COVID-19 Outbreak: Weekly Global Report for Friday, September 3, 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 new milestone of 219 million cases. Deaths around the world have exceeded 4.46 million. The countries with the most reported cases continue to be the U.S. (39.4 million), India (32.9 million) and Brazil (20.8 million).
• U.S. cases exceeded 389.4 million with deaths increasing to 642,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• The latest: The highly transmissible Delta variant has posed the most severe test of Beijing’s “zero tolerance” policy to date. Confronted with its largest COVID outbreak since the initial outbreak in Wuhan beginning last month, Beijing credits the sharp decline in case counts in recent weeks to its “strict, scientific, and swift measures.” All travel into Beijing from hotspots remains cut off. Mass testing is still underway in a few Chinese cities. The world’s third largest container port, in Ningbo, fully re-opened last week after COVID cases were reported there a few weeks prior. Some observers outside and inside China worry that Beijing’s “zero tolerance” policy approach could have economic downsides.
• Overview of China’s containment strategy: 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 arise. Beijing remains ever cautious as the Delta variant circulates worldwide and the efficacy of China’s vaccines is questioned. Many businesses expect that China may retain stringent travel restrictions through February 2022, when Beijing will host the Winter Olympics.
• China reopens terminal at world’s third-busiest port: The Meishan terminal at Ningbo port reopened this Wednesday following a two-week shutdown that further snarled already stressed shipping routes in Asia. The terminal, representing a quarter of the Ningbo-Zhoushan port’s capacity, was shut from Aug. 11 after a worker was found to be infected with COVID-19. This was the second closure of part of a port in China this year due to a COVID outbreak, after the month-long shutdown of Yantian port in Guangdong from late May. With demand for vessels and containers rising this year and companies ramping up exports to Europe and the U.S. for the year-end holiday shopping season, even a limited closure of part of a port is costly for both shoppers and shippers.
• Chinese airports toughen up quarantine rules: Airports around China are lengthening the amount of time some international aircrews and ground staff must spend in quarantine, after containment breaches sparked community spread of the highly infectious delta variant in several regions. Some regional regimes will see airport workers judged to be a higher risk isolated for up to 28 days after two weeks of work. These represent far tougher restrictions than those currently mandated by the country’s national aviation authority.
• China bans vaccination mandate for students: China’s Ministry of Education banned local requirements that students be vaccinated against Covid-19 before returning to school, stressing that inoculations should be voluntary. Earlier this month, the ministry urged local authorities across the country to promote vaccination of all eligible students below the age of 18 amid the recent domestic outbreaks but said the shots must be given only with the consent of students or their guardians. Recently, however, multiple local authorities mandated vaccinations for students and their parents as a requirement for returning to school. Some cities proposed to include vaccinations in personal credit records. The northeastern city of Jilin recently banned unvaccinated people from entering government facilities, banks, hospitals, hotels, restaurants and public entertainment venues and from using public transportation. A county in Henan province and a city in Guangxi province recently required students and their family members to have vaccination proof before they could be admitted to schools.
• 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%. According to Dr. Zhong Nanshan, a key government advisor, China will be able to reach herd immunity by the end of this year. Zhong noted the efficacy of China-developed vaccines is about 70 percent, meaning the country would need more than 80 percent of the population to be vaccinated before establishing herd immunity.” China is well on its way to reach that goal by the end of 2021, Zhong said.
• Weekly COVID-19 statistics: China’s total COVID cases now stand at 107,102, an increase of 229 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 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: CCP General Secretary Xi Jinping pledged to provide two billion doses of COVD-19 vaccines to the world by the end of this year. Xi also declared that the COVAX global vaccine distribution initiative would receive a donation from China of $100mln. China has already supplied over 770 million vaccine doses to other countries, according to the Ministry of Foreign Affairs.
• Revised U.S. intelligence agency community report on COVID’s origins: U.S. President Joe Biden received a copy of the updated findings and was briefed on the classified report last Tuesday. The intelligence community has been "working expeditiously" to prepare an unclassified version for the public, Psaki said without giving a timeline for its release. U.S. officials say they do not expect the review to lead to firm conclusions after China stymied earlier international efforts to gather key information on the ground. The U.S. report is intended to resolve disputes among intelligence agencies considering different theories about how the coronavirus emerged, including a once-dismissed theory about a Chinese laboratory accident.
