The F.D.A. is aiming to give full approval to Pfizer's Covid vaccine on Monday.
Source: New York Times
The Food and Drug Administration is pushing to approve Pfizer-BioNTechs two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agencys planning. Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company.
The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.An F.D.A. spokeswoman declined to comment. The agency had recently set an unofficial deadline for approval of around Labor Day. The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting firmer regulatory backing before implementing mandates.
Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make Covid vaccinations mandatory for the countrys 1.3 million active-duty troops no later than the middle of next month, or sooner if the F.D.A. acts earlier.
The timing of the approval could result in an uncomfortable messaging problem for the Biden administration, which on Wednesday announced that fully vaccinated people should prepare to get booster shots eight months after they received second doses. Approving the vaccine and encouraging boosters at the same time may suggest to some that the vaccine as licensed is inadequate without an extra shot.
Read more: https://www.nytimes.com/2021/08/20/us/politics/fda-pfizer-covid-vaccine-full-approval.html
I really do think that they have most of what they needed from the clinical data and pending any haggling over the branding and labeling (particularly with respect to the language on any product packaging and probably A huge insert. with dosing/adverse reactions/contraindications, etc.), they should be ready to go with it.
LiberatedUSA
(1,666 posts)The unvaccinated wont be covered and wont be working. And they wont be getting beds first come first serve.
Ocelot II
(115,617 posts)The idea that the fully-approved vaccine is ineffective because a booster is recommended is stupid. A lot of vaccines need booster shots - the smallpox vaccine was one of them; its effectiveness decreases over time (I remember having to get a second one before going overseas in the late '60s). And we know what happened to smallpox.
BumRushDaShow
(128,551 posts)"it was rushed".
And as an example of what you're talking about - I know the tetanus shot (originally included in what was called a DTP shot - Dipheria, Tetanus, Pertussis, now the latest version called DTaP), was supposed to be given about every 10 years.
Lucky Luciano
(11,250 posts)genxlib
(5,519 posts)Although I have my doubts that people won't just find another excuse to not take it.
I am sure many will just say that it was approved to fast
Mostly, I am looking for private institutions to have more justification to just require it.
StarryNite
(9,440 posts)NickB79
(19,225 posts)Father of an 11 yr old here. Fingers crossed.
Evolve Dammit
(16,702 posts)two part Pfizer back in June. Take care
Ocelot II
(115,617 posts)Since those data might be different, this approval might not change the timeline for approval for kids' vaccine. But I hope that comes quickly.
Rhiannon12866
(204,856 posts)Jon King
(1,910 posts)Enough is enough, either get vaccinated or not be able to participate in large parts of society.
riversedge
(70,099 posts)IronLionZion
(45,380 posts)will be their excuse.
Hoping for Moderna next. The J&J people probably want some answers on booster shots.
70sEraVet
(3,474 posts)BumRushDaShow
(128,551 posts)Worried2020
(444 posts).
First was in June, second in July, but I could have gotten them earlier if I'd been paying attention.
I'm an old loner that pretty much self-isolates by habit, been wearing masks and distancing for over a year,
and no intention to stop.
OH! - and I had ZERO reactions to both doses although I was prepared for some. I haven't taken good care of this old body so I figured I was overdue for some discomfort.
Not a bit!
W
ps: and I got Certificates in my email for both of them, by the time I got home from each jab!
BumRushDaShow
(128,551 posts)it appears Canada is still debating boosters - https://nationalpost.com/news/covid-booster-shots-are-being-rolled-out-for-all-americans-what-about-canada
And as a note - DU skews "old" so you are among kin.
I keep this bookmarked although it was from over 1 1/2 years ago and obviously not "all" of DU but it gives you an idea - https://www.democraticunderground.com/100213017831
Worried2020
(444 posts).
56 - 75 year olds represent 66% of the membership here, as per the poll.
It could be quite different in reality,
but I think not
W
BumRushDaShow
(128,551 posts)it won't actually bump it (the thread was already archived). But I like to reference it...