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 21, 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 339 million. Deaths around the world have exceeded just over 5.5 million. Around 9.7 billion vaccines have been administered.
U.S. cases exceeded 69.1 million with deaths increasing to 859,000.
The latest: COVID has penetrated Beijing’s “closed loop” fortress as the city gears up to host the winter Olympics in less than three weeks. Health authorities have linked the handful of cases to “infected” mail parcels and frozen meat from North America over the past week. In response, the Chinese government has discouraged consumers from buying products air-mailed to their homes from abroad and has ordered increased inspections of imported frozen food. For Beijing in particular, those entering the city must now also take a PCR test 72 hours after arrival on top of the negative test presented upon entering the city. Cases appear to be under well control in Xi’an and Tianjin, whereas the situation in central Henan province remains a more challenging where both Delta and Omicron variants are at play. Meanwhile, travel during this year’s Lunar New Year holiday period, less than a week away, is expected to far outpace 2021 and 2020, but likely will not reach the high recorded in 2019. China’s aviation regulator again cut more flights from the U.S., concerned about further leaks of the Omicron variant.
Weekly COVID-19 statistics: China’s total COVID cases now stand at 118,380, representing an increase of 1,101 cases over the previous week. 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).
Swift response to Beijing’s “mini” outbreak: China's capital Beijing ramped up efforts to curb COVID-19 infections, ordering checks among cold-chain firms and urging residents to cut unnecessary gatherings, as the city reported an uptick in local cases weeks before the Winter Olympics. Beijing had three domestically transmitted infections with confirmed symptoms on Wednesday, including one previously reported as a local asymptomatic carrier for Jan. 18, according to local health authority data on Thursday. That compared with one local confirmed infection for Jan. 18. The city has reported less than ten local COVID infections since Jan. 15, with both the Delta and Omicron variants detected, a tiny case count compared with the rest of the world. However, the city and China are still working under guidelines of getting any virus flare-up under control as soon as possible. The strategy takes on extra urgency as Beijing and neighbouring Hebei province will host the Winter Olympics from Feb. 4, while the ongoing Lunar New Year travel season raises the risk of virus transmission nationwide.
Study predicts a big travel upswing during the upcoming Lunar New Year holiday: Despite the Chinese government’s exhortations for a second year in a row for people to remain in the places where they work over the upcoming Chinese New Year holiday in a bid to stem further outbreaks of Covid-19, the ‘stay put’ request is expected to have less influence this year, according to a recent study. Around twice as many people are likely to head home this Spring Festival, which lasts from today until Feb. 25, than last year, according to the country’s top investment bank China International Capital Corp. Figures from the Ministry of Transport expect 1.78 billion people to travel, up from 840 million a year ago. Over 72 percent of people “intend to return to their hometowns and spend the New Year holiday there, if conditions permit,” a significant increase from last year’s 50 percent, according to a survey by microblogging site Weibo. As a further disincentive to stay behind, local governments are granting fewer subsidies to those who don’t travel over the Spring Festival this year.
Henan outbreak: Chinese Vice-Premier Sun Chunlan said last Tuesday that strict prevention and control measures are needed in Henan as it battles the twin threats of the Omicron and Delta coronavirus variants, as Sun capped a trip to the central province. Sun said the Omicron strain has spread quickly and was highly infectious, putting containment measures in Anyang, now the center of the province’s main outbreak, to the test. “It is necessary to further improve the efficiency of nucleic acid testing and investigations, adopt strict social control measures, block transmission routes as soon as possible, and strictly prevent the spread of the epidemic,” Sun was quoted as saying. The lockdown of Anyang, home to 5.5 million people, was announced late Monday after two cases of the omicron variant were reported. Residents are not allowed to go out and stores have been ordered shut except those selling necessities.
Delays at Shanghai's port: Delays are growing at the world’s largest port as ships reroute from Ningbo, Bloomberg reports. The strict testing of workers and truckers in Ningbo, which houses China’s third largest port, has strained already pinched global supply chains. Ships are being re-routed to Shanghai and are worsening congestion there, delaying departure schedules for container ships from Shanghai by almost a week.