• As 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: China's businesses and the broader economy came under increasing pressure in August as factory activity expanded at a slower pace while the services sector slumped into contraction, raising the likelihood of more near-term policy support to boost growth. The world's second-biggest economy staged an impressive recovery from a coronavirus-battered slump, but momentum has weakened recently due to domestic COVID-19 outbreaks, high raw material prices, slowing exports, tighter measures to tame hot property prices and a campaign to reduce carbon emissions. The official manufacturing Purchasing Manager's Index (PMI) fell to 50.1 in August from 50.4 in July, holding just above the 50-point mark that separates growth from contraction.
• US will limit some Chinese passenger air carriers to 40% capacity: The US Transportation Department on Wednesday said it will limit some flights from Chinese carriers to 40% passenger capacity for four weeks after China imposed similar limits on four United Airlines flights. China told United on August 6 it was imposing sanctions after it alleged five passengers who traveled from San Francisco to Shanghai tested positive for COVID-19 on July 21. The US order said the department will limit over a four-week period each of four Chinese carriers to 40% capacity on a single China-US flight. United Airlines said it was "pleased to see this action by the (Transportation Department) in pursuit of fairness in this important market." The US government says China's "circuit breaker" policy violates the nations' air services agreement and "places undue culpability on carriers with respect to travelers that test positive for COVID-19 after their arrival in China." The limits come as many Chinese students are headed to the US for the start of fall classes.
• U.S.-China relations: The prospect of Xi Jinping holding a face-to-face meeting with Joe Biden on the sidelines of the Group of 20 Summit in Italy this autumn have dimmed. While Beijing is yet to reach a final decision, the leadership leans towards China’s president attending via a video link rather than flying to Rome for the summit on October 30-31. Virtual attendance would mean there would be no opportunity at the summit for the Chinese and US leaders to hold their first face-to-face meeting since Biden became US president on January 20. While any decision for Xi to not go to Rome for the summit would be partly because of safety concerns over the coronavirus pandemic, it also reflects the lack of progress made to restart the stalled China-US relationship.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – :  32,810,845 total cases, 389,583 active cases/439,529 deaths/ discharged 32,028,825 (John Hopkins & MoHFW) as compared to 32,512,366 total cases, 333,725 active cases/436,365 deaths/ discharged 31,788,440 (John Hopkins & MoHFW) last week. 663,037,334 people have been vaccinated.
• The phase II trials of India’s first intranasal vaccine against Covid-19 being developed by Bharat Biotech in collaboration with Washington University School of Medicine in St Louis, commenced at city’s Prakhar hospital on Tuesday. Kanpur is the only centre in the state where intranasal vaccine trials against Covid are being done. As many as 30 volunteers consisting of doctors, their family members and others were administered the first dose of the intranasal vaccine.
• Healthcare workers and frontline workers were the very first priority groups identified when Covid vaccination started in mid-January, but more than seven months on, nearly one in five healthcare workers and over a quarter of frontline workers have not yet got their second shots, official data shows. A closer look shows widely differing coverage levels in states with Punjab, Tamil Nadu, Karnataka and Delhi having the lowest coverage.
• Hospital sector witnessed a spike in COVID-19 occupancies during Q1 FY2022 in line with the active cases in India that touched an all-time high in May 2021, peaking at more than 4x the first wave peak. The overall occupancy levels were supported by longer average length of stay for COVID patients even as localised lockdowns resulted in a sequential decline in non-COVID occupancies to a certain extent, ICRA credit rating agency indicated.
• Even as the pace of Covid vaccination has increased significantly, low coverage among elderly above 60 years of age – who are most vulnerable to the SARS-CoV2 infection - in certain states have raised concerns amid looming fear of a third wave. States like Tamil Nadu, Uttar Pradesh, Punjab, Jharkhand, Bihar and West Bengal with considerably large population of 60 plus years have significantly low coverage of Covid vaccination doses per 1,000 population in this age category, according to ORF's Covid vaccine tracker.
• Single dose of Covishield vaccine after Covid-19 infection gives “hybrid immunity” that is more potent than two jabs or infection alone, shows a new study from Kerala. The study results show that patients who received a single dose of Covishield after they had Covid-19 infection had 30 times higher antibody levels in comparison with those who received two jabs but were not infected. In the viral neutralization assay, those with hybrid immunity could neutralize the virus much better than those who have received two doses of vaccine or had prior infection alone.
