FDA to require 2-month follow-up period for COVID-19 vaccines before authorization

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Pharmaceutical companies developing COVID-19 vaccines should wait two months after late-stage studies conclude to submit an application for an emergency use authorization to the Food and Drug Administration, the regulator said Tuesday. In a guidance document released in advance of a planned Oct. 22 meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA said an application should include “data from Phase 3 studies that includes a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile.” It is also asking drug makers to wait until there are at least five cases of severe COVID-19 reported among the group of people who received the placebo. The New York Times this week had reported that the Trump administration is trying to block the two-month review in order to speed up the authorization and distribution of coronavirus vaccines. A separate report in Politico this week said that White House officials had told Trump that the drug industry is resistant to the guidelines. There are four COVID-19 vaccine candidates in late-stage clinical trials in the U.S., developed by AstraZeneca and the University of Oxford, BioNTech and Pfizer Inc. , Johnson & Johnson , and Moderna Inc. . None of these companies have released Phase 2 or Phase 3 clinical data at this time. Pfizer CEO Albert Bourla on Tuesday tweeted that “Pfizer has never discussed [the FDA’s COVID-19] vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.”
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