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Retrieved from: https://www.worldometers.info/coronavirus/
By Tom Hals
A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration
The Biden administration was blocked on Tuesday from enforcing two mandates requiring millions of American workers to get vaccinated against COVID-19, a key part of its strategy for controlling the spread of the coronavirus.
U.S. District Judge Terry Doughty in Monroe, Louisiana, temporarily blocked the Centers for Medicare & Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers until the court can resolve legal challenges.
Doughty's ruling applied nationwide, except in 10 states where the CMS was already prevented from enforcing the rule due to a prior order from a federal judge in St. Louis.
Doughty said the CMS lacked the authority to issue a vaccine mandate that would require more than 2 million unvaccinated healthcare workers to get a coronavirus shot.
"There is no question that mandating a vaccine to 10.3 million healthcare workers is something that should be done by Congress, not a government agency," wrote Doughty.
Separately, U.S. District Judge Gregory Van Tatenhove in Frankfort, Kentucky, blocked the administration from enforcing a regulation that new government contracts must include clauses requiring that contractors' employees get vaccinated.
The contractor ruling applied in the three states that had filed the lawsuit, Kentucky, Ohio and Tennessee, one of at least 13 legal challenges nationwide against the regulation. It appears to be the first ruling against the contractor vaccine mandate.
The White House declined to comment.
The legal setbacks for President Joe Biden's vaccine policy come as concerns that the Omicron coronavirus variant could trigger a new wave of infections and curtail travel and economic activity across the globe.
Biden unveiled regulations in September to increase the U.S. adult vaccination rate beyond the current 71% as a way of fighting the pandemic, which has killed more than 750,000 Americans and weighed on the economy.
Republican state attorneys general, conservative groups and trade organizations have sued to stop the regulations.
Tuesday's rulings add to a string of court losses for the Biden administration over its COVID-19 policies.
The most sweeping regulation, a workplace vaccine-or-testing mandate for businesses with at least 100 employees, was temporarily blocked by a federal appeals court in early November.
In August, the U.S. Supreme Court ended the administration's pandemic-related federal moratorium on residential evictions.
Retrieved from: https://www.reuters.com/legal/government/us-judge-blocks-vaccine-mandate-contractors-three-states-2021-11-30/
By Michael Erman and Manas Mishra
A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's (MRK.N) antiviral pill to treat COVID-19.
If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency.
Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
"COVID-19 is still an emergency situation," said committee member Dr. David Hardy, who voted yes. "There is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy."
The vote comes as fears about the new Omicron variant have rattled financial markets and sparked concerns about the strength of the global economic recovery as the world continues to fight the coronavirus pandemic.
Merck's oral therapy called molnupiravir, developed with Ridgeback Biotherapeutics, targets part of the virus called the RNA polymerase that has not been changed much by mutations in the Omicron variant. The pill - and a potentially more promising drug being developed by Pfizer - could become even more vital if vaccine-induced and natural immunity are threatened by the variant.
"If you look at the sequence of the of the RNA polymerase, the sequence of the Omicron variant is not very different from all of these other variants, so you would predict that it should be equally active," Merck scientist Daria Hazuda said in an interview.
Pfizer Inc's (PFE.N) rival pill Paxlovid showed an 89% reduction in hospitalizations and deaths in its clinical trial. The FDA could consider that drug within the next few months.
The FDA's Antimicrobial Drugs Advisory Committee voted 13-10 to recommend the agency authorize the drug after discussing concerns the drug could cause the virus to mutate as well as safety concerns about the potential for birth defects. Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy.
Several members said the reduced number of COVID-related deaths in people who received the drug in the trial convinced them to vote in favor of recommending authorization. Only one patient in the molnupiravir arm died, versus nine in the placebo group.
The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
The U.S. government has a contract to buy as many as 5 million courses of the drug at a price of $700 per course. By comparison, the U.S. paid around $20 a dose for its supply of the two-dose Pfizer/BioNTech vaccine.
Retrieved from: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-panel-weigh-mercks-covid-19-antiviral-drug-2021-11-30/
A woman wearing a protective mask due to coronavirus disease (COVID-19) pandemic walks past a closed store in central Lisbon, Portugal, November 25, 2021. REUTERS/Pedro Nunes
A large hospital near Lisbon, the Portuguese capital, said on Tuesday it has temporarily shut two of its pediatric departments after a health worker, who is also the doctor for a COVID-hit soccer team, tested positive for the Omicron variant of the coronavirus.
