COVID-19 Outbreak: Weekly Global Report for Friday, October 1, 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 (No updates this week)

China (No updates this week)

India

• Weekly COVID-19 statistics:  33,716,451 total cases, 277,020 active cases/448,062 deaths/ discharged 33,014,898 (John Hopkins & MoHFW) as compared to 33,531,498 total cases, 301,640 active cases/446,050 deaths/ discharged 32,815,731 (John Hopkins & MoHFW). 883,470,578 people have been vaccinated.
• Even as the number of COVID-19 cases is declining continuously, the nationwide vaccination drive against the disease is going on at a rapid pace in India. India reported 26,041 COVID cases on Monday, September 27 which was the third consecutive day when the country reported less than 30,000 cases. India reported 2 lakh COVID cases in the last 7 days which is the lowest in two quarters. For the fifth time, India on Monday administered one crore COVID-19 vaccine doses, informed Union Health Minister Mansukh Mandaviya.
• A national network of scientists and people’s science movements has expressed concern over the World Health Organization not granting emergency use listing for ICMR-Bharat Biotech’s Covaxin. It warned that India looked set to repeat the blunders it committed in the Covaxin approval process in the way it was approving Zydus Cadilla’s ZyCov-D three-dose vaccine for those 12 years and older.
• Hyderabad-based Bharat Biotech on Tuesday, September 28 said that it is "diligently working with" the World Health Organization to obtain the emergency use listing (EUL) at the earliest for its Covid-19 vaccine, Covaxin. The company didn't indicate how long the process could take, saying that it was not appropriate to speculate. "As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines," it said. Soumya Swaminathan, WHO's chief scientist, told ET on Tuesday that the "process is ongoing".
• The central government on Tuesday, September 28, extended the nationwide Covid-19 containment measures till October 31 in view of localised spreads of the virus in a few states and the disease continuing to be a public health challenge in the country. In a communication to chief secretaries of all states and union territories, Union home secretary Ajay Bhalla also cautioned against the possibility of Covid-appropriate behaviour not being adhered to strictly during the upcoming festival which may lead to a surge in cases again.
• The government and Zydus Cadila are expected to decide on the price of ZyCoV-D, the world's first DNA vaccine against Covid-19, this week, people aware of the development said. "The final meeting to decide on the price of the vaccine is likely to happen this week," one of them told ET. "The company was asked to submit the details regarding the cost. The negotiations are on and a decision will be taken soon."
• India's drug regulator on Tuesday, September 28 allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its COVID-19 vaccine trial as the country prepares to protect children from the coronavirus. It has already administered more than 870 million doses to adults among its population of nearly 1.4 billion. "After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol," a subject expert panel of the Central Drugs Standard Control Organization said.
• Covid-19 vaccine ZyCov-D will be sent for clinical trial to find out the efficacy of its two-dose regime. The vaccine’s three dose schedule was already approved in August but is yet to get rolled out. Now, the efficacy of the two dose regime will be studied in India on 3,000 volunteers, including 300 at Kolkata’s Peerless Hospital. “Our hospital ethics committee has already given the green light.
• The Indian Council of Medical Research (ICMR) has evaluated a new and simplified RT-PCR testing method to detect SARS-Cov-2, which can potentially reduce testing time and cost. The new diagnostic method omits extraction of the virus’s genetic RNA before RT-PCR testing, simplifying sample purification and reducing test time, ICMR researchers said. Dr Samiran Panda, senior scientist and head of the ICMR’s epidemiology and communicable diseases division, told TOI that RNA extraction before RT-PCR testing was currently a major bottleneck, as it was time consuming, expensive and required trained human resources.
• The numbers of non-Covid patients and surgeries have crawled back to the pre-pandemic level across most private hospitals in Kolkata. Since August, they have seen a sharp surge in both while the number of Covid admissions remained low and stable — below 50 on an average. The reason is a rush to get deferred surgeries and treatment done ahead of the possible third wave.
• Dr NK Arora, the chairman of the Covid-19 working group of National Technical Advisory Group on Immunization (NTAGI), on Saturday, September 21 ruled out any changes in the gap between two doses of Covishield citing scientific studies suggesting the vaccine’s higher efficacy when the interval between the shots was longer. “Any further changes would be based only on scientific evidence and not on random demands,” Arora told TOI stressing that the current interval had been working well.
• India will export eight million coronavirus vaccine jabs by the end of October after ending its ban on sending doses abroad, a top foreign ministry official said Saturday. Prime Minister Narendra Modi promised to resume exports at a meeting of leaders from the so-called Quad in Washington as India, Japan, Australia, and the US try to counter growing Chinese influence across the Asia-Pacific region.
• A recent editorial published in ‘Environmental Science and Pollution Research’ journal by Drs Vivek Malik, Meenu Singh and Ravindra Khaiwal from the ICMR Advanced Center For Evidence-Based Child Health, department of paediatrics and department of community medicine and school for public has highlighted that due to high demand of oxygen during the second Covid surge, there were chances of impurities in oxygen during refill. Increase in demand for medical oxygen resulted in impurity and contamination, leading to deaths.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 1,701,897 reported cases and 17,666 reported deaths compared to 1,688,630 reported cases and 17,400 reported deaths last week.
• Japan’s new case numbers are declining fairly rapidly. Serious cases have fallen by half over the last month, and hospitalizations have plummeted from a high of just over 230,000 in late August to around 31,000.
• The Japanese government lifted the COVID-19 state of emergency covering 19 prefectures including Tokyo at the end of September. The emergency mainly involved requests for restaurants and bars to reduce their hours and not serve alcohol. With the lifting, Japan will be free of emergency requirements for the first time in more than six months.
• After a comparatively slow start, Japan's vaccination program has picked up speed, with 59.4% of the population now fully vaccinated.
• Japan plans to start administering third doses of COVID-19 vaccine to the elderly early next year.
• Japan is easing its quarantine restrictions for travelers entering the country who been fully vaccinated with the Pfizer, Moderna, or Astra Zeneca vaccines. They will no longer be required to self-isolate in designated facilities for 3 days before completing a 14-day quarantine. Instead, they will need to self-quarantine at home for 10 days and then pass a PCR test.
• Japan has agreed to buy 150 million doses of Novavax's coronavirus vaccine, with Japanese firm Takeda expecting to manufacture the formula for distribution early next year.
• 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.
• The central government 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. Tokyo’s restrictions on foreign entries except for returning nationals remain in place.
• Staff Contact: Phil Agress (PAgress@AdvaMed.org).

