FDA panel endorses Pfizer's COVID-19 vaccine booster for people 65 and older, high-risk patients
S E E D E D C O N T E N T
A U.S. Food and Drug Administration (FDA) advisory panel on Friday endorsed emergency approval for the Pfizer-BioNTech COVID-19 vaccine booster shot at least six months following the second dose among people ages 65 and older and those at high risk of occupational exposure and severe COVID-19.
The vote was 18-0. The vote will now go before the FDA to issue a final decision.
The panel earlier Friday afternoon voted to reject licensure of Pfizer's booster vaccine in people ages 16 and older, at a vote of 2-16.
During the deliberations, panel members suggested older, vulnerable populations may benefit from boosters, but noted insufficient data among younger groups and concerns over potential increased risk for heart inflammation, particularly among males ages 16-17.
The committee was most recently charged with voting whether the safety and effectiveness data from Pfizer's clinical trial supported emergency use authorization of the company's booster dose among people 65 years and older and people at high-risk for a severe course of COVID-19 disease.
The meeting included members of the FDA's Vaccines and Related Biological Products Advisory Committee, (VRBPAC), as well as officials from the Centers for Disease Control and Prevention (CDC), lsrael's Health Ministry, vaccine experts and Pfizer representatives.
Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, noted Phase 3 trial data indicating waning protection over time, from 96% vaccine efficacy within two months after the second dose to about 84% by six months and amid the dominant delta variant. While protection dropped against infections, it remained effective in preventing hospitalizations.
Gruber cited evidence suggesting reductions in efficacy owed to waning immunity over time as opposed to the delta variant escaping vaccine protection. Additional data suggested a third Pfizer dose would ramp up protection on par or better than the second dose, however concerns were raised over the potential increased risk of myocarditis. The FDA panel's review included Pfizer's trial results with some 300 participants ages 18-55 who received a booster dose about six months after the second dose.
To be clear, the role of the FDA and advisory panel in this case is to determine whether an additional dose can be used, whereas an expert panel advising the CDC (Advisory Committee on Immunization Practices, ACIP), will convene Wednesday to weigh who should receive vaccine and when, following the FDA's final review. Top health officials last month said this group would likely include health care workers and nursing home residents who were targeted in the earliest phases of the rollout.
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I'm ready.
I await a political-free decision from the FDA.
Good luck with that. Politics has overtaken all of this in such a horrible way.
I do wish they would expand on what they mean by high-risk however. I'm only 63 but I am diabetic so would like to get the booster shot but no clear idea what is needed.
Diabetic makes you eligible. Of course that's assuming you got the Pfizer and not the Moderna or J&J.
You are high risk. That is one part of the so-called science that has been consistent & accurate. When the booster gets approved it will not be for everyone. It will be for people like you and I. Unfortunately for Biden it's going to those who were high risk and are in the high percentage of those vaccinated.
The booster was OK'd today by the FDlA.
You would be eligible because of diabetes.
Not by the full FDA yet.
And it was only approved for the Pfizer not the Moderna or Johnson.
Be that as it may, if it becomes available for those of us who got the Moderna, I'll get one. I have no problem being a pin cushion.
thanks
thanks
One more thing to remember - It was rejected 16-2 for the general public. It's only going to be for certain at risk groups.
My first two shots were Moderna and I received my booster a week ago, also Moderna.
It was approved for everyone over 65 and other high risk groups.
And rejected for most everyone else.
Biden was trying to lead the science.
What about Biden's promise of a booster for everyone by September 20th (Today) ?
President Biden is trying to do what's best for all.
Instead of following the science.
They're still checking the Moderna vaccine. That's what we got in early January. THANKS to President Trump and the great embassy medical staff.
Per what I've read, they believe the Moderna vac is still more effective that the Pfizer after two doses and much better than the J&J.
If it gets approved, I'll get mine. The wife will have to wait to see if federal employees are put in the queue regardless of age like they were in the last go round.
I got the Moderna vaccine too. I'll get the booster as soon as it becomes available.
I also bought stock. Today Moderna is $430 per share.
What's the 'full FDA'????????
Read the article.
My ancient Mom already received a booster shot...
I will get the booster as soon as I can.
I got my flu shot last week and 2nd pneumonia, which made my arm sore for 2 days. The 2nd shingles shot a few months ago feel lousy the next day. But me and the dogs are up on our shots.