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 3 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

Biden Backs House’s Aid Package for Ukraine, Israel While Speaker Johnson Battles to Retain Position

DON'T MISS

Hot Rod Willys: Driven to Bake the Perfect Chicago-Style Pizza

DON'T MISS

Local Leaders Must Put Their Shoulders Into Making Fresno ‘Education City USA’

DON'T MISS

EdSource Welcomes Fresno News Veteran Jim Boren to Its Board

DON'T MISS

Senate Dismissed Two Articles of Impeachment, Ending Trial on Mayorkas

DON'T MISS

Netanyahu Dismisses Calls for Restraint, Says Israel Will Decide Iran Attack Response

DON'T MISS

New Study Calculates Climate Change’s Economic Bite Will Hit About $38 Trillion a Year by 2049

DON'T MISS

Biden Pledges to Block Japanese Takeover of US Steel and Promises Tariffs on Chinese Steel

DON'T MISS

Don Arax Talks About His New Football Job at Visalia’s Central Valley Christian

DON'T MISS

Dem House Challengers Salas, Gray Flex Fundraising Muscle

UP NEXT

Myanmar’s Ousted Leader Suu Kyi Moved From Prison to House Arrest Due to Heat, Military Says

UP NEXT

NPR Editor Suspended Over Claims of Network’s ‘Progressive Worldview’

UP NEXT

Wall Street’s Mixed Trading Day

UP NEXT

New Recruiting Programs Put Army, Air Force on Track to Meet Enlistment Goals. Navy Will Fall Short

UP NEXT

Justice Thomas Misses Supreme Court Session Monday With No Explanation

UP NEXT

‘Civil War’ Declares Victory at the Box Office, Toppling ‘Godzilla X Kong’

UP NEXT

Scheffler Turns the Masters Into Another Sunday Yawner With a Dominating Win

UP NEXT

Vegas, US Tour and More Signings: Wrexham Has Plenty of Fun and Work Ahead After Latest Promotion

UP NEXT

NBA Play-in Game Preview: West Games on Tuesday, East Games on Wednesday, Eliminations on Friday

UP NEXT

Ship That Caused Bridge Collapse Had Apparent Electrical Issues While Still Docked, Source Says

EdSource Welcomes Fresno News Veteran Jim Boren to Its Board

3 hours ago

Senate Dismissed Two Articles of Impeachment, Ending Trial on Mayorkas

3 hours ago

Netanyahu Dismisses Calls for Restraint, Says Israel Will Decide Iran Attack Response

4 hours ago

New Study Calculates Climate Change’s Economic Bite Will Hit About $38 Trillion a Year by 2049

4 hours ago

Biden Pledges to Block Japanese Takeover of US Steel and Promises Tariffs on Chinese Steel

4 hours ago

Don Arax Talks About His New Football Job at Visalia’s Central Valley Christian

5 hours ago

Dem House Challengers Salas, Gray Flex Fundraising Muscle

6 hours ago

Career-High Strike Outs for Ryan Weathers as Marlins Best Giants 6-3

6 hours ago

LeBron’s Lakers Top Pelicans in Play-in, Set up Playoff Rematch With Nuggets

6 hours ago

Storm Dumps Record Rain and Floods Dubai’s Airport

7 hours ago

Biden Backs House’s Aid Package for Ukraine, Israel While Speaker Johnson Battles to Retain Position

WASHINGTON — President Joe Biden said Wednesday that he strongly supports a proposal from House Speaker Mike Johnson to provide aid to Ukrai...

46 mins ago

46 mins ago

Biden Backs House’s Aid Package for Ukraine, Israel While Speaker Johnson Battles to Retain Position

2 hours ago

Hot Rod Willys: Driven to Bake the Perfect Chicago-Style Pizza

2 hours ago

Local Leaders Must Put Their Shoulders Into Making Fresno ‘Education City USA’

3 hours ago

EdSource Welcomes Fresno News Veteran Jim Boren to Its Board

3 hours ago

Senate Dismissed Two Articles of Impeachment, Ending Trial on Mayorkas

4 hours ago

Netanyahu Dismisses Calls for Restraint, Says Israel Will Decide Iran Attack Response

4 hours ago

New Study Calculates Climate Change’s Economic Bite Will Hit About $38 Trillion a Year by 2049

4 hours ago

Biden Pledges to Block Japanese Takeover of US Steel and Promises Tariffs on Chinese Steel

MENU

CONNECT WITH US

Search

Send this to a friend