COVID-19 Outbreak: Weekly Global Report for Friday, July 23, 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 192 million cases. Deaths around the world have exceeded 4.1 million. The countries with the most reported cases continue to be the U.S. (34.2 million), India (34.2 million) and Brazil (19.5 million).
• U.S. cases exceeded 33.98 million with deaths increasing to 609,000.
• 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 and mass testing when flareups return. Beijing remains ever cautious as the Delta variant circulates worldwide and the efficacy of China’s vaccines is questioned. Many businesses expect that China may retain stringent travel restrictions through February 2022, when Beijing will host the Winter Olympics. Chinese regulators last 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.
• New uptick in cases: China this past Tuesday reported the highest daily tally of new confirmed COVID-19 cases since January, driven by a surge in imported infections in Yunnan province, where cases are spilling over from an "alarming spike" in neighboring Myanmar. Mainland China recorded 65 new confirmed cases for July 19, compared with 31 a day earlier, the National Health Commission said in a statement. That was the most since Jan. 30, when 92 new cases were reported. Imported infections accounted for most of the new cases reported for July 19, with Yunnan reporting 41 new cases originating from abroad, all of whom were Chinese nationals who recently returned from Myanmar. The United Nations has said it is stepping up efforts to fight an "alarming spike" in infections in military-run Myanmar. The country registered a record 281 COVID-19 deaths on Monday, and 5,189 new infections, state-run MRTV Television reported. The current bout of cases in Yunnan started on July 4, and has been concentrated in Ruili and Longchuan, two small cities on China's border with Myanmar.
• Mass testing in Nanjing: The eastern city of Nanjing begun testing all 1.9 million residents of its Jiangning district for COVID-19 after nine workers at the city’s airport tested positive this Tuesday. The district-wide testing started Wednesday morning after the cases were discovered during routine nucleic acid testing for workers at Nanjing Lukou International Airport.
• 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.
• Debate within China on making vaccines mandatory: As countries weigh up making Covid-19 vaccination mandatory in certain circumstances, heated debate has erupted in China over orders issued by some cities to deny the unvaccinated entry to places such as shops and schools. Some say such hardline measures will persuade hesitant people to sign up for the shots, but more have argued that it is discriminatory and amounts to mismanagement by local governments. Public health experts have said such restrictions should be imposed with caution, or they could reduce public confidence in pandemic control measures. On Friday the National Health Commission finally weighed in to assure the public that Covid-19 vaccinations were still “consensual and voluntary”. It said it had noted restrictions in some areas and responded with “timely guidance and supervision”. The NHC’s statement came after some cities in 10 provinces announced various restrictions on unvaccinated people on entering public places, from hospitals to nursing homes and markets.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 104,443, an increase of 249 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.
• 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 last 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 soon, the chief executive officer of Suzhou Abogen Biosciences, the vaccine’s developer, said this week. Together with Chinese clinical contract research organization Tigermed, Abogen is preparing to conduct overseas Phase III clinical trials using 28,000 volunteers in countries including Mexico, Columbia and Pakistan. The vaccine can be stored at temperatures of between two and eight degrees centigrade for at least seven months, making it convenient for mass distribution. The clinical trials will not select specific variants, and will also not reject any strains, Ying told Yicai Global. The Suzhou, eastern Jiangsu province-based firm is also developing a separate mRNA vaccine candidate that will target the variants that were first found in South Africa and India.
• Vaccine diplomacy: 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 response to Tedros’s remarks: While China has consistently rejected the lab leak hypothesis, officials sought to draw a line in the sand this Thursday, signaling Beijing won’t engage on the origin hunt if the theory remained in play. It was China’s most direct pushback to date on calls from the WHO and others to investigate the Wuhan Institute of Virology’s high-level lab, which studied bat-borne pathogens and other coronaviruses. “The plan on the second phase of the origin study, it contains language that does not respect science or common sense,” said Zeng Yixin, vice minister of the National Health Commission. “We won’t follow such a plan.”
