COVID-19 Outbreak: Weekly Global Report for Friday, January 29, 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 101 million. Deaths around the world have exceeded 2.18 million. The countries with the most reported cases continue to be the U.S. (25.6 million), India (10.7 million), and Brazil (8.9 million).
• U.S. cases exceeded 23.2 million with deaths increasing to 408,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Overview: With the Lunar New Year travel period having already begun, the government has taken a host of steps aimed at reducing the spread of the virus. Last week, the National Health Commission issued complex quarantine and testing requirements that will likley deter travel. The Sinovac vaccine has a much lower efficacy rate than previously reported, according to Brazilian researchers who conducted the clinical trials.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 99, 698 an increase of 1,154 cases compared to the previous week. Deaths now stand at 4,813, an increase of 12 compared to last week. So far in January, most new cases have been locally transmitted.
• Hebei outbreak: 26 million residents in Hebei are still required to stay at home. Experts said Hebei’s outbreak has possibly revealed holes in the country’s coronavirus prevention strategy for villages, as many rural patients chose to treat themselves rather than go immediately to a hospital for a proper diagnosis.
• Cases in neighboring Beijing: Beijing carried out a second round of mass nucleic acid testing in Daxing District on Jan. 26, in an effort to contain the latest COVID-19 resurgence. Meanwhile. the Beijing government is tracking down and investigating anyone who entered the city from abroad beginning on Dec. 10. Over 1 million people in Beijing have received a first dose of COVID-19 vaccine according to the city’s health commission.
• Beijing tightens entry requirements: from Jan. 28 until March 13, Beijing will require people arriving from low-risk areas in China to show negative COVID-19 test results, tightening curbs ahead of the Lunar New Year and the annual parliament meetings in early March known as the “Two Sessions.” People entering the capital from those areas will need to undergo a 14-day health observation period after arrival.
• Travel rules related to Lunar New Year holiday: China’s National Health Commission announced last Wednesday that people traveling over the holiday period will need to show a negative test issued up to seven days before their departure. Such travelers then need to observe a 14-day quarantine while at home, during which they need to take a COVID-19 test every seven days. Many observers speculated that the highly complex and strict procedures could dissuade many people from returning to the rural areas during the holiday.
• State Council notice: in light of the recent outbreaks, the State Council last Wednesday ordered cities with less than 5 million residents to be able to complete testing in two days, and cities with more than 5 million residents must be able to complete testing in three to five days with provincial and national support. For anti-epidemic controls in villages nationwide, the State Council said pharmacies in villages must register information of people suffering from fever. Any late reporting or concealment will incur punishment, the notice states.
• Vaccine roll-out: On December 31, China approved the Sinopharm coronavirus vaccine, the country’s first for general use. Results from ongoing Phase 3 clinical trials showed an efficacy rate of 79 percent. However, the lack of details by Chinese regulators and Sinopharm has raised concerns in some circles. According to the National Health Commission, 23 million Chinese citizens have received the vaccine as of Jan 27.
• Hiccup in second vaccine: earlier this month, Brazilian researchers celebrated results showing 78% efficacy for the vaccine developed by Beijing-based Sinovac. However, the Brazilian research institute conducting the trials apparently released only partial results, creating unrealistic expectations. Updated results show an efficacy rate of around 51%. Indonesia and Pakistan have approved the Sinovac-developed vaccine for emergency use.
• 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.
• WHO team investigating COVID: China on Jan. 14 finally permitted entry to the WHO researchers investigating the origins of COVID-19. The Chinese government had previously blocked their arrival, claiming visas for some members of the group had not yet been approved.
• China’s economy in 2020: The National Bureau of Statistics (NBS) released economic data for 2020, showing a 2.3 percent increase in annual GDP. While China was the only major economy to record growth in 2020, there remain several problems in the real economy. Low consumption levels, widening inequality and the dominance of less productive state firms may weigh on the sustainability of the recovery, with many analysts predicting longer-term stagnation if the government fails to implement appropriate measures to address these structural issues.
