COVID-19 Outbreak: Weekly Global Report for Friday, November 5, 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 245 million. Deaths around the world have exceeded just over 5 million. Around 7.2 billion vaccines have been administered.
• U.S. cases exceeded 46.2 million with deaths increasing to 752,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: China is facing several new—albeit small—COVID-19 flare-ups that have spread to more than half of its provinces and municipalities, mostly in Northern China. Health officials say this wave is more "complicated" than the Nanjing airport coronavirus cluster spread that began in the summer, as there are multiple sources—many of which remain unknown—and the onset of winter which makes it easier for the virus to propagate. China is pursuing a zero-tolerance approach to these flare-ups: aggressive contact tracing and testing couples with partial lockdowns.
• New restrictions in the Chinese capital: Authorities in Beijing have urged residents not to leave the city unless necessary and restricted those in regions with new infections from entering the Chinese capital, Xu Hejian, a spokesperson for the Beijing municipal government, told a press briefing on Monday. Since last week, more than a dozen cases have been reported in the Chinese capital. Local authorities said the cases are linked to tourist groups visiting north China's Inner Mongolia Autonomous Region. Beijing has improved its daily nucleic acid testing capacity from 746,000 to more than 1.56 million. Its testing labs have increased from 249 by the end of last year to 282 currently, according to the Beijing authorities
• Vaccination program for children aged 3-11: China has launched a nationwide COVID-19 vaccination campaign for minors aged three to 11, in a bid to increase mass vaccine coverage and accelerate the building of herd immunity, as a new rebound in cases hits almost one-third of the country and becomes one of the worst since the initial outbreak in 2020. Furthermore, local city and provincial-level governments in at least five provinces issued notices in recent days announcing that children aged from three to 11 will be required to get vaccinated. China in June had approved two vaccines – Sinopharm’s from the Beijing Institute of Biological Products and Sinovac – for children aged three to 17, but it has only been vaccinating those aged 12 and older.
• Beijing to offer booster shots: Beijing on Thursday reported one newly confirmed COVID-19 case linked to the recent epidemic flare-up in Northwest China, which has been identified as caused by the Delta variant, local health authorities said. The capital city has launched booster shot services for residents, targeting key groups including people going abroad and staff working at ports and medical services.
• 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.
• China to build permanent quarantine centers for foreign arrivals: Health authorities have ordered cities in China to build or convert facilities into permanent quarantine centers for overseas arrivals, as Beijing pushes ahead with its zero-tolerance policy on COVID-19. City governments have been told to move away from using hotels for quarantine and instead provide dedicated facilities. There should be 20 quarantine rooms per 10,000 people available by the end of October, according to National Health Commission official Cui Gang.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 110,042, an increase of 689 cases over the previous week. The number of reported deaths remained unchanged at 4,849.
• China’s vaccines and approval date: Sinopharm (approved Dec. 31, 2020); Sinovac’s CoronaVac (approved on Feb. 5); CanSino Biologics and a second Sinopharm vaccine (both approved in April). Three other vaccines have been approved in May and June.
• China updates its mass testing protocol: In a city with a population greater than 5 million people, mass testing shall now be completed within three days, according to the updated protocol issued by the National Health Commission. The time limit was set at three to five days for cities of the same size in the previous protocol introduced in February. For cities with less than 5 million people, the time limit for completing city-wide testing remains unchanged at two days.
• Chinese airports toughen up quarantine rules: Airports around China are lengthening the amount of time some international aircrews and ground staff must spend in quarantine, after containment breaches sparked community spread of the highly infectious delta variant in several regions. Some regional regimes will see airport workers judged to be a higher risk isolated for up to 28 days after two weeks of work. These represent far tougher restrictions than those currently mandated by the country’s national aviation authority.
• Post-COVID healthcare system upgrade: China will provide funding to build new institutions and infrastructure to fight infectious diseases and improve healthcare, the state planning body said in a "five-year plan" for the sector. The central government will subsidize the construction of new "prevention bases" for infectious disease and new grassroots medical facilities across the country, the National Development and Reform Commission (NDRC) said in the plan, published this Thursday. It said China was facing difficult healthcare challenges, including new emerging infectious diseases, the increasingly heavy burden of chronic illnesses as well as the growing need for mental health services. "The public health system is in urgent need of improvement, and the ability to prevent, control and treat major epidemics is not strong," it warned. High-quality medical resources are also insufficient and not evenly distributed, and there are also gaps when it comes to treating women and children, it added.
• 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.
• COVID’s origins: U.S. intelligence agencies said last Friday they may never be able to identify the origins of COVID-19, as they released a new, more detailed version of their review of whether the coronavirus came from animal-to-human transmission or leaked from a lab. The Office of the U.S. Director of National Intelligence (ODNI) said in a declassified report that a natural origin and a lab leak are both plausible hypotheses for how SARS-COV-2 first infected humans. But it said analysts disagree on which is more likely or whether any definitive assessment can be made at all. The report issued on Friday is an update of a 90-day review that President Joe Biden's administration released in August, amid intense political infighting over how much to blame China for the effects of the global pandemic rather than governments that may not have moved quickly enough to protect citizens.
• China’s Economy: China's economy hit its slowest pace of growth in a year in the third quarter, hurt by power shortages and wobbles in the property sector, highlighting the challenge facing policymakers as they seek to prop up a faltering recovery while reining in the real estate sector. Gross domestic product expanded 4.9% from a year ago, missing forecasts, as attempts by Beijing to curb lending to the property sector exacerbated the fallout from electricity shortages which sent factory output back to levels last seen in early 2020, when heavy COVID-19 curbs were in place. The world's second-largest economy had staged an impressive rebound from last year's pandemic slump but the recovery has lost steam from the blistering 18.3% growth clocked in the first quarter.
• S.-China relations: President Joe Biden’s pick to be ambassador to China drew sharp lines with Beijing over its “aggressive” actions in the Indo-Pacific but said “American strength” gives the U.S. key advantages in the relationship between the world’s two largest economies. Nicholas Burns, a longtime diplomat who previously served as U.S. ambassador to NATO and Greece, said in his Senate confirmation hearing that China has been the aggressor in its relationship with Taiwan, Vietnam, Japan and the Philippines. He also said he’s skeptical about Chinese intentions on issues like 5G technology. But he emphasized his view that the U.S. has the upper hand. “Beijing proclaims that the East is rising and the West is in decline,” Burns said. “I’m confident in our own country,” he added, citing the U.S. military, foreign service and educational system as advantages over China. “The People’s Republic of China is not an Olympian power.”
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India (No Updates this week)