• Enthused by the 20.1 per cent expansion of the Indian economy in the first quarter of the ongoing fiscal year, India Inc on Tuesday, August 31 said the number reflects that the economy being hit by the pandemic has bounced back. Industry chamber CII said it is good to note the impressive bounce-back of the GDP growth despite the adverse impact of the second wave of the pandemic on the economic activity.
• The government is constantly engaging with stakeholders across sectors to ensure economic revival is adequately supported, Finance Minister Nirmala Sitharaman said on Tuesday, August 31. “Revival of the economy, for various other reasons, requires a certain kind of support,” Sitharaman said at the webinar organised to make the healthcare sector aware about the government’s loan guarantee scheme.
• India’s Chief Economic Advisor (CEA), Mr. Krishnamurthy Subramaniam on Tuesday, August 31 reaffirmed government’s prediction of a V-shaped recovery. He mentioned that the Gross nonfunctioning assets (NPAs) declined from 11.2 % to 7.4% in March 2021.
• The government plans to maximize coverage of the first dose of Covid vaccination by September-October to ensure a considerable adult population is fully vaccinated, or has received at least one dose, by the end of this year. With increased pace of vaccination and improved supplies, the government is expecting some states to cover a significant proportion of the adult population with one dose by October itself.
• India's rising output of COVID-19 vaccines and the inoculation of more than half its adult population with at least one dose are raising hopes the country will return as an exporter within months, ramping up from early next year. After donating or selling 66 million doses to nearly 100 countries, India barred exports in the middle of April to focus on domestic immunization as infections exploded, upsetting the inoculation plans of many African and South Asian countries.
• A health ministry official on Thursday, August 26 said pharmaceutical company Cadila Healthcare will supply coronavirus vaccine for children between 12 and 17 from October. Reports said the details of Covid-19 vaccination of children between 12 and 17, including prioritising those with health complications, will be announced before the Zydus Cadila vaccine is rolled out in October.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan (No updates this week)

Korea

• South Korea has 1,956 new COVID cases, which is consistent with their levels over the last few weeks. The country’s numbers are concerning but remain overall low.
• Korea’s cases appear to have stabilized after some recent increases. Cases remain persistently above the early summer numbers, but don’t appear to be spiking dramatically. Korea now has 255,401 total cases, 26,876 active with 2,303 deaths. Total cases per million population have remained low compared to most of the world but Korea is now approaching the 5K threshold with 4,977 cases per million. (S. Korea ranks still as one of the lowest among the more highly populated countries). Deaths per million remain comparatively low as well at just 45.
• South Korea officials credit strict social distancing measures as the reason they are not seeing greater spikes. Authorities plan to announce additional restrictions that will be applied later in September, in preparation for anticipation large scale travel for the upcoming Chuseok holiday.
• South Korea has administered approximately 44,519,263 doses of the COVID-19 vaccine with 31.7% of its eligible population fully vaccinated. An additional 25.7% have received partial (1 shot).  
• Some 1 million doses of the Moderna coronavirus vaccine arrived in South Korea Thursday. But concerns remain that if more shipments do not come in on schedule, the nation’s vaccination plan could face setbacks ahead of the Chuseok holiday. Moderna has promised to supply 7.01 million doses, the majority of which are set to arrive in batches through Sunday. If all those shipments come in on time, 70 percent of the nation can receive their first coronavirus shots before the Chuseok holiday as scheduled. But doubts still remain as arrivals have been delayed due to supply disruptions.      
• Senior Health Ministry official Son Young-rae dismissed the concerns Thursday. “The government has never failed to present and achieve its inoculation goal,” he said. “We inform you that there is no problem in achieving the goal.”
• Health authorities added around 1.5 million doses of vaccines will arrive from Romania in the coming weeks. The batch includes 450,000 doses of Moderna vaccines donated to South Korea by Bucharest.
• Hyundai Heavy Industries announced a blueprint to usher in a paradigm shift in the global shipbuilding industry of its planned market debut on the South Korean main board Kospi on Sept. 16. The major shipbuilder here unveiled its vision of being a first mover for eco-friendly ships during an online press conference with reporters Thursday, while also detailing specific plans for its initial public offering. “Developing eco-friendly and digitalized vessels, constructing smart shipyards and investing in hydrogen infrastructure in the ocean are our three key businesses to achieve the vision,” said Han Young-seuk, chief executive officer of Hyundai Heavy Industries.