• S.-China relations: in its early months, the Biden administration is pursuing “strategic patience” in its approach to China. Practically speaking, the administration will make no sudden moves to either target or engage China, while in the meantime engaging allies and conducting a thorough policy review. Biden cabinet nominees uttered tough language towards China in their confirmation hearings this week, however, perhaps indicating the Biden administration’s overall approach may not be too dissimilar from the that of its predecessor.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – 10,702,031 total cases, 173,740 active cases, 153,847 deaths (John Hopkins & MoHFW) as compared to 10,395,938 total cases, 228,083 active cases, 150,336 deaths last week. 2,355,979 people have been vaccinated. The daily Covid-19 recovered cases in India have been surpassing daily new cases from the last 20 days, while the total active cases stand at 1,76,498 comprising just 1.65 per cent of the total infections, the Union Health Ministry said on Wednesday, January 27.
• As India rolls out one of the world’s biggest inoculation programs, some health-care and other frontline workers are hesitating because of safety concerns over a vaccine that has yet to complete phase III trials. As of Monday, only about 56% of people eligible to get the shot have stepped forward in a nation with the world’s second-worst Covid-19 outbreak.
• India’s first indigenous Covid-19 vaccine, Covaxin, effectively neutralises the more infectious UK variants of SARS-CoV-2 virus, reducing the possibility of the mutant virus escaping the body’s defence system. This was stated by Covaxin developer Bharat Biotech on Wednesday following a research conducted by the company along with experts from National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR).
• In a twist to the Covaxin story, eight doctors from the Mumbai region rejected the Serum Institute’s Covishield vaccine and took shots of Covaxin instead at JJ Hospital on Wednesday, January 27.
• 3L get vaccinated on Day 12, five states account for 79%. While Rajasthan topped the list for the day with 71,632 recipients receiving the shots, Madhya Pradesh vaccinated 60,194 people. Rajasthan and Madhya Pradesh together accounted for 44% of total 2,99,299 recipients immunised against Covid-19 across the country on Wednesday. Karnataka – which has vaccinated the largest number of health workers so far – vaccinated 33,124 recipients, accounting for around 11% of the day’s total count.
• The Subject Expert Committee (SEC) that advises the Indian drug regulator has asked vaccine maker Bharat Biotech to first conduct phase-I trials of its chimpanzee adenovirus vectored Covid-19 intranasal vaccine, codenamed BBV154, on 75 volunteers to ascertain its safety and immunogenicity before seeking approval for phase-II trials.
• Tata Medical & Diagnostics, a newly formed subsidiary of Tata Sons, is said to have started initial discussions with US company Moderna for a partnership to launch its Covid-19 vaccine in India. Tata could team up with the Council of Scientific & Industrial Research (CSIR), the government’s key R&D organisation, to carry out clinical trials of Moderna’s vaccine candidate in India.
• Reliance Group has signed a USD 15 million deal with Israeli company Breath of Health (BOH) to distribute the company's swift Covid-19 breath testing system throughout India, a media report here said. According to the agreement, the Indian corporate giant will purchase hundreds of systems from the Israeli company in a deal valued at USD 15 million and will use them to conduct millions of tests a month at a cost of USD 10 million per month, business portal Calcalist reported.
• The makers of two ayurvedic Coviid-19 remedies have said that the treatments have been found to work better than the standard medicines in a comparative trial. "A clinical trial was conducted in India to monitor the outcome of a combination treatment for Covid. An Ayurvedic Remedy called ‘Immunofree’ by Corival Life Sciences, and a Nutraceutical called ‘Reginmune’ by Biogetica is found to work better in a comparative clinical trial against Standard of Care," said a statement.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 381,139 reported cases and 5,514 reported deaths compared to 352,689 reported cases and 4,886 reported deaths last week.
