COVID-19 Outbreak: Weekly Global Report for Friday, March 19, 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 topped 121.5 million. Deaths around the world have exceeded 2.58 million. The countries with the most reported cases continue to be the U.S. (29.6 million), Brazil (11.7 million) and India (11.4 million).
• U.S. cases exceeded 29.6 million with deaths increasing to 538,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Overview: China’s vaccination campaign has been much slower than other countries, largely due to effective containment measures and minimal cases of local transmission. Over 65 million Chinese citizens have received a COVID vaccine jab as of Feb. 28. A senior government health advisor said last week that Beijing aims to vaccinate 40% of its population by July.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 101,470, an increase of 420 cases over the previous week. Deaths remain unchanged over the previous week at 4,839.
• Vaccine roll-out: in late February, China’s regulator approved for general use a third and fourth vaccine produced by CanSino Biologics and Sinopharm. This follows China’s approval of the Sinopharm coronavirus vaccine on Dec. 31 last year and Sinovac’s CoronaVac vaccine on Feb. 5. CanSino said its one-shot vaccine candidate is 65.28% effective 28 days after the dose is given. It can be stored at 2 degrees to 8 degrees Celsius, “making it more accessible especially to the regions with underserved public health,” it said in a statement.
• Vaccine diplomacy: According to the Ministry of Foreign Affairs, China is providing free vaccines to 69 countries and commercially exporting them to 28 more.
• Updated estimates on 2020 hospital visits: according to the National Health Commission, the total number of hospital visits/medical consultations in January through September 2020 reached 3.9 billion, a decrease of 15.3% over the same period in 2019. It is important to note that this percentage decrease has gotten progressively smaller since June, perhaps indicating Chinese patients have become more comfortable in visiting medical institutions in the second half of 2020.
• Traditional Chinese medicine: China last week approved the sale of three traditional Chinese medicine (TCM) drugs through a special approval procedure, offering more options for COVID-19 treatment, according to the National Medical Products Administration. The three medicines, namely Lung Cleansing and Detoxifying granules, Dampness Resolving and Detoxifying granules and Lung Diffusing and Detoxifying granules were reportedly proven effective in treating COVID-19 patients in central China's Wuhan last year.
• WHO report on COVID’s origins: The WHO team that investigated the origins of Covid-19 in China has decided not to scrap the report’s release after all. The 280 page report is set to be issued next week. The U.S. government has called into question the forthcoming report’s completeness and accuracy, arguing that the Chinese government continues to conceal information.
• Readout from the Two Sessions: Last week, the National People’s Congress (NPC) met in Beijing as part of the annual ‘Two Sessions’ to outline the government’s policy, legislative and economic agenda for the coming year. Alongside the announcement of a six percent GDP growth target for 2021, the announcement of the 14th Five Year Plan (14th FYP) was the headline story. It outlined a wide range of objectives for the next five years, including plans to support technological innovation and advancement, continued reform in the financial sector, and the tightening of environmental regulations as the country attempts to peak carbon emissions by 2030.
• The Chinese economy: As the first major economy to beat back Covid-19, China is now taking the global lead in moving to unwind its pandemic-driven economic stimulus efforts. Unlike the U.S. and Europe, which are still flooding their economies with liquidity and spending, China has started reining in credit in some corners. China’s policy makers have expressed concern about an overheating housing market and want to prevent bigger imbalances. They are also eager to resume a multiyear campaign to curb debt that started building during the previous global recession.
• S.-China relations. The new administration is continuing to review the Trump-era inheritance, but some early indicators show it is doubling down versus reversing. This week, the Biden administration intensified sanctions against Chinese and Hong Kong officials accused of undermining Hong Kong’s autonomy and announced it would continue secondary sanctions on countries that purchase Iranian oil. This Thursday and Friday, Secretary of State Antony Blinken and National Security Advisor Jake Sullivan are holding discussion with their Chinese counterparts in Anchorage, Alaska. Sullivan previously announced that the talks will focus on Xinjiang, Hong Kong, Taiwan, and the South China Sea, with economic and trade issues likely not to be discussed.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – 11,474,302 total cases, 252,364 active cases/159,216 deaths/ discharged 11,063,025 (John Hopkins & MoHFW) as compared to 11,284,311 total cases, 189,226 active cases/158,189 deaths/ discharged 10,938,146 (John Hopkins & MoHFW) 3,71,43,255 people have been vaccinated.
• Prime Minister Narendra Modi on Wednesday, March 17, expressed concern over a rise in Covid-19 cases in parts of the country and called for "quick and decisive" steps to check the "emerging second peak".
• Gland Pharma, which is based out of Hyderabad, has entered into an agreement with Russian sovereign wealth fund, Russian Direct Investment Fund (RDIF), to manufacture and supply 252 million (25.2 crore) doses of Russian Covid-19 vaccine Sputnik V.
• The Centre has placed a new purchase order with the Serum Institute of India (SII) for the supply of 10 crore doses of the Oxford-AstraZeneca COVID-19 vaccine, Covishield, each costing Rs 157.50, including GST, according to official sources.
• India’s export of Covid-19 vaccines to other countries is not at the cost of domestic need, the government told Rajya Sabha on Tuesday. Responding during Question Hour, Health Minister Harsh Vardhan said, "Vaccines aren't being sent to other countries at the expense of Indian citizens. A healthy balance is being maintained.”
