FDA committee votes to recommend emergency authorization of Pfizer virus vaccine

UPDATE: A U.S. government advisory panel on Thursday decided to endorse large-scale use of Pfizer’s Covid-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.

The advisory group, in 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.

The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in U.S. history. Depending on how fast the FDA signs off on the panel’s recommendation, shots could begin within days.

The FDA panel functions like a science court. During the daylong session, it debated and picked apart the data — in public — before deciding to recommend that the vaccine be cleared for emergency use.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said the FDA’s Dr. Doran Fink, who added that the agency's scientists had worked nights, weekends and over Thanksgiving to get that done.

The FDA is not required to follow the committee’s advice but is widely expected to do so. A final FDA decision is expected within days. Once that happens, the U.S. will begin shipping millions of doses of the shot to begin vaccinating health care workers and nursing home residents. Widespread access to the general public is not expected until the spring.

You can watch the entire meeting of the advisory panel in the video player below.

ORIGINAL REPORT: WASHINGTON, DC -- The U.S. appears to be on the cusp of its first Covid-19 vaccine, as an independent panel of infectious disease experts, doctors and scientists planned to recommend Thursday whether the first candidate should be considered safe and effective.

A favorable vote on the Pfizer vaccine by the group, called the Vaccines and Related Biological Products Advisory Committee, would pave the way for an official green light from the U.S. government, which in turn would trigger the first shipment of 2.9 million doses to 636 sites across the country.

So far, all signs are favorable for the vaccine, which is already being distributed in the U.K.; Canada also has authorized the vaccine.

An internal assessment released this week by the Food and Drug Administration already concluded the vaccine was remarkably effective with no known serious risks, although members were expected to ask questions Thursday about whether the vaccine could trigger an allergic reaction in some people.

"I did not see any examples of corners being cut," said Dr. Ofter Levy, a temporary voting member of the advisory committee and director of the Precision Vaccines Program at Harvard Medical School.

"I see the typical safety information one would expect -- and I look forward to the meeting," Levy added.

For many Americans, the vaccines couldn't come soon enough. The U.S. is now averaging more than 200,000 new coronavirus cases every day -- a number that is three times higher than the country's summer peak in July, and more than six times higher than the country's spring peak in April.

Hospitalizations and death numbers are soaring too, with fears in many cities that medical facilities are overwhelmed.

But some critical questions remain, including whether enough Americans will trust the vaccine to take it.

The Food and Drug Administration was livestreaming Thursday's meeting so that the public can listen to outside experts, Pfizer and government scientists review the findings of a clinical trial that involved 44,000 people.

Levy said the transparency is critical.

"I believe if we let the process play out in this transparent way as designed by FDA, we will do justice to this product and to its potential to help the people of this country and hopefully around the world," Levy said.

If all goes well, administration officials predict the FDA would render its decision in days, possibly before next Tuesday. Within 24 hours of an FDA authorization, distribution of the 2.9 million doses would begin with another 2.9 million close behind and 500,000 doses held in reserve.

Each person requires two doses of the Pfizer vaccine, which is estimated to be 95% effective.

Those initial shipments will cover just a fraction of the two groups designated first in line -- front-line health care workers and residents of long-term care facilities. Governors will decide which hospitals or pharmacies get the first doses.

"Hopefully, we will start impacting people's lives very quickly after the onset of the campaigns to immunize," said Moncef Slaoui, Trump's chief scientific advisor on vaccines.

Slaoui also told reporters that he suspects regulators will ultimately advise people with a history of severe allergic reactions not to take the vaccine following reports of two allergic reactions in the U.K.

"My expectation is that this is new news," he said of the allergic reactions. And "the expectation would be that subjects with known severe reaction -- allergic reaction -- should not take the vaccine, until we understand exactly what happened here."

Dr. Anthony Fauci, the nation's top infectious disease expert, said it's possible people will wind up excluded from receiving a particular type of vaccine, but noted there are multiple candidates in the mix.

"If in fact, we do find out that there is a consistent issue of certain subset of people like those with allergic reactions, you'll always have other vaccine platforms that you can use," he said at an event hosted by the Harvard T.H. Chan School of Public Health.

Moderna also has applied for FDA authorization of its vaccine. Slaoui said those details will be published in a few days and that "the data are impressive and compelling."

The U.S. is counting on the Moderna vaccine to come through to hopefully vaccinate 20 million Americans by the end of the year, increasing to 50 million total by the end of January.

"We feel very confident that by late March, early April, the rest of the population -- those beyond the health care workers, those beyond the elderly -- will be able to receive their vaccines as well," Lt. Gen. Paul Ostrowski, director of supply, production and distribution for Operation Warp Speed, told ABC's Good Morning America.