The weekly global report provides brief updates on AdvaMed’s global activities related to COVID-19. For additional information, please contact Ralph Ives at Rives@AdvaMed.org.
COVID-19 Outbreak: Weekly Global Report for Friday, January 7, 2022
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 as we ramp up this work stream, we welcome your feedback.
Global
Weekly COVID-19 statistics. Global cases reached 300 million. Deaths around the world have exceeded just over 5.4 million. Around 9.3 billion vaccines have been administered.
U.S. cases exceeded 58.1 million with deaths increasing to 833,000.
Outlook for 2022: Zero-COVID reigns supreme as China enters a new year with two hugely important events: the Winter Olympics in February and the 20th Party Congress in the late autumn. In the ancient capital city of Xi’an, local authorities in the past two weeks have implemented the most aggressive quarantine requirements in China since Wuhan, which has upset the local population of 13 million but is proving effective in lowering cases. Meanwhile, the annual Lunar New Year migration is just two weeks away. Despite vaccinating around 80% of its population, China is accelerating efforts to develop a homegrown mRNA vaccine as its existing inactivated vaccines show weak efficacy against the Omicron and Delta variants over a sustained periods of time,studiesshow. In a research note, Goldman Sachsprojectsthat China will keep its border shut throughout 2022. Indeed, China is now requiring even more onerous pre-departure requirements for foreign arrivals that affect foreigners and Chinese nationals alike.
Weekly COVID-19 statistics: China’s total COVID cases now stand at 115,916. The number of reported deaths has remained unchanged for several months at 4,849.
Status of the vaccination campaign: 1.2 billion Chinese citizens (80% of the population) have received at least one COVID vaccine dose, according to the National Health Commission (NHC).
Lockdown in Xi’an: The city of 13 million has been under strict lockdown since December 23, as it grapples with China’s worst coronavirus outbreak since Wuhan (over 1,600 reported cases, reportedly he Delta variant). But local authorities have faced a public outcry over perceived incompetence and disproportionately harsh measures. Over the past two weeks, posts have flooded Chinese social media by Xi’an residents saying they have not received food, basic supplies, and even medical care. One heavily pregnant woman was allegedly turned away from a hospital on New Year's Day because she lacked a valid COVID-19 test, according to a post from the woman's niece. The pregnant woman was finally admitted two hours later -- but suffered a miscarriage, said the post, shared widely on Weibo before it was deleted. In more recent days, local health authorities have credited the declining case numbers to the strict measures. Also, Beijing removed two senior Communist party officials in Xi’an from their posts over their “insufficient rigor in preventing and controlling the outbreak”.
Lockdown in Yuzhou: Three asymptomatic cases of COVID-19 were enough for local authorities to lock down this city of almost 1.2 million people in central Henan province on Monday. All Yuzhou residents have been ordered to stay inside and residential communities have sentries posted at gates to enforce the quarantine. Public transport has been suspended and all shops, entertainment and leisure venues have been closed. Yuzhou is 700 km south-west of Beijing, where the winter Olympics are to open on Feb. 4. Yuzhou officials have said “to curb and quash the epidemic within the shortest amount of time is a high-priority political task” for both citizens and government employees.
New pre-departure rules for China-bound travelers: Now, all travelers—to include foreigners and PRC nationals—are required to stay at their city of departure for seven days for personal health observation. During this period, the travelers are also required to complete two rounds of pre-flight tests at designated testing agencies — on the first day of the seven-day stay, and within 48 hours prior to their flight, respectively. For passengers who received inactivated COVID-19 vaccines, such as those developed by China-produced Sinopharm and Sinovac, travelers must conduct two rounds of nucleic acid testing (NATs) during the personal health observation period. For the unvaccinated and those who received non-inactivated vaccines, including Pfizer and Moderna, travelers must first complete a round of nucleic acid testing and then a round of combined testing, including NAT, and IgM antibody tests against the spike(S) and nucleocapsid (N) proteins.
Quest for homegrown mRNA vaccine: Progress towards a domestic mRNA vaccine in China has been slow, as the country’s pharmaceutical companies opted initially to use traditional inactivated virus technology in vaccines. But, China’s race to develop its own messenger RNA vaccine has gained greater urgency of late as Beijing struggles to rein in outbreaks of the Omicron and Delta variants that are threatening its zero-COVID policy. in November, Chinese biotech company Suzhou Abogen Biosciences and its partner Walvax Biotechnology received regulatory approval to test their mRNA vaccine candidate in a booster trial. Pre-clinical trial data showed the Walvax and Abogen vaccine candidate, which is called ARCoV, produced a robust antibody response against coronavirus during the animal testing phase. No data on the more conclusive later-stage trials on human subjects has been published. Even if China rolls out an mRNA vaccine as a booster, experts warn that it may not be a silver bullet that gives authorities the confidence to end its zero-COVID policy, given breakthrough infections of individuals immunized with mRNA shots.