Organizers say Beijing Olympics will proceed smoothly: China has no intention of locking down its capital or changing its coronavirus containment rules for the upcoming Beijing Winter Olympics, despite growing concern about local transmission of the Omicron variant, the organizing committee said this Tuesday. Beijing’s current COVID-19 strategy, including the “closed-loop” system that physically separates participants from the local population, was working well, said Huang Chun, from the Beijing Organizing Committee for the 2022 Olympic and Paralympic Winter Games. “The overall situation remains under control,” said Huang, who is in charge of pandemic prevention efforts. He added there was no plan to seal off Beijing or the neighboring province of Hebei.
China cuts additional flights from the United States: China on Wednesday ordered the suspension of six flights from the U.S. in coming weeks after a surge in passengers testing positive for COVID-19. So far this year, China’s aviation regulator has already cancelled 70 U.S.-originating flights in a schedule that has already been cut back drastically. The six newly suspended flights include two additional United Airlines flights from San Francisco to Shanghai and four China Southern Airlines flights from Los Angeles to Guangzhou from the week of Jan. 31, a move that would also affect return flights in February. Before the latest cancellations, three U.S. airlines and four Chinese carriers were operating about 20 flights a week between the countries, well below the figure of more than 100 per week before the pandemic.
Jail sentences for cargo handlers accused of introducing COVID: Three persons in charge of a cargo handling company in the port city Dalian, whose violations of epidemic prevention led to the spread of COVID-19 from cold-chain goods to society in 2020, were given prison sentences varying from 39 to 57 months last Friday.
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.
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.
China’s economy: China's economy rebounded in 2021 with its best growth in a decade at 8.1%, helped by robust exports, but there are signs that momentum is slowing on weakening consumption and a property downturn, pointing to the need for more policy support in 2022. “Consumption remains the weakest link in China’s growth story at the moment and that will by and large continue for much of this year,” said Louis Kuijs, head of Asia economics at Oxford Economics. “We think Beijing has a bottom line of around 5%. This week, the People’s Bank of China cut the rate on its one-year policy loans by 10 basis points to 2.85%, the first reduction since April 2020. It also cut the rate on the seven-day reverse repurchase rate and net injected 200 billion yuan ($31.5 billion) of medium-term cash into the financial system.
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: 38,218,773 total cases, 1,924,051 active cases/ 487,693 deaths/discharged 35,807,029 (John Jopkins and MoHFW) as compared to 36,317,927 total cases, 1,117,531 active cases/ 485,035 deaths/discharged 34,715,361 (John Hopkins & MoHFW). 1,546,139,465 doses have been administered.
The number of Covid-19 infections has been reducing in Delhiand other parts of India, but experts believe that the reason behind this decrease is not the Omicron situation improving, bot low testing. Except the elderly and patients with comorbidities, asymptomatic contacts of infected individuals are not being tested, according to the latest advisory by the Indian Council of Medical Research (ICMR). Hospitals have also relaxed testing rules of asymptomaticpatients undergoing surgical procedures.
The government has no immediate plans to openprecaution dosesfor people above 45 years with comorbidities. Government officials say they are treading with caution on the third dose in the absence of data. India began administering precaution doses of Covid-19 vaccine to healthcare workers, frontline workers and those aged 60 and above with comorbidities from January 10 amid the Omicron-fuelled surge. While India has followed a step-wise graded approach in offering vaccination to various age groups.
Theresearchconducted by AIG hospitals in association with Asian Healthcare Foundation on 1,636 fully vaccinated volunteers showed that 30 per cent of those surveyed lost immunity developed in response to Covid vaccines. The sample population surveyed had received two doses of vaccines deployed in India’s Covid vaccination drive. Elucidating on the incentive behind the research in view of rising cases, Dr D Nageshwar Reddy, Chairman, AIG Hospital said.
The subject experts committee (SEC), a body under Drugs Controller General of India (DCGI), will meet today to review applications filed by Bharat Biotech and Serum Institute of India for full market approval of their respective Covid-19 vaccines- Covaxin and Covishield. “The review will continue in the meeting today and if all goes well both will be granted full market approval,” people in the know told ET. The SEC had met on Friday but could not finish the review of the “huge amount of data”. On Thursday, Bharat Bioteh had sought market approval from the drug regulator for its indigenous Covid-19 vaccine Covaxin which is at present authorized for emergency use in the country.
