Coronavirus updates: Pfizer vaccine reaches final review for FDA authorization as US nears 290K deaths

Pfizer’s coronavirus vaccine could become first to earn U.S. Food and Drug Administration authorization as early as Thursday.

The 17-member independent Vaccines and Related Biological Products Advisory Committee will meet Thursday to review and discuss data from Pfizer and German startup BioNTech on their vaccine, then vote on whether the FDA should authorize it. 

The companies are requesting an “emergency use authorization,” shy of a full approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed. But corners, FDA says, have not been cut.

And a vaccine could not come soon enough. Around the country, hospitals are running out of beds, prompting stay-at-home orders in some places and mask mandates in 38 states.

Other news you need to know today:

• Canada approved Pfizer’s vaccine “after a thorough, independent review.” The initial approval is for people 16 years of age or older but could be revised in the future to include children if the data from these studies support it.
• The vaccine is already being rolled out across Britain, where it encountered its first rough spot – health officials there have decreed that people with a “significant history” of allergic reactions shouldn’t get the vaccine pending further investigation. 
• Researchers warned that this is just the beginning of viral hoaxes on social media that will feed off the unknowns of the virus and the vaccines to undercut public trust in the coming wave of immunizations.

📈 Today’s numbers: The U.S. has reported more than 15.3 million cases and 289,000 deaths, according to Johns Hopkins University data. The global totals: 68.8 million cases and 1.56 million deaths.

📰 What we’re reading: About a quarter of the U.S. deaths from the coronavirus – nearly 74,000 – have been nursing home residents and caregivers. They have masks and gloves, and there’s more testing capacity. What nursing homes really need is more help, advocates say.

This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.

Sacramento falls into California’s stay-at-home order

The greater Sacramento region will be placed under California’s most restrictive coronavirus rules this week because capacity in hospital intensive care units has fallen below 15%.

The 13-county region encompassing the state capital has an ICU capacity of 14.3% and will face a regional stay-at-home order at 11:59 p.m. Thursday, according to the state Department of Public Health website.

Under the restrictions, restaurants must stop outdoor dining, personal care businesses such as barbers must close and the number of people allowed inside stores is reduced. Residents are asked to stay home except for essential activities.

The Southern California and San Joaquin Valley regions are already in the strictest category, and several counties in the San Francisco Bay Area chose to implement their own voluntary orders independent of the state. The state is divided in to five regions for purposes of determining restriction levels based on ICU capacity.

Texas official who protested COVID-19 regulations tests positive

A Texas state official who has been critical of measures ordered by Gov. Greg Abbott in efforts to slow the coronavirus pandemic said he has tested positive for the virus.

Texas Agriculture Commissioner Sid Miller was among an estimated 200 people who rallied outside Abbott’s home in October to protest his pandemic orders, including a continued statewide mask mandate and lockdowns.

In a statement Wednesday, the 65-year-old Miller said he has been quarantining at his ranch.

In his words: “Not feeling my best, but I’ve survived rodeo injuries, broken bones, hip, double knee and shoulder surgery, west nile virus and cancer, and I’m going to beat this too.”

Wyoming doctor resigns after claiming COVID was biological weapon

A Wyoming Department of Health doctor who told audiences at an event last month that COVID-19 was created by Russia and China to spread communism has resigned from the state agency.

Dr. Igor Shepherd, who shared a debunked conspiracy theory about the forthcoming COVID-19 vaccine at a Nov. 10 event in Loveland, Colorado, has since resigned, a department spokesperson confirmed via email to the Casper Star-Tribune on Wednesday

Allergic reactions to vaccine in Britain not serious problem in US trial

Two British people with severe allergies apparently had allergic reactions to Pfizer/BioNTech’s COVID-19 vaccine, raising questions about whether it is safe for people with preexisting allergies. In response, British regulators advised those with severe allergies to avoid the vaccine.

It was not immediately clear what triggered the allergic reactions. Unlike some vaccines, in the Pfizer/BioNTech vaccine there are no preservatives or egg products, which have been known to trigger reactions with other types of vaccines.

Allergic reactions were not a significant problem in the U.S. trial in which more than 20,000 people have received both two doses of the vaccine, but the U.S. trials kept out subjects who have had severe allergic reactions, said Moncef Slaoui, co-head of Operation Warp Speed – the government program tasked with developing, manufacturing and distributing COVID-19 vaccines.

Slaoui said he assumes that the U.S. Food and Drug Administration committee meeting Thursday will discuss this issue and will suggest that people with severe allergies “should not take the vaccine until we know exactly what happened.”

But a vaccine that triggers dangerous reactions in people with severe allergies poses a major challenge in the U.S., said Dr. Peter Hotez, a pediatrician and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “If you start issuing recommendations that anyone with an EpiPen doesn’t get vaccinated, that could be a showstopper for Americans,” he said. Read more here.

COVID-19 resources from USA TODAY 

Contributing: The Associated Press

*** This article has been archived for your research. The original version from USA TODAY can be found here ***