Even as evidence of the weaker performance of its vaccines mounts, Chinese regulators have held off granting approval to the BioNTech mRNA vaccine. The German drugmaker has sought to enter the Chinese market through a distribution partnership with China’s Fosun Pharma. Even as evidence of the weaker performance of its vaccines mounts, Chinese regulators have held off granting approval to the BioNTech mRNA vaccine. The German drugmaker has sought to enter the Chinese market through a distribution partnership with China’s Fosun Pharma.
Sinovac’s effectiveness against Omicron is “inadequate”: Two doses of the Chinese-made Sinovac vaccine, one of the most commonly used jabs in China and around the world, provide “insufficient” antibodies against the Omicron coronavirus variant, according to researchers in Hong Kong. The findings from a study released by the University of Hong Kong have stoked anxiety as Omicron surges in many parts of the globe and the first two cases were detected in mainland China this week. China has administered more than 2.5bn doses of a Covid-19 vaccine — most of them Sinovac or Sinopharm — and adopted a “zero Covid” strategy that has subjected vast numbers of people to compulsory government quarantine. The new coronavirus strain had already raised questions over the efficacy of Chinese vaccines and Beijing’s ability to keep the virus under control. “[Omicron] has left the Chinese vaccines even more ineffective against the threat posed by Covid,” said Nicholas Thomas, an associate professor at the City University of Hong Kong who specializes in Chinese foreign policy and health security in Asia.
Mixing of booster shots to be permitted: China will allow the mixing of Covid-19 vaccines for its booster shots drive, with an “an optimal immunization combination” to be introduced very soon, a senior health official said. The new strategy will help to reduce severe illness and deaths from Covid-19 and win the country time to adjust its strict pandemic controls, National Health Commission official Zheng Zhongwei told state broadcaster CCTV on Monday. China has thus far prohibited the mixing and matching of vaccines, or sequential immunization, despite studies around the world on its effectiveness and some countries recommending such a regimen. CanSino is likely to benefit from the possible strategy change on booster doses, as its single-dose shot is the only approved vaccine to use a different technology from the inactivated varieties. Zheng’s remarks also offer hope for possible regulatory approval for an mRNA vaccine jointly developed by Germany’s BioNTech and China’s Fosun Pharma.
Approval of COVID therapeutics: China is on track to approve its first drug for Covid-19, possibly within weeks. This comes as Chinese scientists race to find an effective treatment for the disease, crucial for the country with a zero-tolerance strategy before it can consider reopening its borders, even as vaccination remains a priority. Conditional approval may be given to a neutralizing monoclonal antibody treatment co-developed by Chinese and US researchers by the end of the year, according to an official publication of the Ministry of Science and Technology. Brii Biosciences, a multinational pharmaceutical firm based in the US and China, developed the therapy with scientists at Tsinghua University and the Third People’s Hospital of Shenzhen. Interim data from an international trial showed the medication could reduce the risk of hospitalization and death for Covid-19 patients by 78 per cent. If approved, the company would first target the China and US markets, while it would also prioritize countries where it has held clinical trials, including Brazil, South Africa, Mexico, Argentina and the Philippines. The interim results also showed that the drug was effective against Covid-19 variants such as Delta.
Vaccination program for children aged 3-11: China has launched a nationwide COVID-19 vaccination campaign for minors aged three to 11, in a bid to increase mass vaccine coverage and accelerate the building of herd immunity, as a new rebound in cases hits almost one-third of the country and becomes one of the worst since the initial outbreak in 2020. Furthermore, local city and provincial-level governments in at least five provinces issued notices in recent days announcing that children aged from three to 11 will be required to get vaccinated. China in June had approved two vaccines – Sinopharm’s from the Beijing Institute of Biological Products and Sinovac – for children aged three to 17, but it has only been vaccinating those aged 12 and older.
China to build permanent quarantine centers for foreign arrivals: Health authorities have ordered cities in China to build or convert facilities into permanent quarantine centers for overseas arrivals, as Beijing pushes ahead with its zero-tolerance policy on COVID-19. City governments have been told to move away from using hotels for quarantine and instead provide dedicated facilities. There should be 20 quarantine rooms per 10,000 people available by the end of October, according to National Health Commission official Cui Gang.
China’s vaccines and approval date: Sinopharm (approved Dec. 31, 2020); Sinovac’s CoronaVac (approved on Feb. 5); CanSino Biologics and a second Sinopharm vaccine (both approved in April). Three other vaccines have been approved in May and June.
China’s economy: China’s factory activity expanded in December as production and sales picked up, though employment remained weak, a private gauge showed Tuesday. The Caixin Manufacturing Purchasing Managers’ Index rose to 50.9 last month from November’s 49.9, Caixin and IHS Markit said in a statement. Economists had expected a marginal improvement to 50, the dividing line between expansion and contraction. Output rose at the fastest pace in the past year, supported by improved market conditions and stronger customer demand, while inflation eased, according to the statement. Employment fell for the fifth month in a row, with the sub-index dropping to 48.7, the weakest since February last year.