The number of Omicron cases in mostmetroshas started falling but health experts are of the view that a “pan-India peak” is still lurking ahead as infection is now spreading to smaller cities, which are likely to see a surge over the next two to three weeks. Taking note of this, the Centre has asked states and Union Territories to enhance testing to identify new clusters and hotspots of infection. Testing has significantly declined in certain states and UTs even as positivity continues to remain high. “In Mumbai, the decline is clear. In Delhi, the peak has been reached and decline should be seen in the coming week.
There is noevidenceof injectable steroids benefitting Covid patients not requiring oxygen supplementation or in continuation after discharge, according to the revised “Clinical Guidance for Management of Adult Covid-19 Patients”. The revised guidelines issued by AIIMS, ICMR-Covid-19 National Task Force and Joint Monitoring Group (DGHS) under the Union health ministry also stated that anti-inflammatory or immunomodulatory therapy, such as steroids, can have the risk of secondary infection like invasive mucormycosis, when used too early, at higher dose or for longer than required. Injection methylprednisolone 0.5to one mg/kg in two divided doses, or an equivalent dose of dexamethasone, can be given usually for a duration of five to 10 days in moderate cases, the guidelines stated.
Oralantiviralssuch as Molnupiravir, antibiotics, monoclonal antibodies and vitamins have no place in India’s latest Covid management guidelines, which were put up on the Union Health Ministry website on Monday, January 17. Antiviral remdesivir, which is given via an IV drip, is recommended for moderate to severely ill patients on oxygen support. Off-label use of the rheumatoid arthritis drug, tocilizumab, continues for severe coronavirus patients who don’t improve with steroids. The guidelines comes barely 10 days after ICMR chief Dr Balram Bhargava said Molnupiravir has “safety issues”. On Monday, the Maharashtra government, however, allowed the use of Molnupiravir for a select group of patients with “abundant caution”.
Stempeutics, a group company of Manipal Education and Medical Group (MEMG), on Tuesday, January 18 said it has received DCGI clearance to conduct Phase 3 clinical trial on its product for treating Covid-19 patients suffering from acute respiratory distress syndrome (ARDS). The company will be using the stem cell product, Stempeucel, for conducting the label extension Phase 3 clinical trial. The product is already approved for marketing for the treatment of clinical limb ischemia by the Drugs Controller General of India (DCGI).
Covid-19 inoculation guidelinesissued by the Union Health Ministry do not envisage forcible vaccination without obtaining the consent of an individual, the Centre has told the Supreme Court. The Health Ministry in an affidavit filed before the top court submitted that India’s vaccination programme is the largest in the world and as on January 11, 2022, a total of 1,52,95,43,602 doses have been administered. It said that 90.84 per cent of the eligible adult population has received their first dose of the vaccine and 61 per cent has received their second doe as well.
Asurgein coronavirus cases caused by the Omicron variant increasing day by day. Healthcare experts indicate that majority of the people will require booster dose in containing the spread of virus. Speaking at a webinar on Omicron and booster dose, organized by Hospital and Diagnostics Committee, PHDCCI leading healthcare thought leaders spoke about booster doses are important along with key Covid appropriate behaviour. Initiating the discussion Dr Harsh Mahajan, Chair, Hospital and Diagnostics Committee, PHDCCI, mentioned that the Omicron variant of the virus, even though clinically ascertained to be not as lethal, has the potential to cause another wave of the pandemic.
When it has become almost a norm for travellers to carry either negative RT-PCR testreportsfor Covid vaccination certificates, the Union government has informed the Supreme Court that it has “not issued any Standard Operating Procedure (SOP) which makes carrying of vaccination certificates mandatory for any purpose”. The Centre’s statement was in response to petition seekingexemption from vaccination certificates for persons with disabilities and requesting for vaccination arrangements at their places of stay.
While hospitalization amongchildrentesting positive for Covid has remained low, medical experts said that minors are exhibiting more symptoms, like high-grade fever, sore throat and body ache, in the current wave of the pandemic compared to last year when fewer kids were symptomatic. Associate director of the department of neonatology and paediatrics at Jaypee hospital Dr Ashu Sawhney told TOI that while the number of children testing positive for Covid was similar to the second wave last year, this time children were symptomatic with high-grade fever and throat pain and cough persisting for more than 2-3 days in some cases.