• Meanwhile, China continues to push its own lab-leak theory: The South China Morning Post reports that Beijing, in seeking to counter the hypothesis that the virus may have escaped from the Wuhan Institute of Virology, is pushing its own hypothesis that the virus originated from Fort Detrick, about an hour’s drive from Washington and the original home of the US biological weapons program. While most Americans may be unfamiliar with Fort Detrick, hundreds of millions of Chinese netizens are familiar with the Detrick name and its supposed links to COVID-19, mostly thanks to China’s so-called Wolf Warrior diplomats. They have said dozens of times in social media posts and press conferences that Fort Detrick, half a world away from China in the state of Maryland, needs to be investigated as a potential source of the virus.
• China’s Economy: 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: Despite a kerfuffle in Beijing and Washington over proper diplomatic protocol, the U.S. State Department confirmed that Deputy Secretary Wendy Sherman will travel to Tianjin next week for meetings with PRC officials, including State Councilor and Foreign Minister Wang Yi. The State Dept. statement added that Sherman will discuss the U.S.’s “serious concerns about PRC actions as well as where our interests align.” Sherman will the senior most Biden administration official to visit China to date.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – 31,256,839 total cases, 409,394 active cases/418,987 deaths/ discharged 30,429,339 (John Hopkins & MoHFW) as compared to 30,986,803 total cases, 432,041 active cases/411,989 deaths/ discharged 30,143,850 (John Hopkins & MoHFW) last week. 417,851,151 people have been vaccinated.
• Four COVID-19 vaccine candidates are at different stages of human trials while one, developed by Genique Life Sciences, is in the advanced pre-clinical stage, Union Science and Technology Minister Jitendra Singh said on Tuesday, July 22.
• The pace of Covid vaccination has increased significantly with India administering the latest 10 crore doses in 24 days, taking the total coverage to over 41 crore doses given so far. This signifies a major uptake from the first 10 crore doses that took 85 days to administer.
• Union Health Minister Mansukh Mandaviya, speaking in Rajya Sabha on the second day of the Monsoon Session in Parliament informed that centre and states have to work as "bhagidaars" (partners) to combat the third wave of the pandemic. Added that states have been asked to submit a plan and accordingly, funds will be transferred to enable preparedness.
• In a bid to strengthen surveillance and control spread of tuberculosis (TB) in the state, all patients diagnosed with the disease will get Airborne Infection Control (AIC) kits. The state health department has asked all district health heads and the chief municipal health officer at Kolkata Municipal Corporation (KMC) to procure such kits.
• The United States has improved the travel advisory for India, upgrading from Level 4 category to Level 3 which urges citizens to reconsider travel. The Level 4 category means no travel. "Your risk of contracting COVID-19 and developing severe symptoms may be lower if you are fully vaccinated with an FDA authorised vaccine.
• The Supreme Court on Monday, July 19 observed that hospitals in the country have become large industries now thriving on human distress and it is better that they be shut down. "Do we look at hospitals as a real estate industry, or as a service to humanity?" asked Bench of Justice DY Chandrachud and Justice MR Shah. "Hospitals have become a large industry now based on human distress.
• The strategy to prevent resurgence of Covid-19 cases through various public health measures has been deliberated upon in different technical committees and the Centre continues to advise states to strictly follow the strategy of ‘test-track-treat-vaccination and adherence to Covid-appropriate behaviour’, Rajya Sabha was told on Tuesday, July 20.
• States and Union Territories (UTs) licensing authorities/drug controllers have been notified to allow the licensed manufactures for AYUSH-64 under their jurisdiction to include a new indication of AYUSH-64 for repurposing as an intervention for the management of asymptomatic, mild-to-moderate COVID-19 in addition to existing indication(s), informed Mahendrabhai Munjapara, Minister of State for Ayush.
• Officials of the World Health Organisation (WHO) had a meeting with those of Bharat Biotech and the Hyderabad-based vaccine maker's dossier for Emergency Use Listing (EUL) of Covaxin is under review by the technical experts for consideration, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said on Monday, July 19.