S.-China relations: China and the United States have reached a “stalemate” in the process to resume trade talks despite the expiry of the purchases deal under the Phase One agreement last week, with no clear indication from either Beijing or Washington of when the silence will be broken. A long-awaited new round of talks between China’s chief trade negotiator, Vice-Premier Liu He, and US Trade Representative Katherine Tai and US Treasury Secretary Janet Yellen has yet to happen. Liu last met Tai and Yellen via separate video calls in October before the high-profile talk between Xi Jinping and US counterpart Joe Biden in mid-November. “Now [China and the US] are in a stalemate, since everyone is clear that the atmosphere for negotiations has not formed yet,” said Huo Jianguo, the former head of a think tank under China’s Ministry of Commerce. “If [China] is more proactive, there might be some changes, since the negotiations are actually more beneficial to us.”
Weekly COVID-19 statistics: 35,109,286 total cases, 2,85,401 active cases/ 482,876 deaths/discharged 34,341,009 (John Hopkins & MoHFW) as compared to 34,718,602 total cases, 87,245 active cases/ 476,478 deaths/discharged 34,154,879 (John Hopkins & MoHFW) in the second week of December 2021. 1,486,780,227 doses have been administered.
Antiviral drug molnupiravir, which recently got approval from the drug regulator and is being launched by several local drug makers, has serious safety concerns, and thus has not been included in the national Covid-19 clinical protocol recommended by the health ministry, the Indian Council of Medical Research (ICMR) director general Balram Bhargava said. Bhargava said the Covid-19 task force has debated whether to include the drug in the Covid-19 treatment protocol but decided against it because of concerns.
As the country is to begin administering precautionary orthird doseof Covid-19 vaccine for healthcare, frontline workers and senior citizens from January 10. The Union Health Ministry on Wednesday, January 05 announced that there will be no mix-and match of vaccines to be given in view of the Omicron variant that is rapidly spreading in the country. “The precautionary Covid vaccine dose to be given to healthcare and frontline workers, and those over 60 and with co-morbidities will be the same as that administered in the first two doses,” Dr VK Paul, Head of India’s Covid task force, said on Wednesday.
The Subject Expert Committee (SEC) under India’s drug regulator sought more data on Russia’s Sputnik light, the one shot Covid-19 vaccine. Drug maker Dr Reddy’s Laboratories had sought Emergency Use Authorization (EUA) for Sputnik light from the drug regulator. The SEC took up their application for review on Tuesday, Jan 4, however, “more data is needed to ascertain if one dose is adequate to provide protection. The company has been asked to submit additional data from the trials in Russia,” said a senior government official. Sputnik V is a two dose vaccine made from two components-recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5.
The International Road Federation (IRF) on Tuesday, January 4 said Jai Prakash Narayan Apex Trauma Centre, which is a part of the All India Institute of Medical Sciences in Delhi, should not be reconverted into a Covid-19 centre in the wake of the threat posted by the Omicron variant of the coronavirus. In March last year, JPNAT was converted into a full-fledged Covid-19 centre and normal trauma services were recently restored there, the global road safety body said in a statement. Recently, in a meeting chaired by AIIMS director Dr. Randeep Guleria, it was again decided to utilise the ICU and ward at the centre to manage Covid-19 cases in anticipation of the expected rise in cases.
The All India Institute of Medical Sciences (AIIMS) on Tuesday, January 4 announced the cancellation of doctors winter vacation amid rising Covid cases. In a notice issued on Monday, the AIIMS Delhi has directed all faculty members to join back their duty with immediate effect at the hospital. “In continuation of the office memoranda of dated December 22 and 27, it is to inform that the Competent Authority has decided to cancel the remaining part of the winter vacation from 5th to 10th January due to ongoing Covid-19 and Omicron pandemic,” said the notice issued by the hospital administration with approval of AIIMS Director.
Tuesday, January 4 saw anexplosionof Covid-19 infections in the country with the daily tally close to 58,000r registering a single-day-rise of 56%, the highest during a period of surge since the pandemic began. Tuesday’s case count had collapsed to 57,974 by late night and was likely to cross 58,000 after data from two remaining states came in. This was over 20,000 higher than the tally of 37,123 recorded on Monday and India’s highest daily tally since June 19,2021, when 58,570 cases were reported.
Molnupiravir, the antiviral drug which recently got emergency use approval for treatment of mild to moderate Covid-19 in India, was launched on Monday at Rs. 1,399 for the full five-day course, making it one of the cheapest antiviral coronavirus therapies during the pandemic. Over a dozen companies, including Hetero, Sun Pharma, Natco and Dr Reddy’s are in the process of rolling out the oral therapy developed by Merck and its partner, Ridgeback Biotherapeutics, at prices ranging between Rs. 1,500 and Rs. 2,500 for the complete treatment.