India’s “R-value”, which indicates how rapidly Coviid-19 is spreading, was recorded at 2.2 between January 7 and January 13, a drop from the previous two weeks, according to a preliminary analysis by IIT Madras. The R Value of Mumbai was 1.3, Delhi 2.5, Chennai 2.4 and Kolkata 1.6, according to the analysis by IIT Madras’ Department of Mathematics and Centre of Excellence for Computational Mathematics and Data Science headed by Prof Neelesh S Upadhye and Prof S Sundar.
The Covid Vaccination Programme is all set to start for the12-14 agegroup from February end, Dr NK Arora, chairman of the Covid-19working group of the National Technical Advisory Group on immunization told ToI on Sunday, January 16. Adolescent vaccination is making impressive strides across the country. A total of 3.31 crore children I the age bracket of 15 to 17 years have already received their first dose, accounting for almost 45% coverage, just 133 days into the drive on January 3 this year.
MostOmicronvariant infected patients of Covid-19, during the last week of December 2021, had no travel history, which indicates that there as eventually community transmission, according to a study conducted by the Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi. “The respiratory specimen of all RT-PCR confirmed positive cases between November 25-December 23, 2021, collected from five districts of Delhi were subjected to whole genome sequencing. Complete demographic and clinical details were also recorded. Hence, we analysed the formulation of local and familiar clusters and eventual community transmission,’’ the study noted.
India could soon have its first messenger ormRNAvaccine soon, with the near completion of Phase 3 clinical trials by Genova Biopharmaceuticals, even as the company also started developing a variant or Omicron-specific vaccine using the same tech platform. The Pune firm recently submitted Phase 2 clinical trail data of over 3,000 subjects of their two-dose mRNA vaccine developed on the delta variant, and is close to completing Phase 3 trials, sources said. It has started manufacturing the vaccine “at risk” and can roll out “sufficient” quantities once it gets the regulatory nod.
Weekly COVID-19 statistics – 2,026,560 total reported cases and 18,483 total reported deaths compared to 1,812,318 total reported cases and 18,428 total reported deaths the previous week.
The number of new cases in Japan grew rapidly over the past week. Japan reported over 46,000 new cases on January 20, the highest number of new cases since the pandemic began.
Much of this growth has been in Tokyo, Osaka, and areas near U.S. military bases, including Okinawa, although it has spread to other parts of the country as well.
A number of prefectural governments plan to ask the central government to declare a quasi-state of emergency in their regions. This would allow governors, based on their decisions, to request and order restaurants and bars to close early and stop or limit the serving of alcohol.
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 79.2% 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 facilitiesfor 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 6,603 cases today to reach 712,503. Just over 96% of the cases were locally transmitted, with the remainder originating from overseas. This is the first time in 27 days that Korea has gone over the 6,000 threshold. The daily caseload had stayed below 6,000 since December 24. Authorities are concerned about further spiking as Korea readies for its Lunar New Year holiday.
Omicron is spreading through South Korea at a faster pace with the potential to cause a sharper rise than earlier projections, according to an expert advising the government. Dr. Jung Jae-hun, a preventive medicine specialist and COVID-19 adviser to the prime minister, said Thursday the omicron wave is “feared to be worse than previously thought.”
Three weeks ago, all of the scenarios modeled by Jung’s team showed more than 10,000 cases a day and up to 2,000 intensive care admissions by March, or late February if restrictions are eased. Speaking to The Korea Herald on Tuesday, he said as many as 50,000 cases a day is “entirely conceivable.” Now Jung, who works with top national health institutions including the Korea Disease Control and Prevention Agency on COVID-19 response policies, says the daily peak could rise up to and possibly beyond 100,000. “This is because, one, we had not been able to anticipate imported cases contributing to the spread as greatly (as they did),” he said via phone interview. In the past week the infection rates among international passengers have risen to record levels of more than 300 a day.
44,530,525 first doses (86.8% of the population), 43,676,631 second doses (85.1% of the population) and 22,219,031 third doses (47.2% of the population) of the COVID-19 vaccine have been administered in Korea.
Descriptions (many with links, some links in Korean) for updated COVID policies appear below –
Starting January 18, a vaccine pass is required only in “high-risk facilities”.
