COVID-19 Outbreak: Weekly Global Report for Friday, July 16, 2021

 

AdvaMed recognizes that its members, particularly those with global government affairs responsibilities, are tracking COVID-19 related developments around the world to assess the public health and economic impacts on their businesses. Knowing that companies are consuming information from a variety of sources, AdvaMed's global team would like to provide members with a weekly snapshot of the key statistics, policy developments and advocacy initiatives underway in our priority markets.  If you have any suggestions, we welcome your feedback.

 

Global

• Weekly COVID-19 statistics: global cases reached a total of 189 million cases. Deaths around the world have exceeded 4 million. The countries with the most reported cases continue to be the U.S. (33.9 million), India (31.1 million) and Brazil (19.2 million).
• U.S. cases exceeded 33.98 million with deaths increasing to 608,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Overview: Despite a massively efficient vaccine roll-out since May, the Chinese government has given no indication it intends to change its current COVID playbook of closed borders, strict quarantine for foreign arrivals, and aggressive lockdowns when flareups return. Beijing remains ever cautious as variants circulate and the efficacy of China’s vaccines is questioned. Many businesses expect that China may retain stringent travel restrictions through February 2022, when Beijing will host the Winter Olympics. Chinese regulators this week completed an expert review of a COVID-19 mRNA vaccine developed by Germany's BioNTech and Fosun Pharma. Chinese authorities plan to use the vaccine, which goes by the brand name Comirnaty, as a booster shot for those people who have received an inactivated-virus vaccine—i.e., nearly the entire Chinese population.
• Status of vaccination campaign: Over one billion Chinese citizens have received at least one COVID vaccine dose to date, accounting for one-third of total global vaccinations. China’s CDC has revised upwards its threshold to reach herd immunity from 70% to 80-85%. Several local governments in China are planning to bar residents who haven’t been vaccinated against COVID-19 from accessing public venues, stirring controversy as the country makes a push for herd immunity. In recent days, a dozen counties and cities in the eastern provinces of Zhejiang, Fujian and Jiangxi set late-August deadlines for people 18 years or older to complete a two-shot vaccine regimen, according to similarly worded online statements. Many of them also set dates in late July by which unvaccinated people would be barred from entering schools, libraries, prisons, nursing homes and inpatient facilities at hospitals without a valid medical exemption.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 104,194, an increase of 225 cases over the previous week. The number of reported deaths remained unchanged over the previous week, at 4,848.
• China’s vaccines and approval date: Sinopharm (approved Dec. 31, 2020); Sinovac’s CoronaVac (approved on Feb. 5); CanSino Biologics and a second Sinopharm vaccine (both approved in April). Three other vaccines have been approved in May and June.
• China approves Sinovac vaccine for children: China is the first major country to grant vaccine approval for children as young as three. Singapore, Hong Kong and some U.S. states have so far authorized COVID-19 vaccines for children 12 years and above. When exactly this 3 to 17-year-old age group will receive their first doses is unclear.
• Post-COVID healthcare system upgrade: China will provide funding to build new institutions and infrastructure to fight infectious diseases and improve healthcare, the state planning body said in a "five-year plan" for the sector. The central government will subsidize the construction of new "prevention bases" for infectious disease and new grassroots medical facilities across the country, the National Development and Reform Commission (NDRC) said in the plan, published this Thursday. It said China was facing difficult healthcare challenges, including new emerging infectious diseases, the increasingly heavy burden of chronic illnesses as well as the growing need for mental health services. "The public health system is in urgent need of improvement, and the ability to prevent, control and treat major epidemics is not strong," it warned. High-quality medical resources are also insufficient and not evenly distributed, and there are also gaps when it comes to treating women and children, it added.
• BioNTech vaccine: Chinese regulators this week completed an expert review of a COVID-19 mRNA vaccine developed by Germany's BioNTech and Fosun Pharma and the shot is now in the administration review stage, Caixin reported. China hasn't approved any COVID-19 vaccine developed overseas but has greenlighted several domestic brands. Chinese authorities plan to use the vaccine, which goes by the brand name Comirnaty, as a booster shot for people who have received inactivated-virus vaccines, people close to regulators told Caixin. Most people in China have received inactivated-virus vaccines made by Sinovac and state-owned Sinopharm Group that have demonstrated lower efficacy than mRNA vaccines.
• China’s own mRNA vaccine: China’s first messenger RNA (mRNA) COVID-19 vaccine, is expected to start phase three tests in many overseas countries later this month, the chief executive officer of Suzhou Abogen Biosciences, the vaccine’s developer, said this week. Together with Chinese clinical contract research organization Tigermed, Abogen is preparing to conduct overseas Phase III clinical trials using 28,000 volunteers in countries including Mexico, Columbia and Pakistan. The vaccine can be stored at temperatures of between two and eight degrees centigrade for at least seven months, making it convenient for mass distribution. The clinical trials will not select specific variants, and will also not reject any strains, Ying told Yicai Global. The Suzhou, eastern Jiangsu province-based firm is also developing a separate mRNA vaccine candidate that will target the variants that were first found in South Africa and India.
• Vaccine diplomacy: Chinese pharmaceutical companies including Sinopharm and Sinovac signed agreements to supply millions of doses of COVID-19 vaccines with international NGOs. Sinopharm has signed a longer-term agreement to provide up to 120 million doses by the end of 2021 for participating countries and territories in the COVAX program. It is the seventh supply agreement UNICEF has signed for COVID-19 vaccines after agreements with other vaccine suppliers including Pfizer, AstraZeneca, Moderna and Human Vaccine. Meanwhile, GAVI announced on the same day it had signed two advance purchase agreements with Sinopharm and Sinovac to provide up to 550 million COVID-19 vaccines to the COVAX program. The new deals include up to 170 million doses of the Sinopharm shot and up to 380 million shots of the Sinovac vaccine, through to the middle of 2022, the statement said.
• Dispute over COVID-19’s origins: In a rare departure from his usual deference to powerful member countries, WHO Director-General Tedros Adhanom Ghebreyesus said this Thursday that getting access to raw data had been a challenge for the international team that traveled to China earlier this year to investigate the source of COVID-19. Tedros also said there had been a “premature push” to rule out the theory that the virus might have escaped from a Chinese government lab in Wuhan - undermining WHO’s own March report, which concluded that a laboratory leak was “extremely unlikely.”
• China’s Economy: The Chinese economy expanded by 7.9% in the three months ending June compared with a year earlier, according to government statistics released this week. Monthly readings of industrial output, retail sales, fixed-asset investment and urban unemployment all met or topped expectations in June, keeping China on track to meet the official full-year growth target of 6% or more. But beneath the robust growth numbers lurk mounting risks for the economy, including an expected tapering off in global demand for Chinese goods, slower investment in manufacturing and real estate, and the threat of fresh COVID-19 outbreaks that could weigh on domestic consumption.