• The initial fear that many post-Covid patients would later develop lung fibrosis is fast receding in the medical corridors. Even lungs of patients who suffered from severe Covid and pneumonia, are showing signs of healing within 3-6 months, according a new study published by doctors from a city hospital.
• World Health Organisation (WHO) chief scientist Dr Soumya Swaminathan said India could initiate research on heterologous administration (mix and match) of various Covid-19 vaccines to study the breadth and duration of immune responses as well as protection.
• The Centre on Thursday, July 15 asked states and union territories to conduct a quick gap analysis for various infrastructure components under the Emergency Covid-19 Response Package and stressed on effective advance preparations for efficient clinical management of the infection.
• A portable device developed by researchers at BITS Pilani, Hyderabad will help reduce the time taken for DNA amplification or polymerase chain reaction (PCR) test to 15-30 minutes and make it accessible to even those living in remote areas.
• International Finance Corporation (IFC), member of the World Bank Group, is investing USD 16.5 million (around Rs 123 crore) in genetic diagnostics and research company MedGenome to increase access to COVID-19 testing in India.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 858,633 reported cases and 15,121reported deaths compared to 831,792 reported cases and 15,033 reported deaths the previous week.
• As the Olympics get underway, Tokyo is logging its highest numbers of daily cases since mid-January. Emergency measures have been reinstituted in the prefecture through August 22. Spectators are not 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. Nearly 30% of the population had received at least one dose, and over 23% are fully vaccinated. 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 continue to rise, (last week’s number is in parens) with 1,838 (1,600) new daily cases. The country’s numbers are increasing and concerning but remain overall low. There could be extended lockdown repercussions if the trend continues.        
• Korea has increased to 184,103 total cases, 18,967 active (a significant increase in active cases) with 2,063 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 3,588 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 over 22 million doses of the COVID-19 vaccine. 16.4 million people, or 32.3 percent of the country's population, have received their first shots of COVID-19 vaccines, and 6.7 million people have been fully vaccinated, the KDCA said.
• Ten days into the toughest level of distancing curbs in Greater Seoul, the nation has continued to see record-breaking daily case numbers. The current restrictions that end Sunday are likely to be extended to curb further spread.         As the pandemic continues to rage, experts say the nation should extend the period of the highest level of the four-tier distancing measures, which began on July 12 and is set to end Sunday.
• Eom Joong-sik, a professor at Gachon University Gil Hospital, said if the nation lowers the level next week, the confirmed number of cases will surge immediately.
• The greater Seoul area remains 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.
• Most areas outside the greater Seoul area appear poised to remain 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.
• 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 6,436,819 reported cases and 124,590 reported deaths compared to 5,846,738 reported cases and 111,498 reported 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 tenth week in a row.
• Indonesia: Indonesia is the new epicenter of the COVID-19 pandemic. It had the highest number of new infections in the world last week, although the number was down slightly from the 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 an extension of social restrictions through July 25. These include 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 3,033,339 total cases and 79,032 total deaths compared to 2,726,803 total cases and 70,192 total deaths the previous week. Indonesia accounts for 63% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: Malaysia 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 880,782 to 964,918 over the past week. Total deaths have grown from 6,613 to 7,574 over that timeframe.
• Thailand: The number of cases reported by Thailand has grown more than 15-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. The country has extended its nationwide state of emergency until the end of September. 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 372,215 to 453,132 over the past week and reported deaths have increased from 3,032 to 3,697 over that time.
• Philippines: The Philippines is now reporting 1,530,226 total cases, up from 1,490,665 total cases last week. Total reported deaths have increased from 26,314 to 26,891 over that time.
• Cambodia: The number of reported cases has grown more than 28-fold in Cambodia since April 1. Reported cases increased from 63,615 to 69,608 over the past week. Reported deaths grew from 986 to 1,168 over that period.