Social Distancing Measures Eased
January 17, 2022 – February 6, 2022
Korea has extended the existing social distancing measures until February 6, 2022, while raising the limit for private gatherings from four to six nationwide.
48-hour Pre-Departure PCR Test Requirement
January 20, 2022 onwards
Effective January 20, a negative PCR test taken within 48 hours of departurewill be required. Those who do not comply with these new requirements will be denied boarding at the departure airport. Exceptions apply to those with a quarantine exemption certificate which will be issued on a strictly limited basis.
International Arrival Quarantine Measures Extended
December 3, 2021 – February 3, 2022
All international arrivals into Korea must undergo a10-day quarantineregardless of their nationality and vaccination status until February 3, 2022. Quarantine exemption certificatescan be issued for important business trips, diplomatic visits, and other humanitarian reasons.
Latest entry and exit requirements for travel between the U.S. and Korea can be found at theUS Embassy website.
Three South Korean companies are among 27 drugmakers chosen to produce low-cost versions of Merck Co.'s COVID-19 pill for low- and-middle-income countries, the Medicines Patent Pool (MPP) and Seoul's health ministry said Thursday. The U.N.-backed public health organization announced that it signed sublicense agreements with 27 generic drug manufacturers, including South Korea's Celltrion Inc., Hanmi Pharm Co. and Dongbang FTL, to produce the oral antiviral medication molnupiravir to be supplied to 105 countries.
ASEAN now has 15,691,978 total reported cases and 311,210 total reported deaths compared to 15,495,095 total reported cases and 309,199 total reported deaths last week.
The growth in new cases in ASEAN started to decline last week, although the Philippines is experiencing a surge and the number of new cases in Vietnam remains high.
Indonesia: While cases of the Omicron COVID-19 variant continue to grow in Indonesia, the country has so far avoided the massive surges seen in other countries. Indonesia is now reporting 4,277,644 total cases and 144,199 total deaths compared to 4,268,890 total cases and 144,155 total deaths the previous week. Indonesia accounts for 46% of total deaths in ASEAN since the start of the pandemic.
Malaysia: Malaysia has yet to see a major spike in COVID-19 cases from the Omicron variant but is taking preventative steps, including imposing stricter rules on social gatherings, cutting booster interval times, and requiring boosters for high-risk groups. Malaysia is reporting 2,817,163 total cases and 31,831 total deaths compared to 2,795,233 total cases and 31,738 total deaths the previous week.
Thailand: Thailand reported 2,353,062 total cases and 21,990 total deaths compared to 2,300,457 total cases and 21,886 total deaths the previous week.
Philippines: A COVID-19 spike has disrupted businesses in the Philippines, with banks, malls, and airlines reducing operations and some schools suspending online classes due to staff sickness. According to a statement from the Health Under Secretary, the healthcare system is at risk of being overwhelmed. The Philippines reported 3,324,478 total cases and 53,153 total deaths compared to 3,092,409 total cases and 52,736 total deaths the previous week.
Vietnam: Vietnam continues to experience a large number of cases and deaths. The country reported 2,094,802 total cases and 36,266 total deaths compared to 1,958,719 total cases and 34,964 total deaths the previous week.
Singapore: The growth in new cases and deaths in Singapore has remained fairly steady. It is now reporting 296,077 total cases and 844 total deaths compared to 288,125 total cases and 839 total deaths the previous week.
Cambodia: Omicron has reached Cambodia, although the growth in new cases and deaths is small. The Prime Minister has urged high-risk groups in Phnom Penh to receive the fourth dose of the COVID-19 vaccine beginning January 14. Since November, Cambodia has reopened all socio-economic activities, buoyed by its high vaccination rate of at least one dose for nearly 90% of the population. Cambodia reported 120,914 total cases and 3,015 total deaths compared to 120,718 total cases and 3,015 total deaths the previous week.
Laos: Laos detected its first case of the Omicron variant last week. New cases and deaths continue to grow in Laos at a higher rate than in the past, although the growth rate moderated somewhat last week. Laos reported 128,248 total cases and 508 total deaths compared to 122,241 total cases and 471 total deaths the previous week.
