Please ensure Javascript is enabled for purposes of website accessibility
Panel Endorses Widespread Use of Pfizer COVID-19 Vaccine in US
gvw_ap_news
By Associated Press
Published 4 years ago on
December 10, 2020

Share

A government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans.

Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation.

In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and older.

That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.

Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” said panel member Dr. Paul Offit of Children’s Hospital of Philadelphia, who concluded that the shot’s potential potential benefits outweigh its risks.

The independent review by non-government experts in vaccine development, infectious diseases and medical statistics was considered critical to boosting Americans’ confidence in the safety of the shot, which was developed at breakneck speed less than a year after the virus was identified.

The decision came as COVID-19 cases surge to ever-higher levels across the U.S., with deaths hitting an all-time, one-day high of more than 3,100 on Wednesday.

Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But initial supplies will be limited and reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line until the shots become widely available on demand, something that will probably not happen until the spring.

The FDA Next Week Will Review a Second Vaccine

Experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can be held in check. That means it could be several months before things start get back to normal and Americans can put away their masks.

The FDA next week will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University

All eyes now turn to the FDA staff scientists who will make the final decision on whether to greenlight use of the Pfizer-BioNTech vaccine. Regulators not only in Britain but in Canada have already approved it for use in their countries, and President Donald Trump and White House officials have complained for weeks about the pace of FDA’s careful review.

FDA’s vaccine director Dr. Peter Marks said ahead of the expert meeting that a decision would come within “days to a week.”

“Americans want us to do a scientific review, but I think they also want us to make sure we’re not wasting time on paperwork as opposed to going forward with the decision,” FDA Commissioner Stephen Hahn said before the meeting.

A positive vote for the vaccine was virtually assured after FDA scientists issued a glowing review of the vaccine earlier in the week. Agency staffers said data from Pfizer’s ongoing study of 44,000 people showed strong protection across different age groups, races and health conditions with no major, unexpected safety problems.

It Is Not Yet Clear if It Can Stop the Silent, Symptomless Spread

The Pfizer-BioNTech shot remains experimental because that final-stage study isn’t complete. As a result, the expert panel wrestled with a list of questions that have yet to be answered.

For example, while the vaccine is more than 90% effective in blocking the symptoms of COVID-19, the FDA’s advisers stressed it is not yet clear if it can stop the silent, symptomless spread that accounts for up to half of cases.

“Even though the individual efficacy of this vaccine is very, very, very high, you really as of right now do not have any evidence” that it will lower transmission, said Dr. Patrick Moore of the University of Pittsburgh. He urged Pfizer to take additional steps to answer that question.

And the advisers are worried that Pfizer will lose its opportunity to answer critical questions as it begins offering the real vaccine to study participants who had been getting dummy shots.

The company proposed gradually moving those patients to the vaccine group, with priority based on age, health conditions and other factors. Under that plan, 70-year-old participants would cross over before healthy 30-year-olds.

Pfizer must still show whether the vaccine works in children younger than 16 and in pregnant women.

On the safety front, as widespread vaccinations begin, the first recipients will be closely tracked by government health authorities since studies in tens of thousands of people can’t detect rare risks that strike 1 in a million. Hanging over the meeting were the British allergic reactions and a warning from authorities there that people with a history of serious reactions shouldn’t get the vaccine for now.

Pfizer representatives said they have seen no signs of allergic reactions in their trial. But some of the FDA advisers fear the British warning will deter millions of Americans with allergies who might benefit from the COVID-19 vaccine from giving it a try, and urged additional studies to try to settle the issue.

“This issue is not going to die until we have better data,” Offit said.