The Garcia de Orta hospital in Almada, a city on the other side of the River Tagus from Lisbon, said the pediatric emergency and outpatient departments would close from 10 p.m. on Tuesday for a period of 14 days.
In a statement, the hospital said all those who were in contact with the infected health worker, a total of 28 people, were now in isolation and being monitored.
Portuguese health authorities detected on Monday 13 cases of the Omicron variant, all involving players and staff of top division soccer club Belenenses SAD, one of whose players recently returned from South Africa. read more
A Belenenses SAD spokesman told Reuters that the health worker infected with the Omicron variant at the Garcia de Orta hospital was also the doctor of the Belenenses SAD squad.
Multiple countries have reported cases of the variant since it was first detected last week in southern Africa. The World Health Organization said the variant carried a very high global risk of surges.
Retrieved from: https://www.reuters.com/world/europe/lisbon-hospital-shuts-children-services-due-omicron-covid-19-case-2021-11-30/
Streets in Amsterdam were near-empty on Monday, after a coronavirus-related lockdown came into effect.Credit...Peter Dejong/Associated Press
Two people who tested positive for the coronavirus in the Netherlands more than a week ago were infected with the Omicron variant, Dutch health officials reported on Tuesday.
The timing is significant because it suggests that the variant was already present in the country for at least a week before the arrival of two flights from South Africa on Friday, and before the World Health Organization labeled Omicron a “variant of concern,” the step that prompted countries around the world to ban flights from southern Africa, where researchers first identified the variant.
“We have found the Omicron coronavirus variant in two test samples that were taken on Nov. 19 and Nov. 23,” the Dutch health ministry said in a statement on Tuesday. “It is not yet clear whether these people had also visited southern Africa.”
The two samples were taken by municipal health services at public testing sites, and health authorities have started contact tracing in those areas, Dutch health officials said.
Although little is known yet about how transmissible Omicron is, or whether it can evade existing vaccines, its detection in Botswana and South Africa has created the most uncertain moment of the pandemic since the highly contagious Delta variant emerged in the spring.
The announcement from the Netherlands also highlighted that scientists still cannot say with certainty where or when the variant originated. So far, the first known sample of the Omicron variant was collected on Nov. 9 in South Africa, according to Gisaid, an international database for disease variants.
Officials across Europe fear that Omicron will add pressure on countries that are already in the grip of some of the worst coronavirus surges they have seen. Among them was France, which on Tuesday reported about 47,000 new cases over the past 24 hours and sharply rising hospitalizations — mostly thought to be driven by the Delta variant.
The European Center for Disease Prevention and Control said on Tuesday that so far, 44 cases of the new variant have been confirmed in 11 European countries. And in Britain, health officials announced at least 22 confirmed cases involving Omicron, including 13 in England and 9 in Scotland, bringing a new wave of tightened public health restrictions.
Andrea Ammon, the agency’s director, told an online news conference that all the confirmed cases in Europe have exhibited mild symptoms or none at all, and that authorities were analyzing six further “probable” cases. She said that health officials were conducting additional tests on people who have recovered from illness brought on by Omicron to help assess how the variant behaves in vaccinated people, and that more information was expected in a “couple of weeks.”
Countries across the European Union have scrambled to reinforce travel restrictions in the hope of curbing the spread of the heavily mutated variant, as the W.H.O. warned that the risk it posed was “very high.”
But the W.H.O.’s top official on Tuesday cautioned countries that their responses were “not evidence-based.”
“We still have more questions than answers about the effect of Omicron on transmission, severity of disease, and the effectiveness of tests, therapeutics and vaccines,” Dr. Tedros Adhanom Ghebreyesus said in Geneva.
The Dutch officials’ announcement about the two Omicron cases came after a chaotic series of closures in Amsterdam, which left some 600 passengers on two flights from South Africa stranded for a time on Friday. Some 61 passengers on those flights tested positive for the coronavirus, and at least 14 of them were found to be carrying the Omicron variant.