• Of the 1.08 trillion won ($930.5 million) in IPO proceeds that the company aims to raise, about 760 billion won will be used for preemptive investments in future technologies. It is a part of the firm’s effort to pivot to environmental, social and governance-led businesses, the chief said. The shipbuilder seeks to maximize its profitability through high-value vessels such as hydrogen-fueled ships and ammonia-powered ships, and concentrating on electric power solutions. It also looks to advance digitalized ship technologies to accelerate its entry into the autonomous navigation market.
• The greater Seoul area, the epicenter of the latest wave of the outbreak, has been under the Level 4 distancing measures, the highest in the country's four-tier system, since July with most other areas being under Level 3.
• Foreigners arriving at South Korean airports face a mandatory 14-day quarantine procedure and must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation. However, some people who have been vaccinated against COVID-19 in countries other than Korea will be exempt from the 14-day self-quarantine requirement, meaning they can move around freely as soon as they enter the country. A similar exemption has been in place since May for those who were vaccinated in Korea.
• The 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.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN (No updates this week)

Europe

• Europe this week is showing some improvement. The UK is a notable exception, as it now leads Europe in new daily cases. Italy and Spain are showing remarkable reductions in daily cases, and Poland, formerly a hot spot, has seen its numbers drop dramatically. The UK has the unfortunate distinction of reporting the most deaths in Europe (other than 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. We will start again next week with prior week comparisons. France 17,621; Spain 6,818); Russia 18,368; UK 35,693; Italy 6,503; Germany 14,615; and Belgium 1,854.
• In terms of total cases in Europe, see chart below for the specific numbers. Russia is first, UK second, France, Spain and Italy round out the top five. Germany is now 6^th, followed by Poland, Ukraine and the Netherland. The Czech Republic takes the 10^th Poland and Ukraine have shown dramatic decreases in their new cases.
• In terms of cases per million in Europe, Czech Republic is the 4^th highest in Europe with 156,490. Netherlands is 8^th with 113,154, Sweden is 10^th with 110,196. Spain remains at 12^th with 103,940. Belgium has dropped to 15^th with 101,701. France has moved up to 13^th with 103.654. The UK is 16^th at 99,925, and Italy is in good shape, comparatively, at 29^th with 75,325.
• Russia's reported numbers on COVID remain problematic, now just shy of 7 million, the most in Europe and fourth worst in the world (behind the USA, India, and Brazil). Russia deaths per day remain very high compared to the rest of Europe, at 790. The official COVID-19 death toll in Russia now stands at over 184,000, fifth highest in the world behind US, Brazil, India, Mexico and Peru. The real tally for Russia is likely to be much higher. By comparison, Germany, with roughly 3 million fewer cases, reports 92,757 deaths and a death rate of 1,103 per million.

• In terms of deaths per million, Belgium is the 15^th worst in the world with 2,179. Italy is 16^th, with 2,142. The UK is 23^rd with 1,943. Other rankings in this category are Spain, 27th, and France 29^th. (The US ranks 21^st with 1,980 deaths per million).
• The figures for new deaths per day, (which tend to lag any increased infection rates) are as follows:  Spain 132, Germany 27; France 86; UK 207; Belgium 6). Russia reports 790.
• Germany continues to lead Europe in the number of vaccine doses administered with over 101 million doses administered, and over 60% fully vaccinated. The UK is second with just shy of 91 million doses administered, almost 63% fully vaccinated. France and Italy are showing strong positive movement at over 87.8 million (59.8% fully vaccinated) and 78.1 million (61%), respectively. Spain is now over 66 million doses, (71.4% fully vaccinated). These numbers continue to rapidly increase.
• The European Union recommended a pause on all non-essential travel from the US as Covid-19 cases surge. The daily average for hospital admissions has risen past 100,000 for the first time since last winter.
• The recent wave, driven by the Delta variant, is most severe in the US South but cases are rising nationwide. Monday's guidance from the 27-nation bloc reverses advice from June that lifted restrictions on American travelers ahead of tourism season. The recommendation is nonbinding, meaning individual countries will be allowed to decide if they still wish to allow US visitors with proof of vaccination, negative tests, or quarantine.
• Though the EU first lifted travel restrictions on Americans in June, the US has kept their ban on European non-essential travel in place since March 2020.