Amix-matchpilot study of Covishield and Covaxin conducted by Hyderabad based AIG Hospitals has found that the neutralizing antibodies found in the mixed vaccine groups were found four times higher than the same vaccine groups. The mixing of vaccines didn’t point to any safety issues, the study said. As part of the study, a total of 330 healthy volunteers who were not vaccinated and had no history of Covid infection were selected and screened for SARS-CoV-2 antibodies for the study.
NK Arora, chair of India’s Covid-19working group, believes that the increased gap between Covishield doses has meant higher efficacy. In an interview with ET’s Teena Thacker, he said efforts in India are ongoing to develop a pan Corona vaccine. On asked if India will allow the same vaccines boosters or go for mix and match. In the absence of local data, will the decision be taken based on international studies, he replied that the purpose of an additional booster dose is for different objectives.
Most patients suffering from theOmicronvariant, which is behind the sudden surge in cases in Delhi, tend to recover with a week. This has been shown in an analysis of the case history of 105 patients, including seven children, who were treated at Lok Nayak Hospital. Dr. Suresh Kumar, medical director of Lok Nayak Hospital, told TOI that nearly 99% of Omicron patients recovered within a week. This variant spreads fast, but it also gets cleared fast from the body compared with the Delta variant.
Over 6.79 lakhchildrenbetween 15-18 were registered on Co-Win platform till 9 pm Sunday to receive Covid vaccination that will begin for this cohort from Monday, January 3. These children will be due to be administered Bharat Biotech’s Covaxin in two doses with a gap of 28 days. The Centre has advised states and Union Territories to provide separate vaccination centres, session sites, queue and different vaccination teams for the 15-18 age group to avoid any inadvertent mixing of vaccines.
The UnionHealthMinistry on Saturday, January 1 advised the state governments to initiate the process of setting up makeshift hospitals and constitute special teams to monitor patients in home isolation, in the wake of increasing Covid-19 cases in India. Union Health Secretary Rajesh Bhushan wrote to chief secretaries of all states/UTs on measures to deal with a possible surge in Covid cases. He asked all states to operationalize control rooms at all district/sub-district level and revisit the Covid dedicated health infrastructure.
Drawing comparison with vaccination programme across the globe, the Union Health Ministry highlighted that India has achieved highervaccination ratethan expected with the coverage of over 90% population with the first dose and 65% with the second dose. Further highlighted that India has set many records in the process of achieving these numbers including administration of over 100 crore doses in less than nine months, administering 2.51 crore doses in a single day and administering one crore doses per day on several occasions.
In view of the rise in coronavirus infections and its Omicron variant, the Centre has decided to hold a series of webinars from January 5 to 19 on various aspects of clinical management of covid cases in collaboration with AIIMS, Delhi. In a letter to states and Union Territories, Union Health Secretary Rajesh Bhushan has requested that all state-level Centres of Excellence (CoEs) and doctors in public and private district level Covid-19 health facilities along with CDMOs and in-charges of Covid-19 treatment facilities may be directed to attend these webinars. “ The growing trajectory of Covid-19 cases and Variant of Concern (VOC) Omicron, in some of the states and Union Territories in the country is a matter of concern,” Bhushan said.
Weekly COVID-19 statistics – 1,744,493 total reported cases and 18,411 total reported deaths.
The number of new cases in Japan has grown in the past three weeks from an average of about 100 cases per day to over 4,000 cases on January 5. This is the highest number of new cases since mid-September 2021.
Nearly 1,000 of the new cases are in Okinawa Prefecture. Many Japanese are blaming the U.S. military, which has a major base there, for the outbreak.
Japan has banned new entries by foreigners worldwide since Nov. 30 due to the omicron variant. Even entry of spouses and children of Japanese nationals or permanent residents are denied unless they are in "special exceptional circumstances."
Japan has fully vaccinated 79% of its population.
Japan started administering third doses of COVID-19 vaccine in December to medical workers who had their second doses at least 8 months ago.
Japan has approved the Moderna vaccine booster shots for those 18+ years old who got their second doses at least six months ago. It previously approved the Pfizer vaccine booster for the same cohort.
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.
Korea added 4,126 cases today to reach 653,792. Just over 95% of the cases were locally transmitted, with the remainder originating from overseas. Just before the holiday break, Korea reported 7,622 daily cases so it appears they are entering a more positive phase with lower case numbers.
44,291,971 first doses (86.3% of the population), 42,757,523 second doses (83.3% of the population) and 19,673,906 third doses (38.3% of the population) of the COVID-19 vaccine have been administered in Korea.
Starting January 3, 2022, Korea’s COVID-19 vaccine pass will expire after six months since the last vaccination date. A booster shot will be required within six months to be recognized as fully vaccinated for the COVID-19 vaccine pass purposes. See link (in Korean): Vaccine Pass Expiration Policy.
