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Pfizer antiviral drug results; States sue over Biden mandate: Updates

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The U.S. is getting nearer to having an antiviral drug to assist deal with COVID-19 out there, a improvement consultants say will probably be game-changing in limiting the virus’ severity, particularly amongst aged and immunocompromised populations for whom vaccines are much less efficient.

Pfizer plans to finish two more studies of its antiviral therapy, Paxlovid, by the tip of the 12 months earlier than submitting the information to the U.S. Meals and Drug Administration. Preliminary information reveals the drug diminished the chance of hospitalization and demise by 89%.

In the meantime, Merck and Ridgeback have additionally utilized to the FDA for emergency use authorization for his or her tablet molnupiravir. 

On Thursday, a British regulatory company advisable molnupiravir for these with gentle to reasonable COVID-19 and at the very least one threat issue for extreme sickness, making the nation the primary to approve a COVID-19 antiviral tablet. 

Additionally within the information:

►U.S. COVID-19 deaths fell to fewer than 8,000 per week for the primary time in additional than two months, a USA TODAY evaluation of Johns Hopkins College information reveals. Deaths have been final underneath that mark on Aug. 24, and fell to 7,834 within the week ending Thursday.

►Hoping to curb an increase in hostile passengers on planes, the Federal Aviation Administration introduced Thursday it has referred 37 circumstances of unruly passengers to the FBI for potential prison prosecution.

►Vaccine developer Novavax announced Thursday it has submitted its COVID-19 vaccine candidate to the WHO for emergency use itemizing as the corporate prepares to ship its vaccine globally.

📈 Right this moment’s numbers: The U.S. has recorded 46 million confirmed COVID-19 circumstances and greater than 751,000 deaths, in accordance to Johns Hopkins University data. International totals: Greater than 248 million circumstances and 5 million deaths. Greater than 193 million Individuals – 58% of the inhabitants – are absolutely vaccinated, based on the CDC.

📘 What we’re studying: Pfizer’s COVID vaccine is now out there for youths. Will schools require it?

Preserve refreshing this web page for the most recent information. Need extra? Sign up for USA TODAY’s Coronavirus Watch newsletter to obtain updates on to your inbox and join our Facebook group.

11 states sue Biden administration over vaccine mandate

A wave of attorneys general in 11 states on Friday filed lawsuits in opposition to the Biden administration over a brand new federal rule that will require large companies to vaccinate their workforce in opposition to COVID-19 or implement rigorous testing regimes.

A lawsuit filed within the St. Louis-based eighth U.S. Circuit Courtroom of Appeals argues that states, not the federal authorities, has the authority to require vaccinations.

“This mandate is unconstitutional, illegal, and unwise,” stated the courtroom submitting by Missouri Lawyer Basic Eric Schmitt. He stated he sued “to guard private freedoms, protect Missouri companies, and push again on bureaucratic tyrants who merely need energy and management.”

Whereas these lawsuits will doubtless make for good politics in purple states the place federal mandates of any stripe are sometimes considered with skepticism, consultants say that whether or not they’ll make for good authorized challenges is a much more tough query to reply.

Companies with 100 or extra staff will probably be required to face up their vaccine-or-testing necessities by Jan. 4 or face stiff penalties underneath an emergency Occupational Security and Well being Administration rule made public Thursday. President Joe Biden said in September that his administration was engaged on the rule, so its unveiling this week was not a shock however did supply new particulars about its implementation. 

— John Fritze, USA TODAY

Feds not working with problematic vaccine producer 

As soon as the one American producer of the Johnson & Johnson vaccine, Emergent BioSolutions has misplaced its $628 million contract with the federal authorities after it spoiled 15 million doses of the Johnson & Johnson COVID-19 vaccine in April.

In keeping with The New York Times and Washington Post, the termination of the contract was disclosed Thursday by Emergent executives throughout a name with traders. Emergent said in a statement that it and the U.S. Division of Well being and Human Companies “mutually agreed” to finish the contract.

The federal government had already stopped making funds underneath the contract, which was created in Could 2020 and price over $600 million, the Occasions reported. Emergent will surrender roughly $180 million of that quantity, based on firm disclosures.

In April, the FDA issued a withering 13-page report about its Baltimore plant  which stated it was too small, poorly designed and soiled. Inspectors noticed unsealed baggage of medical waste, peeling paint and broken flooring and partitions. Workers weren’t correctly skilled and didn’t correctly deal with components, the report says.

Europe, central Asia at epicenter of pandemic, WHO says

Europe and central Asia are as soon as once more on the epicenter of the pandemic as circumstances method file ranges throughout 53 international locations within the areas, the World Health Organization announced Thursday.

Final week, Europe and central Asia accounted for 59% of worldwide circumstances and 48% of deaths, based on the WHO.

With 78 million reported circumstances, the European area now has extra circumstances than South East Asia, the Jap Mediterranean, the Western Pacific and Africa mixed. Up to now 4 weeks, Europe has seen a 55% enhance in new circumstances, and hospitalizations have greater than doubled up to now week, the WHO stated.

If numbers proceed to rise, the WHO initiatives Europe and central Asia may even see one other half million COVID-19 deaths by subsequent February, and 43 international locations will face “excessive to excessive stress on hospital beds.”

In a Thursday assertion, Hans Henri P. Kluge, WHO regional director for Europe, pointed to inadequate vaccination charges and relaxed public well being measures as causes behind the surge.

“We’re at one other vital level of pandemic resurgence,” Kluge stated. “Europe is again on the epicenter of the pandemic, the place we have been one 12 months in the past. The distinction right now is that we all know extra and we will do extra. We’ve got extra instruments and means to mitigate and cut back the injury to our communities and society.”

Well being consultants urge dad and mom to get 11-year-olds vaccinated as quickly as potential

Many dad and mom and guardians are weighing the risks and benefits of getting their 11-year-old vaccinated now, or ready till their baby’s twelfth birthday after they can get the upper 30-microgram dose approved for adolescents.

However well being consultants say the decrease dose is probably going to provide the kids – whether or not they’re 11 or 12 –  the identical safety in opposition to COVID-19 as the upper one. They urge dad and mom and guardians to get their kids vaccinated as quickly as potential, particularly because the winter holidays carry household gatherings that enhance the chance of coronavirus transmission.

“Delaying vaccination for a birthday to roll round doesn’t appear sensible,” Dr. Susan Coffin, a doctor on the Youngsters’s Hospital of Philadelphia’s division of infectious illnesses, stated throughout a media briefing Wednesday. “Any week that we delay vaccination, we’re growing the chance that our baby may get an an infection, may carry an infection residence or may contribute to the unfold of an infection amongst their associates.”

— Adrianna Rodriguez, USA TODAY

OSHA vaccine mandate permits testing in its place

The Biden administration have new guidelines that requires many employers take a look at their employees for COVID-19 weekly if they refuse his vaccination mandate. The Occupational Security and Well being Administration guidelines introduced Thursday – which cowl an estimated 84 million individuals – don’t require employers to pay for the tests. 

The upshot is that Individuals who decline to be vaccinated could possibly be pressured to pay the tab for his or her weekly screenings. 

The presidential mandate comes because the U.S. financial system goes via a “Nice Resignation,” a file 4.3 million employees quitting their jobs in August for myriad COVID-19-related causes. Here’s what you need to know about how the testing alternative to vaccination could play out.

— Nathan Bomey, USA TODAY

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