• Vietnam: Vietnam is experiencing a major surge in cases, with the number of total cases nearly doubling over the past week and the number of deaths rising sharply. Ho Chi Minh City is the new epicenter of the fourth COVID-19 wave. It 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 suspended non-essential businesses and services amid the rising COVID-19 threat. The number of reported cases has grown over 27-fold since April 1. Cases of COVID-19 infection grew from 38,239 to 71,144 over the past week. The total number of deaths grew from 138 to 371.
• Singapore: Singapore is tightening COVID restrictions from July 22 through August 18 following an increase in new cases. Multiple clusters have emerged around karaoke lounges, wet markets, and food centers. Dining in restaurants is banned and gatherings are limited to two people. Working from home remains the default.  Reported cases increased from 62,804 to 63,621 over the past week. The total number of deaths increased remained at 36.
• Laos: Laos reported a significant growth in total cases from 2,976 to 3,863 over the past week. It has reported 5 deaths from COVID since the outset of the pandemic, including 2 in the past week.

Vaccinations

• Indonesia authorized the Pfizer vaccine for emergency use on July 15. It will be given to Indonesians aged 12 years and up. The country is currently in the second stage of vaccinations following the vaccination of medical workers in the first stage. It reportedly has 76 million doses of the vaccine on hand. It has been administering the Sinovac and AstraZeneca vaccines. Only 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 announced that it will stop using China’s Sinovac vaccine in favor of the Pfizer shot. The country approved both AstraZeneca and Sinovac vaccines for emergency use on March 2 after previously approving the Pfizer vaccine. It has granted conditional approval to the J&J vaccine manufactured in Belgium, and on July 16 it granted conditional approval for emergency use to the Sinopharm vaccine. Mass vaccinations began on February 24 using the Pfizer vaccine and the government aims to vaccinate 80% of its 32 million population by next February. So far, it has fully vaccinated 15% of its population. One million doses of the Pfizer vaccine donated by the U.S. arrived in Malaysia on July 5.
• The Philippines began its immunization program after receiving its first batch of the COVID-19 vaccine (600,00 doses of Sinovac Biotech's CoronaVac, donated by China). It is due to receive another 25 million doses of CoronaVac this year. 
• However, there is little public support for the inoculation drive. Polls show that fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 4.4% 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, 49% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 5% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available. Thailand 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 26% 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 again persistently high levels of daily cases that are being seen in the UK, Russia and Spain. France appears to be trending in the wrong direction as well. Italy, Germany and Belgium are doing comparatively better. Daily fatalities in the UK have significantly increased from prior weeks. Russia daily fatalities continue to spike.
• 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 21,539 (8,875); Spain 30,587 (26,390); Russia 23,704 (23,827); UK 43,907 (42,081), Italy 4,253 (2,171); Germany 1,580 (1,629); and Belgium 1,467 (1,303).
• 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 155,798, but the rate of increase appears to be slowing. Sweden is 8^th with 107,849. Belgium is 12^th with 95,225, France is 14^th with 90,356. Spain is 15^th with 90,215, Italy is 28^th with 70,848, and the UK is 20th with 81,487.
• Russia's reported numbers on COVID remain problematic at over 6 million. Russia remains in the lead for for most COVID cases in Europe. However, Russia reports one of the lowest death rates in the world at just 1,032 per million.  By comparison, Germany, with more than 2 million fewer cases, reports 91,953 deaths and a death rate of 1,0924per million.

• In terms of deaths per million, Belgium is the 14^th worst in the world with 2,166. Italy is 16^th , with 2,119. 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 1,888 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 18 (10); Italy 21 (23); Germany 15 (32); France 29 (6); UK 73 (49); Belgium 0 (2). Russia reports 783 (786).
• Germany now leads Europe in the number of vaccine doses administered with 87,873,728. The UK is second with 82,793,310. France and Italy are showing strong positive movement at over 65 million and 63 million respectively. Spain is now over 45 million doses. These numbers continue to rapidly increase.