Stricter social distancing measures have been extended to January 16, 2022. Gatherings are limited to 4 people nationwide until January 16. Link (in Korean): Stricter Social Distancing Measures.
International Arrival Quarantine Measures Extended through February 3, 2022. All international arrivals into Korea must undergo a 10-day quarantineregardless of their nationality and vaccination status until February 3, 2022. Quarantine exemption certificates can be issued for important business trips, diplomatic visits, and other humanitarian reasons.
The latest entry and exit requirements for travel between the U.S. and Korea can be found at the US Embassy website.
Vaccination Registration Policy: Starting December 9, non-Korean citizens fully vaccinated abroad can register their records at local health centers and get their vaccination status recognized in Korea.
Korea will recognize foreign nationals' vaccination history abroad so they can be verified as "vaccinated" against COVID-19, according to the Korea Disease Control and Prevention Agency (KDCA).
South Korea plans to provide around 40 trillion won ($33.4 billion) in funds to pandemic-hit self-employed people and small firms in a bid to ease their financial troubles ahead of the Lunar New Year holiday, Finance Minister Hong Nam-ki said on Thursday.
ASEAN now has 15,054,418 total reported cases and 306,361 total reported deaths.
ASEAN added 170,000 new COVID-19 cases over the past week, up slightly from 164,000 the week prior, as surges, particularly in Vietnam, offset declining cases in other countries in the region. The Omicron variant has now appeared in nearly all countries in the region, and in countries like Indonesia, it accounts for a quarter or more of all new COVID-19 cases, and nearly half of the new cases in Singapore.
Indonesia: New cases and fatalities remain at extremely low levels. Indonesia is now reporting 4,264,669 total cases and 144,116 total deaths. Indonesia accounts for 47% of total deaths in ASEAN since the start of the pandemic.
Malaysia: New cases and deaths are growing at a very low rate. Malaysia is reporting 2,773,156 total cases and 31,609 total deaths.
Thailand: The growth in new cases and deaths in Thailand remains low. The country reports 2,245,250 total cases and 21,780 total deaths.
Philippines: The Philippines reports 2,888,917 total cases and 51,743 total deaths.
Vietnam: Vietnam continues to experience a surge in cases and deaths. Total reported cases reached 1,817,721 and total reported deaths reached 33,475.
Singapore: The growth in new cases and deaths in Singapore has leveled off. It is now reporting 282,401 total cases and 834 total deaths.
Cambodia: Cambodia continues to experience extremely low numbers of new cases and deaths. It reports 120,553 total cases and 3,015 total deaths.
Laos: New cases and deaths continue to grow in Laos at a higher rate than in the past. Laos reports 114,787 total cases and 409 total deaths.
Vaccinations
Indonesia authorized the Pfizer vaccine for emergency use on July 15. Only 42.2% of the population is fully vaccinated.
Malaysia now has one of the highest vaccination rates in the region. The government announced that civil servants may face disciplinary action or termination if they fail to complete the COVID-19 vaccination process. Malaysia has fully vaccinated 79.2% of its population.
The Philippines has considerable vaccine resistance. Polls show that fewer than one third of Filipinos are willing to be vaccinated due to fears of the potential side effects. Currently, only 46.6% of the population is fully vaccinated.
Singapore has one of the highest vaccination rates in the world. Currently, 88% of the population is fully vaccinated. The country announced that it will cease covering the medical costs of patients who are eligible to get vaccinated but choose not to. It is also considering tightening restrictions on those who decline to receive the vaccine – beginning January 1, unvaccinated employees will be barred from entering the workplace, unless they undergo tests each time.
Thailand began a mass vaccination program using the AstraZeneca vaccine on June 7. Currently, 65.1% of its citizens have been fully vaccinated.
Vietnam has fully vaccinated 57.9% of its population to date. A Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
Cambodia: 81.8% of the population has been fully vaccinated, making it the second-highest country with total inoculation in Southeast Asia, after Singapore.
Travel
Singapore and Malaysia reopened one of the world's busiest land borders to vaccinated travelers after nearly two years.
Singapore is not allowing visitors who have a 14-day travel history to Botswana, Eswatini, Lesotho, Mozambique, Namibia, South Africa.
Singapore’s Vaccinated Travel Lane (VTL) is now available to fully vaccinated visitors from nearly a dozen countries, including Brunei, Britain, Canada, Denmark, France, Germany, Italy, the Netherlands, Spain, and the United States.
Indonesia: Vaccinated travelers from Indonesia can now travel quarantine-free to Singapore. Indonesia remains closed to general travel from Singapore. Sponsored business visas are once again available, though a five-day quarantine in a designated hotel is still required. Indonesia reopened international flights to Bali on October 14 for foreign visitors from countries with a positivity rate of less than 5% and who have been fully vaccinated against COVID-19.
Thailand has temporarily suspend the “Thailand Pass,” which allows quarantine-free visits to the country. It remains unclear how long the scheme will remain suspended.