Korea

• South Korea has 2,564 new COVID cases, which is an increase from last week’s numbers. The country has not seen dramatic spikes recently, but the persistence of cases in the current ranges is a concern. The numbers remain overall low.
• Korea now has 311,2898 total cases, 34,603 active with 2,481 deaths. Total cases per million population have remained low compared to most of the world but Korea is now above the 6K threshold with 6,065 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 48.
• South Korea officials credit strict social distancing measures as the reason they are not seeing greater or more dramatic spikes.
• Some restrictions have been eased to give leeway to vaccinated people and allow more students to take in-person classes to mitigate the prolonged pandemic's impact on the local economy.
• Korea continues to improve its vaccination numbers. A total of 62,733,685 doses have been administered. 49.1% of the population is now fully vaccinated, and another 27% have received their first dose.
• Authorities have extended the current virus curbs ― Level 4 in the greater Seoul area, which is the highest in the four-tier system, and Level 3 in other regions ― through Oct. 3, limiting the size of private gatherings and restaurant business hours.
• As infections continue to soar among those unvaccinated or partially vaccinated, the South Korean government is reviewing a “vaccine pass” that benefits only vaccinated people in accessing multiuse facilities.
• Health and Welfare Minister Kwon Deok-cheol hinted Tuesday at the possibility of introducing a vaccine pass system in Korea. “We are considering ways to ease distancing rules for private gatherings and multiuse facilities centering on those who have been vaccinated,” Kwon said. A vaccine pass would allow those who have been fully vaccinated to visit multiuse facilities, entertainment facilities or movie theaters when they present their certification. In Germany, a vaccine pass is necessary to attend indoor events and visit hospitals. In France, the pass allows entry to theaters and stadiums.
• South Korea is halving the minimum amount of time until a second dose of AstraZeneca’s COVID-19 vaccine to four weeks from eight weeks, in the hopes of accelerating the drive for full vaccination coverage.
• 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

