U.S. FDA Recommends Against Booster Vaccines for Under-65s

The advisory committee of the U.S. Food and Drug Administration (FDA) says booster jabs should be given to the over-65s and the clinically vulnerable but has voted 16-2 against recommending additional doses for everyone else aged 16 and over. MailOnline has the story.

Members said said [sic] there was not enough evidence that a third dose was safe and effective for use in people under age 65.

The FDA is not bound to follow the advisory group’s recommendations but the agency rarely goes against the guidance of VRBPAC.

The next step before the FDA can issue authorisation is a recommendation for approved by the advisory committee for the Centers for Disease Control and Prevention (CDC).

Pfizer had previously submitted data that the company claimed show its vaccine’s efficacy falls by about six percent every two months following the second and final dose.

But many scientists, including senior officials at the FDA, disagree and argue that the vaccines are still highly effective at preventing severe illness and death.

Last month, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.

At least 2.04 million people in the U.S. have received booster doses as of Friday, according to data from the CDC.

The White House also announced last month booster shots would become available for all Americans starting on September 20th due to data suggesting waning efficacy of the initial shots. …

Dr. Phil Krause, Deputy Director of the FDA’s Office of Vaccines Research and Review, said that Pfizer’s data [suggesting that people who received booster doses had high levels of protection] had yet to be independently reviewed by experts.

“One of the issues in this is that much of the data that’s been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA,” he said.

FDA and CDC officials have previously expressed to [sic] their doubts to the White House about the need for extra doses.

Worth reading in full.

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