• Two hundred million Europeans are fully vaccinated against COVID-19, or more than half the adult population, the European Commission has said. The Commission has set a target of having 70 per cent of adult EU citizens vaccinated this summer. Some 200 million people have now had both doses of the COVID-19 vaccine. European Commission spokeswoman Dana Spinant said at a press briefing on Thursday 54.7 per cent of all EU adults were fully inoculated.
• Earlier this week the EU surpassed the United States in the proportion of people who had received at least one jab, with some 81 doses of vaccine now administered per 100 people across the bloc. The disparities in uptake in different countries are high, though. The Netherlands and Denmark have both vaccinated more than 56 per cent of their adult populations. But just 31 per cent of people have had both jabs in Romania, while in Bulgaria, less than 20 per cent of people have even received a first dose.
• 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 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 Delta strain, according to the EMA.  
• 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 head of the European Union's executive arm flatly refused Thursday to renegotiate post-Brexit trade rules with the UK after Prime Minister Boris Johnson urged the bloc to work with his government to find “practical solutions” to red tape and inspections that are causing shortages of some goods in Northern Ireland.
• Johnson called European Commission President Ursula von der Leyen to lay out the UK’s proposed changes a day after British officials publicly said the trading rules the government negotiated with the EU “cannot go on.” Post-Brexit arrangements for Northern Ireland have further strained already difficult relations between the EU and its former member.
• “The EU will continue to be creative and flexible within the Protocol framework,’’ von der Leyen said in a tweet after the call from Johnson. “But we will not renegotiate.’’
• 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 Trump administration which 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.
• In the UK, the government have announced a new innovation strategy to make the UK a world leader in science, research and innovation.
• The Royal College of Nursing is expected to reject the government’s offer of a 3% pay rise for NHS staff.
• Over 600,000 people in the UK were told to self-isolate last week as a result of the NHS track and trace app.
• The European Commission has rejected a request from the UK government to renegotiate the Northern Ireland Protocol.
• The government has announced its decision to overhaulred tape policies to ‘seize the opportunities’ from Brexit.
• The former Director General of the European Commission, Jonathan Faull has said a dual autonomy approach needs to be taken with the Northern Ireland Protocol.
• The Government have launched a consultation to brief new trade rules with developing countries.
• The government has announced that critical workers will not be exempt from isolation if they are ‘pinged’ by the NHS track and trace app.
• Cancer services have been delayed at hospital trusts in Leeds, Manchester and Newcastle as pressure on services rise.
• NHS Digital have announced new plans in relation to the government’s data collection program, which are said to increase protection and strengthen security.
• UK Scientists have backed proposals for Covid boosters in the autumn after blood tests on hundreds of people revealed that protective antibodies can wane substantially within weeks of second vaccine shots being given.
• Falls in antibodies after vaccination are expected and do not necessarily mean people are more vulnerable to disease, but the researchers are concerned that if the declines persist the effectiveness of the vaccines may diminish. The UCL Virus Watch study found that antibodies generated by two doses of the Oxford/AstraZeneca and Pfizer/BioNTech vaccines started to wane as early as six weeks after the second shot, in some cases falling more than 50% over 10 weeks.
• 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.
• 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.
• The number of infections per 100,000 people over seven days in Germany will reach more than 400 in September if case numbers keep rising at their current pace, Health Minister Jens Spahn said on Wednesday. After more than two months of steady decline, Germany's 7-day incidence, at 11.4 per 100,000 on Wednesday, has risen since early July due to the spread of the more infectious Delta variant.
• More than 50 million people in Germany - 60% of the population - have received at least one shot of vaccine against the virus, Spahn said. Around 47% are fully vaccinated.
• The German cabinet on Wednesday extended COVID-19 quarantine regulations for incoming travelers from higher-risk areas until mid-September. It also approved further details of a plan to build up its reserves against future pandemics.
• The death toll from Germany's floods has reached 177, according to the Associated Press, and more than 150 people are still missing as cleanup efforts ensue. Another 31 deaths have been confirmed in Belgium, raising the overall death toll from the flooding disaster to more than 200.