• The total number of infections has doubled over the past six weeks. Hospitals in COVID-hit regions are severely strained, with some reportedly on the brink of collapse. The Chair of the Japan Medical Association said that Japan doesn’t have enough doctors and nurses to deal with the caseload.
• Japan adopted a State of Emergency in Tokyo and three surrounding prefectures through at least February 7 due to the surge in cases. It also adopted a state of emergency in seven additional prefectures around the country.
• Under these declarations, the relevant prefectural governors will ask people to stay at home after 8 p.m., while restaurants, pubs and cafes that serve alcoholic beverages are requested to serve them only from 11 a.m. to 7 p.m. and close by 8 p.m. 
• 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.
• In addition, under the States of Emergency, physicians now have the option, in consultation with patients, of postponing procedures if they feel their hospital’s bed will be needed for COVID-19 patients.
• Japan confirmed that the UK variant of the virus has been found in the country and has banned all foreign tourists from entering Japan as a result.
• In addition, Japan temporarily suspended an arrangement allowing business travelers from 11 Asian countries and regions to enter Japan, effectively banning the entry of nonresident foreign travelers. This suspension will be in effect through February 7. Japanese and foreign nationals with valid legal statuses are permitted to return to the country under the latest entry restrictions.
• 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. Approval of the Pfizer vaccine is expected around February 2021. Pfizer is currently conducting a small-scale trial of the vaccine in Japan. 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.
• Vaccinations are not expected to begin in Japan until late February.
• Japan announced that it 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.
• Hospital beds are running low in many of the hardest hit regions.
• Kanagawa Prefecture’s Governor requested nearly 60 hospitals to postpone non-essential surgeries for one month on January 5 in order to free up beds for Covid-19 patients.
• According to a recent survey, 44% of advanced medical care hospitals are experiencing significant postponements of procedures due to patients’ concerns about COVID-19.
• The pandemic has had a severe impact on the financial situation of Japan’s hospitals. Nearly 70% of Japan’s hospitals are now operating in the red.
• 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 currently are persistent but not increasing dramatically. They are reporting 497 new cases, up from 401 last week. New deaths are back to more in line with prior experience at 8 per day. South Korea continues to avoid the dramatic spikes that many other countries are experiencing.
• South Korea has 76,926 total cases, 9,524 active cases, with 1,386 deaths, reporting 8 deaths per day. Total cases per million population have remained low compared to most of the world at just 1,500 (S. Korea ranks as one of the lowest among the more highly populated countries). Deaths per million remain comparatively low as well at just 27.  
• The South Korean government has unveiled its long-awaited plan for vaccinating the public, with the rollout set to kick off in a few weeks. The first doses will be offered to front-line health care workers in the Seoul area, where the active outbreaks have been concentrated, starting next month. From March, older adults and workers at long-term care homes and other congregate settings and first responders, including contact tracers, will be getting the jabs. Next in line are adults aged 65 or older, residents of group homes and the rest of health care personnel, who can expect their inoculations in May. Then comes the turn for essential workers such as police officers, firefighters and educators and adults with medical conditions in July. Some of the high-risk medical conditions being considered for priority vaccination are diabetes and heart and lung diseases.
• Koreans who are under 50 and healthy may be able to get their shots in the last few months of the year. The government vowed that all Koreans would eventually be vaccinated in phases except for pregnant women and children under 18, unless future trial results demonstrate otherwise.
• Under the plan, 1.3 million people will be vaccinated by March, 9 million by June, and the rest of the 33.25 million in the following months. In other words, over 75 percent of the vaccines will be distributed in the latter half of the year. “The government intends to carry out the COVID-19 vaccinations as planned to reach herd immunity by November,” Korea Disease Control and Prevention Agency Commissioner Jung Eun-kyeong told a news briefing. “Through the vaccinations we hope to achieve two things: to protect health and lives and to begin the journey back to normal.”