Malaysia and Singapore announced that they will launch a vaccinated travel lane (VTL) between Changi Airport and Kuala Lumpur International Airport on Nov 29.
Vietnam announced the resumption of international flights between nine destinations deemed to have “high vaccination rates and good pandemic control.” The destinations include China, Japan, South Korea, Thailand, Singapore, Laos, Cambodia, and the United States.
Philippines: Fully vaccinated international travelers from countries classified as “green” (low-risk) will no longer be required to undergo facility-based quarantine if they provide a negative COVID-19 test result taken within 72 hours of their departure.
Cambodia: Effective 29 November, all travelers who have been physically present or have transited Botswana, Eswatini, Lesotho, Mozambique, Namibia, South Africa, Zimbabwe, Malawi, Angola, and Zambia are prohibited entry into Cambodia.
Other than the above, those who have received a second COVID-19 vaccine shot of any sort can now travel anywhere in Cambodia. Travelers will have to show their negative test 72 hours before travel and have two vaccine doses. Cambodia has lifted all quarantine requirements for vaccinated inbound travelers entering Cambodia by air, waterway, or land border checkpoints. Travelers will be required to take a rapid antigen test on arrival. Those who are unvaccinated will be quarantined for 14 days.
Large scale negative trends continue in Europe, with dramatic spiking in total and new cases. Deaths and deaths per million are also significantly increasing but not at a rate commensurate with the dramatic increases in cases, which seems to support that Omicron may be less deadly than prior strains, but is nonetheless much more transmissible.
The UK is back in the lead with the most new cases, and by a wide margin. France, Russia, Germany, and Spain round out the top 5 in Europe. The Russian reported figures of only 72,492 cases per million are far below virtually any other country in Europe. Experts believe the reported numbers from Russia are highly inaccurate, and that the situation in Russia is 7 to 10 times worse in terms of fatalities due to significant under-reporting. Russia’s current reporting of only 15,772 new cases per day appears to be fictional.
New Daily Case numbers appear in the chart below, and in this section are also compared to the pre-Christmas break are as follows: France 332,252 (60,866); Spain 137,180 (28,900); Russia 15,772 (28,486); UK 194,738 (88,376); Italy 189,098 (17,948); Germany 63,191 (44,997); and Belgium 18,630 (11,851).
In terms of total cases in Europe, see chart below for the specific numbers. The UK has the most COVID cases, followed by France, Russia, Germany, Spain and Italy. Poland, Ukraine, Netherlands and Czech Republic round out the top ten.
In terms of cases per million in Europe, Czech Republic is the 5th highest in Europe with 233,115. The UK is 7th highest with 202,197. Netherlands is 9th with 187,488; Belgium, is 11th with 184,463.
The UK continues to be fourth worst in the world in terms of total cases, behind USA, India, and Brazil. France and Russia are in fifth and sixth positions in total cases.
In terms of deaths per million, Belgium is the 24rd worst in the world with 2,435. Italy is 25th, with 2,292. The UK is 30th with 2,182. Other rankings in this category are Spain, 38th, and France 39th. (The US ranks 21st with 2,556 deaths per million).
The figures for deaths per day (which tend to lag any increased infection rates) are as follows: Russia 828 (1,173); UK 343 (146); France 246 (188); Spain 148 (48); Italy 183 (112); Germany 431 (403); Belgium 22 (44).
Germany continues to lead Europe in the number of vaccine doses administered with over 151 million doses and almost 71% fully vaccinated. German authorities are encountering resistance from many Germans who do not want to be vaccinated. Russia is now second in Europe with over 146 million vaccine doses administered and but only 46% fully vaccinated. The UK has administered almost 140 million doses and is 69.7% fully vaccinated. France has administered over 125 million doses and is now over 71% fully vaccinated. Italy has administered over 103 million doses and is just shy of 74% fully vaccinated. Spain has administered almost 85 million doses and is over 81% fully vaccinated. These numbers continue to increase, but the rate of increase has slowed in many places, such as Germany and the UK, due to population segments who refuse to get vaccinated .
The European Commission is actively exploring the joint purchase of the new antiviral pills that can be taken at home to treat mild and moderate COVID-19, even if some EU countries are moving forward with their own agreements. The two pills, Pfizer's Paxlovid and Merck's Molnupiravir (also known as Lagevrio), have been touted as a revolutionary step in the fight against coronavirus as the highly contagious Omicron variants sends infections numbers to record highs across the world. The medicine prevents the virus from multiplying and reduces the severity of the disease.
The EU must be included when it comes to Ukraine security talks, according to the bloc's foreign policy chief. Speaking from the Ukrainian city of Luhansk — close to the Russian border — European Union high representative Josep Borrell said Europe must be "part of the table" in order to discuss the continent's security. "On this dialogue there are not two actors alone. It's not just US and Russia. If you want to talk about security in Europe, Europeans have to be part of the table," he said. "And the agenda of the meetings is not just the issues that Russia has put on the table. There are other issues on the agenda, many of them affecting Ukraine."
