FDA Set to Approve Pfizer's COVID Vaccine

FRIDAY, Dec. 11, 2020 (HealthDay News) – The U.S. Food and Drug Administration is expected to approve emergency use of Pfizer's coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19.

That means the first vaccinations will likely begin early next week, The New York Times reported. Who is first in line? Health care workers and nursing home residents and staff should get the first shots, according to guidelines issued recently by the U.S. Centers for Disease Control and Prevention.

"Following yesterday's positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization," FDA Director Dr. Stephen Hahn said in a statement released Friday.

The emergency approval comes not a moment too soon. The day before Thursday's advisory panel vote, the United States posted a record-setting 3,000 COVID-19 deaths, only to see that number surpassed by the end of Thursday, the Washington Post reported. Painting an even bleaker picture for the coming days, CDC Director Dr. Robert Redfield warned on Thursday that the coronavirus will kill more people in the United States every day for the next two to three months than were killed in the 9/11 attacks or Pearl Harbor, the Post reported.

Eventually, the Pfizer vaccine, and a similar one made by Moderna that will be eyed by the advisory panel for approval next week, should help tame the spread of coronavirus.

"With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need," Kathrin Jansen, head of vaccine research and development at Pfizer, told the FDA advisory panel Thursday.

A national vaccination campaign will be no easy task, with challenges that include ramping up production to tens of millions of doses, shipping them in specially designed boxes packed with dry ice to keep them ultracold and vaccinating people in every corner of the country, the Post reported.

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval.

Initially, a shipment of 2.9 million doses will leave warehouses and be sent across the country, the Times reported. That is only about half of the doses that have been prepared so far. The other half will used to give the first vaccine recipients a second, required dose about three weeks later, the newspaper said.

In some disappointing vaccine news, Sanofi and GlaxoSmithKline said Friday that their experimental coronavirus vaccine did not work well in older adults, delaying the start of their late-stage clinical trial that had been set to begin in the United States in December, the Times reported.

Instead, a modified version of the vaccine will be tested in a smaller trial set to begin in February, the newspaper said. Rather than compare their candidate with a placebo, the companies noted it could be tested against an already approved vaccine, Still, they now expect their vaccine will not be available until the end of next year.

"We care greatly about public health, which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data," Thomas Triomphe, executive vice president and head of Sanofi Pasteur, the company's vaccine division, told the Times.

The Sanofi vaccine is one of six that were selected by Operation Warp Speed. The companies have negotiated a $2.1 billion agreement with the United States to provide 100 million doses, the Times said.

Third of Americans live where hospitals are short on ICU beds

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

Hospitals serving more than 100 million Americans had fewer than 15% of ICU 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 ICU beds are either completely full or fewer than 5% 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% above levels from just two weeks ago, 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 health care 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 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 Friday, the U.S. coronavirus case count passed 15.6 million while the death toll neared 293,000, according to a Times tally. According to the same tally, the top five states in coronavirus cases as of Friday were: California with nearly 1.5 million cases; Texas with over 1.4 million cases; Florida with just over 1 million cases; Illinois with over 825,000 cases; and New York with over 749,000.

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

In India, where the coronavirus case count neared 9.8 million on Friday, a Johns Hopkins University tally showed. More than 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 nearly 6.8 million cases and over 179,700 deaths as of Friday, the Hopkins tally showed.

Worldwide, the number of reported infections passed 69.6 million on Friday, with nearly 1.6 million deaths recorded, according to the Hopkins tally.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

SOURCES: Washington Post; The New York Times