Japan

• Weekly COVID-19 statistics – 1,723,954 total reported cases and 18,308 total reported deaths compared to 1,718,361 total reported cases and 18,250 total reported deaths last week.
• Japan has seen a remarkable drop in new cases. Daily cases nationwide have averaged between 100-200 for the past few days, the lowest since June 2020. New daily cases had reached a peak of around 25,000 in August.
• The Japanese government lifted the attendance cap of 10,000 at large-scale events such as concerts and sports events. The government lifted the COVID-19 state of emergency covering 19 prefectures including Tokyo at the end of September. The emergency mainly involved requests for restaurants and bars to reduce their hours and not serve alcohol. With the lifting, Japan is free of emergency requirements for the first time in more than six months.
• After a comparatively slow start, Japan's vaccination program has picked up speed, with 73.3% of the population now fully vaccinated.
• Japan plans to start administering third doses of COVID-19 vaccine in December to those who had their second doses at least 8 months ago.
• Japan is easing its quarantine restrictions for travelers entering the country who been fully vaccinated with the Pfizer, Moderna, or Astra Zeneca vaccines. They will no longer be required to self-isolate in designated facilities for 3 days before completing a 14-day quarantine. Instead, they will need to self-quarantine at home for 10 days and then pass a PCR test.
• Japan has agreed to buy 150 million doses of Novavax's coronavirus vaccine, with Japanese firm Takeda expecting to manufacture the formula for distribution early next year.
• Japan provided final approval to the Moderna vaccine and the Astra Zeneca vaccine on May 21. The Pfizer vaccine was approved in February. J&J submitted its application for approval of its vaccine on May 24. It is expected to be approved and available for use around the beginning of 2022.
• The Japanese government continues to maintain its controls on foreign nationals entering the country. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam remain suspended. Tokyo’s restrictions on foreign entries except for returning nationals remain in place.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org).