• S.-China relations: Earlier this week, several media outlets reported that U.S. Deputy Secretary of State Wendy Sherman would travel to Japan and South Korea next week, with China as the last stop. Sherman would be the highest-ranking Biden administration official to visit China so far, and observers widely considered the visit as laying the groundwork for a Biden-Xi meeting later this year at the G-20. However, Sherman’s itinerary—released on Thursday by the State Department—excludes mention of a China stop. The Financial Times is reporting that the PRC Foreign Ministry is not offering a meeting with Sherman’s No. 2 counterpart in the Foreign Ministry, leading to a kerfuffle overall protocol. This week, the Biden administration issued an expanded business advisory for Xinjiang and a new business advisory for Hong Kong that may have angered Beijing.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – 30,986,803 total cases, 432,041 active cases/411,989 deaths/ discharged 30,143,850 (John Hopkins & MoHFW) as compared to 30,708,570 total cases, 460,704 active cases/405,028 deaths/ discharged 29,843,825 (John Hopkins & MoHFW) last week. 391,340,491 people have been vaccinated.
• Union Health Secretary Rajesh Bhushan on Wednesday, July 14, said that the slow pace of procurement and vaccine administration by Private COVID Vaccination Centers (PCVC) is a cause of ‘serious worry.’ A high-level meeting chaired by Rajesh Bhushan with health secretaries and senior immunization officials of 15 States/UTs of Uttar Pradesh, Madhya Pradesh, Rajasthan, Odisha, Telangana, Arunachal Pradesh, Karnataka, Kerala, Tamil Nadu, Maharashtra, Gujarat, West Bengal, Delhi, Punjab and Haryana to review the status and progress of vaccine procurement by Private COVID Vaccination Centers (PCVC).
• The drug price regulator capped the trade margin of five widely-used medical devices, particularly for management of Covid-19, like pulse oximeter, blood pressure monitoring machine, nebulizer, digital thermometer and glucometer at 70%. The move is expected to result in a significant drop in MRP of these products that are in high demand with many Covid patients under home isolation and treatment needing regular monitoring of blood pressure, blood sugar and oxygen level as well as fever, etc.
• The government has exempted basic customs duty on imports of specified API/ excipients for Amphotericin B and raw materials for manufacturing Covid test kits. In a notification dated July 12, the Finance Ministry said the basic customs duty exemption on raw materials for manufacturing Covid test kits would be till September 30, 2021.
• Dr.Reddy's Laboratories Ltd has informed that it will strengthen the commercial roll-out of Sputnik V COVID-19 vaccine in the coming weeks. Cleared that neither the ongoing soft commercial launch nor work towards its ramp-up in India have been put on hold, in a statement. "Starting initially in Hyderabad, the soft launch roll-out of Sputnik V has scaled up speedily and reached cities and towns all over India
• Serum Institute of India (SII) will start production of Sputnik vaccine at the company's facilities in September, Russian Direct Investment Fund (RDIF) said on Tuesday, July 13. "The first batch of Sputnik vaccine is expected to be produced at SII's facilities in September," RDIF said in a statement.
• SpiceHealth, a healthcare company founded by SpiceJet promoters Ajay Singh and Avani Singh, has launched COVID-19 vaccination centres by tying up with major hospitals in Delhi, Haryana, Rajasthan, Bihar and Jharkhand. "The company has launched vaccination centres at Delhi's Aashlok Hospital and Paras Hospitals in four states," a company statement said.
• India's full rollout of the Sputnik V COVID-19 vaccine will have to be put on hold until the Russian producer provides equal quantities of its two differing doses, Dr. Reddy's Laboratories Ltd said on Monday, July 12. Dr. Reddy's had received about 3 million first doses by June 1 and about 360,000 doses of the second by early this month, the company and the Indian government have said.
• Eminent veteran virologist T Jacob John believes that a third wave of Covid-19 across the country is unlikely unless there is an outbreak of a more dangerous and infectious variant than the Delta mutant. “The extent of population that is unexposed to the virus during the last two waves and vaccination coverage will determine the next wave,” former head of departments of clinical virology and microbiology at Christian Medical College (CMC), Vellore.
• Pharma firm FDC Ltd on Monday, July 12 said it has launched oral suspension of Favipiravir to treat mild to moderate cases of COVID-19 in the country. This prescription-only Favenza oral suspension is currently available at all retail medical outlets and hospital pharmacies across India, FDC said in a statement. Convenient loading dosage of the oral suspension helps reduce dosage frequency, it added.
• Healthcare major Abbott on Monday, July 12, said it has launched Covid-19 home test kit in India for the detection of the SARS-CoV-2 virus in adults and children with or without symptoms at a price of Rs 325 for a single test kit pack. The company will deliver millions of Panbio Covid-19 rapid antigen tests, available for self-use, to ease the burden on healthcare systems in urban and rural India, Abbott said in a statement.
• The drug regulator will be considering emergency use approval for Covid vaccines developed by Zydus Cadila for children above 12 this week. The regulator's subject expert committee (SEC) will examine data submitted by Cadila, reported Sushmi Dey.
• India has submitted a proposal to the US, granting legal indemnity as demanded by Massachusetts-based vaccine maker Moderna for shipping its Covid-19 vaccine, albeit with certain conditions, said people aware of the matter. The proposal, which has been further sent to Moderna, will be taken up by its board of directors and once approved, will allow immediate import by India of about seven million doses of the company’s vaccine, they said.
• The Central government on Thursday, July 08, announced a Rs 23,000 crores emergency response package to combat Covid-19. Addressing a press conference, Union Health Minister Mansukh Mandaviya said that the fund will be used to ensure the availability of medical oxygen, critical medicine and infrastructure to deal with the transmission of Covid-19 among children. "In April 2020, Rs 15,000 crores were given as emergency Covid response fund.
• French pharmaceutical company Sanofi and its British partner GSK (GlaxoSmithKline plc) received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomised, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 years and older across sites in the US, Asia, Africa and Latin America.
• Drug firm Mankind Pharma on Thursday, July 08, said it has received licence from the Defence Research and Development Organisation (DRDO) to manufacture and market oral 2-deoxy-D-glucose (2-DG), used for the treatment of COVID-19. 2-DG was developed by the Defence Research and Development Establishment (DRDE), Gwalior. The clinical trials were conducted by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in association with Dr Reddy's Laboratories, Mankind Pharma said in a statement.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 831,792 reported cases and 15,033 reported deaths compared to 814,533 reported cases and 14,933 reported deaths the previous week.
• The number of new infections in the Tokyo metropolitan area is spiking as Japan prepares to host the Olympics later this month. The Prime Minister announced that Tokyo will reinstitute emergency measures through August 22. Spectators will not be allowed at Olympic events in and around the capital.
• Japan had been making good progress ramping up its vaccination efforts, but it now faces a shortage of vaccines. Over 19 million Japanese are fully vaccinated (out of a total population of 126 million) and nearly 30% of the population had received at least one dose as of July 12. Prime Minister Suga said that his goal is to complete all vaccinations by November.
• Japan provided final approval to the Moderna vaccine and the Astra Zeneca vaccine on May 21. The Pfizer vaccine was approved in February. J&J submitted its application for approval of its vaccine on May 24. It is expected to be approved and available for use around the beginning of 2022.
• Moderna will provide 50 million doses of the vaccine by September. It is being used at mass vaccination centers in Tokyo and Osaka, as well as elsewhere. AstraZeneca has contracted to provide 120 million doses, which the government will stockpile for later use.
• The central government has asked companies to reduce the number of workers going to the office by 70% and facilitate telecommuting and staggered commuting hours.
• Prefectural governments are urging hospitals to open up more Covid-19- dedicated beds, which is putting further pressure on patients to avoid elective surgeries.
• The Japanese government continues to maintain its controls on foreign nationals entering the country. Reciprocal business travel arrangements that were forged with China, South Korea, Singapore, and Vietnam remain suspended. 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.
• Staff Contact:  Phil Agress (PAgress@AdvaMed.org).

