Please ensure Javascript is enabled for purposes of website accessibility

West Bank Town Becomes ‘Big Prison’ as Israel Fences It In

2 days ago

Trump Says He’s Willing to Let Migrant Farm Laborers Stay in US

2 days ago

US Electric Vehicle Tax Breaks Will Expire on Sept. 30

3 days ago

Eyeing Arctic Dominance, Trump Bill Earmarks $8.6 Billion for US Coast Guard Icebreakers

3 days ago

Trump’s Sweeping Tax-Cut and Spending Bill Wins Congressional Approval

3 days ago

Americans Celebrate Their Independence With Record-Breaking Travel Numbers

3 days ago

US Supreme Court to Decide Legality of Transgender School Sports Bans

3 days ago

Nvidia Set to Become the World’s Most Valuable Company in History

3 days ago

Poll: 41% in US ‘Extremely Proud’ to Be American, Near Historic Low

3 days ago
US Experts Convene to Decide Whether to OK Pfizer Vaccine
gvw_ap_news
By Associated Press
Published 5 years ago on
December 10, 2020

Share

WASHINGTON — A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.

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 scheduled daylong session, it was expected to debate and pick apart the data — in public — on whether the vaccine is safe and effective enough to be cleared for emergency use. With unprecedented interest in the normally obscure panel, the FDA broadcast the meeting via Youtube, and thousands logged on.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said FDA’s Dr. Doran Fink, who described agency scientists working 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. Once that happens, the U.S. will begin shipping millions of doses of the shot.

Later this month, the FDA is expected to pass judgment on another vaccine candidate, developed by Moderna and the National Institutes of Health, that has proved about as protective as Pfizer’s shot. A third candidate, by AstraZeneca and Oxford University, is also making its way through the pipeline.

The initial supplies from Pfizer and Moderna will be limited and reserved primarily for health care workers and nursing home patients, 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 meeting came as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including about 290,000 in the U.S.

Hanging over the meeting is a warning from British officials that people with a history of serious allergic reactions shouldn’t get the vaccine. Government authorities there are investigating two reports of reactions that occurred on Tuesday when Britain became the first country in the West to begin mass vaccinations against the scourge.

An Opportunity for Regulators to Try to Boost Public Confidence

Still, a positive recommendation and speedy U.S. approval appeared nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.

FDA said results from Pfizer’s large, ongoing study showed that the shot, which was developed with Germany’s BioNTech, was more than 90% effective across people of different ages, races and underlying health conditions, including diabetes and obesity. No major safety problems were uncovered. Common side effects included fever, fatigue and pain at the injection site.

“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins University’s International Vaccine Access Center. “Nothing that I see would delay an emergency use authorization.”

The meeting also represented an opportunity for regulators to try to boost public confidence in the breakneck development process that has produced the Pfizer vaccine and a string of other upcoming shots with remarkable speed — less than a year after the virus was identified.

The FDA has also faced weeks of criticism from President Donald Trump for not rushing out a vaccine before Election Day.

“There have been a lot of questions about why it takes us so long or ‘are we being rigorous enough?’” FDA Commissioner Stephen Hahn said in an interview. “I’m hoping that people will see with our transparency that we have taken a very rigorous stance on this.”

Hahn said the agency had already teed up the process to authorize the vaccine by filling out all the legal paperwork in advance, regardless of the ultimate decision.

On Thursday’s Agenda

RARE ADVERSE REACTIONS

The FDA uncovered no major safety problems in its review of Pfizer’s 44,000-person study, including no allergic reactions of the type reported in Britain. But such studies can’t detect rare problems that might only affect a tiny slice of the general population.

FDA reviewers noted four cases of Bell’s palsy that occurred among people getting the vaccine. They concluded the cases were probably unrelated to the vaccine because they occurred at rates that would be expected without any medical intervention. But the agency did say cases of the nerve disorder should be tracked, given that other vaccines can cause the problem.

“I think we have to be upfront, without scaring people, that we don’t know yet about any potential, rare, long-term adverse events,” Moss said.

EFFICACY QUESTIONS

The FDA found the vaccine highly effective across various demographic groups. But it is unclear how well the vaccine works in people with HIV and other immune-system disorders.

The study excluded pregnant women, but experts were expected to tease apart the data for any hints in case women get vaccinated before realizing they’re pregnant.

A study of children as young as 12 is underway.

IMPACT OF EMERGENCY AUTHORIZATION

Answering some of these questions will require keeping Pfizer’s study going for many more months.

When the FDA panel met in October, experts warned against allowing study participants who received dummy shots to switch and get the real vaccine as soon as it receives the FDA’s emergency OK. Doing that could make it impossible to get answers to certain questions, such as ho long the protection lasts.

Pfizer and BioNTech say they want to allow such participants to get the vaccine on request or, at the latest, after six months of follow-up. The FDA hasn’t made clear if it will accept that approach.

“FDA is adamant that they want these trials completed,” said Norman Baylor, former director of FDA’s vaccine office.

RELATED TOPICS:

DON'T MISS

What Are Fresno Real Estate Experts Predicting for 2025 and Beyond?