Korea

• Korea added 2.480 new cases to reach 373,120. This week again, Korea has seen an increase of slightly over 500 cases per day from the rates seen last week. However, the country has not seen dramatic spikes recently, but the persistence of cases in the current ranges is a concern.
• Korea is also reporting a large increase in new deaths per day, currently 24, which is more than double last week’s figure. The death rate has increased to from 55 to 57 per million. These are significant but are also good in comparison to most other countries.
• Korea has administered 41,336,297 first doses (80.5% of the population) and 38,973,579 second doses (75.9% of the population) of the COVID-19 vaccine. 75.9% of the population has now been fully vaccinated.      
• Over the past week, the daily average of confirmed COVID patients under the age of 19 was around 480, and patients aged 60 or older marked about 568, accounting for more than half of the total cases. The surge in these age groups is thought to have been fueled by increasing face-to-face activities of minors as schools reopen, and due to falling efficacy of vaccines in older populations who were inoculated more than six months ago, experts say.
• Korea’s schools are on track to return to normalcy step by step from late this month, but mass infections in schools are piling up all over the country, including in the cities of Seoul, Incheon and Gwangju as well as other provinces. The vaccination rate of minors remains low due to anxiety over side effects. Of the 2,768,386 people aged 12 to 17 eligible for vaccination in the fourth quarter of this year, only 10,660, or 0.6 percent, are now fully vaccinated. The reservation rate for vaccinations for ages 16 and 17 closed at 65.4 percent. The prebooking rate for 12-15, which ends Nov. 12, is currently under 30 percent.
• 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.
• Foreigners arriving at South Korean airports face a mandatory 14-day quarantine procedure and must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation. However, some people who have been vaccinated against COVID-19 in countries other than Korea will be exempt from the 14-day self-quarantine requirement, meaning they can move around freely as soon as they enter the country. A similar exemption has been in place since May for those who were vaccinated in Korea.
• The exemption applies only to people who were fully vaccinated at least two weeks before traveling to Korea. It also applies only to those who have received a COVID-19 vaccine that is approved for emergency use by the World Health Organization. The list includes those from Pfizer, Janssen, Moderna, AstraZeneca, Sinopharm and Covishield. All international arrivals still have to show a negative result from a COVID-19 test taken within 72 hours of departing for Korea. Without one, you can still be refused entry.
• The exemption also only applies to those visiting Korea for business or academic purposes, for the public interest or to visit immediate family members. Otherwise, you still have to self-quarantine for two weeks upon entry. Immediate family members are defined as spouses, lineal ascendants or descendants, and lineal ascendants or descendants of spouses. You will have to fill out forms and prove your intent to visit them. The necessary forms are available online from Korean embassies and consulates abroad or other government agencies.
• Those coming from countries experiencing the spread of certain COVID-19 variants are also ineligible for this exemption.
• For a list of current travel and entry restrictions, see the following link: https://www.koreaonlinevisa.com/travel-restrictions/.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

 

Cases

• ASEAN now has 13,305,971 total reported cases compared to 13,104,489 total reported cases last week. It has a total of 280,386 reported deaths compared to 277,378 reported deaths last week.
• The growth in new cases continues to drop across the ASEAN region with the exception of Singapore and Vietnam. ASEAN added its lowest number of new cases last week since the end of June.  The region added just over 200,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: New cases and fatalities continue to fall to extremely low levels. Indonesia recorded just over 4,000 new cases last week, the lowest since April 2020. There is concern, however, of a possible new wave during the upcoming holiday season. Indonesia is now reporting 4,246,802 total cases and 143,500 total deaths compared to 4,242,532 total cases and 143,333 total deaths the previous week. Indonesia accounts for 51% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: Malaysia is preparing to shift into an endemic COVID-19 phase where it will not impose wide lockdowns again if cases rise. The number of new cases is at the lowest since late June. Those vaccinated may now dine in restaurants, reopen businesses, and visit salons. Total reported cases have grown from 2,448,372 to 2,486,630 over the past week. Total deaths have grown from 28,674 to 29,091 over that time.
• Thailand: The number of new cases is declining slightly. Total reported cases grew from 1,884,973 to 1,943,424 over the past week and reported deaths have increased from 19,006 to 19,462 over that time.
• Philippines: New case numbers in the Philippines are moderating and the country is starting to ease restrictions on some businesses.  The Philippines is now reporting 2,795,642 total cases, up from 2,772,491 total cases the previous week. Total reported deaths have increased from 42,575 to 43,825 over that time.
• Vietnam: Total reported cases grew from 905,477 to 946,043 over the past week. Total reported deaths grew from 21,920 to 22,343 over that time. Authorities have permitted Ho Chi Minh City to carefully begin relaxing social distancing measures and to gradually reopen. The city will also license businesses and production facilities to resume operations provided that they meet safety requirements.  
• Singapore: The number of new cases in Singapore remains relatively high and has more than doubled since October 1. The country has paused the easing of social restrictions amid growing case numbers, despite an 80%+ vaccination rate. Total reported cases increased from 184,419 to 207,975 over the past week. The total number of deaths increased rose from 349 to 442 over that period.
• Cambodia: Cambodia has experienced nearly three weeks of drastically lower case counts. Total reported cases increased from 118,220 to 118,870 over the past week. Total reported deaths grew from 2,776 to 2,813 over that period.
• Laos: Laos reported a growth in total cases from 38,281 to 44,061 over the past week. It reported 76 total deaths, up from 59 last week.