Korea

• South Korea’s numbers are up again, sufficiently so that it could be called a spike (last week’s number is in parens) with 1,600 new daily cases (762). The country’s numbers are increasing and concerning but remain overall low. There could be extended lockdown repercussion if the trend continues.
• Korea has increased to 173,511 total cases, 14,952 active cases (a significant increase in active cases) with 2,050 deaths. Total cases per million population have remained low compared to most of the world but Korea is now spiking a bit above the 3k threshold with 3,381 cases per million.       (S. Korea ranks as one of the lowest among the more highly populated countries). Deaths per million remain comparatively low as well at just 40.
• South Korea has administered 15,836,992 first doses (30.8% of the population) and 6,183,732 second doses (12.0% of the population) of the COVID-19 vaccine.
• South Korea is closer than ever to a lockdown in its second pandemic summer, as large increases of new COVID-19 cases continue for nearly a week on end. Korea counted 1,600 more cases Thursday, down slightly from the record high of 1,615 cases set the previous day. Nearly 70 percent of the freshly logged cases were traced to Seoul and its surrounding areas.
• For two weeks starting Monday, the wider Seoul area was under the strictest restrictions available under the country’s four-tier social distancing system. After 6 p.m., all social gatherings larger than three people are banned. Gyms and restaurants can only remain open until 10 p.m. Bars, nightclubs and other places considered to be high risk cannot operate at all. The constraints on businesses and daily life dictated by the tier are the harshest form of social distancing Koreans have endured since the pandemic began. For now, the rules are set to end on July 25.
• While the fourth tier is not a lockdown in a true definition of the word, it’s been widely called a “near-lockdown” or “soft lockdown” due to the unprecedented restrictions on in-person activities put in place. The Ministry of Health and Welfare’s spokesperson Son Young-rae said, “The idea is that you shun all travel and gatherings that aren’t essential.” Health officials have said that the intense social distancing will not be necessary for long.
• Two key promises were made in a series of Ministry of Health and Welfare briefings held Wednesday and Thursday. About 8 million doses of COVID-19 vaccines will arrive in Korea before the end of this month, to hopefully speed up the painfully slow rollout. Additionally, the latest wave will more or less come under control in two weeks.
• As new cases in the greater Seoul area account for 80 percent of the daily caseload, the country implemented a semi-lockdown in the region that centers on banning gatherings of more than two people after 6 p.m.  
• Under the highest social distancing measures of Level 4, entertainment establishments, including nightclubs and bars, are ordered to shut down in the capital area, while restaurants are allowed to have dine-in customers only until 10 p.m.      
• Starting Thursday, most areas outside the greater Seoul area will be placed under the second-highest restrictions, in which gatherings of more than eight people are banned around the clock, according to health authorities. The ceilings, however, vary depending on provincial governments' policies.       Non-capital regions have been under the lowest social distancing scheme with no ceiling on gatherings. Restaurants are allowed to operate until midnight at Level 2. Some regions, including the central administration city of Sejong, along with North and South Jeolla provinces, will be under Level 1 distancing.
• But Korea has been put on edge due to rising variant cases and soaring untraceable infections.
• Baek Young-ha, head of the ministry’s vaccine procurement program, said Thursday that “supplies due for arrival over the remainder of July are roughly 8 million doses,” adding that these have been “agreed upon with pharmaceutical companies,” namely, AstraZeneca, Pfizer, Moderna and Johnson & Johnson. “The vaccine shipments are coming in on a weekly basis,” he said. Lee Ki-il, another senior official at the ministry, said a day prior that “the COVID-19 situation here is predicted to stabilize in two weeks.” “For just the next two weeks, refrain from nonessential outings and social events,” he said. Some experts are skeptical that two weeks will be sufficient.
• Hundreds of small-business owners took to the streets Wednesday night, denouncing the government for once again putting their livelihoods at risk in its drive to contain COVID-19 with strict social distancing rules. With limits on private gatherings that continued since last year, coupled with the most recent minimum wage increase, small-business owners are asking the government for monetary support and to relax restrictions on business operations to boost consumption. To make their demands heard, a committee comprising 22 small-business owners’ associations staged a drive-through rally for two hours from Yeouido, western Seoul, to streets of Jongno-gu, central Seoul.
• South Korea has secured enough vaccines to inoculate some 100 million people in a country of 52 million. The vaccines are made by five pharmaceutical firms -- AstraZeneca, Pfizer, Johnson & Johnson's Janssen, Moderna and Novavax. "Experts say the COVID-19 outbreak will not end immediately and will continue for some time, and numerous variants are expected to proliferate," Vice Health Minister Kang Do-tae said. "The government is thoroughly preparing to secure vaccine bottles for next year."
• Foreigners arriving at South Korean airports face a mandatory 14-day quarantine procedure and must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation. However, starting July 1, some people who have been vaccinated against COVID-19 in countries other than Korea will be exempt from the 14-day self-quarantine requirement, meaning they can move around freely as soon as they enter the country. A similar exemption has been in place since May for those who were vaccinated in Korea.
• The new exemption applies only to people who were fully vaccinated at least two weeks before traveling to Korea. It also applies only to those who have received a COVID-19 vaccine that is approved for emergency use by the World Health Organization. The list includes those from Pfizer, Janssen, Moderna, AstraZeneca, Sinopharm and Covishield. All international arrivals still have to show a negative result from a COVID-19 test taken within 72 hours of departing for Korea. Without one, you can still be refused entry.
• The exemption also only applies to those visiting Korea for business or academic purposes, for the public interest or to visit immediate family members. Otherwise, you still have to self-quarantine for two weeks upon entry. Immediate family members are defined as spouses, lineal ascendants or descendants, and lineal ascendants or descendants of spouses. You will have to fill out forms and prove your intent to visit them. The necessary forms are available online from Korean embassies and consulates abroad or other government agencies.
• Those coming from countries experiencing the spread of certain COVID-19 variants are also ineligible for this exemption. As of June, those countries were South Africa, Malawi, Botswana, Mozambique, Tanzania, Eswatini (formerly Swaziland), Zimbabwe, Bangladesh, Equatorial Guinea, Brazil, Suriname, Paraguay and Chile. The list could change depending on the global situation.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