• Korea has so far obtained vaccines for up to 56 million people. Of those, the doses for 10 million people would come from AstraZeneca, 10 million from Pfizer, 20 million from Moderna, 6 million from Janssen and 10 million from the WHO-led COVAX scheme.
• Health authorities said they will decide whether to extend or lower the current social distancing level on Saturday, ahead of the Lunar New Year holiday slated for Feb. 11-13. The Level 2.5, the second highest in the country's five-tier scheme, has been applied in 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.
• Korea plans to expand the proportion of in-person classes and make improvement to virtual learning to ensure its students are better served when the new school year begins in March.
• South Korea’s current snowballing budget deficit, fueled by the COVID-19 pandemic “can be offset by gradual consolidation” in coming years, the International Monetary Fund said Thursday. The remark by Andreas Bauer, Korea mission chief at the IMF, apparently aims to alleviate concerns surrounding the nation’s government debt surged by four rounds of supplementary budgets implemented to finance COVID-19 relief programs.
• South Korea’s Prime Minister has pledged to place top policy priority on turning 2021 into the "original year" of overcoming the pandemic and thanked the people for related cooperation so far. He noted that the "biggest credit in the nation's battle against the pandemic goes to the public," lauding the people for uniting in the spirit of solidarity and cooperation in times of crises. South Korea reported its first confirmed COVID-19 case on Jan. 20, 2020. The nation has often been cited among the world's most successful countries in the battle against the pandemic.
• The government is slated to provide a plan to prevent the kinds of hospital bed shortages it has experienced over the past year. At one point in December, 595 patients in Seoul were waiting at home for hospital beds to open up after being diagnosed with COVID-19. Between December and mid-January, at least 11 patients in the capital area died waiting for treatment for more than a day.
• South Korea continues to impose suspension of direct flights from Britain until at least February 11.
• Foreigners arriving at South Korean airports 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.
• Health authorities will continue to conduct further tests, known as next-generation sequencing, on infected people from Britain and South Africa to detect the mutant virus and are set to implement strengthened measures on those from abroad.
• 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 1,970,045 reported cases and 43,731 reported deaths compared to 1,826,491 reported cases and 40,738 reported deaths last week.
• The vast majority of cases are in Indonesia, the Philippines, and more recently Myanmar and Malaysia. Indonesia surpassed 1 million cases last week and the Philippines has reported over 518,000 cases.
• Indonesia’s total COVID-19 deaths have reached 29,311, the highest level in East Asia.  The Philippines reported 10,481 deaths.
• Myanmar continues to experience a major surge that started in September.     It is now reporting 138,368 total cases. The number of deaths is 3,089.
• Cambodia and Laos have each reported zero deaths, while Brunei has reported 3 deaths, and Singapore has reported 29 deaths (despite having over 59,000 cases). These numbers are unchanged from last 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 15,465 cases ad 76 deaths. Thailand will begin vaccinations in late February.
• Indonesia has secured orders for 600 million doses of vaccine from four producers. Indonesia’s President has set a target of finishing the vaccination process within this year.
• 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.
• Hospitals in some parts of Indonesia, including Java and Bali, are on the brink of collapse as the nation passed one million confirmed cases.
• As of January 1, Indonesia has closed its border to foreign nationals to mitigate the increased spread of COVID-19. The border will remain closed until at least January 25. 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. 
• Malaysia has adopted lockdown measures that will apply to most of the country as daily coronavirus cases in Malaysia continue to surge. Five essential sectors including construction, agriculture, and manufacturing will remain open with limited capacity, while interstate domestic travel will be banned and a number of businesses will be required to close under the Movement Control Order (MCO). 
• 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.
• Singapore is requiring travelers who are not Singaporeans or permanent residents entering Singapore from high-risk countries to take a COVID-19 PCR test within 72 hours before their departure.