Vaccinations

• Indonesia authorized the Pfizer vaccine for emergency use on July 15. It will be given to Indonesians aged 12 years and up. It has been administering the Sinovac and AstraZeneca vaccines. Only 27.7% of the population is fully vaccinated. The country announced its intention to achieve a 100% vaccination rate for those aged 12 and above by year’s end.
• Malaysia has increased its vaccination rate sharply in recent weeks. The government announced this week that civil servants may face disciplinary action or termination if they fail to complete the COVID-19 vaccination process.  Malayia has fully vaccinated 76.0% of its population.
• The Philippines began its immunization program after receiving its first batch of the COVID-19 vaccine (600,00 doses of Sinovac Biotech's CoronaVac, donated by China). It is due to receive another 25 million doses of CoronaVac this year. 
• However, there is little public support for the inoculation drive. Polls show that fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 22.2% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 84% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 45.5% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available.
• Thailand's Food and Drug Administration has approved Siam Bioscience as a manufacturing facility for the COVID-19 AstraZeneca vaccine. Thailand plans to export the vaccines to eight Southeast Asian countries.
• Vietnam has fully vaccinated only 26.3% of its population to date. 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, 77.8% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore is expanding quarantine-free travel to visitors from Australia and Switzerland, beginning November 8. The Vaccinated Travel Lane (VTL) is now available to fully vaccinated visitors from nearly a dozen countries, including Brunei, Britain, Canada, Denmark, France, Germany, Italy, the Netherlands, Spain, and the United States. The U.S. government, however, has raised its COVID-19 travel advisory level for Singapore to the highest risk category and is asking visitors to avoid travel to the country.
• Singapore and Hong Kong agreed to drop their travel bubble that had been scheduled to start May 26 due to an outbreak of cases in Singapore.
• Indonesia: Sponsored business visas are once again available, though a five-day quarantine in a designated hotel is still required. Indonesia reopened international flights to Bali on October 14 for foreign visitors from countries with a positivity rate of less than 5% and who have been fully vaccinated against COVID-19.
• Thailand approved a plan to end quarantine for vaccinated air travelers from the U.S., U.K, China, Germany, and Singapore starting November 1, in a bid to boost tourism ahead of the year-end holiday season. The tourists would be allowed to enter all regions in Thailand by air with no quarantine requirements.
• Malaysia hopes to reopen to international tourists in November, starting with the resort of Langkawi.
• Vietnam is planning to reopen key tourist destinations to fully vaccinated visitors from countries deemed low COVID-19 risk, including the U.S., in December, ahead of a full resumption targeted for June next year. Vietnam had recently announced it would reopen the resort island of Phu Quoc to vaccinated travelers beginning November. In December, the country plans to allow tourists from approved countries to visit the UNESCO World Heritage site Halong Bay and Hoi An, the highlands town of Dalat, and beach destination Nha Trang.
• Philippines: Fully-vaccinated international travelers from countries classified as “green” (low-risk) will no longer be required to undergo facility-based quarantine if they provide a negative COVID-19 test result taken within 72 hours of their departure.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

 

• Negative trends are emerging in places in western Europe that have doing well in recent weeks, such as France. While Europe had been trending positive in most of its larger Western countries, the story has been different throughout much of Europe, with spiking or persistent rates of infection. Germany continues to see persistently high numbers of new cases. The UK and Russia are continuing negative trends, although the hospitalization rate in the UK appears to be lower than that in Germany. The UK’s early COVID success has now deteriorated to where is consistently in the top range for new cases in the EU, by a wide margin. Russia’s COVID numbers remains high as well, second worst in Europe, and its deaths per day are consistently the worst reported figures in Europe.
• The UK’s deaths per day and death rate (deaths per million) continue to remain high. France, Italy’s and Spain’s improvements are continuing overall. Experts believe the situation in Russia is 7 to 10 times worse in terms of reported fatalities due to significant under-reporting.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 10,050 (6,528); Spain 2,287 (2,532); Russia 40,443 (36,582); UK 41,299 (43,662); Italy 5,188 (4,595); Germany 26,453 (26,099); and Belgium 6,750 (5,745).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed 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 4th^h highest in Europe with 166,106. The UK remains at 9^th, with 134,160. Netherlands is 12^th with 125,487; Belgium, is 14^th, ; Sweden is 16^th and France is 18^th. Italy continues to be a winner in this group with just 79,261 cases per million (34th).
• The UK continues to be fourth worst in the world in terms of total cases, behind USA, India, and Brazil. Russia is fifth worst in the world in total cases.
• In terms of deaths per day, Russia remains by far the highest in Europe, at 1,189. Russia’s consistent lead in deaths per day is in contrast to some of its other reported numbers, and is one factor experts cite to indicate the Russian numbers are being significantly under reported. Ukraine, Romania, UK, and now Germany (184) comprise the remaining top 5 countries in Europe in deaths per day.