• The European Union will return to Africa millions of doses of Johnson & Johnson ’s Covid-19 vaccine that it received from a plant in South Africa, following criticism by health activists that the bloc was taking away shots from a continent that has the lowest immunization rate in the world.
• The European Union has reached its goal of fully vaccinating 70% of all adults against COVID-19, EU President Ursula von der Leyen said Tuesday. She announced the "important milestone" in a video message posted online. "I want to thank the many people making this great achievement possible," she said. "But we must go further! We need more Europeans to vaccinate. And we need to help the rest of the world vaccinate, too."
• Many experts estimate that herd immunity requires between 60% and 70% of populations to be vaccinated against the novel coronavirus to make its spread unlikely.
• Countries should hold off on widespread use of boosters until at least next month, though some at-risk people may need third doses, World Health Organization Director-General Tedros Adhanom Ghebreyesus said in Berlin on Wednesday.
• European Union health authorities said there’s no urgent need for widespread use of Covid-19 vaccine booster shots, though people with weakened immune systems should be offered a third dose.
• The priority now should be to vaccinate the roughly one-third of Europe’s adults who aren’t fully inoculated, the European Medicines Agency said on Thursday, citing a report by the European Center for Disease Prevention and Control. Older and frail people, particularly those in care homes, could also be given an extra dose, the agency said.
• The EMA’s statement is in line with guidance issued this week in the U.K., which is so far focusing its booster shot efforts on those whose immune systems aren’t able to react strongly to the first two doses, such as organ-transplant recipients.
• The EU Digital COVID Certificate is now live. All EU Member States are issuing and verifying the pass in a bid to boost tourism across the region this summer and beyond. The pass is proof that a person has:
  • Been vaccinated against COVID-19
  • Tested negative for COVID-19
  • Recovered from COVID-19
• The certificate is an EU-wide scheme for travel within the EU, and is available in digital or paper form, free of charge. https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en. EU citizens and their families, and legal EU residents, may use it. There are discussions underway to allow US and UK citizens to obtain and use the digital certificates.
• Each EU Digital COVID Certificate has a QR code containing a digital signature. When the code is scanned, this signature is verified. The gateway created by the European Commission allows all certificates to be verified across the EU. Significantly, personal data does not pass through the gateway. The European Union has said that travelers with an EU Digital COVID Certificate should be exempt from entry restrictions.
• In theory, anyone with the vaccine passport will be able to go on vacation without having to self-isolate on arrival or have further tests. Travel restrictions should only apply if there is a specific cause for concern, such as a new variant. To introduce restrictions for COVID-19 passport holders, the Member State will need to inform the Commission and justify the restrictions. With fewer obstacles to travel, people are more likely to book a trip abroad this summer. International tourism has an important role to play in Europe’s economic recovery.
• 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 EU currently allows all travelers with proof of vaccination into the EU, with some restrictions. Please check if you intend to travel as these situations can change rapidly. See link for full explanation: COVID-19: travel from third countries into the EU - Consilium (europa.eu). For incoming US travelers, EU countries in most instances now allow entry with proof of vaccination and/or a negative COVID-19 test result. Those showing proof of vaccination can enter in most instances without restrictions. Again, please check before you travel as situations can change.
• The United Kingdom 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 trade deal between New Zealand and the UK is expected to be delayed until next week.
• The UK Government has opened applications for two new commercial directors to lead the new Health Promotion agency.
• The risk of ‘long Covid’ in children is expected to be much lower in children than had been initially feared.
• Schools are not "drivers" or "hubs" of Covid infection, Public Health England's medical director has said. Dr. Yvonne Doyle said she understood parents' nervousness about schools returning after the summer in England, Wales and Northern Ireland. She stressed that lots of measures to cut Covid spread remained in place. But Prof. Calum Semple, a government scientific adviser, said with most adults vaccinated, schools were likely to be a "greater part of the problem". Some have suggested a surge in cases in Scotland, where pupils returned in August, could be linked to schools.
• However, more than 32,000 pupils have been absent from school this week due to COVID-19.   The most up-to-date figures - for Tuesday - show that 6,471 pupils were not in school because they had the virus and 25,622 were self-isolating. The number of pupils with Covid has gone up by almost 3,500 in a week, while those isolating have doubled from 12,636 the week before. Whole classes no longer need to isolate following a positive case. Due to the relaxation of the rules, many pupils are likely to be off school for just one or two days if their test is negative, rather than 10 days.