• Experts from diverse fields including public health, ethics, medicine and law have written an open letter expressing concern about the lack of information on the investigations of deaths following Covid-19 vaccination in India.
• India has seen a drastic drop i.e. 80 to 90 per cent drop in the sale of masks and sanitisers in the recent times despite fervent appeal from all quarters asking not to stop wearing masks and frequently use sanitisers or wash hands with soap.
• A 33-year-old man admitted to Lok Nayak Hospital became the first person to be confirmed positive in the city for Covid-19 caused by the South Africa variant of novel coronavirus in India on Monday, March 15.
• India will manufacture Johnson & Johnson’s single-dose Covid shot as part of the first Quad vaccine initiative. The project will be financed by Japan and the US, while Australia will use its logistics capability to ship the vaccines to Southeast Asia and Pacific countries.
• Public health experts have cited emerging evidence and said India could consider delaying the second dose of the Covid vaccine to improve immunogenicity.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 453,483 reported cases and 8,777 reported deaths compared to 445,048 reported cases and 8,477 reported deaths last week.
• Japan has approved the Pfizer vaccine and began providing it to a small subset of health care providers. Vaccination of a further 3.7 million front-line health care providers is set to begin in March, followed by 36 million people age 65 or above beginning April 12. People with pre-existing conditions and those working at elderly care facilities will be next in line, followed by the general population.
• Japan has contracted with Pfizer for 120 million doses of its COVID-19 vaccine to be delivered in the first half of 2021, and for enough vaccine for 72 million people by the end of 2021. Japan has also contracted for 50 million doses of the Moderna vaccine and 120 million doses of the Astra Zeneca vaccine. Astra Zeneca will manufacture 90 million of those doses in Japan. The company submitted its application for approval on February 8. The application for the Moderna vaccine was made on March 5 and is not expected to be approved until at least May.
• Japan plans to inoculate its entire population with a COVID-19 vaccine by the time the Olympics start in July 2021.
• It has asked local governments to make arrangements to allow 30-40 million elderly citizens to be vaccinated by the end of March. About 10,000 healthcare workers who work with COVID-19 patients should receive the vaccine by the end of February, and around 3 million other healthcare workers will receive it by mid-March.
• Japan decided to end the State of Emergency in Tokyo and three surrounding prefectures as planned on March 21, but not all curbs will be lifted. After the end of the emergency, the four prefectures will ask restaurants to close by 9 p.m. at least until the end of March. Infections have fallen since the restrictions were imposed, but the decline has bottomed out and even rebounded in some prefectures including Tokyo.
• 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.
• The Japanese government has decided to maintain its controls for foreign nationals entering the country. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam are expected to remain suspended in the near term. While Tokyo’s restrictions on foreign entries except for returning nationals remain in place, the government will make exceptions for athletes entering the country for the upcoming Olympic Games.
• Japan's Ministry of Health has adopted priority regulatory review procedures for new COVID-related medical devices.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org).

Korea

• South Korea’s numbers have remained consistent for the last few weeks, with a slightly downward trend. They are reporting 445 new cases per day, down slightly from 465 last week. New deaths are down slightly from the previous week, just 2 per day. South Korea continues to avoid the dramatic spikes that many other countries are experiencing.
• South Korea has 97,294 total cases, 6,428 active cases, with 1,897 deaths, reporting 2 deaths per day. Total cases per million population have remained low compared to most of the world at just 1,897 (S. Korea ranks as one of the lowest among the more highly populated countries). Deaths per million remain comparatively low as well at just 33.  
• The Korea Disease Control and Prevention Agency (KDCA) has said new COVID variants are present in Korea, and that these variants are different from the three most-known mutations from Britain, South Africa and Brazil that are known to be more transmissible. However, there is no indication yet whether these new strains are more deadly than current circulating variants of the virus, the KDCA said.
• Korean health authorities are being criticized for failing to promptly relay a case of blood clots in a woman who had received AstraZeneca’s coronavirus vaccine, as a second report of blood clots in a vaccine recipient emerged Thursday. The Korea Disease Control and Prevention Agency waited at least five days before making the disclosure Wednesday.
• The agency’s Commissioner Jung Eun-kyeong told lawmakers on Wednesday morning that medical examiners found clots in the organs of a deceased vaccine recipient in her early 60s last week. Her autopsy was performed on March 8.
• Experts in Korea said the AstraZeneca COVID-19 vaccine’s reputation here was already being damaged from the suspensions in Europe ahead of the hotly anticipated verdict on the jab from the European Union’s top regulator. The European Medicines Agency is due to release the findings from its investigations into whether there is a link between the vaccine and the number of blood clot cases among people who had received it.
• Korean health authorities said earlier this week if the EU watchdog finds that the blood clot incidents in people inoculated with the AstraZeneca vaccine aren’t a coincidence, they may halt its use here at least temporarily. As Korea awaits the announcement from the regulators, health authorities continued to assure the public the vaccine is to be trusted.
• As of Wednesday midnight, more than 598,000 people in Korea have received their first AstraZeneca shot, with at least two reporting blood clots. One of them was a chronically ill patient in her early 60s, and the other one a paramedic in his 20s.