• Singapore is piloting a new business travel pass for senior executives with regional or international responsibilities. Travelers on this pass would need to keep to a strict itinerary while abroad. On returning to Singapore, they would have the option of a COVID-19 test in lieu of a stay-home notice and would need to self-isolate until the results are released.
• Singapore has lifted border restrictions for all visitors from mainland China, Taiwan, and Australia’s Victoria State.
• Thailand now allows long-term stay visitors, including business travelers and tourists, who will be able to remain in the country for up to 90 days (with up to two extensions possible). Visitors must be from a designated low-risk country, must undergo testing, and must quarantine for 14 days upon arrival in Thailand.
• Thailand has extended its nationwide state of emergency through February 28 and deferred a proposal to shorten the quarantine period for foreign tourists to 10 days to prevent a COVID-19 resurgence during the peak holiday season.
• Thailand lifted the ban on international flights and allows certain categories of individuals from Japan, China, South Korea, Hong Kong, and Singapore to enter the country. The Civil Aviation Authority will still apply stringent international travel restrictions preventing the entry of tourists.
• Vietnam has banned flights from countries that have recorded the new COVID-19 variant. The country will limit inbound repatriation flights from January 10 until mid-February.
• Staff Contact:  Phil Agress (PAgress@AdvaMed.org)

Europe

• Europe overall continues to struggle in its attempts to abate the virus, with many countries experiencing persistent or increased spiking (UK, France, Spain, and even Germany). Italy and Belgium seem to be making progress in getting its numbers and rate of increase to lower levels.
• In terms of new cases, Spain leads with 40,285, followed by France (26,916), UK (25,308), Russia (17,741), Germany (15,611), Italy (15,152) and Portugal (15,073). Italy’s numbers have been on a significant downward trend, while Spain and France remain high. Germany is having lower but persistent spiking.
• The UK leads Europe in deaths at 101,887 followed by Italy, France, Russia, Spain and Germany. (see chart below). Russia's reported numbers on COVID remain problematic with perhaps the highest number of total cases of any country at 3,774,672 (but now only slightly higher than the UK’s total) and 71,076 reported deaths (and reporting one of the lowest death rates in Europe at 487 per million).  By comparison Germany with more than 1.5 million fewer cases (2,179,679) reports 55,358 deaths and a death rate of 660 per million.

• New daily cases, which tend to show which countries are increasing in COVID incidence are as follows (prior week figures are in parentheses):  Spain 40,285 (down from 41,476); Italy 15,192 (up from 13,571); Germany 15,611 (down from 18,559); France 26,916 (about par from 26,784); UK 25,308 (down from 38,905; Belgium 1,479 (down from 2,099); and Russia 21,152 (down from 22,850). Daily rates continue to remain at problematic levels across most of Europe and the UK. Belgium is the third worst in the world in deaths per million population, but their overall numbers now appear to be flattening. Italy, UK, Spain and France are respectively ranked #7, 5, 16 and 21 in deaths per million. (The US ranks 11).
• New deaths per day (which tend to lag any increased infection rates) are increasing and are as follows:  Spain 492; Italy 467; Germany 968; France 350; UK 1,725; Belgium 65. Russia reports 594 new deaths per day.
• As of January 1, Portugal is president of the EU Council, taking over from Germany. The new president indicated a key priority of Portugal's tenure must be to secure the continent's economic recovery from the impact of coronavirus. He also stated that climate change must be addressed.
• As the second wave of the pandemic continues, jobs and businesses across Europe are being hit hard. However, many have been cushioned from the worst of the economic fallout by government job retention schemes to keep people in work. Although unemployment is set to rise to 9.4% in 2021 in the eurozone area, an increase of 1.9% from the 2019 pre-pandemic level of 7.5%, it has stayed relatively low when compared to the drop in economic activity.