• Entire towns were inundated by the flooding, with roads and bridges washed out by the water, as can be seen in the photos above. Much of the worst damage occurred in the western German state of Rhineland-Palatinate along the Ahr River. The extent of the damage is yet to be determined, but the rebuild is expected to cost billions. Germany's Cabinet approved a roughly 400-million-euro package on Wednesday to aid flood victims.
• More than 4,500 civil defense workers, firefighters and soldiers have been deployed for the cleanup efforts, according to the AP.
• German Chancellor Angela Merkel made her last ever appearance at the summer federal press conference, a tradition organized by a union of Berlin journalists. Many of the questions look back at her 16 years in office. She used the occasion to review her accomplishments and urge people to get vaccinated against COVID.
• 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.
• 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. The latest polling indicates they would get 29% of the vote — down from 33% at the last election in 2017.
• 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.
• German pharmacies have stopped issuing digital COVID-19 vaccination certificates after hackers created passes from fake outlets, the industry association said on Thursday, the latest blow to the inoculation drive.
• Germans who have been fully vaccinated are entitled to a certificate which allows them more freedoms, especially to travel. Pharmacies and vaccination centres issue them. The German Pharmacists' Association (DAV) said hackers had managed to produce two vaccination certificates by accessing the portal and making up pharmacy owner identities. DAV were alerted to the fact by the Handelsblatt newspaper.
• "The DAV, in consultation with the Health Ministry, stopped issuing certificates on Wednesday to investigate further," said the association in a statement, adding it had so far found no other indication of unauthorised access to the portal.
• 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 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 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 Delta variant of the coronavirus that causes Covid-19 is now the main variant circulating in France, Prime Minister Jean Castex said on Wednesday, adding that 96 percent of the 18,000 new cases reported the day before were among the unvaccinated. "We're in the fourth wave," Castex told TF1 television, stressing that the goal of the health pass, which came into effect Wednesday, was to avoid a fourth nationwide lockdown. "The Delta variant is the majority one, it is more contagious," Castex said, speaking of the variant first detected in India.
• Health Minister Olivier Véran told lawmakers that total cases had increased by around 150 percent over the past week as a result of the fast-spreading Delta variant, describing the increase as unprecedented.
• The French government has began to present lawmakers this week with a new plan to fight Covid-19, which will include requiring a health pass in a wide array of venues from the start of August and making vaccination mandatory for health workers.
• President Macron has announced 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.
• The French government adjusted its new plan to fight COVID-19 on Monday, slashing planned fines and postponing them to an unspecified date, spokesman Gabriel Attal said. The measures, which include requiring a health pass in a wide array of venues from the start of August and making vaccination mandatory for health workers, will still account for some of the toughest in Europe. The health pass provides proof that a person has been vaccinated against COVID-19, has recently had a negative coronavirus test or has newly recovered from the virus.
• A significant change is that a planned 45,000 euro fine for businesses which do not check that clients have a health pass will be much lower, starting at up to 1,500 euros and increasing progressively for repeat offenders. Besides, checks will initially be meant to help people apply the measures but the fines will not be imposed immediately. Government spokesman Attal told a news conference he could not say exactly when the "run-in period" would end and fines would be imposed.
• France said Saturday it would require people not fully vaccinated and arriving from some European countries to show a negative Covid test taken within the previous 24 hours. Arrivals from the United Kingdom, Spain, Portugal, Cyprus, Greece and the Netherlands will be subject to the new rule, which comes into effect at midnight Saturday into Sunday, Prime Minsiter Jean Castex said in a statement. To date, people arriving from the United Kingdom are required to show a negative test taken within the past 48 hours.
• Arrivals from Spain, Portugal, Cyprus, the Netherlands and Greece have had to show tests taken within 72 hours.
• But Castex said that people who are fully vaccinated with a jab recognised by the European Medicines Agency—Pfizer/BioNTech, Moderna, AstraZeneca or Johnson & Johnson—will not be required to show a test.
• 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