Cases

• ASEAN now has 5,846,738 reported cases and 111,498 reported deaths compared to 5,311,990 reported cases and 102,287 reported deaths last week.
• ASEAN remains in the midst of a sharp spike in cases and deaths. The number of new cases last week set a record for the ninth week in a row.
• Indonesia: Indonesia is suffering from a major surge in COVID-19 cases driven by a surge in travel following the post-Ramadan holidays.  The number of new cases over the past week far surpassed the weekly record it set the previous week. Authorities plan to increase hospital capacity by 40% in Jakarta, while hotels will be converted into isolation centers. The government announced a six-week extension of stricter social restrictions, including tighter restrictions on movement and air travel, the closure of malls, a work-from-home policy for non-essential workers, reduced public transportation capacity, and requirements for vaccines or COVID-19 tests for domestic air travelers. Indonesia is now reporting 2,726,803 total cases and 70,192 total deaths compared to 2,417,788 total cases and 63,760 total deaths the previous week. Indonesia accounts for 63% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: Malaysia set four daily records for new COVID cases over the past week. The country has extended its nationwide lockdown indefinitely amid a continuing high caseload. Only essential businesses, such as supermarkets and medical clinics, may operate. Schools and shopping malls are closed and only two people per household may venture out to buy essentials or for medical services, with movement limited to a 10km radius.  Reported cases have grown from 808,658 to 880,782 over the past week. Total deaths have grown from 5,903 to 6,613 over that timeframe.
• Thailand: The number of cases reported by Thailand has grown more nearly 13-fold since April 1. The country is experiencing new daily records of COVID fatalities, and beds designated for patients in critical condition at all state-run hospitals in Bangkok are now fully occupied with COVID-19 infected patients. Thailand is converting several airport terminals into field hospitals. A 14-day lockdown of Greater Bangkok began on July 12 as Thailand continues struggling to contain its third and deadliest COVID-19 wave. Restaurants, markets, convenience stores, and public transit will operate with shortened hours of operation, and shopping malls will close except for certain essential tenants such as supermarkets, banks, pharmacies, and eateries. Private and public sector workers are being encouraged to work from home. Reported cases grew from 308,230 to 372,215 over the past week and reported deaths have increased from 2,462 to 3,032 over that time.
• Philippines: The Philippines is now reporting 1,490,665 total cases, up from 1,455,585 last week. Total reported deaths have increased from 25,650 to 26,314 over that time.
• Cambodia: The number of reported cases has grown more than 26-fold in Cambodia since April 1. Reported cases increased to 63,615 from 57,103 over the past week. Reported deaths grew from 798 to 986 over that period.
• Vietnam: Vietnam experienced five successive days of a record number of COVID cases last week. Ho Chi Minh City is the new epicenter of the fourth COVID-19 wave and has suspended dozens of daily flights and announced strict curbs on movement and gatherings for 15 days that went into effect on July 9. Hanoi has also imposed movement restrictions, and as of July 13, suspended non-essential services amid the rising COVID-19 threat. The number of reported cases has grown over 14-fold since April 1. Cases of COVID-19 infection grew from 23,385 to 38,239 over the past week. The total number of deaths grew from 102 to 138.
• Singapore: Singapore slightly relaxed COVID precautions amid low infection rates. The relaxed measures include a reopening of gyms and in-restaurant dining in groups of two. Working from home remains the default.  Reported cases increased slightly from 62,652 to 62,804 over the past week. The total number of deaths increased remained at 36.
• Laos: Laos reported a growth in total cases from 2,400 to 2,976 over the past week. It has reported 3 deaths from COVID since the outset of the pandemic.

