The Food and Drug Administration on Wednesday released a review of Pfizer’s application for a COVID-19 booster shot, saying that while third shots boosted immune responses in study participants , the company’s vaccine stood firm against serious forms of the virus without the need for a shot.
The agency released the company’s request a few days before the FDA convened an external committee of experts to recommend whether to approve the reinforcement proposal. President Joe Biden announced last month that the government would begin offering third-party shots next week to people eight months after getting the second Pfizer-BioNTech inoculation shot, subject to FDA approval and a recommendation of the Centers for Disease Control and Prevention.
But that timeline has been under study this week amid a series of studies on the need for booster injections amid the spread of the highly transmissible delta variant of the virus. All three vaccines used in the U.S. offer strong protection against COVID-19, including the delta variant, although studies show that the effectiveness of some vaccines decreases about six months after a second stroke.
Pfizer noted in its application that the effectiveness of the vaccine against symptomatic cases of COVID-19 fell from 96% to 84% after six months, but that it was still extremely effective in preventing serious cases of the disease. . The company says a third dose would restore the vaccine’s effectiveness to around 95%.
“Overall, the data indicate that currently licensed or licensed COVID-19 vaccines still offer protection against serious COVID-19 disease and death in the United States,” the FDA wrote in its review of the Pfizer application.
The FDA is not required to follow the advice of its external expert group, which will be convened on Friday, but it often does. The agency said Pfizer’s booster application met the specified conditions under which the pharmaceutical company needed to meet its booster shots.
The New York Times notes that FDA warnings may affect the way the White House strengthening program is launched. The agency could reduce any authorization for a third stroke of Pfizer-BioNTech or recommend boosters only to certain subsets of the population, such as those aged 65 or over or with underlying conditions, the newspaper added.
Either strategy would undermine Biden’s plans for a wide-ranging launch of booster shots.
Two major FDA regulatory authorities on Monday released a review questioning the need for an immediate reinforcement program for the general public. The two scientists, Dr. Philip Krause and Dr. Marion Gruber, head the FDA’s vaccine office and said that while they did not write on behalf of the agency, they believed that no study “had provided credible evidence of ‘a substantial decline in protection against serious diseases’. ”In those who have been completely vaccinated against COVID-19.
In light of doctors’ comments, the FDA said this week that it was still in the “deliberative process of reviewing Pfizer’s supplemental approval filing,” and that, as a matter of practice, the FDA does not comment on pending matters before the agency. “.
“We look forward to a solid and transparent discussion on Friday on this request,” the agency said.
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