,474 (John Hopkins & MoHFW) as compared to 33,139,981 total cases, 393,614 active cases/441,749 deaths/ discharged 32,304,618 (John Hopkins & MoHFW) last week. 765,717,137 people have been vaccinated. India has crossed the landmark of administering 75 crore Covid-19 vaccine doses, Union Health Minister Mansukh Mandaviya said Monday, September 13. More than 71 lakh doses were administered on Monday till 7 PM, according to the provisional data available on the Co-WIN portal.
• The government plans to begin Covid vaccination of children in the 12-17 age group who have co-morbidities like obesity, heart disorders, or immunodeficiency by October-November, official sources said. The plan keeps in mind that supplies of Zydus Cadila’s DNA vaccine ZyCoV-D — the only one to have received emergency authorisation for use in children in the country so far — are likely to begin in October.
• Over two lakh ICU beds, with 50% of them assisted with ventilators, are being earmarked for Covid-19 patients as the government gears up for a likely spike in infections in the wake of festival season, officials said. Around 40,000 additional beds with ventilators in ICUs are being added as part of the large-scale augmentation of Covid-health infrastructure across the country.
• India is worried that growing complacency as COVID-19 infection rates and deaths decline could lead to people skipping their second vaccine shots, leaving communities vulnerable to the coronavirus, said two health experts briefed on the matter. India has administered more than 744 million vaccine doses - with 60% of its 944 million adults getting a first shot and 19% fully vaccinated with the required two shots.
• India on Wednesday, September 15 offered to collaborate with east Asian countries for producing off-patent medicines, vaccines and other medical technologies to combat Covid-19, while calling for waiver of patent and other intellectual property rights to deal with the menacing virus. During the East Asia Summit-Economic Ministers’ Meeting, junior minister for commerce and industry Anupriya Patel said that 70% of the global vaccines are produced in India and its capacity to produce quality medicines and vaccines at affordable prices are globally recognized.
• The Central Drug Research Institute (CDRI) on Tuesday, September 14, claimed that the clinical trials of antiviral drug, Umifenovir, in treatment of Covid-19 have been successful. The trial of Umifenovir on 132 Covid-19 patients showed that, if the proper dose is given twice daily for five days, the drug can effectively reduce viral load in mild or moderate symptomatic and asymptomatic patients by checking multiplication of the virus.
• The Supreme Court on Monday, September 13, asked the Centre to consider suicide committed by Covid positive patients as Covid death cases to enable their family members for compensation as the person must have taken the extreme step due to the suffering from Covid infection.
• According to Dr Gillurkar, the results of the nasal vaccine made by Bharat Biotech are astonishing. He added that “We have noticed that nasal form of Covaxin brings instant protection and good amount of antibodies right in the nasal cavity, where the virus attacks first. This can stop the virus right at its entry point of human body. If the second dose is intravascular, it may bring sustainable protection,”.
• The Drugs Controller General of India (DCGI) has granted permission for the conducting of the Phase III bridging trials of Sputnik Light on the Indian population. The Sputnik Light is a single-dose Covid-19 vaccine of the Russian vaccine Sputnik. The nod comes after a recent study published in the medical journal The Lancet said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines.
• The discussion on the pricing of Zydus Cadila's COVID-19 vaccine ZyCoV-D is underway, said Dr VK Paul, Member (Health) NITI Aayog on Tuesday. "The discussion on the pricing of ZyCoV-D is ongoing. A decision will be taken soon. We are looking to include this vaccine in the national vaccination program," said Dr Paul in an exclusive interview with ANI. Country's drugs regulator Drugs Controller General of India (DGCI) approved the Zydus Cadila's vaccine for emergency use on August 20.
• The Defence Research and Development Organisation (DRDO) has contracted 10 private sector players, including city-based Godrej & Boyce (G&B), to manufacture oxygen generators. Godrej Precision Engineering (GPE), a unit of G&B, has received the order from the Defence Bio-engineering and Electromechanical Laboratory, a DRDO laboratory in Bengaluru, to manufacture oxygen generators, G&B said in a statement.
• India is considering resuming exports of COVID-19 vaccines soon, mainly to Africa, as it has partly immunised a majority of its adults and supplies have surged, a source with knowledge of the matter told Reuters. India, the world's biggest maker of vaccines overall, stopped vaccine exports in April to focus on inoculating its own population as infections exploded. The government wants to vaccinate all of its 944 million adults by December and has so far given at least one dose to 61% of them.