The European Centre for Disease Prevention and Control warned that vaccination alone will not prevent Omicron from spreading. Dr Andrea Ammon, director of the EU public health agency, said that "a further, rapid increase in Omicron cases is imminent" in the European Union and the European Economic Area.
"We assess the probability of further spread of the Omicron variant in the EU/EEA as very high and it is considered very likely to cause additional hospitalisations and fatalities," Ammon said in a video statement.
She called for countries to take urgent "strong action" to reduce transmission and alleviate the burden on health care systems.
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.
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 EU’s COVID Digital 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 pass is proof that a person has: Been vaccinated against COVID-19; Tested negative for COVID-19; and/or Recovered from COVID-19.
POSITIVE DEVOLOPMENT ON SWISS LABELLING REQUIREMENTS. We are happy to we have made progress and have good news to report on the labelling requirements that were to be imposed by the Swiss on imported medical products, beginning December 31, 2021. There is now a transitional period for MDR products and more reasonable labelling requirements for MDD/AIMD products, as follows:
Medical devices under old legislation (MDD/AIMD products)
MDD/AIMD products of all classes: The Swiss authorized representative (CH-REP) and importer may now, for example, also be listed on the delivery note / packing slip (a declaration directly on the product, packaging, or instructions for use is no longer obligatory).
Medical devices under new regulation (MDR products)
MDR products of all classes: The Swiss authorised representative (CH-REP) must be indicated on the product or packaging (e.g. label). The importer may now, for example, also be listed on the delivery note / packing slip (a declaration directly on the product, packaging, or instructions for use is no longer obligatory).
MDR Class I products: A transitional period until 31 July 2023 has been granted for the declaration of the Swiss authorized representative (CH-REP) on the product or packaging (e.g. label). Until then, such information declared on the delivery note / packing slip will likewise be accepted.
Swiss Medtech summary of current state of play for devices moving into and out of Switzerland from the EU: pdf (swiss-medtech.ch).
POSITIVE DEVELOPMENTS ON IVDR. We also have good news to report on IVDR. The proposal of the European Commission to extend the IVDR transition period is now fully supported by both European Parliament (15 December) and Council (20 December). The next step will be the publication of the amendment in the Official Journal of the EU. At that point, the amendment will fully apply in all EU Member States from the date of its publication.
The effect of the adoption of the proposal will include the following:
Extending the IVDR transitional provisions by between 3-6 years depending on IVD risk class (except class A non-sterile);
Maintaining the date of application. All class A (non-sterile) devices including instrumentation, will need to comply with the IVD Regulation by 26 May 2022 in order to be placed on the market after that date;
Postponing the applicability of most requirements for health institutions (in-house assays) by 2-7 years.
As infection rates surge in parts of Europe, the EU will limit the validity of its flagship Covid-19 certificate to nine months. The pass is designed to allow for restriction free travel within the bloc but certain countries are stepping up restrictions.
The Commission on Tuesday adopted rules that will make the certificate valid for just nine months after the holder became fully vaccinated, Reuters reported. That means after two shots of a two dose vaccine such as Pfizer or Moderna or after one shot of the Johnson & Johnson vaccine. After a booster shot, the validity of the COVID-19 pass will be extended further without a set limit.
The new rule could still be blocked by a qualified majority of EU governments or a simple majority of European Parliament members, but Reuters reports that officials have said there is sufficient support for it. If passed, the new rules will be binding on the 27 EU states from Feb 1st.
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.
Italy is set to expand its mandate to require all residents 50 and older to be inoculated against Covid-19 or potentially face monthly penalties. Italy's government has issued a decree requiring that everyone 50 years old and up be vaccinated against Covid-19, exempting only those who have recently recovered from the virus or who can”t take the shots for medical reasons.
Italy’s Council of Ministers unanimously approved the new mandate on Wednesday after weighing various possible measures to reduce the strain on hospitals amid the rapid strain of Covid-19's Omicron variant. The order is effective from February 15 and is set to continue through at least June 15.
In the UK, The Department for International Trade has announced UK exporters to South Korea have secured over £70 million worth of trade deals from the departments support.
The Labour Party has said UK ministers ‘showed weakness’ when negotiating the new Australian trade deal.
The NHS Confederation has said thegovernment must act swiftly to reduce the NHS staffing crisis.
A report from the Health and Social Care Committee has called on the government to fix the staffing crisis to reduce waiting times for treatment.
Foreign Secretary, Liz Truss is expected to meet with European Commission Vice President, Maroš Šefčovič next.
New standard contracts in the NHS are reported to ‘water down several waiting time targets’.
Prime Minister, Boris Johnson has said he accepts that parts of the NHS may be overwhelmed due to the new wave of covid-19. He also said there would be no new restrictions in England.