• Kwon Jun-wook, Korea National Institute of Health Director, told a news briefing Thursday afternoon that he expects the EMA to “give a verdict based on science and reason,” adding that the AstraZeneca suspensions were “choices of individual nations irrespective of a scientific connection.”
• The city of Seoul has decided to mandate coronavirus tests for all foreign workers in the city. The Seoul Metropolitan Government issued an administrative order on Tuesday requiring all foreign workers in the city to undergo diagnostic tests March 17-31 to prevent the spread of the coronavirus. Fines of up to 2 million won ($1,778) will be imposed if they fail to get tested during the period. The measure was announced after a rise in the number of confirmed cases among foreign factory workers who live in groups and work in enclosed, crowded environments. The decision has come under fire from medical experts, who say it discriminatory, scientifically unjustifiable and may even violate human rights.
• On Thursday, South Korea and the US signed an agreement that settled a protracted dispute over sharing the burden of supporting 28,500 US troops in Korea, on the last day of the first in-person talks of their foreign and defense ministers in Seoul. The US state and defense secretaries flew to Seoul a day earlier
• South Korea's economy is expected to grow 3.2 percent this year as the start of vaccinations raised hopes of a solid economic recovery from the COVID-19 pandemic, a regional macroeconomic research agency said Thursday.
• The forecast by the ASEAN+3 Macroeconomic Research Office (AMRO) is slightly higher than the Bank of Korea's outlook of 3 percent growth for this year.
• Korea’s Disease Control and Prevention Agency has publicly stated they expect the COVID-19 pandemic to be sufficiently tamed by November or earlier. The statement also indicated a key factor in their assessment is the expectation that Korea’s vaccination program will be in full effect soon.
• South Korea, 52 million population, has secured access to coronavirus vaccines enough for 56 million people. The COVAX project will supply 20 million doses of vaccines to inoculate 10 million people.
• South Korea's upcoming fourth round of COVID-19 relief handouts may amount to more than 19.5 trillion won ($17.6 billion). The scale of the government's proposal for the new batch of pandemic relief fund has been tentatively set at around 19.5 trillion won, but the final amount could rise further during the National Assembly's review of the related bill.
• South Korea has imposed Level 2.5, the second highest in the country's five-tier scheme, to the greater Seoul area, with Level 2 in other areas. Private gatherings of five or more have been banned across the country, while the operation of restaurants has been limited after 9 p.m.
• South Korea continues to impose suspension of direct flights from Britain.
• 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.
• Foreigners from Britain and South Africa who fail to present negative PCR test results will be banned from entering the nation, and incoming Korean nationals without test results will be isolated in temporary living facilities for two weeks upon their arrival in the nation, the KDCA said.
• South Korea’s movement toward implementation of a proposal that would potentially reduce the price of certain cardiac and peripheral stents has been at least temporarily postponed. A December meeting that was scheduled to occur to discuss the proposal has been postponed. AdvaMed is in touch with members and the medtech association in Korea and has had several discussions with the US Government on this topic. We have sent a letter to the health ministry expressing opposition to the proposal.
• We have submitted a letter in response to a recently issued request for comments on the proposal for potential implementation of pricing controls on stents. Please contact Joseph Gatewood (jgatewood@advamed.org) if you have an interest in this matter and are not already engaged.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

• Weekly COVID-19 statistics – ASEAN now has 2,647,484 reported cases and 56,613 reported deaths compared to 2,557,353 reported cases and 55,137 reported deaths last week.
• Indonesia reported 1.44 million cases last week and the Philippines has reported over 640,000 cases.
• Indonesia’s total COVID-19 deaths have reached 39,142, which accounts for 69% of all COVID-related deaths in Southeast Asia.  The Philippines reported 12,887 deaths.
• Myanmar is now reporting 142,190 total cases and 3,203 deaths, although there is almost certainly substantial under reporting since February 1 due to the military coup.
• Cambodia reported its first death from COVID last week. Laos reported zero deaths, while Brunei has reported 3 deaths, and Singapore has reported 30 deaths (despite having over 59,000 cases).
• Cases of COVID-19 infection have leveled off in Vietnam following an outbreak in late January. The total number of confirmed infections was 2,567, up from 2,529 the previous week.
• Thailand, which in mid-December had just over 4,000 cases of COVID-19, experienced a major surge that originated in a shrimp market southeast of Bangkok. It is now reporting over 27,494 cases ad 89 deaths. Thailand began vaccinations in late February.
• Indonesia has administered 2.6 million doses of the Sinovac coronavirus vaccine since the mass vaccination campaign began on Jan. 13. Indonesia is currently in the second stage of vaccination following the vaccination of medical workers in the first stage.
• Indonesia has secured orders for 600 million doses of vaccine from four producers. This includes between 13.7 million and 23.1 million doses of the AstraZeneca vaccine through the COVAX system. The vaccines will arrive in two phases: 25-35% of doses in Q1 2021, and 65-75% in Q2. The Ministry of Health said this vaccine can be used for those who are over 60, unlike the Sinovac vaccine, currently in use in Indonesia. President Jokowi has set a target of finishing the vaccination process within this year.