• European governments have been subsidizing wages and keeping workers on the payroll during the coronavirus pandemic through short-time work and furlough schemes, supported by the EU’s SURE (Support to mitigate Unemployment Risks in an Emergency). SURE acts as a second line of defense for these EU members’ schemes, in particular for the self-employed, by providing emergency financial assistance of 90.3 billion euros in loans to 18 EU countries.
• The war of words between pharmaceutical giant AstraZeneca and the European Commission continued on Thursday after a crisis meeting the previous evening failed to resolve the row over vaccine supplies. AstraZeneca told the European Commission last week there would be a 60% shortfall in supplies this quarter due to production problems. Talks that were held on Wednesday failed to solve the issue but were described as ‘productive.’ The vaccine is set to be approved for use in the EU by the end of this week.  
• Belgian health authorities said on Thursday they had inspected a pharmaceutical factory to find out whether expected delays in the deliveries of AstraZeneca’s coronavirus vaccine were due to production issues, as the company has claimed. The European Commission had asked the Belgian government to inspect the factory amid the heated public dispute between the 27-nation bloc and the Anglo-Swedish drugmaker.
• The dispute could spark a UK-EU trade war unless it changes course over its vaccine supply row with Brussels. Meanwhile, doubt has been cast in Germany on the vaccine after the country's vaccination commission questioned its effectiveness in older adults and declined to recommend its use for people over 65.
• Speaking in an interview with Euronews, Alexander Stubb, a former Finnish premier, argued that the EU was doing a good job with its vaccine rollout but it was facing a "new" and "difficult situation" in its ongoing contractual disagreement with AstraZeneca. "I think we are all facing a new situation. It's a very difficult one, both for the companies and then the other contractual party. Of course, we'd love to live in a world where everything would work perfectly and the rollout would go exactly as expected but that simply does not happen in these kinds of cases," he told Euronews.
• The WHO COVAX program aims to distribute vaccines across the globe in an equitable manner. In a meeting this week, the WHO Director General 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.
• Pfizer-BioNTech – 300 million
• Moderna – 160 Million
• Astra-Zeneca – 400 Million
• Sanofi-GSK—300 Million
• CureVac: 405 Million
• Johnson & Johnson – 400 Million
• Talks are in progress with Novavax for 200 million doses
• EU vaccine delays have prompted expressions of frustration from commentators and press alike. However, part of the issue that the EU is having with supply stems from the fact that they spread their risk by purchasing from many manufacturers, and some have yet to pass their clinical trials. Many of the doses thus purchased are not yet available for use. Sanofi has also indicated it may be in a position to produce additional doses of the Pfizer vaccine to help offset a temporary cut in deliveries that was necessitated as Pfizer ramps up production capacity in its Belgium facility.
• Europe continues to ramp up inoculations against COVID. Belgium, Czech Republic, United Kingdom, Denmark, Slovenia and Italy lead Europe in full vaccinations (completed even if 2 doses) per 100,000. In terms of raw numbers, the UK has over 7,600,000 doses administered, followed by Germany (1,990,000), Italy (1,575,000), Turkey (1,522,600), Spain (1,356,500) and France (1,137,000). Approximately 10.13 million of the EU’s 448 million people have been vaccinated so far.
• Poland's ruling Law and Justice party (PiS) has suspended an MP after it was revealed he had received a COVID-19 vaccine.
• In non-COVID news, police in the EU and across the globe have collaborated to solve an important international case involving dangerous computer malware. Police in six European countries have helped dismantle 'Emotet', a global criminal hacking scheme. Law enforcement authorities in France, Germany, Lithuania, the Netherlands, Ukraine and the United Kingdom were involved in the major operation to uncover the network. Police in Canada and the United States, as well as Europol, were also involved.
• The scheme had stolen data from banks in the US and several European countries, causing an estimated $2.5 billion (nearly €2.1 billion) in damage. "Emotet was currently considered the most dangerous malware worldwide," Germany’s BKA federal police agency said in a statement, adding that the network had "infected a large number of IT systems of companies, authorities and institutions" in the country.
