FDA vaccine panel unanimously recommends boosters for everyone who got J&J shot

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The FDA's vaccine advisory committee voted unanimously Oct. 15 to recommend that everyone who got Johnson & Johnson's single-dose COVID-19 vaccine be eligible for a booster shot at least two months after the first. 

A final decision from the FDA could come within days, according to CNBC. A CDC vaccine advisory group is meeting next week to recommend who should get a Johnson & Johnson booster, and the last step before boosters can be administered to the public would be for CDC Director Rochelle Walensky, MD, to approve the advisory group's recommendation. 

Many members of the FDA's Vaccines and Related Biological Products Advisory Committee said Johnson & Johnson's shot should be considered a two-dose vaccine like Moderna's and Pfizer's, CNBC reported. 

Johnson & Johnson has submitted data showing a second dose of its vaccine given two months after the first dose raises protection against symptomatic COVID-19 infection from 72 percent to 94 percent. 

But the FDA published documents Oct. 13 saying it was unable to verify most of Johnson & Johnson's data because it wasn't submitted in enough time before the meeting. 

Some FDA committee members questioned why they were voting on a Johnson & Johnson booster before the FDA could verify the drugmaker's data, according to CNBC. But the committee's chair, Arnold Monto, MD, said the vote took place because of concerns over the vaccine's lower effectiveness compared to Moderna's and Pfizer's vaccines. 

"There is a public health imperative here, because what we're seeing is this is a group with overall lower efficacy than we have seen with the mRNA vaccines, so there is some urgency to do something," he said, according to CNBC

More than 15 million people in the U.S. have gotten a Johnson & Johnson COVID-19 vaccine, according to CDC data

Peter Marks, MD, PhD, head of the FDA's vaccine center, said the FDA may consider authorizing Johnson & Johnson recipients to receive a booster of Moderna or Pfizer's vaccines, but he gave no timetable for the decision, The New York Times reported. 

According to an agenda of the FDA committee's Oct. 15 meeting, the members will be presented with data from the National Institutes of Health on mixing and matching COVID-19 vaccines for booster doses.

 

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