• The Indonesian Health Ministry on March 16 commenced a two- to three-week investigation into the AstraZeneca vaccine as concerns grow about the vaccine’s potential side effects in causing blood clots. The Indonesian government has decided to halt inoculations of the AstraZeneca vaccine as the investigation is underway, meaning the country will instead rely on its shipments of Chinese vaccines for the time being as it continues to carry out its vaccination program. 
• Indonesia authorized one of the world’s first private vaccination schemes to run alongside its national program so that companies can buy state-procured vaccines to inoculate their staff. The regulation stipulates that companies can buy vaccines and inoculate staff and their families for free at privately-run health centers with vaccines distributed by state-owned pharmaceutical company Bio Farma. The vaccines in the scheme must differ from the current rollout, which includes China’s Sinovac Biotech and is slated to include the AstraZeneca and Novavax vaccines. Indonesia’s private sector expects to receive 2 million doses of Sinopharm vaccine.
• Malaysia approved both AstraZeneca and Sinovac vaccines for emergency use on March 2. 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.
• Malaysia has agreed to buy 25 million doses of the Pfizer vaccine. It has also signed agreements for 18.4 million doses of vaccines produced by Russia's Gamaleya Research Institute and China's Sinovac.
• 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 less than a third of Filipinos are willing to be vaccinated due to fears of the potential side effects.
• Singapore began its vaccination program in January with seniors aged 70 and above and more than 50,000 active taxi and private-hire car drivers eligible for the shot. Those aged 60 and above are expected to eligible at the end of March, with a forecast of 1.25 million individuals vaccinated by the end of April.
• Thailand's COVID-19 vaccination program began on March 1. Thailand has approved the AstraZeneca and Sinovac vaccine, and the government has announced plans to administer over 60 million doses in 2021.
• Vietnam received its first batch of vaccines (117,000 doses from AstraZeneca) in late February. It aims to obtain 90 million COVID-19 vaccine doses this year, including 30 million through the COVAX scheme, 30 million from AstraZeneca, and the rest from ongoing negotiations with Pfizer and Russia's Sputnik V vaccine. Meanwhile, a Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine. If trials are successful, it is expected to be approved for emergency use in May.
• Elective surgeries have resumed in Thailand and Vietnam.
• In Indonesia, provincial hospitals are resuming elective surgery with COVID-19 protocols in place.
• Malaysia maintains limits on elective surgery except in emergency cases.
• Singapore restricts most elective surgeries but allows certain procedures including cancer screening, surgical operations for advanced cataracts, flu vaccinations, and dental procedures.  
• The Philippines extended its State of Calamity by a year to counter the pandemic. This extension will give national and local governments latitude to continue utilizing appropriate disaster relief funds and affords the government powers to monitor and control necessities and provide essential services to the affected populations.
• As of January 1, Indonesia has closed its border to foreign nationals to mitigate the increased spread of COVID-19. The new policy provides exemptions for holders of diplomatic visas and official visas related to foreign officials at the ministerial level, holders of limited stay permits, and permanent resident permits. 
• The Philippines has imposed restrictions on travelers from the United States and 20 other countries where cases of the new COVID-19 variant were reported.
• As of February 1, Singapore suspended its Reciprocal Green Lane (RGL) arrangements with Malaysia, Germany, and South Korea for three months due to a resurgence of COVID-19 cases. Travelers who have already been approved to enter Singapore under these RGLs can continue to do so. The move does not affect Singapore’s Periodic Commuting Arrangement with Malaysia, which includes longer-term workers and business travel. Following this latest suspension, only the green lanes with Brunei and a few cities in China remain open.
• Starting in April, Thailand will reduce 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 banned flights from countries that have recorded the new COVID-19 variant. The country will limit inbound repatriation flights until mid-February.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

• Europe is still struggling with persistently high numbers even as some countries appear to be experiencing reduction or flattening in the rate of increase. Spain and the UK appear to be continuing to level off. France seems to be lagging the other large EU countries in its recovery, and Italy is concerned enough about recent spiking that it has moved toward stricter lockdown measures. Germany seems to be having a hard time getting its numbers much below current levels. The UK’s vaccination program, ahead of virtually all of the EU, seems to be having large positive impact.
• In terms of new daily cases, which tend to benchmark increasing COVID incidence, the numbers appear to be stubbornly persistent or increasing in some of the EU’s larger countries. Of the larger countries, Spain and the UK seem to be doing the best, with Germany slightly behind. Germany is still concerned about its inability to get its numbers lower and a potential third wave of infections. France seems to be having the most difficulty with increasing rates and new cases. In terms of numbers of new cases, France, ranks 1^st Poland is second, Italy third. Most comparator countries of similar size appear to be in better shape than France. Figures indicate new case per day with prior week figures in parentheses). France has 38,501 (30,303); Spain 6,092 (6,672); Russia 8,998 (9,079); UK 5,926 (6,385), Italy 22,385 (20,684); Germany 12,246 (10,835); and Belgium 2,163 (2,050). France is only slightly ahead of the UK in terms of cases per million population. Belgium, Portugal and Spain are among the leaders in the EU in cases per million.