• 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.
• On 19 January 2021, the Commission adopted a Communication setting out actions needed to avoid a third wave. 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.
• On 25 January 2021, the Commission proposed to add ‘dark red’ to the European Centre for Disease Prevention and Control’s mapping of high-risk areas. The latest measures on stricter travel requirements can also 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. These measures were issued before the formal Brexit, so are likely to be updated again shortly. 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; We expect further details will be forthcoming and will of course be updating members accordingly as information becomes available.  
• In the UK, the number of COVID positive hospital patients has fallen by the largest amount since the pandemic started.
• The Cabinet Office confirmed that the UK has enough COVID vaccinations to continue the roll-out. The government intends to provide 13.9 million people with a first dose of a vaccine by the middle of February.
• Phased return of students for schools could begin as early as March 8 in England.
• UK experts have contradicted their German counterparts on the efficacy of the AstraZeneca vaccine. While Germany indicated the vaccine should be given only to people under age 65, the UK indicated it believes the vaccine is highly effective even in the 65 and older age group.
• 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 has added UAE, Burundi and Rwanda to its ‘red’ list of countries from which travel to the UK is banned.
• According to a poll of police officers by the UK Police Federation, 32% said they someone they thought to be infected with COVID had threatened to breathe or cough on them. 21% of officers said a suspected infected person tried to spit at them. Assaults on officers increased by as much as 40% during the pandemic lockdown. Police chiefs have reiterated calls for officers to be prioritized for vaccination, along with teachers and firefighters.
• The UK remains generally under lockdown, with slightly different rules depending on location. In England, citizens are not to leave their homes except where necessary.
• UK Ministers are considering paying £500 to everyone in England who tests positive for Covid-19, in a dramatic overhaul of the self-isolation support scheme. The proposed change is thought necessary because government polling found only 17% of people with symptoms are coming forward to get a test for fear a positive result could stop them from working.
• 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 is conducting 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 is considering stopping almost all incoming flights from countries affected by COVID-19 variants, regardless of what is agreed at an EU level. Talks are ongoing within the EU about how countries could implement further restrictions, but the Interior Ministry of Germany said on Thursday “if no satisfactory measures are decided at EU level” the country would act at a national level.
• Federal Interior Minister Seehofer had raised the possibility of cutting air traffic to Germany “to almost zero”, as he suggested "drastic measures" would be needed, but on Thursday told a news conference new measures would focus on air traffic with the United Kingdom, Brazil, South Africa and Portugal.
• 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.
• Germany is contemplating additional restrictions on travelers inbound from so-called ‘COVID mutation areas.’
• German MEP Peter Liese warned that the EU risked a trade war with the UK, which ordered its doses three months in advance of the EU, over the supply of vaccine doses if the EU did not change course. Stubb also criticized the poor communication on both sides in what is becoming a public relations disaster for both parties, he said. "I think probably AstraZeneca need to look at their communication strategy as well [as the EU],". "I'm not very convinced that the way in which the company, and especially its CEO, came out early on in this discussion was conducive to diplomatic and constructive discussion for the future". He went on to say that the only solution to the ongoing spat was "a robust and effective rollout of the vaccine".
• Germany’s vaccine commission has recommended limiting use of Astra-Zeneca’s COVID vaccine to include only those under 65. This comes as German officials have expressed doubts about the vaccine’s efficacy in the over 65 population.
• According to the head of Germany’s vaccine panel, it will take until 2022 to vaccinate all of Germany's population. "If you can administer shots on 150,000 to 200,000 people a day, so on five or six days a week – assuming vaccines are available and people are willing to be vaccinated – then you can calculate how long it will take," Thomas Mertens, head of STIKO, Germany's expert panel on vaccine use, told the Rheinische Post. "Then you would need 100 days to vaccinate 15 million people."