• In terms of deaths per million, Belgium is the 22nd worst in the world with 2,236. Italy is 24th, with 2,191. The UK is 27^th with 2,065. Other rankings in this category are Spain, 31^st, and France 37th. (The US ranks 16^th with 2,311 deaths per million).
• The figures for deaths per day (which tend to lag any increased infection rates) are as follows:  Russia 1,189 (1,123); UK 217 (207); France 39 (34); Spain 39 (51); Italy 63 (50); Germany 184 (146); Belgium 19 (25).
• Germany continues to lead Europe in the number of vaccine doses administered with over 112 million doses and is just over 66% fully vaccinated. The UK is second in Europe in vaccine doses administered with 104,477,012 and 67.1% fully vaccinated. Russia has provided 106,519,046 doses, but has just 33% fully vaccinated. France is at over 99 million doses administered and 68.1% fully vaccinated. Italy has administered over 90 million doses and is 71.7% fully vaccinated. Spain is now over 72 million doses, just shy of 80% 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 rising number of cases of COVID-19 in Europe is of "grave concern" and the region could see another half a million deaths by early next year, the World Health Organization warned Thursday. With 78 million cases in the WHO's European region - which spans 53 countries and territories and includes several nations in Central Asia - the cumulative toll now exceeded that of South East Asia, the Eastern Mediterranean region, the Western Pacific, and Africa combined, the organization said. "We are, once again, at the epicenter," WHO Europe director Hans Kluge told a press conference.
• Kluge noted that the "current pace of transmission across the 53 countries of the European Region is of grave concern." According to "one reliable projection" the current trajectory would mean "another half a million COVID-19 deaths" by February, Kluge added. The increases were observed "across all age groups," he said. Kluge blamed the soaring caseload on "insufficient vaccination coverage" and "the relaxation of public health and social measures." Hospital admission rates were higher in countries with lower vaccination rates, he said. Measures like testing, tracing, physical distancing and the use of face asks were still part of the "arsenal" in fighting the virus. "We must change our tactics, from reacting to surges of Covid-19, to preventing them from happening in the first place," Kluge said.
• The number of new cases per day has been rising for nearly six consecutive weeks in Europe and the number of new deaths per day has been rising for just over seven consecutive weeks, with about 250,000 cases and 3,600 deaths per day, according to official country data compiled by AFP.
• Euro zone business growth slipped to a six-month low in October as supply chain bottlenecks and logistical issues related to the COVID-19 pandemic pushed input prices to rise at the fastest rate in over two decades, a survey showed.
• The Irish government has published its Climate Action Plan which aims to reduce greenhouse gas emissions by 51% by the year 2030. The program will cost €125bn (£107bn), with a combination of public and private sector investment. The plan, which runs to more than 200 pages, lists a range of emissions reductions for multiple sectors, rather than specifying precise figures.
• The European Parliament has approved reforms to the EU's Blue Card Directive, designed to facilitate the employment of highly skilled workers from outside the bloc and help plug the gap where labour shortages exist in certain sectors. In what will be the only changes to EU migration law in recent years, MEPs voted 556 in favor of the revisions, 105 against and 31 abstained. Brussels wants to make it easier to attract highly skilled non-EU workers in sectors like healthcare and information and communication technologies (ICT) where significant shortfalls exist.
• Here is a link to a regularly updated article describing in detail the latest on EU travel restrictions: https://www.euronews.com/travel/2021/09/30/what-s-the-latest-on-european-travel-restrictions.
• All EU Member States are issuing and verifying a COVID Digital Certificate in a bid to boost tourism across the region this summer and beyond.
• The EU’s COVID Digital Certificate is an EU-wide scheme for travel within the EU, and is available in digital or paper form, free of charge. https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en. EU citizens and their families, and legal EU residents, may use it. There are discussions underway to allow US and UK citizens to obtain and use the digital certificates. The pass is proof that a person has: Been vaccinated against COVID-19; Tested negative for COVID-19; and/or Recovered from COVID-19.
• The Swiss Federal Council has indicated that there remain "substantial differences between Switzerland and the EU on key aspects of the agreement" and "the conditions are thus not met for the signing". The main stumbling blocks were freedom of movement, the level playing field and state aid rules.
• The Swiss government argues that incorporating a 2004 EU law called Citizens' Rights Directive (CRD), which gives citizens from the European Economic Area (an area that includes the 27 EU countries, Iceland, Norway and Liechtenstein) the right of free movement and residence, could entail "higher social security costs" and "effectively constitute a paradigm shift in Switzerland's migration policy".
• Among the particular objections, Switzerland didn't want to incorporate the notion of permanent residence for EU citizens and access to social security for non-employed residents, such as job-seekers and students. Switzerland was not comfortable either with the concept of EU citizenship, although Brussels insisted that this aspect was not part of the deal.
• While discussions could be restarted at any time, this has not occurred. The Implications for the medical technology industry from the failure of the EU and Switzerland to reach an agreement on a mutual recognition agreement (MRA) include the following:  
  • For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
  • Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognized as valid in the EU.
  • For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorized representative was previously established in Switzerland, must designate an authorized representative established in the EU.
  • On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.

