FDA Grants Full Approval of Pfizer Covid-19 Vaccine
In a process the FDA is saying that took only 40% of the usual time, the Pfizer Covid-19 vaccine has been full approved for use.
The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 and older.
Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.
Albert Bourla, the chair and chief executive officer of Pfizer, said the decision reaffirms the vaccine’s safety.
“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans,” Bourla said.
As an anecdotal observation – local coastal Mississippi media reports of this achievement have been met – online anyway – with extreme skepticism and overt silence from local and state political leaders. There’s still a lot of rampaging about how it was rushed, is still experimental, and thus not something you need to put into your bodies. A even as our state now leads the WORLD in new daily case confirmations. this on top of Trump again getting booed by his own supporters when he says people should take the shot.
It must be so delightful for Republican politicians to see their 4 plus decade long war on science and intellectual expertise coming to such a fantastic head.Report
I am hoping that this provides an “out” for a lot of people.
Like, sure, they spent the last 3 months posting about how the shot gives you 5G and the important thing to do is eat organic raspberries because they boost your immune system… but they’ve seen no shortage of stories of wheezing people in hospitals saying “I feel like such a damn fool” before being intubated and now, hey, Pfizer has an approved shot!
“That’s all I wanted!”, they can say. And they now have an out.
I’m hoping that it’s a significant chunk.Report
Be prepared to be disappointed.Report
yeah, my thought is ALL this will do is enable some businesses/schools (not in MY state, though, I guess) to enact vaccine mandates/programs of “either show your vaccination card or agree to weekly testing.” I have no hopes of this convincing a single one of the people who either couldn’t be arsed (because they’re “young and healthy” and think the risk is low) or are out and out anti vaxxers. I figure we’re just going to be living with COVID forever at this point, and we’ll all eventually contract it, vaccinated or not, and the only difference vaccination makes is you’re a lot less likely to die and POSSIBLY less likely to suffer cognitive decline.Report
As a fed I have already had to attest to my vaccination status or begin weekly testing if I go to federal facilities. Thankfully my agency is still on maximum possible telework, though I am fully vaccinated.Report
More likely, I think, that a bunch of people get vaccinated now because mandates are going to be in effect. For example, the Texas Tribune reports that the San Antonio school district started moving yesterday to implement mandatory staff vaccinations. The article points out that Gov. Abbott’s ban on mandates is specific to EUA vaccines, and the case the school district has been involved in with the AG is also specific to EUA vaccines.Report
Yeah a lot of this is probably going to get tougher for Republican politicians now that Pfizer has been approved. It will get worse for them when Moderna and J&J achieve the same status.Report
Moderna’s not too far behind. J&J have not applied for a full license yet, and do not expect to do so until late in this year. Depending on whether they get the same accelerated consideration, maybe by next May, maybe not until next fall.Report
Hey, if someone is on the fence and a mandate pushes them over? I’m good with that too.Report
A friend has been looking at the vaccine like a new Windows product or a new car model: wait till they get the bugs out before you buy it. I don’t know if this will motivate him, or just time will.Report
Does said friend see any down side to that approach, either for him/her/them or for their community?Report
Microsoft only wishes they could release any new version of Windows that was as nearly bug-free as the mRNA vaccines.Report
I’m sure there’s a good anti-virus pun just waiting to be found.Report
Fox is calling the timing suspicious because of course they are.
Kilmeade: “All of a sudden, out of nowhere, the FDA is going to give full approval to the Pfizer vaccine … do you believe the timing is curious?
https://twitter.com/LisPower1/status/1430151696009793546Report
I’m not endorsing this, but I was surprised to see opposition to the approval from a senior editor at the BMJ. Citing the Israeli data without noting that it was heavily confounded by age isn’t a great look.Report