Good, if belated, news: The Food and Drug Administration has finally decided to accelerate its effort to review Pfizer ’s Covid-19 vaccine for full approval. The agency disclosed the news last week amid political pressure and consternation that its delay may contribute to vaccine hesitancy.
Pfizer’s messenger RNA vaccine was approved last year under emergency-use authorization, and hundreds of millions of doses have been administered with few negative side effects. You’d think the benefits of the vaccine would prompt the FDA to move fast on full approval. But this is a government agency with bureaucratic rules for everything, and the White House seems not to have pressed the issue until the latest bounce in Covid infections.
The FDA had recently put Pfizer’s application on an accelerated process to offer approval within six months, rather than the typical 10 or more. But officials told the website STAT that the agency will now initiate a “sprint” for final review. Officials said this will mean shifting resources and manpower to the Pfizer review from plant inspections and perhaps reviewing other biologic applications.
President Biden has said he believes full FDA approval for Pfizer’s vaccine could come as early as September or October, which ought to be possible. If the “emergency” label is holding back vaccinations at all, then there is no higher public-health priority than reassuring Americans that the accumulated evidence shows that the vaccine is safe and saves lives.
opinion Pharmaceuticals need to be held accountable for these vaccines
opinion Not that long ago the 'experts' using 'science' Said all wll be well after the vaccine.. yet here we are because. 'the science has changed'. And we suddenly have a threatening virus ... Cases Hospitalizations...Deaths all UP UP UP Why can't 'the science' change again?
opinion After reading some comments on this article, you seemed to fail insisting on the fact that a vaccine doesn't need 7 years of testing to be approved.
opinion Every vaccine needs a minimum of five to 10 years... Before it is deemed safe and approved by government But let's completely forget about that right now
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opinion So these folks say they don't trust govt. but they're waiting on FDA approval to get vaxxed. 😁
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opinion Take the EUA away they won’t be injecting anyone. Because they don’t want the liability. Game over. Exp on those jabs is ticking daily billions gone. And its somewhat glorious but not for the ones who fell for the lies...
opinion Right… and when it all of a sudden gets speedy approval, none of those who are hesitant will be at all suspicious… The process needs to run its course. Can people really not see that?
opinion Liar
opinion Uh yeah, I've noticed a lot of people out there have zero interest in the truth. Like the more you try to convince them with evidence, the more they dig their heels in.
opinion It’s basically the same data as the modern day flu
opinion thanks
opinion That’s the excuse people use when they really mean “I’ve been watching FOX and….”
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