A trust in Greater Manchester has cancelled operations due to rising pressure on the NHS.
Boris Johnson has accused anti-vaccine campaigners of speaking "mumbo jumbo" when it comes to coronavirus jabs. The prime minister said those spreading false information on social media were "totally wrong" and it was time for him "to call them out".
About 1.3 million people in the UK have "long Covid", symptoms lasting more than four weeks after an initial infection, anOffice for National Statistics survey suggests. Of those, 892,000 (70%) first caught the virus at least 12 weeks ago and 506,000 (40%) at least a year ago.
Testing requirements are 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.
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/.
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 can avoid a sweeping lockdown even if the omicron strain of Covid-19 fuels a “drastic increase” in infections in coming weeks, according to Finance Minister Christian Lindner.
Speaking ahead of Friday’s talks over the next steps in the government’s pandemic strategy, Lindner said that Germany can tackle the virus and prevent overloading the health system with “reasonable” measures that avoid closing businesses and schools. He hinted that Chancellor Olaf Scholz and regional leaders will agree on both shorter isolation times to avert staff shortages in critical services as well as curbs on social contact. He said that accelerating the vaccine and booster campaign will help keep Covid at bay.
High-profile virologist Christian Drosten has spoken out in favor of shortening the duration of quarantine to prevent staff shortages during an Omicron wave. Speaking to DPA on Tuesday, Drosten said it could “make perfect sense” for someone to be cleared to leave the house after five or seven days, especially in terms of preventing severe staff shortages in critical infrastructure. People with full vaccination protection who become infected can fight the virus faster and earlier due to the immune reaction, he explained.
However, “this can only be done seriously if it is accompanied by a negative test,” said the Secretary General of the German Society for Immunology. “To simply shorten it like that because they say, we’d rather let people out after seven days, with or without a test, than have too many people out of action – I would consider that negligent.”
A draft law on mandatory vaccination is still on track to be submitted to parliament for entry into force in February or March. Masks are to be required in schools, and new limits imposed on private meetings. The moves follow a ruling from a top German court upholding government measures to tackle all-time high COVID-19 infections. The Federal Constitutional Court found that a curfew and school closures were in line with the country's constitution.
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.
French President Emmanuel Macron said in an interview published late Tuesday that part of his coronavirus strategy was to "piss off" the unvaccinated (using the term "emmerder" in French), a remark that prompted surprise among the public and condemnation from political rivals less than four months before presidential elections. Macron said he wanted to severely limit the ability of unvaccinated people to participate in social life, vowing to make life difficult for them.
After three days of tumultuous debates, fueled by controversial remarks by President Emmanuel Macron, the French National Assembly approved a bill early Thursday morning that would transform the country’s health pass into a stricter “vaccine pass”. It still needs to pass in the Senate, which is due to review it early next week. Macron’s government wants the new measures to take effect on January 15, but implementation will likely be delayed after debate was held up in the Assembly.
Under the bill, people over 12 years of age will be required to prove their vaccination status to access restaurants and bars, cultural venues, or interregional public transport. A negative Covid-19 test will no longer be sufficient, except for access to health facilities and services.
French health authorities on Tuesday said they had registered 271,686 new Covid-19 infections, the highest recorded to date, confirming France's position as Europe's hardest-hit country as the Omicron wave sweeps across the continent.
The more-contagious Omicron variant of coronavirus drove the number of confirmed cases in France to more than 160,000 per day last week and more than 200,000 for four consecutive days over the weekend. France on Saturday became the sixth country in the world to report more than 10 million Covid-19 infections since the outbreak of the pandemic, according to official data. "The tidal wave has indeed arrived, it's enormous, but we will not give in to panic," Health Minister Olivier Véran told parliament.
France has banned non-essential travel to and from Britain to slow the spread of the Omicron Covid-19 variant that is causing record numbers of cases on the other side of the Channel. However, after several weeks of these measures, France is now relaxing some of the restrictions.
France just announced that although travel between France and the UK is still only allowed for essential reasons, the list of accepted reasons has been expanded to include work trips. A work trip that cannot be postponed will now be allowed, with an attestation from the employer stating that the trip is essential. The new rule covers travel both to and from France, and takes effect immediately.
Also added to the list of allowed reasons for travel is people passing through France on their way to their home in another EU country. Previously this had only been allowed for EU citizens, leaving Brits who live in another EU country unable to travel through France to get home.
COVID screening tests in France are no longer free. This change signals a new phase in the government’s strategy to quell coronavirus infections by encouraging people to get inoculated.
Unvaccinated people in France essentially have to pay to enter cafes, restaurants and theaters, because under a law enacted this summer, entering many indoor venues requires proof of being fully vaccinated, of a recent negative test or of a recent Covid-19 recovery. Tests will remain free for vaccinated people.
France has made it mandatory 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 outdoor terraces.
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.
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.
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 IVDR and MDR implementation.
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/