Vaccinations

• Indonesia is currently in the second stage of vaccinations following the vaccination of medical workers in the first stage. It reportedly has 76 million doses of the vaccine on hand. It is administering the Sinovac and AstraZeneca vaccines. Only 5.6% of the population is fully vaccinated.
• 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. President Jokowi has set a target of finishing the vaccination process within this year.
• 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. So far, it has fully vaccinated 12% of its population. One million doses of the Pfizer vaccine donated by the U.S. arrived in Malaysia on July 5.
• 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 fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 3.4% of the population is fully vaccinated.
• Singapore is on track for two-thirds of its population to have received their first vaccine dose by early July and aims to have two-thirds fully vaccinated by August 9. Currently, 41.5% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 4.8% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available. Thailand announced it is on track to receive six million AstraZeneca vaccine doses this month.
• Thailand's Food and Drug Administration has approved Siam Bioscience as a manufacturing facility for the COVID-19 AstraZeneca vaccine. Thailand plans to export the vaccines to eight Southeast Asian countries.
• Vietnam’s health ministry said the country will have nearly 125 million doses of Covid-19 vaccines this year. The total includes 5 million doses from Moderna, 20 million doses of the Sputnik V vaccine, and 31 million doses of the vaccine developed by Pfizer. Vietnam will also acquire 30 million AstraZeneca doses and 38.9 million doses through the Covax initiative.  The U.S. shipped 2 million doses of the Moderna vaccine to Vietnam in July. The country has fully vaccinated less than 1% of its population to date. Meanwhile, a Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
• Cambodia has fully vaccinated 24% of the population, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore has suspended its Reciprocal Green Lane (RGL) arrangements with Malaysia, Germany, South Korea, and Brunei due to a resurgence of COVID-19 cases. The move does not affect Singapore’s Periodic Commuting Arrangement with Malaysia, which includes longer-term workers and business travel.
• Singapore and Hong Kong agreed to postpone their travel bubble that had been scheduled to start May 26 due to an outbreak of cases in Singapore.      
• Indonesia has closed its border to foreign nationals to mitigate the increased spread of COVID-19. The 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. 
• Thailand’s Prime Minister announced in mid-June his goal of fully opening the country to foreign visitors within 120 days to pave the way for economic recovery. As of April, Thailand reduced its mandatory quarantine from 14 to seven days for foreigners arriving in the country who have been vaccinated against the coronavirus. Vaccinations must be administered within three months of the travel period and visitors will still be required to show negative COVID-19 test results within three days of their departure. Those not yet inoculated but with coronavirus-free certificates would be quarantined for 10 days.
• Vietnam has temporarily restricted the entry of foreigners and overseas Vietnamese to focus on COVID-19 preventative measures. It has also increased the quarantine period for incoming travelers and close contacts of confirmed cases to 21 days.
• Staff Contact:  Phil Agress (PAgress@AdvaMed.org)

Europe

• The story in Europe this week is the dramatic spikes in daily cases that are being seen in the UK, Russia and Spain. In Russia the issue is more persistence at a higher level than spiking. Positive or holding trends are continuing in many of the larger European countries, including France, Italy, Germany and Belgium. Daily fatalities in the UK have significantly increased from prior weeks. Russia daily fatalities continue to spike. In contrast, Italy, France and Germany are all showing more stability in daily case rates (while France has increased it remains at a much lower level than UK, Spain or Russia).
• Increases in new cases per day (New Daily Cases) tend to benchmark increasing COVID incidence. We’ve put the new daily case numbers in the chart below. Additionally, here are the current figures with (two weeks) prior figures in parentheses.  France 8,875 (2,457); Spain 26,390 (9,227)); Russia 23,827 (21,042 ); UK 42,081 (25,923, Italy 2,171 (773); Germany 1,629 (831); and Belgium 1,303 (1,072).
• In terms of total cases, see chart below for the specific numbers. Russia is now ahead of France. UK, Italy, Spain, Germany, Poland, Ukraine Netherlands and Czech Republic round out the top 10 countries with the largest number of total cases in Europe.
• In terms of cases per million in Europe, Czech Republic remains 3^rd highest in Europe with 155,653, but the rate of increase appears to be slowing. Sweden is 8^th with 107,624. Belgium is 12^th with 94,344, France is 14^th with 89,108. Spain is 16^th with 86,405, Italy is 28^th with 70,848, and the UK is 21th with 76,662.
• Russia's reported numbers on COVID remain problematic at 5,857,002. Russia has moved again into the lead for most COVID cases in Europe. However, Russia reports one of the lowest death rates in the world at just 995 per million.  By comparison, Germany, with more than 2 million fewer cases, reports 91,831 deaths and a death rate of 1,092 per million. Russia has authorized a one-shot Sputnik Light version of its Covid vaccine.

