US FDA panel clears COVID-19 booster shots for people over 65

The recommendation comes after the Scientific Advisory Board rejected Pfizer’s proposal to provide booster shots to most people.

A U.S. Food and Drug Administration (FDA) advisory group has approved a recall of the Pfizer COVID-19 vaccine for people over 65 and others at high risk of contracting the disease.

But the influential group of FDA scientists on Friday rejected the large-scale delivery of boosters to most Americans, dealing a surprise blow to the Biden administration’s plan to combat the highly contagious Delta variant by rolling out the third injection of the vaccine next week.

Members of the FDA’s external expert panel voted unanimously to support recalls for elderly Americans and those at risk after rejecting Pfizer’s proposal to provide recalls of the vaccine to the general public.

The FDA’s decision to pave the way for booster injections only for the elderly and at risk came as President Joe Biden planned to hold a COVID-19 summit on the sidelines of the United Nations General Assembly in New York next week.

The United States urged partner countries to increase vaccine availability worldwide. The World Health Organization has urged the United States to do not provide boosters to its citizens until more of the world’s population has received an initial inoculation.

“We will ask participants to commit to a higher level of ambition” on a “common vision to jointly defeat COVID-19,” White’s press secretary Jen Psaki said in a statement.

During several hours of discussion, the FDA panel of scientific advisers expressed frustration that Pfizer provided little data on the safety of additional doses. And they complained that the information Israeli researchers provided about their recall campaign was not helpful in predicting the American experience.

Pfizer Inc and its German partner BioNTech, as well as rival vaccine maker Moderna Inc, presented clinical trial analyzes showing that vaccine effectiveness declines over time.

As a result, people who were vaccinated earlier in the pandemic are now more vulnerable to infections, especially in the face of the Delta variant of the rapidly spreading coronavirus.

The booster doses help restore the decreasing levels of antibodies produced by the original inoculation, the drugmakers said.

Key FDA members have been divided over the need for the boosters, with interim director Janet Woodcock supporting them, but some of the agency’s top scientists arguing they aren’t needed yet.

Members of the advisory group said Pfizer and the FDA’s request for approval for people as young as 16 is too broad. Most of them said they would support boosters for older Americans, but didn’t think they were needed for young adults yet.

Many vaccine experts have said the data so far only suggests a need for boosters in the elderly and people with weakened immune systems. Critics include two FDA scientists who resigned when the Biden administration announced its recall plans.

A separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House has said it is ready to roll out boosters next week if health officials approve the plan. This program is now likely to be scaled back in light of the views of the advisory committee and partial FDA approval for the use of boosters.

A published report in The Lancet medical journal of September 13, concluded that even with the threat of the more contagious Delta variant, “booster doses for the general population are not appropriate at this stage of the pandemic.”

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