Vaccinations
Indonesia authorized the Pfizer vaccine for emergency use on July 15. Only 44.3% 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 79.4% of its population.
The Philippines has considerable vaccine resistance, but the country is making progress in vaccinating its population. Currently, 51.5% 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 – as of January 1, unvaccinated employees are 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, 68.2% of its citizens have been fully vaccinated.
Vietnam has fully vaccinated 70.3% of its population to date. A Vietnamese pharmaceutical company has begun second phase trials on a coronavirus vaccine.
Cambodia: 82.1% 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.
Singaporean officials reiterated in early January that there were no plans to tighten travel restrictions, noting that imposing harsher rules and shutting its travel lanes could affect Singapore’s reputation and might not even improve the situation.
Indonesia: Visitors from 14 countries are barred from entering Indonesia under current travel restrictions, including South Africa, Botswana, Norway, France, Angola, Zambia, Zimbabwe, Malawi, Mozambique, Namibia, Eswatini, Lesotho, the United Kingdom, and Denmark.
Thailand’s quarantine-free visa program for vaccinated visitors has been suspended indefinitely as new cases jump.
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. On January 5, Ho Chi Minh City and the central province of Binh Dinh received approval from the government to reopen to foreign visitors this month. However, although Vietnam has resumed some regular international flight routes, many remain uncertain of how to get approvals to enter or face issues at entry points due to unexpected and inconsistent requirements.
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.
Brunei: Brunei had planned to lift its 21-month ban on non-essential air travel as of January 1, but the government postponed the plan, removing all countries in the green travel list (Australia, China, Singapore, and the UK) amid fears over the Omicron COVID-19 variant.
Large scale negative trends continue in Europe, with some countries, such a France, continuing to see double digit increases in case numbers, and record high numbers overall. Italy appears to have stabilized with only .3% increase in cases over last week. The UK’s cases are down 37% from last week. Deaths and deaths per million are significantly increasing in Europe 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. Hospital capacity in many EU countries remains scarce or non-existent.
In terms of total cases in Europe, see chart below for the specific numbers. The UK, France, Russia, Italy and Spain comprise the top 5.
New Daily Case numbers appear in the chart below, and in this section are also compared to last week are as follows: France 436,167 (361,119); Spain 157,941 (179,125); Russia 33,899 (17,946); UK 108,069 (128,435); Italy 192,320 (196,186); Germany 121,952 (80,542); and Belgium 37,435 (21,311). France has jumped ahead of the rest of Europe by a wide margin with over 436,000 new daily cases reported. It is worth monitoring if this ends up being a tremendous short term spike or a longer term trend. France, Italy, Spain, Germany and UK comprise the top 5 in new daily cases in Europe.
In terms of cases per million in Europe, numbers are up across the continent. Czech Republic is the 6th highest in Europe with 247,005. France has moved to 8th with 231,696. The UK is 9th highest with 226,580. Ireland is 10th with 223,449. Belgium is 12th with 216,105. The Russian reported figures on 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 on cases per day also appears to be an arbitrary or pre-selected number.
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, Bulgaria is second worst in the world at 4,722. Much of eastern Europe has poor numbers in this category. Belgium is the 24rd worst in the world with 2,459. Italy is 25th, with 2,357. The UK is 31st with 2,234. Other rankings in this category are Spain, 38th, and France 39th. (The US ranks 19th with 2,638 deaths per million).
The figures for deaths per day (which tend to lag any increased infection rates) are as follows: Russia 698 (745); UK 359 (398); France 231 (246); Spain 160 (125); Italy 380 (313); Germany 258 (331); Belgium 34 (21).
Germany continues to lead Europe in the number of vaccine doses administered with over 160 million doses and just over 72% fully vaccinated. German authorities are encountering resistance from many Germans who do not want to be vaccinated. Russia has administered over 150 million vaccine doses but only just 47.3% fully vaccinated (virtually all with Sputnik vaccine). The UK has administered over 136 million doses and is 70.4% fully vaccinated. France has administered over 133 million doses and is now over 75.5% fully vaccinated. Italy has administered over 122 million doses and is just above 75% (75.4) fully vaccinated. Spain has administered over 87 million doses and is just shy of 82% 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.