• The UK still leads Europe in deaths, followed by Italy, France, Russia, Germany and Spain. (see chart below). Russia's reported numbers on COVID, despite its Sputnik vaccine, remain problematic with perhaps the highest number of total cases of any country at 4,428,239 (slightly higher than the UK’s total) and 93,824 reported deaths (and reporting one of the lowest death rates in Europe at 618 per million).  By comparison, Germany with one of the best track records for the larger Western European countries, has more than 1.7 million fewer cases (2,610,769) and reports 74,732 deaths and a death rate of 890 per million.

• In terms of deaths per million, Belgium is the fourth worst in the world with 1,924. The UK is seventh worst in deaths per million at 1,848. Other rankings in this category are Italy 10, Spain 16, France 22. (The US ranks 12).
• New deaths per day (which tend to lag any increased infection rates) are increasing and are as follows:  Spain 228 (234); Italy 431 (332); Germany 246 (295); France 267 (264); UK 141 (190); Belgium 27 (35)). Russia reports 427 (466).
• The European Medicines Agency (EMA) has concluded that the AstraZeneca COVID vaccine is "safe and effective" after its safety review of the vaccine after reports of blood clots in some people vaccinated.
• "Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the possible risks," EMA executive director Emer Cooke said at a press conference. Yet, she qualified that they "cannot rule out definitively a link between these [blood clot] cases and the vaccine." The safety review committee will continue their investigations.
• Denmark, Iceland and Norway had previously suspended use of the AstraZeneca COVID-19 vaccine as a precaution amid reports of blood clotting in some people who have received it. The Danish health authority said that there was a reported death in the country but that "at present, it cannot be concluded whether there is a link between the vaccine and the blood clots." Use of the vaccine will be suspended until further notice, the health authority said on Thursday, but the decision will be reviewed in two weeks' time.
• It would appear most countries that had suspended administration of the AstraZeneca vaccine will resume, but not all have yet publicly declared they will do so following the announcement from EMA. Italy, France, Germany and several other countries have stated they will resume doses on Friday. Portugal will resume on Monday and Spain and the Netherlands next week.
• Italy has blocked a shipment of coronavirus vaccines going to Australia - the first time a new EU export control mechanism has been used. The government of Mario Draghi, Italy's newly appointed prime minister, asked Brussels for the export to be blocked last Friday. The European Commission has now given its approval to the request. The shipment reportedly contained more than 250,000 doses, according to Italian news agency ANSA.
• Brussels introduced the export control mechanism in January amid a row with AstraZeneca after the pharmaceutical firm said it be delivering fewer jabs to the EU than planned. The idea was to stop vaccines made in the EU from leaving the bloc if needs be. Amid criticism of the mechanism, Brussels insisted it had - prior to Italy's request - approved all export requests. Many countries around the world, like Canada, Japan and Australia, depend upon European plants to procure vaccines for their citizens. Since taking office, Draghi has voiced his concern around the sluggish vaccine roll-out.
• Italy recorded 502 COVID-19 deaths on Tuesday, its highest daily number since late January. The country's death toll from the pandemic now stands at 103,001, according to the Health Ministry. This is the highest tally in the European Union and the second in Europe after the UK. Nearly 20,400 new cases were also confirmed. The total number of infections in the country since the beginning of the global health crisis to more than 3.2 million. The latest numbers come as half of Italy's region entered a strict lockdown on Monday to counter a spike in infections. The nine regions in the so-called "red zone" — including Lazio where the capital, Rome, is located — will remain locked down until at least April 6. They will be joined by the rest of the country over the Easter holiday from April 3 to 5. A slowdown in delivery of vaccines by manufacturers and other logistics problems had bogged down Italy's vaccine rollout, but the pace of injections has improved in recent days.
• Hungary has recorded 195 deaths from COVID-19 in the last 24 hours, the highest daily number since the start of the pandemic. The number of patients being treated for the disease also rose to nearly 10,300, around three times the number hospitalized at the start of the latest surge of cases. The previous record of 193 daily deaths from coronavirus was reported in early December. According to Johns Hopkins University, Hungary has the seventh-highest COVID-19 deaths per 1 million inhabitants in the world. A sharp increase of positive cases, linked to the UK variant, has put an unprecedented strain on Hungary's healthcare system in recent weeks.
• The European Union unveiled a plan Wednesday to set up a travel certificate to help restore freedom of movement within the bloc for citizens inoculated against the coronavirus. “With this digital certificate we aim to help member states reinstate the freedom of movement in a safe, responsible and trusted manner,” European Commission president Ursula von der Leyen said. It will show “whether the person has either been vaccinated, or has a recent negative test, or has recovered from Covid, and thus has antibodies.” The plan may however face stiff resistance from many members states, particularly over fears of discrimination against those still waiting for a vaccine.
• The so called EU vaccine passport should be in place between May 17 and June 1 before the tourism season kicks off, says Margaritis Schinas, European Commission Vice-President in charge of Promoting our European Way of Life. Schinas is confident that, because the Digital Green Certificate is a regulation and therefore legally-binding across the bloc, the approval process will speed up drastically.
• AstraZeneca’s CEO has said it will provide the EU with 40 million doses in the first quarter of this year. This represents a marked decrease from the original commitment, which ranged between 80 and 120 million doses for the same period. EU policymakers have pointed to growing agreement that such a measure is necessary to recovery.