• The following links may be of interest on the Swiss/EU MRA issue
  • EU Commission Announcement and Notice to Stakeholders on the failure to reach agreement-- mdcg_eu-switzerland_mra_en.pdf (europa.eu)
  • Swiss MedTech statement on the ‘downgrade’ of Switzerland to third country status: Swiss medtech downgraded to «third country» status | Swiss Medtech (swiss-medtech.ch).
  • Swiss Medtech summary of current state of play for devices moving into and out of Switzerland from the EU: pdf (swiss-medtech.ch).
  • Swiss schedule for Swiss importers to meet requirements to continue to place devices on the market in Switzerland (initial date is December 2021 for Class III);
    https://www.swiss-medtech.ch/sites/default/files/2021-04/20210401_Brancheninformation_MDR_eMepV_EN.pdf.
    • While the schedule says ‘not yet passed’ it became effective when the MRA was not renewed on May 26.
• The EU currently allows all travelers with proof of vaccination into the EU, with some restrictions. Please check if you intend to travel as these situations can change rapidly. See link for full explanation: COVID-19: travel from third countries into the EU - Consilium (europa.eu). For incoming US travelers, EU countries in most instances now allow entry with proof of vaccination and/or a negative COVID-19 test result. Those showing proof of vaccination can enter in most instances without restrictions. Again, please check before you travel as situations can change.
• The United Kingdom has become the first country to approve the use of the anti-COVID pill molnupiravir. The drug has been licensed for use treating adults with "mild to moderate" COVID-19 who are at risk of developing severe disease as a result of pre-existing health conditions like heart disease and obesity. An antiviral drug, molnupiravir is the first pill shown to be an effective treatment for COVID, and is intended to be taken twice a day for five days after symptoms of the virus appear. In clinical trials the pill, which was originally conceived as a treatment for flu, almost halved the risk of death or hospitalisation from COVID.
• The UK's health and social care secretary called it a "game changer" for patients at high risk from COVID-19, as well as for those who are unable to be vaccinated against the virus.
• Britain, its hospitals and its COVID-19 strategy are under the microscope as the country enters the dangerous winter period while accounting for almost a tenth of the world's recorded new infections. PM Johnson outpaced many governments by lifting England's pandemic restrictions in one broad stroke in July, betting the National Health Service will be able to take the strain after a successful vaccination campaign. Some health frontliners, virologists and pandemic modelers aren't confident. Even though COVID-19 hospitalizations are far lower than a year ago, the experts say pressures will be compounded by other winter viruses previously halted by lockdowns, as well as vaccine immunity fading and a backlog of treatment for other conditions.
• Brexit Minister Lord Frost has met France's Europe minister in Paris in an attempt to resolve a dispute over post-Brexit fishing rights. Tensions flared up last month after the UK and Jersey denied fishing permits to several French boats. France then threatened a series of measures against the UK unless more licences were granted by 2 November. But President Emmanuel Macron suspended the threats at the 11th hour ahead of more talks between the two sides.
• The French government has insisted that punitive measures - which could include a ban on British trawlers landing their catches in French ports and tighter customs checks on cross-Channel trade - remain "on the table" if a deal cannot be reached. Brexit Minister, Lord Frost played down speculation that the UK and France are close to resolving the disagreement over fishing licences.
• The UK government has announced that medicine and medical goods which are at risk of shortages will be shipped to the UK this week through a ‘new international transport system’.
• Hospital admissions for covid-19 more than doubled for two regions in the UK during October.
• Covid-19 vaccinations are to be made compulsory for NHS staff from April 2022.
• Irish Prime Minister Michael Martin has said the UK would be ‘irresponsible and reckless’ to use Article 16 of the Northern Ireland Protocol.
• Although the UK’s ‘traffic light” system has been officially scrapped, the UK will retain a two-tier system, with high risk countries classified as red, and the remainder as ‘open.’
• Testing requirements are eased for fully vaccinated arrivals to England from open countries, who will no longer have to take a COVID-19 test before traveling. Travelers will still need a test after landing, but from the end October an inexpensive lateral flow test will suffice, rather than a more sensitive - but pricier - PCR test.  
• Unvaccinated travelers will still have to self-isolate for 10 days, as well as taking coronavirus tests before and after their trips. In a boost to tourism, Britain said it will recognize vaccinations given in 17 more countries, including Australia, Canada, Japan and South Korea. It previously had recognized only shots given in the U.K., the U.S. and the European Union.
• UK regulator MHRA has issued a consultation on the future of medical devices in the United Kingdom. The consultation is available here: https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom. Member companies are strongly encouraged to make their views known regarding the future of the UK’s regulatory system. AdvaMed and ABHI will be providing responses as well, but we believe MHRA most urgently wants to hear directly from those companies who are currently or who plan to provide medical technology to the UK market. The consultation closes November 25, 2021.