Some European countries have taken steps to target the unvaccinated, and additional programs are being rolled out to get young children vaccinated. France and Italy have restricted access to bars, restaurants and other public places to those who have been vaccinated, have recently recovered, or have tested negative. Germany has implemented measures that even the unvaccinated who test negative are excluded from some public places.
Spain has capped the price of COVID test kits in the face of an enormous surge in demand. The move comes after an outcry during the Christmas holidays when demand for rapid antigen tests outpaced supply.
The maximum price for the kits on sale at pharmacies from Saturday will be €2.94, Health Minister Carolina Darias told a news conference. The price cap aimed to make self-tests “as accessible as possible while ensuring they are available at pharmacies,” Darias added.
Austria’s parliament is due to vote this week whether to become the first European country to introduce a vaccine mandate for adults. All citizens aged over 18 would need to be fully vaccinated -- except for pregnant women, those with medical exemptions, and those who have recently recovered from infection. The proposed law would become effective in February if passed.
Roberta Metsola has been elected as the youngest ever president of the European Parliament and the first woman in the role for 20 years. She is one of three women in the top EU jobs, along with the head of the European Commission and Central Bank.
The European Union is seeking to resolve the impasse with Britain over Northern Ireland's trading arrangements by the end of February. European Commission Vice President Maros Sefcovic, who oversees post-Brexit relations with Britain, told a closed session of European Parliament members that a window of opportunity was likely to close by the end of February. Northern Ireland elects its assembly on May 5.
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 DEVELOPMENT ON SWISS LABELING REQUIREMENTS. We are happy to have made progress and have good news to report on the labeling 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 labeling 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 has limited 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 certificate is now 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 rule is effective from Feb 1.
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, authorities have relaxed measures after government scientists reported that the surge of infections “has now peaked nationally”. Face masks will no longer be mandatory in public places and schools in England, while health passes will no longer be needed for large events.
British Prime Minister Boris Johnson told MPs on Wednesday that hospital admissions and patients in intensive care units in most of England were stabilizing or falling. The government will no longer advise people to work from home, while face masks will be scrapped in classrooms starting Thursday. Johnson added that more than 90 per cent of those aged over 60 in the UK have now had their booster shot. The UK is also debating whether to scrap the requirement for those infected to self-isolate for five full days.
Boris Johnson appears to be in a politically perilous situation as PM. His premiership has been punctured in recent weeks by numerous revelations that while most of country obeyed severe lock down restrictions, his inner team were living it up.
Even before "party gate", Johnson had been under fire after a series of scandals and criticism of his handling of the coronavirus pandemic. Johnson has also been criticized for conduct related to home renovations that appear to have been done at below market value and without full disclosure of how he paid for the work. Members of his own party are becoming increasingly and openly critical of him. A senior Conservative lawmaker this week accused the Johnson led government of intimidating and attempting to ‘blackmail’ lawmakers they suspect want Johnson to step down. The blackmail allegation relates to allegations that local funding will be denied to jurisdictions where MPs don’t fully support Johnson remaining as PM.
The Health Secretary, Sajid Javid is planning to set up ‘academy-style’ hospitals which would create chains of hospitals run by leading NHS managers to address waiting lists.
The Stroke Association has warned of avoidabledeaths and disabilities as stroke patients are waiting nearly an hour longer to get to hospital.
Sir Keith Willett, National Director for Emergency Planning and IncidentResponse at NHS England is stepping down.
The number of positive covid-19 patients being admitted to hospital has fallen in England this week.
The British Chambers of Commerce trade group has raised concerns over disruption caused by Brexit and UK leaving the EU’s single market.
Politico have written a piece on the impactthe UK’s trade deal with India could have on developing nations.
NHS England has called for the public to attend cancer check ups, due to the NHS reporting 50,000 fewer cancer diagnoses since the start of the pandemic.
Outgoing NICE Chief Executive, Dr Gillian Leng said NICE are reviewing how to expand digital technologies in the NHS.
NHS staff absences due to covid-19 have started falling across England.
European Commission Vice President, Maroš Šefčovič has said talks with the UK must conclude by the end of February.
Foreign Secretary, Liz Truss has traveled to Australia to confirm trade and security ties with the country following the Aukus deal.
Unvaccinated travelers must self-isolate for 10 days, as well as taking coronavirus tests before and after their trips.