• Netherlands Prime Minister Mark Rutte's political party won the most seats in the Dutch parliament, according to a preliminary forecast by ANP news agency based on a count of 88.5% of the votes. "I note that the result of this election is that Dutch voters gave my party an overwhelming vote of confidence," Rutte said as exit polls were released.
• The European Union says it has begun legal action against the UK over "breaches" related to the Northern Ireland protocol. Brussels is upset over London's recent move to postpone British exporters to Northern Ireland having to provide export certificates. Major exporters to Northern Ireland from the British mainland were initially given a three-month grace period to avoid the extra bureaucracy of export certificates, which became necessary after Brexit kicked in earlier this year. But some supermarkets in Northern Ireland were hit by shortages, due to supply issues brought about by Brexit and the coronavirus pandemic. The UK unilaterally decided to extend this grace period - which covers areas such as animal products and parcel deliveries - until October.
• EU Council President Charles Michel has accused Britain of vaccine nationalism and of imposing an export ban on vaccines. The British deny the charge, stating that they supported the development of the AstraZeneca vaccine at the University of Oxford. The EU, however, points out that Oxford was one of the biggest recipients of EU research money prior to Brexit. The EU and Germany also financed the development of the BioNTech-Pfizer vaccine. The situation is a difficult one, with some in the European Parliament, including German MEP Peter Liese expressing anger at Britain, according to Euronews.
• A leading EU official has stated that Britain’s foreign secretary ‘totally misunderstands’ the Brexit deal, after the foreign secretary claimed the EU was trying to ‘erect a barrier’ between Northern Ireland and Great Britain.
• AdvaMed met with the EU Delegation to raise concerns about potential impacts from the export restriction. The restriction is set to expire on March 31 if not renewed. If you are experiencing any issues due to the EU’s vaccine export restriction, please inform us as soon as possible.
• The WHO COVAX program aims to distribute vaccines across the globe in an equitable manner. The WHO Director General has levelled criticism against countries who have entered into bilateral deals for vaccines and have purchased more vaccine than they need, stating that this undermines the COVAX program and needed availability of vaccines. https://tinyurl.com/yxh9j54e.
• The EU Commission published an informational notice that confirms allowance of virtual audits in limited circumstances. The notice indicates that Notified Bodies may temporarily deviate, in extraordinary and individual cases, from the IVDR/MDR requirement for audits of manufacturers’ quality management systems (QMS) to take place ‘on site.’ https://tinyurl.com/yya88q5a.
• The EU prohibition against inbound travelers from the US, Russia and Brazil based on COVID concerns remains in place. Inbound travel is permitted from any of 15 approved countries and the list is updated every two weeks. The EU recommended member states gradually lift the travel restrictions for the following countries: Japan, Canada, Georgia, Australia, Montenegro, New Zealand, Rwanda, South Korea, Thailand, Tunisia and Uruguay.
• The Commission has indicated all non-essential travel should be strongly discouraged until the epidemiological situation has considerably improved. Restrictions on travel should be proportionate and non-discriminatory, in line with the Council Recommendation from October 2020. Proportionate restrictions, including testing of travelers, should be maintained.
• The latest measures on the EU’s stricter travel requirements can be found here: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_195.
• The EU has also recommended to Member States several actions to address the new UK variant of the virus. These measures include discouraging all non-essential travel to and from the UK should be discouraged until further notice. Currently, these additional measures are in place:
  • Union citizens and UK citizens travelling to their Member State or country of residence as well as third-country nationals that enjoy EU free movement rights should be exempted from further temporary restrictions provided that they undergo a test or quarantine.
  • Travelers with an essential function, for instance medical staff, should be required to undergo a test (RT-PCR test or a rapid antigen test within 72 hours prior to departure), but should not be required to undergo quarantine while exercising this essential function.
  • Facilitate transport staff and transit of passengers, especially for essential travel.
  • Cargo flows need to continue uninterrupted, for example to ensure the timely distribution of COVID-19 vaccines.
  • The public health authorities of the Member States should increase sequencing efforts to swiftly identify cases of the new variant. They should also immediately identify cases involving persons who travelled to or from the UK in the past 14 days or who are close contacts of confirmed cases in order to ensure the appropriate follow.
• The United Kingdom and the European Union have agreed to a Trade and Cooperation Agreement, an Agreement on Nuclear Cooperation and an Agreement on Security Procedures for Exchanging and Protecting Classified Information. The Trade and Cooperation agreement itself sets forth many objectives and principals and leaves many key details to be determined. https://www.gov.uk/government/publications/agreements-reached-between-the-united-kingdom-of-great-britain-and-northern-ireland-and-the-european-union#history;  https://www.gov.uk/government/publications/agreements-reached-between-the-united-kingdom-of-great-britain-and-northern-ireland-and-the-european-union/summary-explainer#heading-five--fisheries.
• Several elected officials, as well as leading civil service and health care personnel are calling for an inquiry into the early stages of the Johnson administration’s handling of the COVID pandemic in the UK.
• The Secretary of State for Health and Social Care, Matt Hancock has announced an extra £6.6 billion to help NHS England recover from the pandemic.
• NHS Chiefs in England have warned that there could be disagreements with Ministers over how quickly the backlog of elective care in the NHS can be cleared.
