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U.S. FDA advisers recommend COVID-19 boosters for 65 and older after rejecting broad approval

Stock MarketsSep 17, 2021 08:41PM ET
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2/2 © Reuters. FILE PHOTO: A person receives a dose of the Pfizer-BioNTech vaccine for the coronavirus disease (COVID-19), at a mobile inoculation site in the Bronx borough of New York City, New York, U.S., August 18, 2021. REUTERS/David 'Dee' Delgado 2/2

By Michael Erman, Julie Steenhuysen and Manojna Maddipatla

(Reuters) - Advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers.

Despite the narrowed scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the U.S. vaccination campaign.

"Today was an important step forward in providing better protection to Americans from COVID-19," White House spokesperson Kevin Munoz said. "We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week," he said.

The FDA is expected to make its decision on the third round of shots soon. It is not bound by the panel's recommendation but will take it into consideration.

Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania and a member of the panel, said the recommendation was "a step back" from the Biden administration's recommendation of widespread boosters starting Sept. 20.

"That is not this. This is: 'We're going to test the water, one foot at a time,'" said Offit, who voted "no" on the initial question of widespread use of boosters and "yes" on the more modest offering of vaccines for those at higher risk.

By a vote of 16 to 2, members of the FDA's Vaccines and Related Biological Products Advisory Committee declined to recommend a third dose of the Pfizer/BioNTech vaccine to anyone age 16 and older who received their second shot at least six months earlier.

The panelists suggested the evidence supporting broad approval was inadequate, and they wanted to see more safety data, especially concerning the risk of heart inflammation in younger people after vaccination.

The panel members then unanimously approved the recommendation for a third shot for older and other high risk Americans, convinced by evidence showing they were at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots.

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) are scheduled to meet on Sept. 22 and 23 to discuss further recommendations for who will be eligible for the shots.

"We wonder how well this restriction can be managed in real-world or how to stop people, but the point is - it will be available for those that need it," said Jefferies (NYSE:JEF) analyst Michael Yee.

Pfizer (NYSE:PFE) could still come back with more data to support a wider authorization or approval.

The drugmaker said it "will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population."

Pfizer shares closed down 1.3%, while BioNTech's U.S.-traded shares finished the day 3.6% lower.

Some countries, including Israel and the UK, have already begun COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and some 2 million people had already received a third shot, according to the CDC.

President Joe Biden has pushed for the additional shots in the face of surging hospitalizations and deaths caused by the highly contagious Delta variant of the coronavirus, mostly among the unvaccinated, and rising cases of breakthrough infections among fully vaccinated Americans.

Recent polls have shown that most vaccinated Americans want a booster shot to enhance their immunity.

U.S. FDA advisers recommend COVID-19 boosters for 65 and older after rejecting broad approval
 

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Comments (6)
Trevor Roberts
LimitUp Sep 18, 2021 12:02AM ET
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Its always about control with comm party.
Nura Saleh AG
Nura Saleh AG Sep 17, 2021 10:52PM ET
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good covid 19
Roger Miller
Roger Miller Sep 17, 2021 10:13PM ET
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Obviously the benefit to healthy people was not evident, but I am sure the politicians and bureaucrats will eventually find someone to say it is. They need the pandemic distraction to continue.
Hans Billings
Hans Billings Sep 17, 2021 6:05PM ET
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sigh ence
Me comment
Me comment Sep 17, 2021 5:53PM ET
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They also recommended no republicans can claim high risk status to get a booster shot.
Frank Taylor
Frank Taylor Sep 17, 2021 5:53PM ET
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a comment of no sense or value.
Chris Sundo
Chris Sundo Sep 17, 2021 7:30AM ET
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I received Covid vaccine shot #2 exactly two days ago. I was injected by a medical doctor who sat close by me and did a superb job. I didn't feel a thing and only at night did the typical sore injection point become noticeable. I'm saying this because the picture under the heading here shows SOMEONE standing with a nearly outreached arm and doing a mediocre job guaranteed! A doctor outside the USA sat close by me and did a superb injection job. Goes to show that USA-trained people are more often poorly trained and supervised. Re: '..a panel of independent expert advisers ..' That is ridiculous! You USA people are wasting serious taxpayer money on panels that need to be adjudicated when the outcome of the panel's discussion is already visible by pure logic. In my country here outside of the USA people are already vaccinated with booster shots. Ridiculous. And over in Europe the same. Older folks need the booster shot.
cj go
cj go Sep 17, 2021 7:30AM ET
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its logical that you'll need 3 shots plus boosters? what country are you from?
Chris Sundo
Chris Sundo Sep 17, 2021 7:30AM ET
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cj go  -- You Amis are behind the curve. Europe and the rest of North America are leading. And people of your capacity need to sharpen your scope and watch the future. If what's going to happen in USA is already happening elsewhere like Europe and my nation then obviously the now will happen in the future of USA. -- Good Luck, man. Lie down before you hurt yourself. (Remember that scene from the movie Lion King?)
cj go
cj go Sep 17, 2021 7:30AM ET
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so no real substance- I'm not American but you never said where you're from- it matters so I can see how educated you are but I can tell, not too much- america does have one of the lowest deaths per capita- Israel is the highest vaccinated yet still really high death per capita and spreading- not to mention there hasn't been long term studies on these shots and if the vaccines don't stop spread or protect anyone- they're not vaccines- I got vaccinated because they said it would stop the spread- I'm now in a large lawsuit against them for it
Josh Davis
Josh Davis Sep 17, 2021 7:30AM ET
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cj go funny how pharma lied huh? Nust like always. Im in the medical field, had covid, and refuse to get the shot. Lets just say it isnt covid killing people and the average bmi for patients is over 30.
 
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