 

Cases

• ASEAN now has 12,078,952 reported cases compared to 11,697,460 reported cases last week. It has a total of 262,239 reported deaths compared to 256,502 reported deaths last week.
• The overall number of new COVID-19 cases in Southeast Asia has declined for each of the past three weeks.  The region added 381,000 new cases over the past week, down sharply from the high of 664,000 cases added the week ending July 28. 
• Indonesia: Indonesia’s metrics continue to move in a positive direction. This past week, it reported its lowest number of new deaths since May. Indonesia is now reporting 4,213,414 total cases and 141,826 total deaths compared to 4,201,559 total cases and 141,114 total deaths the previous week. Indonesia accounts for 54% of total deaths in ASEAN since the start of the pandemic.
• Malaysia: The number of new cases is dropping in Malaysia. Companies with 40-59% fully vaccinated workers may now operate at 60% capacity, while companies with 60-79% fully vaccinated workers may operate at 80% capacity, and companies with 80-100% fully vaccinated workers may now operate at full capacity. Fully vaccinated individuals may now quarantine at home following overseas travel, visit long-distance spouses, travel within the country to meet children under 18 years old, and visit houses of worship. Reported cases have grown from 2,142,924 to 2,232,960 over the past week. Total deaths have grown from 24,565 to 26,143 over that time.
• Thailand: The number of new cases is trending downward. Reported cases grew from 1,524,613 to 1,603,475 over the past week and reported deaths have increased from 15,884 to 16,727 over that time.
• Philippines: Cases in the Philippines are moderating slightly.  The Philippines is now reporting 2,549,966 total cases, up from 2,434,753 total cases the previous week. Total reported deaths have increased from 37,405 to 38,294 over that time.
• Vietnam: Vietnam recorded 4,589 new COVID-19 cases on September 29, the lowest number of daily infections since July 19. The death toll fell 12% compared to the previous week, and 16 localities have gone through 14 days without any new infections. Authorities have permitted Ho Chi Minh City to carefully begin relaxing social distancing measures and to gradually reopen starting October 1. The city will also license businesses and production facilities to resume operations provided that they meet safety requirements.   Cases of COVID-19 infection grew from 728,435 to   779,398 over the past week. The total number of deaths grew from 18,017 to 19,098 over that period.
• Singapore: Singapore reported its highest daily COVID-19 case total ever (2,236 new cases) on September 28. Officials once again tightened social restrictions, with the government reducing the size of permissible social gatherings and making work from home the default. Fortunately, Singapore’s high vaccination rates mean the vast majority of cases are mild and much of the country is well-protected. Reported cases increased from 81,356 to 94,043 over the past week. The total number of deaths increased rose from 68 to 93 over that period.
• Cambodia: Total reported cases increased from 106,619 to 112,651 over the past week. Reported deaths grew from 2,176 to 2,319 over that period.
• Laos: Laos logged 467 new COVID-19 cases last Saturday, including 383 local transmissions, the highest daily tally since the pandemic broke out in the country.  Laos reported a growth in total cases from 19,952 to 23,488 over the past week. It reported 17 total deaths from COVID since the outset of the pandemic, with one new death reported last week.