• In terms of deaths per million, Belgium is the 14^th worst in the world with 2,165. Italy is 16^th , with 2,117. The UK is 20^th with 1,883. Other rankings in this category are Spain, 25th, and France 26^th. (The US ranks 21^st with 1,873 deaths per million).
• New deaths per day (which tend to lag any increased infection rates) are decreasing in many of the larger countries as follows:  Spain 10 (29); Italy 23 (30); Germany 32 (64); France 6 (33); UK 49 (19); Belgium 2 (3). Russia reports 786 (548).
• Germany now leads Europe in the number of vaccine doses administered with 84,203,433. The UK is second with 81,192,857. France and Italy are showing strong positive movement at over 61 million and 59 million respectively. Spain is now over 48 million doses. These numbers continue to rapidly increase.
• Seven countries have begun using the EU's COVID-19 'Digital COVID certificate' to facilitate travel across the bloc. The European Commission says seven member states - Bulgaria, Czech Republic, Denmark, Germany, Greece, Croatia and Poland - have connected to the gateway and started issuing the first certificates. Other countries will follow suit when all functions are deployed nationwide. The certificate is available in digital or paper form, free of charge. The gateway allows for all certificates' QR codes to be accessed. The EU's plan is for a single system to facilitate safe travel by verifying the pass holder's coronavirus status – whether through vaccination, a recent negative test result, or proof of recovery from the virus.
• The EU 27 member states have announced that fully vaccinated travelers will be able to enter the bloc this summer. The agreement still needed to be formally adopted by the European Council. To be ‘fully vaccinated’ travelers would have to have received EU-approved vaccines and all necessary doses.
• The EU Digital COVID Certificate Regulation has entered into application. This means that EU citizens and residents will now be able to have their Digital COVID Certificates issued and verified across the EU. 21 Member States as well as Norway, Iceland and Liechtenstein had already started to issue certificates ahead of today's deadline, and five EU countries are starting today.
• Two doses of a COVID-19 vaccine are needed to protect against the Delta variant of coronavirus, the European Medicines Agency (EMA) has said. The European regulator also called on EU member states to speed up their vaccination programs amid an increase in infections. Several European countries have blamed a rise in COVID-19 case numbers on the highly contagious Delta variant, which first emerged in India. "Preliminary evidence suggests that both doses of a COVID-19 vaccine are needed to provide adequate protection against the Delta variant," the EMA said in a statement. "Adherence to the recommended vaccination course is vital to benefit from the highest level of protection against the virus," it added. The regulator reaffirmed its approval of two doses of the Pfizer/BioNTech, Moderna, and AstraZeneca vaccines for European citizens.
• Pfizer/BioNTech and Moderna vaccines appear to be effective against the new Indian strain, the European Medicines Agency (EMA) said on Wednesday.
• EU countries are increasingly mandating ordering health workers to be vaccinated. France and Greece are the latest countries to do this, following on success demonstrated by Italy when it imposed these requirements.
• The European Union and the United States have agreed a truce in their near 17-year conflict over aircraft subsidies for U.S. plane manufacturer Boeing and European rival Airbus, the EU said on Tuesday. The two sides agreed to suspend for five years tariffs that stem from the dispute.
• The European Union and the United States have also agreed to engage in discussions to resolve differences on measures regarding steel and aluminum by the end of the year. Commission President Ursula von der Leyen told reporters at a press conference following the summit that a steel tariffs "working group" will be established with the aim of "making good progress in moving forward within months". The trade dispute on steel and aluminum dates back to the administration of former US President Donald Trump who, in March 2018, decided to slap extra tariffs on EU exports of steel and aluminum entering the US. The duties were set at 25% on steel and 10% on aluminum. According to the European Commission, this represents €6.4 billion worth of trade. As a countermove, the EU imposed extra duties on a list of US imports worth €2.8 billion. The targeted products included steel, aluminum, peanut butter, whiskey, motorcycles and jeans.
• The Swiss Federal Council has indicated that there remain "substantial differences between Switzerland and the EU on key aspects of the agreement" and "the conditions are thus not met for the signing". The main stumbling blocks were freedom of movement, the level playing field and state aid rules.
• The Swiss government argues that incorporating a 2004 EU law called Citizens' Rights Directive (CRD), which gives citizens from the European Economic Area (an area that includes the 27 EU countries, Iceland, Norway and Liechtenstein) the right of free movement and residence, could entail "higher social security costs" and "effectively constitute a paradigm shift in Switzerland's migration policy".
• Among the particular objections, Switzerland didn't want to incorporate the notion of permanent residence for EU citizens and access to social security for non-employed residents, such as job-seekers and students. Switzerland was not comfortable either with the concept of EU citizenship, although Brussels insisted that this aspect was not part of the deal.
• While discussions could be restarted at any time, the Implications for the medical technology industry from the failure of the EU and Switzerland to reach an agreement on a mutual recognition agreement (MRA) include the following:  
  • For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
  • Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognized as valid in the EU.
  • For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorized representative was previously established in Switzerland, must designate an authorized representative established in the EU.
  • On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.