RELATED TOPICS:

DON'T MISS

What to Know About Pam Bondi, Trump’s New Pick for Attorney General

DON'T MISS

North Korean Leader Says Past Diplomacy Only Confirmed US Hostility

DON'T MISS

Democrats Strike Deal to Get More Biden Judges Confirmed Before Congress Adjourns

DON'T MISS

Newsom Gaslights on Potential Gas Price Hikes in Fresno Visit

DON'T MISS

Automakers to Trump: Please Require Us to Sell Electric Vehicles

DON'T MISS

President Biden Welcomes 2024 NBA Champion Boston Celtics to White House

DON'T MISS

Ohtani Makes History With 3rd MVP, Judge Claims 2nd AL Honor

DON'T MISS

Trump Chooses Pam Bondi for Attorney General Pick After Gaetz Withdraws

DON'T MISS

Average Rate on a 30-Year Mortgage in the US Rises to Highest Level Since July

DON'T MISS

Cutting in Line? American Airlines’ New Boarding Tech Might Stop You at Now Over 100 Airports

UP NEXT

Bomb Cyclone Kills 1 and Knocks Out Power to Over Half a Million Homes Across the Northwest US

UP NEXT

Volunteers Came Back to Nonprofits in 2023, After the Pandemic Tanked Participation

UP NEXT

New Study: Proposed Trump Tariffs Could Cost US Consumers $78 Billion a Year

UP NEXT

Riders Stuck in Midair for Over 2 Hours on Knott’s Berry Farm Ride

UP NEXT

Shouting Racial Slurs, Neo-Nazi Marchers Shock Ohio’s Capital

UP NEXT

More Logging Is Proposed to Help Curb Wildfires in the US Pacific Northwest

UP NEXT

Scientists Fear What’s Next for Public Health if RFK Jr. Is Allowed To ‘Go Wild’

UP NEXT

Warren Slams Biden Admin for Failing to Hold Israel Accountable on Gaza Aid

UP NEXT

Suicides in the US Military Increased in 2023, Continuing a Long-Term Trend

UP NEXT

New FDA Rules for TV Drug Ads: Simpler Language and No Distractions

Newsom Gaslights on Potential Gas Price Hikes in Fresno Visit

5 hours ago

Automakers to Trump: Please Require Us to Sell Electric Vehicles

6 hours ago

President Biden Welcomes 2024 NBA Champion Boston Celtics to White House

6 hours ago

Ohtani Makes History With 3rd MVP, Judge Claims 2nd AL Honor

6 hours ago

Trump Chooses Pam Bondi for Attorney General Pick After Gaetz Withdraws

6 hours ago

Average Rate on a 30-Year Mortgage in the US Rises to Highest Level Since July

7 hours ago

Cutting in Line? American Airlines’ New Boarding Tech Might Stop You at Now Over 100 Airports

7 hours ago

MLB Will Test Robot Umpires at 13 Spring Training Ballparks Hosting 19 Teams

7 hours ago

Death Toll in Gaza From Israel-Hamas War Passes 44,000, Palestinian Officials Say

8 hours ago

Jussie Smollett’s Conviction in 2019 Attack on Himself Is Overturned

8 hours ago

What to Know About Pam Bondi, Trump’s New Pick for Attorney General

NEW YORK — Pam Bondi, the former Florida attorney general, was chosen Thursday by Donald Trump to serve as U.S. attorney general hours after...

4 hours ago

4 hours ago

What to Know About Pam Bondi, Trump’s New Pick for Attorney General

4 hours ago

North Korean Leader Says Past Diplomacy Only Confirmed US Hostility

5 hours ago

Democrats Strike Deal to Get More Biden Judges Confirmed Before Congress Adjourns

5 hours ago

Newsom Gaslights on Potential Gas Price Hikes in Fresno Visit

President Joe Biden with Mary Barra, the chief executive of General Motors, at the Detroit Auto Show, Sept. 14, 2022. President-elect Donald Trump has promised to erase the Biden administration’s tailpipe rules designed to get carmakers to produce electric vehicles, but most U.S. automakers want to keep them. (Doug Mills/The New York Times)
6 hours ago

Automakers to Trump: Please Require Us to Sell Electric Vehicles

6 hours ago

President Biden Welcomes 2024 NBA Champion Boston Celtics to White House

6 hours ago

Ohtani Makes History With 3rd MVP, Judge Claims 2nd AL Honor

Former Florida Attorney General Pam Bondi, speaks before Republican presidential nominee former President Donald Trump arrives to speak at a campaign rally at First Horizon Coliseum, Saturday, Nov. 2, 2024, in Greensboro, NC. (AP/Alex Brandon)
6 hours ago

Trump Chooses Pam Bondi for Attorney General Pick After Gaetz Withdraws

Help continue the work that gets you the news that matters most.

Search

Send this to a friend