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FDA Approves Emergency Use of Pfizer's COVID Vaccine

By Robin Foster HealthDay Reporter

SATURDAY, Dec. 12, 2020 (HealthDay News) – The U.S. Food and Drug Administration approved Pfizer's coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19.

In what looks like a powerful turning point in the pandemic, the United States becomes the sixth country -- in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico -- to authorize the vaccine, The New York Times reported. The first shots in this country will likely begin early next week.

"The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," FDA Commissioner Dr. Stephen Hahn said in a statement released Friday. "The tireless work to develop a new vaccine to prevent this novel, serious and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide."

Who is first in line to be vaccinated? Health care workers and nursing home residents and staff should get the initial shots, according to guidelines issued recently by a U.S. Centers for Disease Control and Prevention advisory panel.

The nursing home industry applauded the approval.

"On behalf of the long-term [care] industry, we welcome the decision by the FDA to approve emergency use authorization to expedite the distribution of a COVID vaccine," said Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living. The association represents 14,000 nursing homes and assisted living facilities.

"The delivery of a safe and effective vaccine can't come soon enough," he said in statement released late Friday. "More than 100,000 in long-term care have died from this virus in the U.S. and our nursing homes are now experiencing the worst outbreak of new cases since last spring, with more than 2,000 residents succumbing to this virus each week."

The logistics of a national COVID vaccination campaign are daunting: Every state, along with six major cities, has submitted to the federal government a list of locations -- mainly hospitals -- where the Pfizer vaccine is to ship initially. In Florida, hospitals in Jacksonville, Miami, Orlando, Tampa and Hollywood will get the initial doses of vaccine, the Times reported. In rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies.

Not only will vaccine doses be shipped all over the country: medical supplier McKesson Corp will send kits of syringes, alcohol pads, face shields and other supplies to the same locations, where they will meet up with the vaccines, the Times reported. As for the vaccines, Pfizer will ship them in specially designed containers packed with dry ice, to keep the temperature inside at minus 94 degrees Fahrenheit. Each container will have a tracking device and a thermal probe, to make sure no vaccine doses are lost or degraded.

The emergency approval comes not a moment too soon. 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 FDA advisory panel for approval next week, should help tame the spread of coronavirus.

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.

More information

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

SOURCES: The New York Times

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