• The following links may be of interest on the Swiss/EU MRA issue
  • EU Commission Announcement and Notice to Stakeholders on the failure to reach agreement-- mdcg_eu-switzerland_mra_en.pdf (europa.eu)
  • Swiss MedTech statement on the ‘downgrade’ of Switzerland to third country status: Swiss medtech downgraded to «third country» status | Swiss Medtech (swiss-medtech.ch).
  • Swiss Medtech summary of current state of play for devices moving into and out of Switzerland from the EU: pdf (swiss-medtech.ch).
  • Swiss schedule for Swiss importers to meet requirements to continue to place devices on the market in Switzerland (initial date is December 2021 for Class III);
    https://www.swiss-medtech.ch/sites/default/files/2021-04/20210401_Brancheninformation_MDR_eMepV_EN.pdf.
    • While the schedule says ‘not yet passed’ it became effective when the MRA was not renewed on May 26.
• The 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: Albania; Armenia (new); Australia; Azerbaijan (new); Bosnia and Herzegovina (new); Brunei Darussalam (new); Canada (new); Israel; Japan; Jordan (new); Lebanon; Montenegro (new); New Zealand; Qatar (new); Republic of Moldova (new); Republic of North Macedonia; Rwanda; Saudi Arabia (new); Serbia; Singapore; South Korea; Thailand; United States of America
• The EU is now allows all travelers with proof of vaccination into the EU, with some restrictions. See link for full explanation: COVID-19: travel from third countries into the EU - Consilium (europa.eu).
• 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.
• The number of COVID positive patients in hospital in England has risen by 48% in a week. The UK new case totals are at their highest rate since January.
• Almost 53% of UK citizens are now fully vaccinated.
• UK citizens who have yet to take up a COVID vaccine are being told international travel will be difficult without it. National clinical director Prof Jason Leitch said travel was another incentive for the cohort to get jabbed.
• It was announced on Wednesday that Ibiza, Majorca, Menorca and Formentera were being moved onto the amber travel list for England. The Scottish and Welsh governments followed suit and Northern Ireland is expected to join them. The rules take effect from 04:00 BST on Monday - 15 days after they were moved to the green watchlist. The addition of popular holiday destinations to the amber list makes the requirement to have both Covid jabs more pressing for those who do not want to have to self-isolate.
• The number of new Covid cases reported in Northern Ireland is "concerning", Health Minister Robin Swann has said. More than 1,000 new cases of Covid-19 have been reported over the past 24 hours. It is the highest figure that has been recorded since the peak of cases in January. But official statistics from the Department of Health show there have been no Covid-related deaths during the same time frame. There are 80 patients being treated for coronavirus in hospitals and two people are in intensive care.
• Economists have said that new Brexit checks and rules have hurt trade, but six months on, the full scale of the damage is still uncertain.
• The UK expects to pay a Brexit divorce bill of 37.3 billion pounds, which is less than previous estimates.
• Under UK travel rules, there are three categories of countries, Red, Green and Amber. All countries are placed on the amber list unless there is specific evidence they should be on green or red lists. The UK requires the use of a high accuracy test, such as PCR or antigen test, as supporting evidence. Failure to provide proof of a negative test before travelling to England could result in a £500 fine.
• Very few countries are on the green list, and those include Israel, Singapore and Iceland. If you are coming into the UK from a green list country, you must still 1) take a COVID 19 test before departure and have proof of a negative result; 2) book a test for the second day of your return; and 3) complete a passenger locator form. You do not need to quarantine unless your day two test is positive.
• If returning from an Amber country (most countries are categorized as Amber), you must take a COVID-19 test before departure and have proof of a negative result; 2) book a COVID-19 test on days two and eight after you return; 3) complete a passenger locator form; and 4) quarantine for 10 days. The government advises not to travel to Amber countries, although this is a suggestion and people still travel to amber listed countries. It may be possible to end the amber quarantine early in England if you pay for an additional test under the test to release scheme, which would occur on day 5.  
• Red list countries are those the UK government says are at the highest risk from Covid and should not be visited "except in the most extreme of circumstances". Dozens of countries are on the red list, including India, Pakistan, Turkey, Brazil and South Africa. If you have been in a red list country in the last 10 days, you can only enter the UK if you are a UK or Irish national, or UK resident. If you're returning from a red list country, you must 1) take a Covid-19 test before departure and have proof of a negative result; 2) complete a passenger locator form; 3) self-isolate for 10 days in a government-approved quarantine hotel, which you must book and pay for in advance (Rates are as follows: 10 days (11-nights) for one adult - £1,750; Additional adult (or child over 11) - £650; Children aged five to 11 - £325).
• The UK has matched the deal reached by Brussels and Washington for a five-year cease-fire on the 17 year-long trade war over subsidies for the plane makers Airbus and Boeing. The agreement was determined after two days of meetings between the British trade secretary, and her USTR counterpart. "The United States and the United Kingdom today reached an understanding to resolve a long-standing trade irritant relating to large civil aircraft. This development strengthens our special relationship and builds on the revitalized Atlantic Charter, which affirms our ongoing commitment to sustaining and defending our enduring values against new and old challenges," a joint statement read. As with the EU-U.S. arrangement, there will be a Working Group on large civil aircraft which will require regular meetings for the two sides' trade ministers.
• UK vaccine order summary
  • Secured 40 million doses of Pfizer/BioNTech, rollout began in September 2020.
  • 100 million doses of Oxford/AstraZeneca have been ordered. Utilization began January 2021.
  • Use of NIH/Moderna began on April 7, 17 million doses have been ordered.
  • Novavax is expected to receive UK approval very shortly. 60 million doses have been ordered and manufacturing will occur in facilities in the UK
  • UK medicines is conducting a rolling review of Janssen/JNJ vaccine, expected to resume use shortly, with 30 million doses ordered
  • Up to 100 million doses of Valneva vaccine have been secured. This vaccine, not yet approved in the UK, uses the traditional mechanism of deactivated virus and an adjuvant to strengthen immune response. Its utilization is expected to be as a booster to existing vaccines.
  • Ordered 60 million doses of GSK/Sanofi vaccine, still in trials
  • Ordered 50 million doses of mRNA vaccine from CureVac (Germany), still in trials.
• 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 less than 100 days, Germans will go to the polls to vote for a new parliament. The latest opinion polls show that the coronavirus pandemic is overshadowing all other concerns.
• Despite the fear of another dramatic rise in infections, Germans have a positive view of economic development; 60% of those polled believe the country's economy is healthy and growing. Green party supporters are the most optimistic: 87% of them say the economy is in good shape.
• If the general election were now rather than on September 26, Angela Merkel's conservative bloc — the Christian Democrat Union (CDU) and their Bavarian sister party, the Christian Social Union (CSU) — would again emerge strongest. They would get 28% of the vote — down from 33% at the last election in 2017.
• Germany’s vaccine committee has recommended that everyone who received an AstraZeneca first dose switch to Pfizer or Moderna jabs for better protection against COVID. Studies show that the immune response is “clearly superior” when an AstraZeneca shot is combined with a second mRNA vaccine, compared with double AstraZeneca jabs, said Stiko. The commission therefore recommended the mix “regardless of age” and with a minimum gap of four weeks between the two jabs.
• The German Health Ministry continues to indicate that it expects that 80% of Germany’s adult population will be vaccinated by mid-July.
• Angela Merkel is in the US this week for a final time as Chancellor, for a set of meetings with President Biden.
• The German Medtech Association BVMed considers the MDR not yet fit for practice. There are still too few Notified Bodies, too bureaucratic regulations, and a lack of clarification. BVMed is therefore in favour of quick and pragmatic solutions and better support for small and medium-sized companies. Among other things, BVMed calls for Notified Bodies to be notified more quickly, for remote audits to be permitted, for the transition period for old certificates to be extended, and for pragmatic solutions to be established for proven existing devices and niche devices.
• Here is a link to state-by-state relaxation of COVID restrictions in Germany: https://www.thelocal.de/20210601/explained-how-states-across-germany-are-relaxing-covid-rules/.
• If you want to enter Germany,the following cautions are advised: First, you should make sure whether the country you are entering from is classified by Germany as a risk area, If this is the case, a digital entry declaration has to be filled out. In addition, travelers must present a negative coronavirus test if they have not yet been vaccinated against Covid-19 or have not recovered from an infection in the past six months. Holidaymakers do not then have to undergo quarantine.
• On July 1, the EU-wide digital vaccination passport was introduced. It makes it easier to enter Germany and gain access to events, for example. This makes retrieving information on the status of vaccinations, tests, and past infections quick and easy.
• Travelers from the UK to Germany will face softer quarantine restrictions, after altered recommendations from the German public health agency, the Robert Koch Institute published on Monday, July 5. Portugal, Russia, India, and Nepal have also been downgraded. The change will mean simpler requirements for people visiting those countries. People who have had either both vaccination doses or who can demonstrate they have recovered from COVID, will not need to isolate on their return or arrival.
• People who have not been vaccinated will be required to self-isolate, but only for up to 10 days. They will also have the option to leave quarantine early with a negative coronavirus test on the fifth day.
• Under the countries' previous classification, all people reaching Germany were required to self-isolate for 14 days, no matter what their personal COVID status. And only German citizens or residents were permitted to travel from the affected countries, not visitors from places like the UK. The plan will kick in on Wednesday.
• There are no longer any high-incidence areas in Europe.
• France's president, Emmanuel Macron, is betting his political future on a nationwide Covid health pass. Approaching the launch of his campaign for re-election to a second five-year term next April, Macron went on nationwide television on the eve of France's national holiday of Bastille Day with a series of some of the world's most stringent anti-pandemic edicts -- an effort to stifle the surging Delta variant, he said, and fend off a fourth COVID wave.
• Seemingly prepared to take hard and politically polarizing choices, Macron announced Monday that all health care workers — in hospitals, nursing and retirement homes, even home-care nurses — must be fully inoculated against Covid or, quite simply, they won't be paid after September 15.
• Beginning August 1, nobody will be allowed in any French bar, restaurant, shopping mall, concert hall, or any long-distance train or airplane without a "sanitary pass" attesting to full vaccination or a recent negative COVID test. Violators could face fines up to 45,000 euros ($53,000) and a year in jail.
• The traditional parade on France's national day returned Wednesday after a one-year hiatus due to the Covid-19 pandemic.   European special forces involved in anti-jihadist operations in Africa's Sahel region had a prime position in France's Bastille Day celebrations in a sign of President Emmanuel Macron's military priorities. Around 80 French and European special forces drawn from the multinational Takuba force in the Sahel led the procession, a choice intended to send a diplomatic message from Paris.
• Macron, who presided over the ceremony, is banking on often reluctant European partners to step up their commitments to Takuba. He announced plans for a drawdown of French troops in the Sahel region last month.
• French Prime Minister Jean Castex has announced that the mandatory wearing of masks outdoors is now waived, citing advice from public health experts and an easing in the numbers of people in hospital with COVID-19. However, masks must still be worn in most workplaces, in shops, on public transport, and in outdoor spaces where lots of people are gathered, for example in stadiums.
• France is gradually opening its borders, but many restrictions are still in place to curb the spread of the coronavirus pandemic and the country is only accepting fully vaccinated overseas visitors who have received one of the four jabs approved by the European Medicines Agency. Visitors who were vaccinated outside the EU with Pfizer, Moderna, AstraZeneca or Johnson & Johnson can receive a certificate from the French social security allowing them entry into the country.
• However, this does not make them eligible for a French health pass, soon to be required in trains, restaurants and bars.
• In France, rules are in place to reopen to fully vaccinated visitors from around the world as of June 9. Under new rules, vaccinated people traveling from the EU and countries on France's "green" list, including South Korea, Japan, and Israel, can avoid COVID-19 testing requirements altogether. Unvaccinated travelers from these regions can enter with a negative test. Meanwhile, vaccinated tourists from France's "orange" list, which includes the UK, and most countries in Africa and Asia, will no longer need an essential reason to travel. These visitors will be exempt from quarantine but must still present a negative COVID-19 test. Here is a description of the categories and how they work:
  • Red
  • Vaccinated: Inoculated visitors from red countries must provide results of a PCR or antigen test no more than 48 hours old, provide an essential reason for travel, self-isolate for seven days and take a mandatory antigen test upon arrival.
  • Unvaccinated: Those who haven’t gotten their shots have the same requirements as vaccinated travelers from red countries, but their isolation time is increased to 10 days, and their compliance is checked by authorities.
  • Orange
  • Vaccinated: If you’re vaccinated and coming from an orange/amber country, you will need a PCR test no more than 72 hours prior to departure or an antigen test that’s no more than 48 hours old. Travelers can visit for any reason, such as tourism, provided they meet these other requirements.
  • Unvaccinated: Unvaccinated arrivals must observe the same testing requirements as vaccinated travelers under the orange/amber category, but they must also provide a “pressing reason” for travel (i.e. essential travel), take additional tests on arrival and self-isolate for seven days.
  • Green
  • Vaccinated: There are no restrictions if you are vaccinated, and arriving from a country labeled green.
  • Unvaccinated: If you are not vaccinated, you need a PCR or antigen test within 72hrs before departure.