The Netherlands imposed tighter restrictions starting on Sunday in response to a Covid wave that began before Omicron was identified, ordering many businesses, including bars, restaurants and theaters, to close from 5 p.m. to 5 a.m. Dutch health officials reported more than 22,000 new coronavirus cases on Monday, one of the country’s highest daily totals since the pandemic began.
By Sameer Yasir
A health care worker testing for the coronavirus at Indira Gandhi International Airport in New Delhi on Monday.Credit...Anushree Fadnavis/Reuters
The Omicron variant has stirred alarm in India, which was hit hard this year by a devastating Covid wave fueled in part by another variant.
The new variant has forced the Indian government to review its decision to resume scheduled international flights beginning on Dec. 15. The flights had been stopped when Prime Minister Narendra Modi ordered a nationwide lockdown in March 2020, though some resumed after it established air travel bubbles with several nations.
While experts say it will most likely be weeks before more is known about Omicron’s transmissibility and the severity of the illness it produces, countries have scrambled to introduce new travel restrictions to halt its spread.
On Monday, Mr. Modi held an emergency meeting to review India’s travel rules. The country had only recently resumed issuing tourist visas as it reported the lowest daily cases since the pandemic began. India has also restarted exports of vaccines manufactured domestically.
Hospitals in New Delhi, the capital, where the earlier wave driven in part by the Delta variant shook the health care system, have been asked to remain on high alert. New Delhi’s top elected official, Arvind Kejriwal, asked Mr. Modi’s government to halt all flights from countries where the new variant had been found.
Instead, the Indian authorities reissued guidelines on Monday for travelers arriving from countries where cases of the Omicron variant have been reported. Passengers arriving from Europe, South Africa and other affected countries now face mandatory testing on arrival. They must quarantine at home for seven days after testing negative, and take another test on the eighth day.
Starting on Wednesday, the authorities said, they will require passengers to produce their travel history over the previous 14 days, along with results of a negative P.C.R. test before boarding any plane flying to India. Government officials said they had designated a hospital to treat and isolate any individual who tests positive for Omicron.
Officials in Mumbai, India’s financial capital, said that over the past 15 days, at least 1,000 travelers have landed in the city from African countries where Omicron has been detected.
Singapore has announced it will require mandatory PCR testing for all travellers and additional antigen rapid tests for travellers on vaccinated travel lanes.
“To step up detection and containment of the Omicron variant until more information is available, we will enhance our testing protocols for travellers arriving in Singapore after 2 December 2021, 2359 hours (Singapore time). These enhanced measures will apply for four weeks in the first instance, and will be reviewed and extended if necessary,” the ministry of health said in a statement.
All travellers entering or transiting through Singapore, after 2 December, must undergo a pre-departure test within 2 days of their departure for Singapore and obtain a negative result. All travellers entering Singapore must undergo a Covid-19 PCR test on-arrival.
Those with confirmed cases or suspected cases of Covid-19 will no longer be able to undergo home recovery and will need to undergo quarantine at the National Centre for Infectious Diseases.
Here’s a round-up of the day’s leading Covid stories:
· The WHO advises vulnerable, unvaccinated and over 60s, against travel in a new travel warning.
· South Korea reported a new daily record of 5,123 new Covid cases for Tuesday, the Korea Disease Control and Prevention Agency (KDCA) said.
· Germany reported a daily rise of 67,186 Covid cases and 446 deaths, according to data from the Robert Koch Institute of public health.
· The US is set to toughen testing requirement for all international travellers, including returning Americans and both vaccinated and unvaccinated people, entering the country. US officials will reportedly require everyone entering the country to be tested one day before boarding flights, regardless of their vaccination status or country of departure. The Biden administration is expected to make an official announcement on Thursday.
· Singapore also introduces tougher testing for all arrivals and will require mandatory PCR testing for all travellers and additional antigen rapid tests for travellers on vaccinated travel lanes.
· Hong Kong adds non-residents from Japan, Portugal and Sweden to the list of travellers unable to enter the city due to concerns over the Omicron variant.
· Canada’s mandatory vaccination for travel within and out of the country took effect from 30 November.
· Japan is set to expand its travel ban on foreigners entering the nation even further, preventing those with resident status from ten African nations including South Africa.
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