• 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.
• Germany's public health body reported a record-high number of COVID-19 cases on Thursday. The Robert Koch Institute (RKI) said 33,949 new cases had been registered in the last 24 hours, up from 28,037 daily cases a week ago. The previous record was 33,777 new cases on 18 December 2020.
• Federal health minister Jens Spahn is set to meet with state health ministers to discuss how to limit the virus' spread ahead of the winter as intensive care units in hospitals fill up and infections in children surge. "We are currently experiencing a pandemic mainly among the unvaccinated and it is massive," Spahn said at a press conference earlier in the week. At least 96,192 people have died from COVID-19 since the beginning of the pandemic and more than 4.6 million Germans have contracted the virus.
• Germany’s states are preparing for the upcoming winter by strengthening restrictions for public gatherings. Restrictions are already varied by state actions, so if you are travelling to Germany, you must check state restrictions as well as federal.
• The three German parties working to form a new coalition government aim to wrap up their talks by the end of November and elect Social Democrat Olaf Scholz chancellor in the week of Dec. 6, party officials said on Thursday. Speaking as formal coalition negotiations began between the SPD, the Greens and the Free Democrats (FDP), the SPD's general secretary Lars Klingbeil said the aim was for 22 specialist policy working groups to report back by Nov. 10.
• Germany's automotive industry - whose gross production value is worth nearly €500 billion a year - is bracing for some bumps in the road ahead as global supply chains slowly grind to a halt. It means Tesla, which has built Germany's newest car factory, could face the same problems now hitting German carmakers hard. Tesla hopes to start production of the Model Y at the sprawling new production site outside Berlin before the end of the year.
• Germany is currently debating whether to extend the epidemic measures of national scope that is expiring at the end of November. After the outbreak of COVID-19, the state of emergency was first declared by the Bundestag in March 2020. The three parties currently in talks to form a coalition government have made public statements that oppose extending the COVID state of emergency.
• BVMed, the German MedTech association, expects the new German government to ensure that the core topics of the future-oriented medical technology industry are also reflected in the coalition agreement for the new legislative period. In the EU Medical Device Regulation (MDR), BVMed is lobbying for an "addendum" in order to establish solutions for the transition periods as well as existing and niche products. In order to strengthen Germany as a medical technology location, BVMed is proposing a "Medtech 2030 Initiative" to the new German government to coordinate measures between research, economic, labor, and health policy.
• According to a recent industry survey by BVMed, the MDR is already having a dramatic impact on the medtech market. More than 70 percent of BVMed member companies have discontinued individual medical devices or entire product lines due to the new MDR regulations. This is the result of a BVMed survey in which 88 member companies participated. More than 55 percent of the companies indicated that previous suppliers have already discontinued their business activities due to the MDR.
• If you are interested in the latest travel, testing and quarantine regulations for Germany, please see the following link: https://www.auswaertiges-amt.de/en/coronavirus/2317268.
• Germany’s version of the EU-wide digital vaccine pass certificates was launched earlier this summer and these can be used as proof of vaccination. Although authorities have stressed that the pass with a QR code does make travel into the country and around the EU easier, it is not compulsory. For activities where some kind of immunity or proof of not having Covid is required, people can also show a paper copy of their vaccine certificate, recovery or test.
• To access the German version of the EU digital pass, people have to be fully vaccinated and can get it from most pharmacies, a doctor or the vaccination centre they got their jabs. People can also get it if they’ve recovered from Covid recently and therefore received one shot. People can use the paper certificate with a QR code on it, or scan it into an app.
• France’s transport minister said on Wednesday that Britain has shown a "constructive" spirit in its talks with France over post-Brexit fishing licences, "I spoke to my counterpart yesterday evening. The spirit is a constructive one on this topic," Djebbari told Europe 1 radio. Talks would continue through Thursday, he added.
• French health authorities reported 10,050 daily new COVID-19 infections on Wednesday, the first time the tally has topped 10,000 since Sept 14.
• In another sign the virus is ramping up again, hospitalizations for the disease are up by 84, at 6,764, a rise unseen since Sept 6.
• The French government has proposed to extend the country's COVID-19 state of emergency until July 31 next year. The current state of emergency bill in France - allowing the government to impose coronavirus-related restrictions - is set to expire on November 15.
• Under current rules, citizens must use a COVID-19 health pass to access bars, restaurants, cinemas, theatres, and other venues. Speaking after a cabinet meeting, Attal told reporters that the extended state of emergency would help France deal with the health crisis.
