FDA Panel to Vote on Pfizer’s COVID Vaccine

THURSDAY, Dec. 10, 2020 – A U.S. Food and Drug Administration advisory panel will vote on Thursday whether to recommend emergency approval of Pfizer’s coronavirus vaccine, a decision that will come not a moment too soon as the country reported more than 3,000 new COVID-19 deaths on Wednesday.

That record-breaking statistic is unlikely to drop significantly anytime soon: The number of people hospitalized with COVID-19 reached a record 106,000 on Wednesday, the Washington Post reported.

With no relief in sight, the United States is poised to break yet another record in the next few days: 300,000 deaths since the coronavirus outbreak began.

Meanwhile, U.S. officials are racing to approve and distribute a COVID-19 vaccine for Americans. Britain began inoculating its citizens with the Pfizer vaccine this week, and Canada has also approved the Pfizer vaccine, The New York Times reported.

If the FDA’s vaccine advisory panel recommends that the Pfizer vaccine be approved, it will kick off a national campaign to inoculate enough Americans to finally stop the virus’s spread. It will be no easy task, with challenges in making tens of millions of doses, sending vaccine doses in boxes packed with dry ice to keep them ultracold and vaccinating people in every corner of America, the Post reported.

“It’s staggering where we find ourselves,” Robert Wachter, chairman of the department of medicine at the University of California, San Francisco, told the Post. “And this remarkable week will either put us on a path to getting out of this in six months, or if people lose trust in the process, put us back by months, or a year.”

The FDA sees Thursday’s panel meeting, which includes time for the general public to speak, as a critical part of its effort to be transparent and convince people to take the vaccine, the Post reported.

“We feel it’s our responsibility to make it happen as fast as possible,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the Post. But, he added, “We want to show that we really thought this all through carefully.”

If the advisory panel recommends emergency approval of the Pfizer vaccine, the FDA is expected to authorize the vaccine’s use within days, clearing the way for quick distribution to all 50 states, the Post said. Operation Warp Speed has said it plans to begin shipping the vaccine within 24 hours of an FDA approval. But if the advisory panel raises concerns, the process could be slowed.

The independent panel has a core group of 15 voting members, including all-star experts on immunology, virology and infectious diseases. They include Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and the co-developer of a rotavirus vaccine, the Post said.

Next week, the panel will tackle the safety and efficacy of Moderna’s coronavirus vaccine. On Tuesday, the agency will post documents on its view of the vaccine’s safety and efficacy, in preparation for a Thursday meeting of the advisory panel.

Third of Americans live where hospitals are short of ICU beds

In a sign that the coronavirus pandemic is entering its most dire stage yet, new federal data shows that more than a third of Americans now live in areas where hospitals are critically short of intensive care beds.

Hospitals serving more than 100 million Americans had fewer than 15 percent of intensive care beds still available as of last week, a Times analysis of government data on hospitals finds.

Things are even more troubling across much of the Midwest, South and Southwest, where intensive care beds are either completely full or fewer than 5 percent of beds are available. Under that scenario, experts warn that caring for the sickest patients may be difficult or impossible.

“There’s only so much our frontline care can offer, particularly when you get to these really rural counties which are being hit hard by the pandemic right now,” Beth Blauer, director of the Centers for Civic Impact at Johns Hopkins University in Baltimore, told the Times. “This disease progresses very quickly and can get very ugly very fast. When you don’t have that capacity, that means people will die.”

Hospitalization figures collected by the COVID Tracking Project show that the number of people hospitalized with the virus nationwide has doubled since the beginning of November, the Times reported.

The new hospital data shows that some areas — like Amarillo, Texas, Coral Gables, Fla., and Troy, Mich. — are seeing rates of serious illness that approach the levels seen in New York City during the worst weeks of the spring, the Times said.

In California, more than 10,000 COVID-19 patients are now hospitalized, more than 70 percent above levels from just two weeks ago, and the effects of Thanksgiving travel may not have been fully felt yet, the Times reported.

While survival rates have improved as doctors have learned which treatments work, hospital shortages raise the possibility of increasing mortality rates once again if patients don’t get the level of care they need.

Thomas Tsai, an assistant professor of health policy at Harvard University, told the Times that healthcare workers must make tough decisions about who receives care when resources are critically tight.

Already, there is some evidence that is happening, Tsai said. For the last several weeks, the rate at which COVID-19 patients are going to hospitals has started decreasing. “That suggests that there’s some rationing and stricter triage criteria about who gets admitted as hospitals remain full,” he explained.

So far, policymakers have relied heavily on data on testing and cases to make policy decisions, but the new, detailed data on hospitals could prompt a rapid shift in what leaders consider as they make decisions, Blauer told the Times.

“If you’re living in a place where there’s no ICU bed for 100 miles, you have to be incredibly careful about the social interaction that you allow the community to take,” she explained.

A global scourge

By Thursday, the U.S. coronavirus case count passed 15.4 million while the death toll passed 289,500, according to a Times tally. According to the same tally, the top five states in coronavirus cases as of Thursday were: California with over 1.4 million cases; Texas with over 1.3 million cases; Florida with just over 1 million cases; Illinois with nearly 814,000; and New York with nearly 734,000.

Curbing the spread of the coronavirus in the rest of the world remains challenging.

Many European countries are tightening restrictions, the Associated Press reported. France has entered a nationwide lockdown, and Germany and Austria have started partial lockdowns as government officials across the continent scramble to slow a sharp rise in infections that threatens to overwhelm their health care systems.

England has followed suit, while Italy, Greece and Kosovo also announced new measures, the AP reported.

Things are no better in India, where the coronavirus case count passed 9.7 million on Thursday, a Johns Hopkins University tally showed. Nearly 142,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India’s younger and leaner population. Still, the country’s public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.

Meanwhile, Brazil had over 6.7 million cases and nearly 179,000 deaths as of Thursday, the Hopkins tally showed.

Worldwide, the number of reported infections passed 69 million on Thursday, with over 1.5 million deaths recorded, according to the Hopkins tally.

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