• Ireland’s Prime Minister, Micheál Martin has told US President Joe Biden that the UK and EU must ‘stand by what was agreed’ during the Brexit negotiations.
• The new US trade representative Katherine Tai will meet with the Secretary of State for International Trade, Liz Truss next week.
• Secretary of State for Health and Social Care, Matt Hancock has said delays in the UK’s supply of covid vaccines in April will not affect the predicted roadmap for the end of lockdown. PM Johnson subsequently supported this position with a statement.  
• England’s Chief Medical Officer has stated demand for AstraZeneca shot remains high, despite the recent spate of concerns raised about the vaccine in the EU. PM Johnson subsequently announced he will be receiving the AstraZeneca vaccine on Friday.
• According to Prof. Marcel Levi, chief executive at the University College London Hospitals trust, the NHS was ill-prepared for the seismic shock of COVID. He stated to BBC that it ‘could take a very long time’ to clear the backlog of routine surgery and procedure cases which were caused by the pandemic. He says more money will be needed to run weekend and evening sessions in operating theaters. He also noted that the most successful responses to the pandemic were those under the control of the NHS, in contrast to those that were controlled by independent contractors.
• Travelers from South America and Portugal are banned from arriving in the UK as a precautionary measure aimed at preventing the new Brazilian COVID variant from reaching the country. In all, arrivals from more than a dozen countries including Argentina, Venezuela, Bolivia and Peru have been halted.
• The UK has also extended its ban on travelers entering England from southern African countries in a measure to prevent the spread of a new Covid-19 variant identified in South Africa.
• The UK government announced its post-Brexit tariff with duty suspensions for COVID goods on the WHO list (matching the existing EU duty suspensions). https://www.gov.uk/government/news/legislation-for-the-uks-independent-tariff-policy.
• A wide range of waiting times data has been released by the British government as part of its return to treatment initiative. The number of people waiting for over a year for treatment in England has reached its highest levels since 2008. The official and detailed data from NHS England on waiting times can be found here: https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/.
• ABHI has conducted a comprehensive analysis of the re-start of elective procedures in each Trust and Health Board in the UK. The results can be found here: https://www.abhi.org.uk/membership/members-area/updates/2020/july/the-restart-of-planned-care/.
• If you are experiencing issues with exporting goods to the UK from the EU, or to the EU from the UK, please let us know immediately and advise the UK’s Border and Protocol Delivery Group at this e-mail address: enquiries@cabinetoffice.gov.uk.
• In Germany, the medical device sector, which is dominated by SMEs, is currently under double strain: On the one hand, by the financial impact of the Corona pandemic due to postponed surgeries, and on the other hand, by the completely new legal framework of the EU Medical Device Regulation (MDR), which will apply from May 26, 2021. "Our medical technology SMEs need more support and pragmatic solutions here," said BVMed managing director Dr. Marc-Pierre Möll at the digital BVMed SME forum with around 80 companies on March 11, 2021. Dr. Philipp Birkenmaier from the Federal Ministry of Economics and Technology promised support with pragmatic solutions, for example with the possibility of virtual MDR audits. "In the BMWi, we are ready to fight for such pragmatic solutions, especially for the medtech SMEs," Birkenmaier told BVMed.
• The COVID crisis is also straining the reserves of the Statutory Health Ínsurance (SHI). According to the current financial report, the health insurance funds posted a deficit of about 2.65 billion euros in 2020. However, the financial reserves of the SHI funds were still at 16.7 billion euros at the end of the year.
• The combination of slow vaccine progress in Germany, and economic strain brought on by COVID lockdown restrictions may make it tough for Merkel’s CDU party to maintain control in upcoming elections.
• The famous asparagus season is about to begin in Germany, with migrant workers flocking in to harvest the vegetable and then staying to harvest other crops as the come into season. Many of these workers are from Eastern Europe, and Germany is maintaining strict controls that only those with a negative COVID test may come into the country. They are also putting in place a series of protocols relating to separating residences for the workers to ensure disease is not spread among them or to the community. Meals for the workers are also supposed to be taken in their rooms, not at the large communal dining areas they previously had.
• German regional leaders urged the EU Thursday to speed up its review of Russia's Sputnik V vaccine and ensure that it could be rolled out efficiently across the bloc once approved. “It’s important to accelerate approval procedures, especially in the case of Sputnik,” said Bavarian premier Markus Söder at a news conference after Germany’s 16 state leaders held talks with European Commission president Ursula von der Leyen. He added that European studies of the Russian vaccine had so far shown that it was “highly safe” and “in some cases better than vaccines which have already been approved”. “We need to approve it quickly and efficiently, not get bogged down in the classic, bureaucratic details,” he said.
• On Thursday, German health authorities registered a leap in new Covid-19 infections, as the percentage of cases coming from mutations also shot up. The more contagious B.1.1.7 variant originally detected in the UK now accounts for 72 percent of all cases in Germany, according to the Robert Koch Institute (RKI) on Thursday.
• Last week, the RKI was still talking about a B.1.1.7 share of about 55 percent. At the beginning of the RKI survey about one and a half months ago, the share of the mutant stood at only about six percent. A rapid increase in Germany had been feared following similar experiences in other countries, including the UK, South Africa, Czech Republic and Slovakia.
