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FDA panel recommends booster shot of Johnson & Johnson vaccine

A Food and Drug Administration (FDA) advisory committee voted to recommend authorizing a second dose of Johnson & Johnson’s COVID-19 vaccine.

The agency’s vaccine advisory committee voted unanimously, 19-0, to recommend authorization of a second dose as early as two months after the primary shot for anyone ages 18 and older.

Johnson & Johnson representatives told the panel that a second dose given either two months or six months after the first shot increased antibody levels, but a single dose of the vaccine continued to offer protection. 

The recommendation, which is not binding, will now be taken up by the FDA, which could make a decision within days.

Committee members expressed concern with the quality of data presented by the company, because there were ultimately only 17 people included in an analysis, who were followed for six months. 

The FDA said it relied heavily on studies conducted by Johnson & Johnson and could not independently confirm many of the findings because data from the trials were not submitted in time. 

Archana Chatterjee, an infectious disease expert at Rosalind Franklin University, asked FDA officials why there was even a meeting if the agency hadn’t been able to conduct its own studies.

Peter Marks, the head of the agency’s vaccine division, said it could have taken months to review all the data, and the agency is trying to act as quickly as possible. 

Still, the vote and subsequent FDA action will likely add some clarity to the path forward for the 15 million people who received a Johnson & Johnson vaccine.

The panel was originally asked to vote on a more complicated series of questions, including whether to recommend a booster six months after the initial dose. They asked to simplify the original questions instead, and voted on the two-month period.

Unlike the recommendations for boosters of Pfizer’s and Moderna’s vaccines, the panel did not limit who should get a booster. Many panel members said they always thought the vaccine would need a booster dose, and some wondered why it was presented as a single-dose shot.

Marks said it was used as an “outreach vaccine” to people who may not have been part of an organized health system. He also expressed some skepticism about the efficacy of a single dose, despite what the company was presenting.

“All of the data don’t align on this being a vaccine that retains strong efficacy over time against all forms of disease, including for more severe outcomes,” Marks said. “There are data that suggest the effectiveness of their vaccine is less robust than what the company is presenting. That is a finding of concern.”

Following the vote, the panel will discuss a study about the possibility of “mixing and matching” booster doses. A preliminary study from the National Institutes of Health found Johnson & Johnson vaccine recipients may benefit more from a booster of the Moderna or Pfizer-BioNTech vaccine.

The panel won’t vote on a recommendation to authorize such a strategy, because the data is still considered preliminary, and the FDA has not yet reviewed the study.

Updated at 2:18 p.m.

Tags booster coronavirus vaccines FDA johnson & johnson Johnson & Johnson COVID-19 vaccine

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