• The French government is extending the requirement for a health pass (pass sanitaire) to access most public spaces, possibly until July 31, 2022. The pass is required for anyone seeking to access long-distance transport or venues like restaurants, cafés, bars, cinemas, museums and sports stadiums.
• COVID screening tests in France will no longer be free for unvaccinated people starting on Oct. 15, according to the French authorities, a change that signals a new phase in the government’s strategy to quell coronavirus infections by encouraging people to get inoculated.
• Unvaccinated people will now essentially have to pay to enter cafes, restaurants and theaters, because under a law enacted this summer, entering many indoor venues requires proof of being fully vaccinated, of a recent negative test or of a recent Covid-19 recovery. Tests will remain free for vaccinated people.
• France has made it mandatory to show the health pass – proving that you are vaccinated or have tested negative for Covid-19 – for access to public venues for more than 50 people since July 21. On August 9 the health pass requirements were extended to a range of new settings, including long-distance transport, restaurants and cafés – even France’s outdoor terraces.  
• Any of the following documents can be used as a health pass in France:
  • Proof of having completed a vaccination program (two doses of an EU-approved vaccine: Pfizer, Moderna, AstraZeneca or Johnson & Johnson)
  • A negative PCR or antigen test taken within the last 48 hours
  • A Covid-19 recovery certificate that is less than six months old
  • Anyone who enters an establishment without showing a valid pass can be fined €135 for a first offence.
• Workers who work face to face with the public – for instance at cafés, cinemas or on public transport – are now required to show proof that they are fully vaccinated or have tested negative for the coronavirus in the last 72 hours. It will apply to some 1.8 million workers across the country. Members of the public are already required to carry health passes in order to access eateries and cultural or leisure venues.
• Here is a link to policies related to entry and travel to France: https://www.diplomatie.gouv.fr/en/coming-to-france/coronavirus-advice-for-foreign-nationals-in-france/. (Also see EU section above for updated travel restriction information for any country in the EU, including France).
• Meanwhile, vaccinated tourists from France's "orange" list, which includes the UK, and most countries in Africa and Asia, will no longer need an essential reason to travel. These visitors will be exempt from quarantine but must still present a negative COVID-19 test. Here is a description of the categories and how they work:
  • Red
  • Vaccinated: Inoculated visitors from red countries must provide results of a PCR or antigen test no more than 48 hours old, provide an essential reason for travel, self-isolate for seven days and take a mandatory antigen test upon arrival.
  • Unvaccinated: Those who haven’t gotten their shots have the same requirements as vaccinated travelers from red countries, but their isolation time is increased to 10 days, and their compliance is checked by authorities.
  • Orange
  • Vaccinated: If you’re vaccinated and coming from an orange/amber country, you will need a PCR test no more than 72 hours prior to departure or an antigen test that’s no more than 48 hours old. Travelers can visit for any reason, such as tourism, provided they meet these other requirements.
  • Unvaccinated: Unvaccinated arrivals must observe the same testing requirements as vaccinated travelers under the orange/amber category, but they must also provide a “pressing reason” for travel (i.e., essential travel), take additional tests on arrival and self-isolate for seven days.
  • Green
  • Vaccinated: There are no restrictions if you are vaccinated, and arriving from a country labeled green.
  • Unvaccinated: If you are not vaccinated, you need a PCR or antigen test within 72hrs before departure.
• An online calculator has been launched which will allow people in France to see when they will be able to get the COVID vaccine. The tool was developed by the University of Vienna. https://www.omnicalculator.com/health/queue-pour-vaccin-france.
• If you are experiencing difficulties with exporting PPE from the EU, please let us know immediately. We have not seen any instances of this occurring since an initial incident was resolved.
• If you are having any issues moving medical supplies or medical products from the EU to the UK, or vice versa, please let us know immediately.
• AdvaMed's joint programs in Germany and the UK continue to provide COVID-19 updates and support on IVDR and MDR implementation.
• Resources: https://www.ecdc.europa.eu/en
• https://www.europarl.europa.eu/news/en/headlines/priorities/eu-response-to-coronavirus;
• https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public;
• https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/economy_en;
• https://www.abhi.org.uk/what-we-do/abhi-covid-19-hub/;
• https://ec.europa.eu/commission/presscorner/detail/en/IP_20_582;
• https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html;
• https://www.medtecheurope.org/covid-19-information-hub;
• https://www.medtecheurope.org/resource-library/european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/;
• https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
• https://www.medtecheurope.org/resource-library/eu-materials-covid-19/.
• Med Tech Europe White Paper on Companion Diagnostics under the IVDR: https://www.medtecheurope.org/resource-library/joint-medtech-europe-efpia-white-paper-on-companion-diagnostics-under-the-ivdr/
• Staff Contact:  Joe Gatewood (jgatewood@advamed.org)

Latin America

 

Reuters COVID-19 Tracker – Latin America

 

WHO/PAHO COVID-19 Information