• The US and Canada have been reclassified as “green” under France’s traffic light classification for Covid travel restrictions, which means Covid-19 cases are low enough to allow for people to travel more freely. They had been classed as orange when the traffic light system was first announced on June 9th, but an announcement in the government’s Journal officiel signaled the change. Arrivals from the two North American countries will now no longer have to go into quarantine on arrival in France and will be able to enter the country without an “essential reason”, even if they have not been vaccinated.
• Here is a link to policies related to entry and travel to France: https://www.diplomatie.gouv.fr/en/coming-to-france/coronavirus-advice-for-foreign-nationals-in-france/.
• An online calculator has been launched which will allow people in France to see when they will be able to get the COVID vaccine. The tool was developed by the University of Vienna. https://www.omnicalculator.com/health/queue-pour-vaccin-france.
• If you are experiencing difficulties with exporting PPE from the EU, please let us know immediately. We have not seen any instances of this occurring since an initial incident was resolved.
• If you are having any issues moving medical supplies or medical products from the EU to the UK, or vice versa, please let us know immediately.
• The proposed one-year suspension of implementation of the EU's MDR is final and 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's joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation.
• Resources: https://www.ecdc.europa.eu/en
• https://www.europarl.europa.eu/news/en/headlines/priorities/eu-response-to-coronavirus;
• https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public;
• https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/economy_en;
• https://www.abhi.org.uk/what-we-do/abhi-covid-19-hub/;
• https://ec.europa.eu/commission/presscorner/detail/en/IP_20_582;
• https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html;
• https://www.medtecheurope.org/covid-19-information-hub;
• https://www.medtecheurope.org/resource-library/european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/;
• https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
• https://www.medtecheurope.org/resource-library/eu-materials-covid-19/.
• Med Tech Europe White Paper on Companion Diagnostics under the IVDR: https://www.medtecheurope.org/resource-library/joint-medtech-europe-efpia-white-paper-on-companion-diagnostics-under-the-ivdr/
• Staff Contact:  Joe Gatewood (jgatewood@advamed.org)

Latin America

 

Reuters COVID-19 Tracker – Latin America

WHO/PAHO COVID-19 Information