Vaccinations

• Indonesia is now vaccinating 1.5 million people daily. The country authorized the Pfizer vaccine for emergency use on July 15. It will be given to Indonesians aged 12 years and up. It has been administering the Sinovac and AstraZeneca vaccines. Only 18.6% of the population is fully vaccinated.
• Malaysia has increased its vaccination rate sharply in recent weeks. It announced that it will stop using China’s Sinovac vaccine in favor of the Pfizer shot. Mass vaccinations 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 62.9% 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 22.2% of the population is fully vaccinated.
• Singapore has one of the highest vaccination rates in the world. Currently, 82% of the population is fully vaccinated.
• Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 22.8% of its citizens have been fully vaccinated. Thailand has granted emergency use authorization for the Johnson & Johnson, Moderna, AstraZeneca, and Sinovac vaccines, although only the latter two are actually available.
• Thailand'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 only 9.3% of its population to date. Meanwhile, a Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
• Cambodia: According to the Cambodian authorities, the government has vaccinated over 98% of the target adult population of 10 million and 88% of the 12-17 age group of nearly two million, which is 72% of the country’s population. It just kicked off a campaign to vaccinate 6-11 year-olds. According to third party sources, 66.6% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.

Travel

• Singapore debuted its vaccinated travel lane, opening up quarantine-free visits to travelers from Germany and Brunei (travelers from China, Taiwan, and Hong Kong were already eligible for quarantine-free travel). 
• Singapore and Hong Kong agreed to drop their travel bubble that had been scheduled to start May 26 due to an outbreak of cases in Singapore.
• Indonesia: The Indonesian government announced that it plans to gradually reopen its borders to foreigners once 70% of the target population of 208 million have received at least one vaccine dose.
• Thailand announced it will waive its mandatory quarantine requirement in Bangkok and nine regions beginning this November to vaccinated arrivals. Authorities will also reduce the quarantine time nationwide for visitors arriving in October. 
• 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

• Europe is trending overall positive in its larger countries, although the UK and Germany have persistently high numbers for new cases. France and Italy seem to be improving. The UK has by far the highest number of new daily cases in Europe. Russia continues to report high numbers.
• New Daily Case numbers appear in the chart below, and in this section are also compared to prior week. France 5,835 (6,794); Spain 2,761 (2,840); Russia 22,430 (19,706); UK 36,722 (34,460); Italy 3,212 (3,970); Germany 12,209 (11,165); and Belgium 1,874 (1,797).
• In terms of total cases in Europe, see chart below for the specific numbers. The UK is first, Russia second, followed by France, Spain, Italy and Germany. Poland, Ukraine, Netherlands and Czech Republic round out the top ten.
• In terms of cases per million in Europe, Czech Republic is the 5^th highest in Europe with 157,519. Netherlands is 10th with 116,479; the UK is 11^th with 113,733; Sweden is 12^th with 113,277. France, Belgium and Spain are 14 – 16. (see numbers in chart below). Italy continues to be a winner in this group with just 77,352 cases per million (29^th).
• Russia's reported numbers on COVID remain problematic, continuing at almost 7.5 million total cases, the second most in Europe (the UK is worst in this category)
• Russia is the fifth worst in the world in terms of total cases, behind USA, India, Brazil and UK.
• In terms of deaths per day, Russia remains very high compared to the rest of Europe, at 857. Ukraine is second in this category to Russa, and reports only 217 deaths per day. Romania is third with 207 deaths per day, the UK is 4^th with 150 deaths per day.

