FDA Advisory Panel Says Yes to Pfizer's COVID Vaccine

THURSDAY, Dec. 10, 2020 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended on Thursday that the agency approve the emergency use of Pfizer's coronavirus vaccine, clearing the way for a national campaign to inoculate enough Americans to stop the spread of COVID-19.

The decision came not a moment too soon, as the country reported a record-breaking 3,000 new COVID-19 deaths on Wednesday. The panel vote was 17-4, with one member abstaining. Some panel members expressed concern that there was not enough data on 16- and 17-year-olds to know whether the vaccine would help them, but the committee decided the benefits for that group outweighed the risks.

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 Washington Post reported.

The FDA is expected to authorize the vaccine's use within days, the Post reported. An advisory committee to the U.S. Centers for Disease Control and Prevention will also vote on whether to recommend the vaccine and for whom, the Post reported. First in line are health care personnel and residents and staff of long-term care facilities, according to earlier recommendations released by the CDC panel. But states will have the final say on who gets the first shots and where they are administered, the Post said.

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.

The FDA panel included all-star experts on immunology, virology and infectious diseases. Among them was 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, in preparation for a meeting of the advisory panel next Thursday.

Third of Americans live where hospitals 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 New York 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, 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 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 Thursday, the U.S. coronavirus case count passed 15.5 million while the death toll passed 291,000, 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 825,000; and New York with nearly 739,000.

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.

More information

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