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

November 5, 2021
FDA panel urges Pfizer vaccine for kids; COVAXIN US trials: Updates
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The U.S. is getting closer to having an antiviral drug to help treat COVID-19 available, a development experts say will be game-changing in limiting the virus’ severity, especially among elderly and immunocompromised populations for whom vaccines are less effective.

Pfizer plans to complete two more studies of its antiviral therapy, Paxlovid, by the end of the year before submitting the data to the U.S. Food and Drug Administration. Initial data shows the drug reduced the risk of hospitalization and death by 89%.

Meanwhile, Merck and Ridgeback have also applied to the FDA for emergency use authorization for their pill molnupiravir. 

On Thursday, a British regulatory agency recommended molnupiravir for those with mild to moderate COVID-19 and at least one risk factor for severe illness, making the country the first to approve a COVID-19 antiviral pill. 

Also in the news:

►U.S. COVID-19 deaths fell to fewer than 8,000 a week for the first time in more than two months, a USA TODAY analysis of Johns Hopkins University data shows. Deaths were last under that mark on Aug. 24, and fell to 7,834 in the week ending Thursday.

►Hoping to curb a rise in hostile passengers on planes, the Federal Aviation Administration announced Thursday it has referred 37 cases of unruly passengers to the FBI for possible criminal prosecution.

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

📈 Today’s numbers: The U.S. has recorded 46 million confirmed COVID-19 cases and more than 751,000 deaths, according to Johns Hopkins University data. Global totals: More than 248 million cases and 5 million deaths. More than 193 million Americans – 58% of the population – are fully vaccinated, according to the CDC.

📘 What we’re reading: Pfizer’s COVID vaccine is now available for kids. Will schools require it?

Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY’s Coronavirus Watch newsletter to receive updates directly 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 against the Biden administration over a new federal rule that will require large companies to vaccinate their workforce against COVID-19 or implement rigorous testing regimes.

A lawsuit filed in the St. Louis-based 8th U.S. Circuit Court of Appeals argues that states, not the federal government, has the authority to require vaccinations.

“This mandate is unconstitutional, unlawful, and unwise,” said the court filing by Missouri Attorney General Eric Schmitt. He said he sued “to protect personal freedoms, preserve Missouri businesses, and push back on bureaucratic tyrants who simply want power and control.”

While those lawsuits will likely make for good politics in red states where federal mandates of any stripe are often viewed with skepticism, experts say that whether they’ll make for good legal challenges is a far more difficult question to answer.

Businesses with 100 or more employees will be required to stand up their vaccine-or-testing requirements by Jan. 4 or face stiff penalties under an emergency Occupational Safety and Health Administration rule made public Thursday. President Joe Biden said in September that his administration was working on the rule, so its unveiling this week was not a surprise but did offer new details about its implementation. 

— John Fritze, USA TODAY

Feds no longer working with problematic vaccine manufacturer 

Once the only American manufacturer of the Johnson & Johnson vaccine, Emergent BioSolutions has lost its $628 million contract with the federal government after it spoiled 15 million doses of the Johnson & Johnson COVID-19 vaccine in April.

According to The New York Times and Washington Post, the termination of the contract was disclosed Thursday by Emergent executives during a call with investors. Emergent said in a statement that it and the U.S. Department of Health and Human Services “mutually agreed” to end the contract.

The government had already stopped making payments under the contract, which was created in May 2020 and worth over $600 million, the Times reported. Emergent will give up roughly $180 million of that amount, according to company disclosures.

In April, the FDA issued a withering 13-page report about its Baltimore plant  which said it was too small, poorly designed and dirty. Inspectors observed unsealed bags of medical waste, peeling paint and damaged floors and walls. Employees were not properly trained and failed to properly handle ingredients, the report says.

Europe, central Asia at epicenter of pandemic, WHO says

Europe and central Asia are once again at the epicenter of the pandemic as cases approach record levels across 53 countries in the regions, the World Health Organization announced Thursday.

Last week, Europe and central Asia accounted for 59% of global cases and 48% of deaths, according to the WHO.

With 78 million reported cases, the European region now has more cases than South East Asia, the Eastern Mediterranean, the Western Pacific and Africa combined. In the past four weeks, Europe has seen a 55% increase in new cases, and hospitalizations have more than doubled in the past week, the WHO said.

If numbers continue to rise, the WHO projects Europe and central Asia may see another half million COVID-19 deaths by next February, and 43 countries will face “high to extreme stress on hospital beds.”

In a Thursday statement, Hans Henri P. Kluge, WHO regional director for Europe, pointed to insufficient vaccination rates and relaxed public health measures as reasons behind the surge.

“We are at another critical point of pandemic resurgence,” Kluge said. “Europe is back at the epicenter of the pandemic, where we were one year ago. The difference today is that we know more and we can do more. We have more tools and means to mitigate and reduce the damage to our communities and society.”

Health experts urge parents to get 11-year-olds vaccinated as soon as possible

Many parents and guardians are weighing the risks and benefits of getting their 11-year-old vaccinated now, or waiting until their child’s 12th birthday when they can get the higher 30-microgram dose authorized for adolescents.

But health experts say the lower dose is likely to give the children – whether they’re 11 or 12 –  the same protection against COVID-19 as the higher one. They urge parents and guardians to get their children vaccinated as soon as possible, especially as the winter holidays bring family gatherings that increase the risk of coronavirus transmission.

“Delaying vaccination for a birthday to roll around doesn’t seem smart,” Dr. Susan Coffin, a physician at the Children’s Hospital of Philadelphia’s division of infectious diseases, said during a media briefing Wednesday. “Any week that we delay vaccination, we’re increasing the risk that our child might get an infection, might bring infection home or might contribute to the spread of infection amongst their friends.”

— Adrianna Rodriguez, USA TODAY

OSHA vaccine mandate allows testing as an alternative

The Biden administration have new rules that requires many employers test their workers for COVID-19 weekly if they decline his vaccination mandate. The Occupational Safety and Health Administration rules announced Thursday – which cover an estimated 84 million people – don’t require employers to pay for the tests. 

The upshot is that Americans who decline to be vaccinated could be forced to pay the tab for their weekly screenings. 

The presidential mandate comes as the U.S. economy is going through a “Great Resignation,” a record 4.3 million workers quitting their jobs in August for myriad COVID-19-related reasons. 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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Life is like a running cycle right! I am a news editor at TIMES. Collecting News is my passion. Because my visitors have the right to know the truth and perfectly.

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