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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsFDA, under pressure, plans 'sprint' to accelerate review of Pfizer's Covid-19 vaccine for full
FDA, under pressure, plans sprint to accelerate review of Pfizers Covid-19 vaccine for full approval
WASHINGTON Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizers application for the formal approval of its Covid-19 vaccine, a senior agency official told STAT.
Pfizers vaccine is currently cleared under a so-called emergency use authorization, which allows the company to sell the vaccine for as long as Covid-19 is considered a public health emergency.
But with Covid-19 still raging, and its spread now fueled by the Delta variant, lawmakers and prominent health experts have urged the FDA to expedite full approval of Pfizers vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and in giving businesses and other entities a stronger legal foundation to impose vaccine mandates.
The process requires FDA staff to review millions of pages of complex data, conduct plant inspections, and negotiate with Pfizer over issues including the terms of the FDAs approved label and the companys postmarketing responsibilities. Now, the senior agency official said, the agency will initiate a sprint.
WASHINGTON Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizers application for the formal approval of its Covid-19 vaccine, a senior agency official told STAT.
Pfizers vaccine is currently cleared under a so-called emergency use authorization, which allows the company to sell the vaccine for as long as Covid-19 is considered a public health emergency.
But with Covid-19 still raging, and its spread now fueled by the Delta variant, lawmakers and prominent health experts have urged the FDA to expedite full approval of Pfizers vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and in giving businesses and other entities a stronger legal foundation to impose vaccine mandates.
The process requires FDA staff to review millions of pages of complex data, conduct plant inspections, and negotiate with Pfizer over issues including the terms of the FDAs approved label and the companys postmarketing responsibilities. Now, the senior agency official said, the agency will initiate a sprint.
https://www.statnews.com/2021/07/30/fda-under-pressure-plans-sprint-to-accelerate-review-of-pfizers-covid-19-vaccine-for-full-approval/
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FDA, under pressure, plans 'sprint' to accelerate review of Pfizer's Covid-19 vaccine for full (Original Post)
herding cats
Jul 2021
OP
marybourg
(12,631 posts)1. Then the needle scaredy-cats will say "it was too rushed"
herding cats
(19,564 posts)2. Most definitely.
But, it will open the door to federal mandates.
Volaris
(10,270 posts)3. Dont care. Once general approval happens, private sector can require shots
As a condition of new or continued employment.
FINALLY there will be consequences for their stupidity.
Get stuck or gtfo.