• Exports of food and drink to the EU have suffered a “disastrous” decline in the first half of the year because of Brexit trade barriers, with sales of beef and cheese hit hardest. Food and Drink Federation (FDF) producers lost £2bn in sales, a dent in revenue that could not be compensated for by the increased sales in the same period to non-EU countries including China and Australia.
• Dominic Goudie, head of international trade at the FDF, said: “The return to growth in exports to non-EU markets is welcome news, but it doesn’t make up for the disastrous loss of £2bn in sales to the EU. It clearly demonstrates the serious difficulties manufacturers in our industry continue to face and the urgent need for additional specialist support.”
• He said the difficulties now facing British food and drinks manufacturers and farmers were compounded by the lorry driver and warehouse workers shortages, which were choking the supply chain. “At the same time, we are seeing labour shortages across the UK’s farm-to-fork food and drink supply chain, resulting in empty spaces on UK shop shelves, disruptions to deliveries and decreased production,” Goudie said. “Unless steps are taken to address these issues, the ability of businesses to fulfill vital export orders will be impacted.”
• In an interview this week, Prof Saul Faust, chief investigator of the Cov-Boost study whose data next week is expected to inform a decision on boosters, indicated that there is “almost certainly no urgency” to press ahead with booster shots for healthy adults and it may be better to see how the pandemic pans out before a decision is made. He further indicated that for now it may be preferable to prioritize only the vulnerable, including those with compromised immune systems.
• Members of the UK government’s Scientific Advisory Group for Emergencies (Sage) have been sent suspicious packages and hate mail throughout the pandemic, one of the UK’s leading virologists has revealed.
• Prof Calum Semple, a member of Sage and the New and Emerging Respiratory Virus Threats Advisory Group (Nervtag), said the incidents of abuse included one “particularly nasty” experience when he was targeted by anti-vaxxers. Semple, a professor of child health and outbreak medicine at the University of Liverpool, has regularly appeared on television and radio to be interviewed about Covid since the pandemic began. He said during this time he and his colleagues on Sage had “attracted adverse attention” from people frustrated by the government’s response to Covid. He added: I’ve never been at a Sage meeting where we’ve sat around drinking coffee saying ‘wouldn’t it be a jolly good idea if we closed the pubs?’ That conversation has never and will never happen. It’s about what is the likely contribution of construction versus schools versus large matches, and that’s where you can then present a menu of likely impacts, and then it’s for policymakers to make the decisions, but we’re not a talking shop or we’re not a suggestion box or a brains trust, it’s very much about dealing with inadequate information and giving best opinion.
  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 traveling 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.
• A wide range of waiting times data has been released by the British government as part of its return to treatment initiative. The number of people waiting for over a year for treatment in England has reached its highest levels since 2008. The official and detailed data from NHS England on waiting times can be found here: https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/.
• ABHI has conducted a comprehensive analysis of the re-start of elective procedures in each Trust and Health Board in the UK. The results can be found here: https://www.abhi.org.uk/membership/members-area/updates/2020/july/the-restart-of-planned-care/.
• If you are experiencing issues with exporting goods to the UK from the EU, or to the EU from the UK, please let us know immediately and advise the UK’s Border and Protocol Delivery Group at this e-mail address: enquiries@cabinetoffice.gov.uk.
• In Germany, employers are demanding legal protection to ask workers whether they have been vaccinated. The government, so far, has sided instead with employee's rights to privacy. The German government was set to pass a new workplace coronavirus hygiene ordinance on Wednesday but rejected the suggestion to give employers legal ground to ask their workers whether they have been vaccinated. Even as other countries mandate vaccinations for certain professions, Germany has avoided forcing anyone to get vaccinated against the coronavirus.
• The German government has pledged to donate at least 30 million vaccine doses of the AstraZeneca and Johnson & Johnson vaccines by the end of 2021 to an international vaccine relief effort.
• Germany, as well as Switzerland and Canada have been reclassified by the US as high-risk countries "due to a high level of COVID-19." The decision comes as the EU calls for reimposing restrictions on American tourists.
• Germany's annual consumer price inflation accelerated to a fresh 13-year high in August, data showed on Monday, underlining growing price pressures as Europe's largest economy recovers from the pandemic and companies struggle with supply shortages. Consumer prices, harmonized to make them comparable with inflation data from other European Union countries (HICP), rose 3.4% compared with 3.1% in July, preliminary figures from the Federal Statistics Office showed.