• In terms of deaths per million, Belgium is the 16^th worst in the world with 2,195. Italy is 19th, with 2,168. The UK is 25^th with 1,998. Other rankings in this category are Spain, 29th, and France 32nd. (The US ranks 20th with 2,141 deaths per million).
• The figures for new deaths per day, (which tend to lag any increased infection rates) are as follows:  Russia 817; UK 150; France 42; Spain 39; Italy 63; Germany 70; Belgium 13.
• Germany continues to lead Europe in the number of vaccine doses administered with over 107 million doses administered, and 63.7% fully vaccinated. France is now second in Europe with over 94.5 million doses administered and 65.6% fully vaccinated. The UK is third in Europe with over 5 million doses, approximately 65.7% fully vaccinated. Italy has administered over 84 million doses and is just over 67% fully vaccinated. Spain is now over 70 million doses, over 78% fully vaccinated. These numbers continue to increase.
• European Union guidance (nonbinding) has recommended a pause on all non-essential travel from the US as Covid-19 cases surge. 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.
• The World Health Organization (WHO) has suspended the approval process for Russia's Sputnik V COVID vaccine. A regional WHO official said the manufacturing process of the jab had not met the necessary standards. Russia first applied for approval from the WHO for their vaccine in February but has not yet received an Emergency Use Listing (EUL).
• Here is a link to a regularly updated article describing in detail the latest on EU travel restrictions: https://www.euronews.com/travel/2021/09/30/what-s-the-latest-on-european-travel-restrictions.
• All EU Member States are issuing and verifying a COVID Digital Certificate 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.
• The EU has approved a €5.4 billion emergency fund aimed at helping businesses tackle the short-term effects of Brexit. The money will cover extra costs and compensate pos-Brexit losses, according to the European Council, which represents the national government of every EU member state.
• Ireland, the only EU country sharing a land border with the UK, will receive €1.1 billion, while France will benefit from €735 million.
• 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, this has not occurred. 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.
• In the UK, the UK’s announced intention to attempt to join the USMCA trade pact between the US, Mexico and Canada appears to have been premature, and to have occurred with little in the way of diplomatic preparation.  
• GPs (general practice physicians) are to receive funding to support the delivery of care and return to pre-pandemic levels of appointments.
• Only 58% of patients in England received a face-to-face appointment when seeing a GP in August.
• The Deputy Chief Executive of NHS Providers, Saffron Cordery has said addressing health inequalities must be a ‘fundamental priority’ for the NHS.
• Covid-19 infection rates in England have risen by 18% this week.
• Labour Party leader Keir Starmer has blamed the fuel crisis on Boris Johnson’s “whack-a-mole” approach to running the country, urging him to plan ahead or risk staff shortages in a string of other industries in the coming months. Ministers have suspended competition law in the energy sector and called in the army in recent days as they scramble to alleviate the shortages at filling stations caused by a lack of HGV drivers. Other sectors including social care, hospitality and food production have also highlighted difficulties in finding staff as a result of Brexit and the Covid pandemic, and the CBI said this month the problems could persist for up to two years.
• The UK’s MHRA has published its consultation on the New UK Regulatory Framework (including the CA mark). AdvaMed will provide information to members as this develops. https://tinyurl.com/7cjkcb9n. We have sent a communication to the UK WG and will be providing direct input through our MTG advocacy group and in consultation with ABHI.
• From Oct. 4, the UK is scrapping its ‘traffic light” system and will implement a two-tier system, with several dozen countries where COVID-19 is widespread classed as red, and the remainder as open.
• Testing requirements will be eased for fully vaccinated arrivals to England from open countries, who will no longer have to take a COVID-19 test before traveling. Travelers will still need a test after landing, but from the end October an inexpensive lateral flow test will suffice, rather than a more sensitive - but pricier - PCR test.
• Unvaccinated travelers will still have to self-isolate for 10 days, as well as taking coronavirus tests before and after their trips. In a boost to tourism, Britain said it will recognize vaccinations given in 17 more countries, including Australia, Canada, Japan and South Korea. It previously had recognized only shots given in the U.K., the U.S. and the European Union.
• Until October 4, 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).
• 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.