• Germany has updated rules to deal with coronavirus variants, such as those which have emerged in the UK and South Africa.
  • From January 14^th, 2021, travelers aged six or older, who have been in an area deemed very high risk or with a virus variant "of concern" in the last 10 days, have had to bring proof of a recent negative coronavirus test when arriving in Germany.
  • The general travel ban from people coming from the UK and South Africa has now been lifted. However, the travel advice for arrivals from the UK still currently states that only Germans, nationals of other EU member states or Schengen-associated countries (Iceland, Norway, Switzerland and Liechtenstein) are allowed to enter the country.
  • Third-country nationals who are resident and have a long-term right of residence in one of these countries, including British citizens (who lived in the EU before December 31st) are also able to enter, although the below strict testing rules apply.
  • Travelers from the UK are only allowed to enter Germany if they are returning to their place of residence, if they serve an important role if they have an urgent need.
  • Anyone coming from an area affected needs to be able to show the test result to authorities, and - if needed - the carrier they are travelling with. The test must have been taken no more than 48 hours before entry (time of swabbing). Proof of the test result must be on paper or in an electronic document in English, French or German. The test result must be kept for at least 10 days after entry.
• French Prime Minister Jean Castex announced Thursday a month-long limited lockdown for Paris and other regions of the country starting Friday as the number of Covid-19 patients in intensive care units spikes. Schools and essential shops, including bookstores, will remain open. In all, 16 French departments will be placed under a four-week lockdown because of rapidly increasing COVID infections.
• Castex said the new restrictions will take effect from Friday midnight and will last four weeks. The restrictions will be imposed on 16 regions, including the Paris area. While non-essential businesses will close and movement outside will be restricted in the affected regions, schools will stay open and outdoor exercise allowed up to 10 kilometres (6 miles) from home, he said. The curfew will also be reduced, starting at 7pm from Friday. The progression of the Covid-19 epidemic in France is clearly accelerating, Castex said. "More and more this is looking like a third wave," he told the news conference.
• One of the largest Covid-19 vaccination centers in France opened Monday at the Vélodrome stadium, home of football club Olympique de Marseille, where up to 2,000 people a day may soon be able to receive jabs against the virus. It is hoped the stadium's symbolic importance will encourage more locals to get vaccinated in a country where vaccine hesitancy is notoriously high.
• France aims to have vaccinated at least 10 million people by mid-April, 20 million by mid-May and a total of 30 million by the summer.
• France has announced it will not halt the use of the AstraZeneca vaccine, despite concerns expressed by several other EU countries, including Denmark, of adverse effects from blood clotting.
• Former French president Nicolas Sarkozy went on trial on Wednesday over claims of illicit financing for his failed 2012 re-election bid, just two weeks after a landmark conviction for corruption. On March 1, the 66-year-old became France's first post-war president to be sentenced to prison when he was given a three-year term, two years of which were suspended, for corruption and influence peddling. This case was one of several hanging over him since he left office. Sarkozy has denied any wrongdoing, saying he is the victim of a vindictive judicial system with which he tangled while in power between 2007 and 2012.
• 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 a the University of Vienna. https://www.omnicalculator.com/health/queue-pour-vaccin-france.
• Travel in or out of France to non-EU countries is banned with some exemptions (https://tinyurl.com/197k0szc) since January 31.
• France recently tightened these rules to the entire Schengen zone, requiring travelers to present a negative COVID test within 72 hours, and sign a sworn statement verifying they have no COVID symptoms.
• 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.
• The proposed one-year suspension of implementation of the EU's MDR is now final.  The measure extends until May 26, 2021 the date of application of the current regulation but does not extend every target deadline referenced in the law.  It also creates the possibility of EU-wide derogations for specific medical devices.
• https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718;
• https://www.medtecheurope.org/news-and-events/press/medtech-europe-welcomes-the-amendment-of-the-medical-devices-regulation-and-urges-similar-action-for-the-ivd-regulation/.
• The EU Commission has published a document that permits Notified Bodies to perform virtual audits under IVDR and MDR on a temporary basis. While this Notice does not modify the legal text of the Regulations, it recognizes that Member States – who are responsible for monitoring of Notified Bodies – may exercise discretion in allowing (case-by-case, and temporarily) QMS audits under the IVDR/MDR to take place virtually/remotely, in cases where this is justified, e.g., because continued supply of devices to the market is otherwise at stake. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2021.008.01.0001.01.ENG&toc=OJ%3AC%3A2021%3A008%3ATOC.
• AdvaMed, AdvaMedDX and MedTech Europe are conducting a joint survey of IVD member companies to support our advocacy work and efforts to improve implementation of the IVDR. Please contact Joseph Gatewood (jgatewood@advamed.org) if you wish to receive the survey but did not, or if you have other questions. Survey responses are due by March 5, 2021.  
• AdvaMed's joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation. We recently hosted joint webinars and working group calls with ABHI to give members the latest information. We will be hosting a webinar with Q&A session with MHRA on March 9. We will send out details via our UK WG, and our EU and Germany Groups. If you need additional information, or wish to receive an invite to the webinar, please contact Joseph Gatewood, jgatewoo@advamed.org.
• Resources: https://www.ecdc.europa.eu/enlll.
• 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://www.ecdc.europa.eu/en;
• 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