• Group A will be given both doses of traditional vaccine. Group B will get the first dose of traditional injectable vaccine while the second will be of nasal vaccine. Group C will get first dose of nasal and second dose of injectable vaccine, while Group D will get both doses of nasal vaccines.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,657,004 reported cases and 16,959 reported deaths compared to 1,616,826 reported cases and 16,652 reported deaths last week.
• Japan’s case numbers are now declining 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 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 52.8 percent of the population now fully vaccinated.
• 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 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 1,943 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 been able to achieve significantly lower numbers over the summer, but neither has it seen dramatic spikes. The numbers remain overall low.
• Korea now has 279,930 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 5,454 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.
• Korea continues to improve its vaccination numbers. A total of 34,977,073 people (68.1% of the population) have received first doses, while 21,168,093 (41.2% of the population) have received second doses of the COVID-19 vaccine.
• 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.
• 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.
• 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.
• Kim Ki-nam, leading the Korea Disease Control and Prevention Agency’s COVID-19 vaccination planning council, told a press briefing Thursday that “a stabilizing supply of vaccines has allowed us to expand eligibility and move up the timeline for second doses.” He said people who had AstraZeneca as their first shot will be able to move their second appointment forward to four weeks from Sept. 28 onward.
• Previously, the gap between two AstraZeneca doses was even longer -- 11 to 12 weeks -- before it was shortened to eight weeks in July. There are about 7.5 million people who have either received, or are scheduled to receive their second AstraZeneca dose at least 11 weeks after the first dose, according to the KDCA.
• 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 11,244,298 reported cases compared to 10,740,240 reported cases last week. It has a total of 248,283 reported deaths compared to 238,461 reported deaths last week.
• The overall number of new COVID-19 cases in Southeast Asia has been declining in recent weeks.  The region added 504,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: COVID-19 cases continued to decline in Indonesia, with daily cases down 87% nationwide from their July peak. Cases fell 32% over the past week, with bed occupancy at 19% and vaccinations up 100,000 per day over last week’s averages. Indonesia is now reporting 4,181,309 total cases and 139,919 total deaths compared to 4,153,355 total cases and 138,116 total deaths the previous week. Indonesia accounts for 56% 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 1,900,467 to 2,030,935 over the past week. Total deaths have grown from 19,163 to 22,009 over that time.
• Thailand: The number of total cases has started to trend downward, falling about 30% from two weeks ago. Reported cases grew from 1,338,550 to 1,434,237 over the past week and reported deaths have increased from 13,731 to 14,953 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 2,304,192 total cases, up from 2,161,892 total cases the previous week. Total reported deaths have increased from 34,733 to 36,018 over that time.
• Vietnam: Vietnam continues to experience a high number of new cases. Ho Chi Minh City, the country’s outbreak epicenter, will extend its restrictions for an additional 15 days until the end of the month. Ho Chi Minh City authorities said the extension was necessary to isolate clusters, speed up inoculations and prevent hospitals from being overwhelmed. Hanoi and several provinces are reported to be seeking to ease curbs gradually. Cases of COVID-19 infection grew from 576,096 to 656,129 over the past week. The total number of deaths grew from 14,470 to 16,425 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 69,582 to 73,938 over the past week. The total number of deaths increased rose from 56 to 58 over that period.
• Cambodia: Total reported cases increased from 96,935 to 102,136 over the past week. Reported deaths grew from 1,987 to 2,078 over that period.
• Laos: Laos reported a growth in total cases from 16,576 to 17,905 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 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 15.9% 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 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. 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 55.8% 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 16.3% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 78.6% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 19% 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 6% 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, 59.7% 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: 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 – a target the Minister of Health said could be achieved by this November.
• 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 trending overall positive in its larger countries, although with some persistently high numbers for new cases, particularly in the UK and Germany.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 9,144 (12,828); Spain 3,723 (5,619); Russia 18,841 (18,024); UK 30,402 (38,974); Italy 4,830 (5,919); Germany 13,047 (14,683); and Belgium 1,725 (1,847).
