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Is FDA Taking Too Long to Approve the Covid Vaccines?
(Thursday, July 29, 2021) With 343 million doses administered and 163 million people fully vaccinated in the US, it may be annoying for the layman as to why has FDA not yet fully approved any vaccine. And it would not be an unreasonable question to ask, although probably unfair to the FDA. It is important to understand a few other numbers to put this in context. FDA cannot arbitrarily approve products; the developers have to file for a full approval for their products with FDA first. The first application for vaccine approval was filed in early May, less than 3 months ago. By the fastest regulatory timelines allowed to it, it is barely enough time for FDA to verify that the application is even complete. And FDA does not have the same circumstance it had 7 months ago. Vaccines are freely available to anyone who wants, so there is no regulatory urgency to expedite the approval. One must remember that FDA authorized the vaccines in a matter of weeks. Under the US approval there are no regulatory pathways to grant emergency approval to drugs or vaccines, there is no provision to grant conditional approvals, and no mechanisms to withdraw approval without major safety issues. FDA is working within those legal boundaries and that is a good thing. On the other side of the argument, the COVID pandemic is unprecedented in all aspects of the word. FDA should probably be conducting rolling reviews of the vaccine applications. During the emergency authorization reviews, FDA did get to review the manufacturing processes and the clinical studies, so when the applications were formally submitted, it likely already knew most of the data contained in those applications well. Should it give the applicants credit for what it already knew at the time of filing, and approve? Probably, that’s what would happen if the full approval comes in September, as predicted by some pundits 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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