DON'T MISS

First California EV Mandates Hit Automakers This Year. Most Are Not Even Close

DON'T MISS

How Trump’s ‘Big, Beautiful Bill’ Will Make China Great Again

DON'T MISS

What’s Caitlin Clark Worth to the WNBA? A Lot More Than Her $78,066 Salary.

DON'T MISS

Trump to Sign Tax-Cut and Spending Bill in July 4 Ceremony

DON'T MISS

Madre Fire Spurs Evacuations Across 3 Counties, Grows to More Than 70,000 Acres

DON'T MISS

Clovis, Sanger, Madera, and Bass Lake Will Light the Sky With Fireworks Shows Tonight

DON'T MISS

Oil Dips Ahead of Expected OPEC+ Output Increase

DON'T MISS

613 Killed at Gaza Aid Distribution Sites, Near Humanitarian Covoys, Says UN

DON'T MISS

Fresno County Authorities Investigating Suspicious Death of Transient Man

DON'T MISS

West Bank Town Becomes ‘Big Prison’ as Israel Fences It In

DON'T MISS

Israeli Military Kills 20 in Gaza as Trump Awaits Hamas Reply to Truce Proposal

UP NEXT

Americans Celebrate Their Independence With Record-Breaking Travel Numbers

UP NEXT

Poll: 41% in US ‘Extremely Proud’ to Be American, Near Historic Low

UP NEXT

Poorest Americans Dealt Biggest Blow Under Senate Republican Tax Package

UP NEXT

Poll: Most Americans Say National Divide, Political Violence Threaten Democracy

UP NEXT

Trump Pulls Back 150 Guard Troops From Federal Duties in California

UP NEXT

Suspect Identified in Ambush Shooting That Killed 2 Idaho Firefighters

UP NEXT

Suspect Identified in Ambush Shooting That Killed 2 Idaho Firefighters

UP NEXT

US Supreme Court Lets Parents Take Kids Out of Classes With LGBT Storybooks

UP NEXT

Bill Moyers, Broadcaster and LBJ’s White House Press Secretary, Dies at 91

UP NEXT

Tesla Executive, Elon Musk Confidant Leaves EV Maker, Bloomberg News Reports

Madre Fire Spurs Evacuations Across 3 Counties, Grows to More Than 70,000 Acres

2 days ago

Clovis, Sanger, Madera, and Bass Lake Will Light the Sky With Fireworks Shows Tonight

2 days ago

Oil Dips Ahead of Expected OPEC+ Output Increase

2 days ago

613 Killed at Gaza Aid Distribution Sites, Near Humanitarian Covoys, Says UN

2 days ago

Fresno County Authorities Investigating Suspicious Death of Transient Man

2 days ago

West Bank Town Becomes ‘Big Prison’ as Israel Fences It In

2 days ago

Israeli Military Kills 20 in Gaza as Trump Awaits Hamas Reply to Truce Proposal

2 days ago

Valley Crime Stoppers’ Most Wanted Person of the Day: Rachelle Maria Blanco

2 days ago

Russia Pounds Kyiv With Largest Drone Attack, Hours After Trump-Putin Call

2 days ago

Boxer Chavez Jr Expected to Be Deported to Mexico to Serve Sentence, Mexican President Says

2 days ago

How Trump’s ‘Big, Beautiful Bill’ Will Make China Great Again

Can you hear it — that loud roar coming from the East? It’s the sound of 1.4 billion Chinese laughing at us. Thomas L. Friedman The New Yo...

20 hours ago

Solar Farm in Riesel, Texas
20 hours ago

How Trump’s ‘Big, Beautiful Bill’ Will Make China Great Again

Caitlin Clark Signs T-Shirt
20 hours ago

What’s Caitlin Clark Worth to the WNBA? A Lot More Than Her $78,066 Salary.

President Donald Trump speaks during a press conference in the Roosevelt Room at the White House in Washington, D.C., U.S., May 12, 2025. (Reuters File)
2 days ago

Trump to Sign Tax-Cut and Spending Bill in July 4 Ceremony

The Madre Fire burning near New Cuyama has scorched 70,801 acres as of Friday, July 4, 2025, afternoon, making it California’s largest wildfire of the year, with only 10% containment and multiple evacuation zones in place. (CalFire)
2 days ago

Madre Fire Spurs Evacuations Across 3 Counties, Grows to More Than 70,000 Acres

2 days ago

Clovis, Sanger, Madera, and Bass Lake Will Light the Sky With Fireworks Shows Tonight

A pumpjack operates at the Vermilion Energy site in Trigueres, France, June 14, 2024. (Reuters File)
2 days ago

Oil Dips Ahead of Expected OPEC+ Output Increase

Palestinians gather to collect what remains of relief supplies from the distribution center of the U.S.-backed Gaza Humanitarian Foundation, in Rafah, in the southern Gaza Strip, June 5, 2025. (Reuters File)
2 days ago

613 Killed at Gaza Aid Distribution Sites, Near Humanitarian Covoys, Says UN

Billy Wayne Sinisgalli, a 54-year-old transient known locally as Wayne, was found dead along a rural Fresno road Wednesday in what authorities are investigating as a suspicious death. (Fresno County SO)
2 days ago

Fresno County Authorities Investigating Suspicious Death of Transient Man

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

Search

Send this to a friend