BREAKING: No, The Vaccine Is NOT FDA Approved! Not Even Close! -

submitted by Magawillrise from proudamerican.site

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[–]raven9 3 insightful - 2 fun3 insightful - 1 fun4 insightful - 2 fun -  (2 children)

On the FDA website they say it is approved...

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

[–]StillLessons 3 insightful - 1 fun3 insightful - 0 fun4 insightful - 1 fun -  (0 children)

Thanks. Doesn't get clearer than that. The FDA has approved Pfizer's shot.

I still recommend people go ahead and read the official letter they sent. Doesn't read how I would expect a "full approval" to read:

https://www.fda.gov/media/150386/download

So they approve the shot, while simultaneously trying to cover their asses for the future, pretending actually to pay attention to the fact that this is still wildly experimental, without the time required to know even the medium-term (1-5 years) biological effects. Once again, number of jabs does not equal time, and time will be required to learn a lot more about how these shots are going to affect us. 8 months tells us very little indeed.

[–]infocom6502 1 insightful - 1 fun1 insightful - 0 fun2 insightful - 1 fun -  (0 children)

Not really, it hardly sounds like a full and final approval, but like conditional approval to progress the trials towards the latter stages. Note that the first sentence does not mention "full approval", and continue to read (2nd+3rd sentence) after the first sentence:

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Please read or at least skim through the FDA letter linked by the original tweeter.

--*Update:-- Ooops, Raven9 is correct on this. Other very credible sources like Dr. Campbell and Zero wedge confirm this.

The last paragraph of the Press Release mentions the application was given 6-month rush priority review. Their justification is that they believe the benefits outweight the risks (which is a far cry from 'safe' in the 'safe and effective' campaign). Technically speaking, almost certainly for those with no choice but to be on immunosuppressants and unable to isolate, and likely for some very high age groups and people with conditions like obesity and unwilling to take vitamin D supplements to maintain healthy levels over 30ng/ml, this prescription would improve net odds of suffering an iinjury from this new SARS, at least assuming the share of new variants aren't changing outcomes significantly, from the original strain and early variations of them. The youtube link above discusses the problem of outdated data that the FDA is using to justify approval of the application)