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Pfizer's COVID-19 vaccine wins full approval from the FDA:
Pfizer's COVID-19 vaccine is now fully approved by the US Food and Drug Administration, making it the first shot against the coronavirus to get all the way through the regulatory review.
The FDA on Monday approved the mRNA vaccine against COVID-19 developed by Pfizer and its partner BioNTech for two doses, given three weeks apart, in people 16 years of age and older. The vaccine was previously being given under an emergency use authorization, which is still in place for the Moderna and Johnson & Johnson vaccines.
"While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," said acting FDA Commissioner Janet Woodcock in a release. "Today's milestone puts us one step closer to altering the course of this pandemic in the US."
Full approval is expected to make it easier for local governments, schools and businesses to require vaccinations and may encourage people who are hesitant to get a shot. Three in 10 unvaccinated adults said they'd be more likely to get a vaccine if one moved from emergency authorization to full approval by the FDA, according to a June poll by the Kaiser Family Foundation.
[...] The Pfizer vaccine will now be marketed as Comirnaty, said the FDA.
Also at Washington Post and CNN.
(Score: 1, Flamebait) by Anonymous Coward on Tuesday August 24 2021, @04:58AM (5 children)
Now that the science is settled and Pfizer's jab has been proven safe, and in the interest of removing any reason to be hesitant, one would assume they will be waiving their immunity from legal liability as granted by the invocation of the PREP Act.... right?
I mean... it's safe, so they don't need to be worried about people having bad outcomes as a result of accepting the jab. Right?
(Score: 0) by Anonymous Coward on Tuesday August 24 2021, @05:22AM (2 children)
The situation may be different in other counties, but afaik liability for vaccine injuries in the US has been taken over by a federal government agency in 1986.
If you suffer injury and the agency agrees, you may get compensation. But money can't really make up for living with serious after effects for decades.
(Score: 1, Informative) by Anonymous Coward on Tuesday August 24 2021, @08:49PM
So you think the PREP Act is fake news? I mean, CNBC has a story about it...
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html [cnbc.com]
(Score: 0) by Anonymous Coward on Wednesday August 25 2021, @04:00AM
You get money if you get infected by COVID?
(Score: 4, Insightful) by Beryllium Sphere (r) on Tuesday August 24 2021, @05:50AM (1 child)
Given the way the legal system works, they'd be fools to let greedy lawyers and prostituted "expert witnesses" make things up and sell them to juries chosen for ignorance in exchange for $19.50 per dose.
(Score: 0) by Anonymous Coward on Tuesday August 24 2021, @08:56PM
Would it be fair to characterize your opinion as "Vaccine makers (or pharmaceutical companies in general?) should never bear any liability for injuries incurred by patients because that would allow for fraudulent claims to be made against them"?
Does this reasoning extend to all realms of medicine?
To any area of human endeavor which is complex enough to require the testimony of expert witnesses?
What would cite as the distinguishing factor between an industry which should bear liability for the safety of its products (if there are any) versus the industries which shouldn't, due to the possibility of fraudulent claims?