• Germany will face a difficult and long process of forming a government after the federal elections on September 26, 2021. This is because after 16 years of Angela Merkel's chancellorship, there are no longer any large, decisive popular parties. Both Olaf Scholz (SPD) and Armin Laschet (CDU) are ready to succeed Merkel, but they need partners. The time of three-party alliances is dawning, because none of the political leaders wants to continue the grand coalition of the recent years.
• BVMed, the German MedTech association, expects the new German government to ensure that the core topics of the future-oriented medical technology industry are also reflected in the coalition agreement for the new legislative period. In the EU Medical Device Regulation (MDR), BVMed is lobbying for an "addendum" in order to establish solutions for the transition periods as well as existing and niche products. In order to strengthen Germany as a medical technology location, BVMed is proposing a "Medtech 2030 Initiative" to the new German government to coordinate measures between research, economic, labor, and health policy.
• According to a recent industry survey by BVMed, the MDR is already having a dramatic impact on the medtech market. More than 70 percent of BVMed member companies have discontinued individual medical devices or entire product lines due to the new MDR regulations. This is the result of a BVMed survey in which 88 member companies participated. More than 55 percent of the companies indicated that previous suppliers have already discontinued their business activities due to the MDR.
• The medtech industry in Germany is showing a slight recovery from the sharp drop in sales in the corona crisis year of 2020. After a 2.1 percent decline in sales in the previous year, the industry expects a sales growth of 3.0 percent in Germany this year, and 3.1 percent worldwide. However, the pre-corona level of 4.2 percent growth in Germany and 5.8 percent worldwide is still a long way off. The companies' profit situation is severely strained by increased raw material and logistics costs.
• In the third wave of the pandemic, the number of cases in German hospitals also declined – but not as sharply as in the first two waves. This is shown by an evaluation of the Scientific Institute of the AOK (WIdO) based on the data of AOK-insured treated as inpatients.
• 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.
• The former French president Nicolas Sarkozy has been sentenced to a second jail term after being found guilty of illegal campaign financing for the vast, showman-style political rallies of his failed 2012 re-election campaign.
• The 66-year-old Sarkozy, who remains an influential figure on the French right, received a one-year sentence that the judge said could be served under house arrest by wearing an electronic ankle bracelet. Sarkozy is now in the extraordinary and unprecedented situation of having two custodial sentences.
• French fisherman have become increasingly angry over how Britain has controlled access for EU boats into its waters after it exited the bloc. London says it has pursued a "reasonable approach", issuing nearly 1,700 licences to EU boats to fish in Britain's exclusive economic zone, which is defined as being 12-200 miles from the coast. "We have been considering applications for vessels of under 12 metres in length to fish in this zone and, on the basis of the evidence available, we are able to grant licences for 12 of the 47 applications made." But French Maritime Minister Annick Girardin called it "a new British refusal to apply the conditions of the Brexit accord. "French fishing must not be held hostage by the British for political ends," she added.
• Sanofi is dropping plans for its own mRNA-based Covid-19 vaccine because of the dominance achieved by BioNTech-Pfizer and Moderna in using the technology to fight the pandemic, the company said on Tuesday (September 28).
• French Ambassador to the United States Philippe Etienne has returned to Washington after almost two weeks of absence amid the dispute between two countries over the US submarine contract with Australia, a Sputnik correspondent reported from the airport. Etienne declined to answer journalists' questions upon his arrival at Washington's Dulles International Airport on Wednesday.
• The ambassador was called back to Paris on September 17, two days after Australia abandoned a $66 billion agreement on submarines with France in favour of a partnership with the United States and the United Kingdom under the trilateral security alliance AUKUS. France considered the move a "stab in the back," and also recalled its ambassador from Australia.
• On September 22, following a phone conversation with US President Joe Biden on the matter, French President Emmanuel Macron decided to send Etienne back to Washington.
• 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.
• Workers 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.
• 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.
• 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/. (Also see EU section above for updated travel restriction information for any country in the EU, including France).
• 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.
• 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. 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