Pfizer vaccine still effective, according to FDA, days before recall proposal review

The Food and Drug Administration on Wednesday released a review of Pfizer’s request for a COVID-19 booster, saying that although the third injections increased immune responses in study participants, the company’s vaccine was highly resistant. to severe forms of the virus without further shooting.

The agency released the company’s request just days before the FDA convened an external expert panel to recommend whether or not to approve the recall proposal. President Joe Biden announced last month that the government would begin offering a third injection next week to people eight months after receiving their second injection of Pfizer-BioNTech, subject to FDA approval and a recommendation from the Centers for Disease Control and Prevention.

But that schedule has come under scrutiny this week amid a series of studies into the need for booster vaccines amid the spread of the highly transmissible delta variant of the virus. All three vaccines used in the United States offer strong protection against COVID-19, including the delta variant, although studies show that the effectiveness of some vaccines declines about six months after a second vaccine.

Pfizer noted in its application that the effectiveness of its vaccine against symptomatic cases of COVID-19 fell from around 96% to 84% after six months, but was still extremely effective in preventing severe cases of the disease. The company claims that a third dose would restore the vaccine’s effectiveness to around 95%.

“Overall, the data indicates that the COVID-19 vaccines currently licensed or authorized in the United States still provide protection against severe COVID-19 disease and death in the United States,” the FDA wrote in its review of Pfizer application.

The FDA is not required to follow the advice of its external expert panel, which will meet on Friday, but it often does. The agency said Pfizer’s booster app meets specified conditions the drug company must meet with its booster injections.

The New York Times notes that the FDA warnings could affect how the White House recall program is rolled out. The agency could reduce any clearance for a third Pfizer-BioNTech jab or recommend boosters only to certain subsets of the population, such as those 65 and older or with underlying conditions, the newspaper added.

Either strategy would undermine Biden’s plans for a wide deployment of the recall shots.

On Monday, two major FDA regulators also released a review that questioned the need for an immediate recall program for the general public. The two scientists, Dr Philip Krause and Dr Marion Gruber, head the FDA’s office of vaccines and said that while they were not writing on behalf of the agency, they believed no studies were had “provided credible evidence of declining substantial protection against serious illness.” in those who have been fully vaccinated against COVID-19.

In light of comments from doctors, the FDA said this week that it is still “in the middle of a deliberative process to review Pfizer’s request for further approval of the recall, and the FDA, in practice, does not. not comment on the issues pending before the agency. ”

“We look forward to a solid and transparent discussion on this app on Friday,” the agency said.