F.D.A. Authorizes Pfizer Booster Shots for Older and At-Risk Americans
Source: New York Times
WASHINGTON After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTechs coronavirus vaccine to get a booster shot at least six months after their second injection. The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming severely ill with Covid-19 or are at risk of serious complications from the disease due to frequent exposure to the coronavirus at their jobs.
The authorization sets up what is likely to be a staggered campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for possibly tens of millions of vaccinated people to receive boosters at pharmacies, health clinics, doctors offices and elsewhere. Roughly 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention. About half of them are 65 and older. Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to learn whether they, too, can get boosters.
The F.D.A.s decision will be followed as soon as Thursday by a recommendation from the C.D.C., which issues guidance on vaccine policy for clinicians and public health officials throughout the United States. An advisory committee of the C.D.C. is now in the midst of a two-day meeting on the issue. But even if the C.D.C. takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the F.D.A.s eligibility criteria.
The ruling followed weeks of internal disagreement at the F.D.A., where some vaccine regulators openly challenged the idea of offering booster shots to the general population. Public health experts and state officials have criticized what they said were confusing public messages from the Biden administration about who should be eligible for a booster shot and when.
Read more: https://www.nytimes.com/2021/09/22/us/politics/pfizer-boosters-fda-authorize.html
This is the follow-on to the VRBPAC approval last week. CDC's ACIP met today to look at some of the data and ask questions and have a follow up meeting tomorrow to get public comments as well, with an agenda that will take into consideration this final FDA approval.
SheltieLover
(57,073 posts)Ty!
BumRushDaShow
(128,958 posts)Still gotta wait for CDC's final take.
They have another meeting tomorrow where their Committee might vote on whether to recommend approval and then it goes to the CDC leadership for the final yay or nay!
SheltieLover
(57,073 posts)Israel is planning for 4th boosters. 😏
I'll sure be glad to get mine!
BumRushDaShow
(128,958 posts)is a need to tweak the timing of doses based on what they have found so far. The Pfizer guy said that since they knew they would need 2 doses, they sortof randomly picked the 3-week timing between dose 1 and 2 just to get people done (Moderna has a 4 week dose 1 to dose 2 interval).
As time has gone on, some research has found that there might be better outcomes with a further-apart timing for dose 1 and 2, and subsequently a dose 3. So I expect Pfizer will be testing that and you'll start seeing the dosing schedule change at some point.
SheltieLover
(57,073 posts)I think I would've stroked out if mine had been more than 3 weeks apart.
I was counting days till I could get 2nd shot.
BumRushDaShow
(128,958 posts)sheshe2
(83,754 posts)I will be happy to get the booster.
totodeinhere
(13,058 posts)But what about those of us who got the Moderna shot? The report I saw said it may be weeks before Moderna is authorized for boosters. That doesn't seem fair. What's taking them so long?
BumRushDaShow
(128,958 posts)So Moderna is several months behind in terms of their submission. I would figure that Moderna could get an approval by December ALTHOUGH there is also a possibility, based on info that came out in last week's FDA VRBPAC meeting and today's CDC ACIP meeting, that since Moderna's vaccine did not have the type of efficacy drop over the same period of time as Pfizer, a booster/3rd dose might not necessarily be needed right away and if anything, a more targeted vaccine (like they do with the flu) could handle variants.
So it's possible that you (and me because I got Moderna) might not need a booster at all. They aren't quite ready to come right out and say that at this point because they are still looking at Moderna's data, but it's not out of the question and in fact, what might be do-able is to have Moderna as a 2-dose but separate out the 1st and 2nd dose interval further, and possibly not need that 3rd dose.
Also I think Moderna was testing 1/2 a dose to use an actual "booster" vs doing a 3rd full dose.
They are trying to nail down the "why". I.e., the Moderna shot is 100ug of active biologic where Pfizer's is only 30ug and Moderna has a 4-week interval between shots where Pfizer's is 3 weeks. So they want to confirm what might be making the difference. Is it the amount? Is it the separation between doses? Is it the candidate entity that was chosen?
This particular slide deck from today's meeting delved into what was found across 7 different sets of data-gathering systems to compare how the 3 vaccines performed for infections and/or hospitalizations, across age groups, underlying conditions, and occupations (PDF) - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-09-22/04-COVID-Link-Gelles-508.pdf
elias7
(3,999 posts)Maybe not all of us are under 65 or have co-morbidities or are immunosuppressed, but not all of them are getting a face full of Covid 3-4 x per shift .
BumRushDaShow
(128,958 posts)That was definitely discussed (i.e., the medical staff and other first responders) in today's meeting. I streamed it and watched it all day, literally "gavel to gavel" from 10 am EDT - 5 pm EDT (where it was running about 1/2 hour late). They noted that this group had always been at the front of the priority list during the initial vaccine rollout.
spooky3
(34,451 posts)BumRushDaShow
(128,958 posts)I'll be watching their "part 2" meeting tomorrow to see where that goes.
Wounded Bear
(58,653 posts)BumRushDaShow
(128,958 posts)temporary311
(955 posts)compared to Pfizer and JnJ. Probably due to higher dosage and more spaced out injections.
ShazzieB
(16,394 posts)As a diabetic he's a higher risk patient than I am, so I really hope what you say about the lower drop in efficacy holds true for him.
I'm happy to know I can get a booster soon, but my relief is tempered by disappointment that he won't be able to.
Sucha NastyWoman
(2,748 posts)yellowdogintexas
(22,252 posts)in cases/deaths and risk of catching it
A third dose of vaccine would ease his mind
yellowdogintexas
(22,252 posts)in the development of boosters that science would discover the missing variant and progect us.
Who new?
BidenRocks
(826 posts)It should be about 2 to 3 weeks before they are ready.
Meanwhile I got my yearly flu shot at the CVS.
No anti-vax here!