WASHINGTON (Pakistan Point News / Sputnik - 18th September, 2021) An advisory panel to the US food and Drug Administration (FDA) on Friday voted unanimously to endorse Pfizer-BioNTech's COVID-19 booster shots for people who are 65 years and older, after rejecting approval of the shot for all Americans who were already vaccinated for the novel coronavirus.
"It's likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don't think we're there yet in terms of the data," Ofer Levy, a vaccine and infectious disease specialist at Boston Children's Hospital who was among 18 medical professionals who held a live-streamed public discussion on the merits of the booster before voting on it, said.
The partial approval was a face-saving grace for the Biden administration, which had already announced it would begin distributing by September 20� boosters for all Americans who had previously received two shots of the Pfizer-BioNTech and Moderna vaccines and one shot of the Johnson & Johnson vaccine.
A total rejection of the booster would have put in jeopardy a key part of President Joe Biden's plan to combat COVID-19 and its more dangerous and transmissible Delta variant.
Earlier in the hearing, panel members overwhelmingly rejected the booster shot for younger people, citing the inadequacy of data samples that had been submitted for their consideration.
Aside from seniors, the panel approved the booster for anyone with a high risk of contracting a severe case of COVID-19. It also also approved emergency use authorization rather than a supplemental approval of the already fully-licensed vaccine.
"There was a very small data set that was done in the third dose for Pfizer ... we really do need broader safety data,"� said Hayley Gans, a professor of pediatrics and pediatric infectious disease at Stanford University, who was among those who voted. "I would support having a third dose available for other high-risk groups, such as individuals over the age of 50 to 60."
Prior to the vote, Biden administration officials had cited three studies from the US Centers for Disease Control and Prevention that showed fully vaccinated people could still experience diminished immunity after several months. As such, the administration had planned to call people up to get a third dose of Pfizer or Moderna's vaccine eight months after their second shot.
Biden himself had said that scientists were reviewing whether to move the third shot up by three months.
Friday's vote considered analyses from not just Pfizer but also Moderna, which showed the incidence of breakthrough COVID-19 cases - occurring in fully vaccinated people - was less frequent in clinical trial participants who were more recently inoculated, suggesting that the initial protection from the vaccines waned over time.
Pfizer also submitted a study in Israel showing a third dose of the vaccine six months after a second shot restores protection from infection to 95%.