• The August reading was in line with a Reuters poll and marked the highest since July 2008, when the harmonized inflation rate also hit 3.4%. The national inflation rate (CPI) even soared to 3.9% in August, hitting its highest since December 1993 when the economy boomed following German reunification. "This is due to higher energy and food prices, while the core inflation probably even fell slightly form 2.9% to 2.8%," Commerzbank analyst Ralph Solveen said.
• If you are interested in the latest travel, testing and quarantine regulations for Germany, please see the following link: https://www.auswaertiges-amt.de/en/coronavirus/2317268.
• Germany’s version of the EU-wide digital vaccine pass certificates was launched earlier this summer and these can be used as proof of vaccination. Although authorities have stressed that the pass with a QR code does make travel into the country and around the EU easier, it is not compulsory. For activities where some kind of immunity or proof of not having Covid is required, people can also show a paper copy of their vaccine certificate, recovery or test.
• To access the German version of the EU digital pass, people have to be fully vaccinated and can get it from most pharmacies, a doctor or the vaccination centre they got their jabs. People can also get it if they’ve recovered from Covid recently and therefore received one shot. People can use the paper certificate with a QR code on it, or scan it into an app.
• 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.
• Twelve million children in France went back to school Thursday for the new academic year, wearing face masks as part of rules aimed at slowing down the spread of the coronavirus in the country.
• In France as in other European countries, many fear the end of the summer break will see a new surge in COVID-19 infections fueled by the highly contagious delta variant. French media cite the example of Scotland and Germany where reports of new cases increased after schools reopened.
• Visiting a primary school in the southern city of Marseille, French President Emmanuel Macron praised as “a victory” being able to open schools. Macron was greeted with a fist bump by children and teachers, all wearing masks, which are mandatory indoors starting from age 6.
• France is extending a mandate to carry health passes to certain categories of workers as of Monday, marking a new step in the government's strategy to persuade members of the public to get vaccinated against Covid-19.
• France has made it obligatory to show the health pass – proving that you are vaccinated or have tested negative for Covid-19 – for access to public venues for more than 50 people since July 21. On August 9 the health pass requirements were extended to a range of new settings, including long-distance transport, restaurants and cafés – even France’s famed outdoor terraces. This week’s mandate adds to the number of people who are required to carry the health pass in order to engage in various public activities.
• Any of the following documents can be used as a health pass in France:
  • Proof of having completed a vaccination program (two doses of an EU-approved vaccine: Pfizer, Moderna, AstraZeneca or Johnson & Johnson)
  • A negative PCR or antigen test taken within the last 48 hours
  • A Covid-19 recovery certificate that is less than six months old
  • Anyone who enters an establishment without showing a valid pass can be fined €135 for a first offence.
• The new measure means staff who work face to face with the public – for instance at cafés, cinemas or on public transport – are now required to show proof that they are fully vaccinated or have tested negative for the coronavirus in the last 72 hours. It will apply to some 1.8 million workers across the country. Members of the public are already required to carry health passes in order to access eateries and cultural or leisure venues.
• A total of 160,000 people protested across France last Saturday, the interior ministry said, angered at the country's Covid-19 health pass system which they say unfairly restricts the unvaccinated. By early evening the authorities had logged 222 separate protest actions, including 14,500 people who turned out in Paris. Sixteen people were arrested and three police officers slightly injured in what was the seventh consecutive weekend of Covid protests.
• The French economy is "doing well" thanks to a rise in consumer spending and despite restrictions still in place to tackle the coronavirus, French Finance Minister Bruno Le Maire said on Monday. Le Maire told France 2 television the aim now was for France to return to pre-pandemic economic growth levels by the end of the current year. The finance minister said France's economy had grown 15 percent in the first half of August compared to the same period last year. He reiterated the government's six percent growth target for the whole of 2021.
• Le Maire said an uptick in business for French restaurants in August was evidence that the public had "adapted well" to the introduction of health passes, which the government has made mandatory in cafés and restaurants – triggering angry protests among those opposed to Covid-19 vaccinations.
• In France, 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. However, this could change given the EU’s reclassification of the US this week. The US had been classed as orange when the traffic light system was first announced on June 9th, but an announcement in the government’s Journal official 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