• 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 156,933. Netherlands is 9th with 115,073; Sweden is 10^th with 112,428. UK, France, and Spain and 12 – 14 (see numbers in chart below). Italy continues to be a winner in this group with just 75,973 cases per million (29^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 797. The official COVID-19 death toll in Russia now stands at over 195,000, 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 2,187. Italy is 16^th, with 2,156. The UK is 25^th with 1,971. Other rankings in this category are Spain, 28th, and France 31st. (The US ranks 22^nd with 2,055 deaths per million).
• The figures for new deaths per day, (which tend to lag any increased infection rates) are as follows:  Russia 792, UK 201; France 79; Spain 90; Italy 45; Germany 78; Belgium 4.
• Germany continues to lead Europe in the number of vaccine doses administered with over 104 million doses administered, and over 62% fully vaccinated. The UK is second with over 92 million doses, just under 65% fully vaccinated. France has now administered almost 92 million doses, with 63.5% fully vaccinated. Italy has administered over 81 million doses and is just under 65% fully vaccinated. Spain is now over 68 million doses, over 76% 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.
• 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 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.
• Italy is planning to be the first European country to make COVID-19 health passes mandatory for all workers. The Italian government has presented a draft proposal that, from October, digital vaccine certificates will be compulsory for both public and private sectors. The move aims to improve vaccine uptake and reduce the infection rate amid a potential surge in COVID-19 cases this winter.
• All employees will be required to prove that they have been vaccinated against COVID-19, are recovering from the infection, or have recently tested negative for the virus.
• 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.
• Speaking to lawmakers in the eastern French city of Strasbourg, von der Leyen hailed the EU’s vaccination drive. With 70 percent of its adult population fully vaccinated so far, the bloc is now among the world’s leaders in its pandemic response.   Looking forward, von der Leyen said the next year will be "a test of character" for the EU. "A pandemic is a marathon, it's not a sprint," she noted. "Let us make sure that it does not turn into a pandemic of the non-vaccinated."
• 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, PM Boris Johnson has reshuffled his Cabinet. Details are still emerging. https://www.bbc.com/news/uk-politics-58578385.
• 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.
• Additional funding of £5.5 billion will be allocated to support NHS to address backlog issues.
• Additional funding to address patient waiting lists/COVID backlog in the UK has been a longstanding advocacy/policy initiative for our MTG advocacy.
• 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 Scottish government has asked the Ministry of Defence for military assistance for the country's ambulance service. The Scottish Prime Minister stated that health services were dealing with the most challenging combination of circumstances in their history due to the Covid-19 pandemic. Opposition politicians have highlighted a series of serious ambulance delays, including one where a man died after a 40-hour wait.
• 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.
• 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 officials are concerned because, despite being offered COVID-19 shots near supermarkets, stadiums and even on trains, fewer people have been vaccinated in Germany than in many other European nations.
• According to the Robert Koch Institute (RKI), the country's top agency for infectious diseases, only around 5 to 10% of people are vehemently opposed to vaccination. But, many citizens are still unsure whether they should get vaccinated. That's despite the numerous vaccination centers in the country (many of which have since closed again) as well as having the option of being vaccinated by their family doctor.
• The UK is expected to drop out of the list of Germany's top 10 trading partners by the end of this year, official German statistics suggest.
• Germans spent £13.8bn, or nearly 11%, less on British goods in the first six months of 2021, according to data from the Federal Statistics Office. The UK has been in Germany's top 10 trading partners since 1950. But with Brexit-related hurdles taking a toll, it looks set to drop to the 11th spot by the end of 2021.
• 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.
• The nursing staff in Berlin's state-owned hospitals are escalating their strike. On Tuesday, according to the union, a total of 1,200 beds in Charité and Vivantes clinics had been closed because of the walkout.
• On each campus of the university hospital and in all eight Vivantes hospitals, a total of hundreds of appointments were postponed. The two hospital groups together have almost 9000 beds.
• 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.
• About 3,000 health workers in France have been suspended because they have not been vaccinated against Covid-19.
• A new rule, which came into force on Wednesday, 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's national public health agency estimated last week that roughly 12 percent of hospital staff and around six percent of doctors in private practices have yet to be vaccinated. Apparently "several dozen" workers had turned in their resignations rather than sign up for the jabs.
• Available figures point to nearly 1,500 suspensions Thursday at just over a dozen hospitals, according to an AFP tally, with dozens more elsewhere across France. Making the comparison to those refusing to the 2.7 million health workers overall, Veran said, "continued healthcare is assured."
• 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.
• 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.
• 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