• However, the Robert Koch Institute Chief said Germany will have COVID-19 under control by the end of 2021. But he added that the spread of new virus variants might pose a challenge. People in Germany must refrain from nonessential travel, he reiterated on Thursday, after the country detected cases of new coronavirus variants. "We will have more variations ...Therefore don't travel," RKI President Lothar Wieler said. Germany has reported 16 cases of the coronavirus variant that was first detected in Britain, and four other cases of the variant from South Africa. The RKI said these would not be the last new COVID-19 variants, as a new variant has been detected in Brazil. All infections of the new COVID-19 variants in Germany have been related to travel, Wieler said.
• The RKI reported that for the first time since the end of October, Germany’s COVID infections per 100,000 residents has fallen below 100.
• There are likely around 2,000 cases of the new COVID variants in France per day, health minister Olivier Véran said, adding that the number had previously been around 500 earlier this month. It's one of the several worrying factors in France that could force the government to impose stricter measures, with many anticipating a decision will come soon. Véran said that France's 6 pm to 6 am curfew was likely having an effect and had probably allowed the country "to avoid the same epidemic curve seen in many neighboring countries". But, he added, the curfew is "not enough to stop the spread of the virus" especially with the circulation of more transmissible variants. Veran noted an increase in new variants might compel further restrictive measures to address the spread.
• Earlier in the week, the President of the government's Scientific Council said a national lockdown would likely be necessary to control the spread of the virus. "If we do not tighten regulations, we will find ourselves in an extremely difficult situation from mid-March," Professor Jean-François Delfraissy said in an appearance on French broadcaster BFMTV, adding that this week was critical in France's fight against COVID-19. France has reached a plateau of around 20,000 cases a day, a number that has increased around 10% each week for the past three weeks, the health minister said. Pressure in hospitals is rising with 60% of intensive care units occupied by COVID-19 patients in the country.
• A third national lockdown "will probably be necessary" in France the head of the scientific council that advises the country's leaders, has said. "If we do not tighten regulations, we will find ourselves in an extremely difficult situation from mid-March," Professor Jean-Francois Delfraissy said in an appearance on French broadcaster BFMTV, adding that this week was critical in France's fight against COVID-19. Delfraissy called for swift government action amid rising concerns about the spread of new, more contagious variants of COVID-19 discovered in the UK, South African, Brazilian and now California. He added that these variants "are the equivalent of a second pandemic".
• France’s PM Macron is said to be weighing options despite his belief that French citizens can’t tolerate much more in the way of additional restrictions or lockdowns. Small business owners are the focus of much anxiety and are worried that their businesses won’t survive if restrictions are bolstered or extended.
• 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.  
• 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

WEEKLY HIGHLIGHTS –COVID 19

Prospectiva COVID-19 LATAM Weekly Updated for January 18, 2021

• Argentina: ANMAT recommended the use of Sputnik V vaccine in people over 60 years old.
• Bolivia: President Arce announced the arrival of vaccines by the end of January.
• Brazil: Foreign Affairs Minister under pressure.
• Colombia: Attention placed on the rise of legal actions to access COVID-19 vaccines.
• Chile: The Public Health Institution (ISP) approved the Sinovac vaccine for emergency use.
• Ecuador: The government kickstarted the vaccination campaign pilot plan.
• Ecuador: Health minister rejects calls to resign
• Mexico: President AMLO tested positive for COVID-19.
• Mexico: Discrepancy uncovered in official Covid-19 death toll
• Mexico: Calls to increase emergency spending
• Mexico: Government under fire for erratic vaccination plan
• Paraguay: Government closes deals to secure access to COVID-19 vaccines beyond COVAX mechanism.
• Peru: The Foreign Affairs Ministry assured that the country has secured a total of 28 million doses of vaccines from COVAX and Sinopharm.
• Uruguay: The President announced purchase agreements for Pfizer and Sinovac vaccines.
• Staff Contact: Steven Bipes (sbipes@advamed.org)