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 saw a new record number of confirmed cases on Thursday, with 133,536 newly confirmed infections in the past 24 hours, as well as 234 deaths. But Germany's association for intensive care medicine (DIVI) said the number of COVID-19 patients in intensive care units was falling despite the increase in cases.
Health Minister Karl Lauterbach has warned that the country has not yet reached the peak of infections and has recommended that Germany introduce a nationwide vaccine mandate by May. Almost 73 per cent of the German population have received a full course of vaccines against COVID-19, while nearly 48 per cent have had an additional booster shot.
German police are investigating thousands of forged vaccine certificates, according to the DPA news agency. Those who supply or use fake certificates could face severe penalties, from fines and suspended prison sentences to losing their jobs.
20 million people in Germany face higher health insurance costs due to several large insurers raising their rates. Still, only about 1/4 of the largest insurers have raised their rates.
The German government is reportedly mulling over plans to scrap quarantine pay for people who haven't received their full course of COVID jabs or whose last jab was more than three months ago. According to reports in the German media, certain groups of vaccinated people could soon lose their wages if they have to go into quarantine after having contact with an infected person. According to media sources, “The absence of the Covid-19 booster vaccination would lead to the exclusion of the claim for compensation.” Though nothing concrete is in the pipeline yet, the change would primarily affect people who had received their COVID jabs in or before October last year but haven’t yet received a booster jab.
Retired German Chancellor Angela Merkel has declined an offer for a job with the UN. She retired after 16 years as Germany’s leader.
Germany has put Austria back on its list of high risk countries, along with 30 other countries.
With 2.7 percent growth in 2021, the Germany economy has shown some resilience in the face of COVID. However, this increase, while positive, was lower than leaders had hoped.
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.
France is dealing with record numbers of patients nationwide. More than 25,000 patients are now in hospital, straining the capacity of care providers.
Emmanuel Macron is facing growing political divisions over COVID rules in the run-up to the spring presidential election, after his proposed vaccine pass was delayed and teachers took strike action, amid ongoing street demonstrations and a rise in violent threats against politicians.
With an increasing mood of fatigue among French voters after two years of the pandemic and a significant mistrust of the political class, the president –– who is likely to hold off declaring his re-election bid for several weeks as the coronavirus health crisis continues –– wants to be seen as reliable but firm.
French teachers' unions called Monday for a second major strike this week to protest the government's COVID testing and isolation protocols, which they say are severely disrupting classes. The move follows a one-day walkout last week that saw half of the country's primary schools close, according to unions, who accuse authorities of failing to establish clear rules that would keep as many students in school as possible.
Teachers say class disruptions have become unmanageable with the spread of the highly contagious Omicron coronavirus variant, with many parents struggling to get vaccination appointments for their children and long lines for tests forming outside pharmacies.
In response the government promised to provide five million high-grade FFP2 face masks for school staff and to hire over 3,000 substitute teachers to replace those forced to isolate after contracting COVID or coming into contact with an infected person. But that was not enough for unions, who said the new strike Thursday would be a prelude to a "massive" nationwide walkout on January 27.
France’s parliament has given final approval to the government’s latest measures to tackle COVID-19, including a vaccine pass contested by anti-vaccine protesters. Lawmakers in the lower house of parliament voted 215 in favor to 58 against on Sunday, paving the way for the law to enter force in the coming days.
The new law, which had a rough ride through parliament, with opposition parties finding some of its provisions too tough, will require people to have a certificate of vaccination to enter public places such as restaurants, cafes, cinemas and long-distance trains.
Currently, unvaccinated people can enter such places with the results of a recent negative Covid-19 test. Nearly 78% of the population is fully vaccinated, according to the health ministry on Saturday.
French schoolchildren are now allowed to do self-tests instead of a PCR test if one of their classmates tests positive for coronavirus, as a surge in Covid-19 infections has made the health protocol in the education sector too heavy. According to the French government, this will have an effect on the queues [outside pharmacies]. “I have understood the worries of parents, teachers and school headmasters", PM Castex told France 2 television, after a surge in cases due to the Omicron variant led to chaos and paralysis in French schools recently.
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 must 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 – proof of vaccination or negative COVID test -- for access to public venues of more than 50 people and also on 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/
