FDA panel endorses Johnson & Johnson COVID-19 vaccine booster with 2-month gap for ages 18 and up

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A Food and Drug Administration (FDA) advisory committee on Friday endorsed an emergency authorization for the Johnson & Johnson COVID-19 vaccine booster when administered at least two months after the initial dose among people ages 18 years and older. 

The vote was 19-0. The recommendation is not final and will go before the FDA to issue an official decision.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) was charged with weighing whether safety and effectiveness data supported an emergency authorization for a booster shot at two months following the initial dose, stemming from a trial involving 30,000 participants.

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The panel’s vote Friday applied to all individuals ages 18 and older, while the panel previously endorsed authorizations for the Pfizer-BioNTech and Moderna booster shots across certain high-risk groups, like adults over age 65 and people ages 18-64 at high risk of exposure and severe COVID-19 disease.

Company findings presented during the meeting Friday indicated the initial dose was 74% effective against severe disease and 70% protective against symptomatic disease, however a booster shot administered at two months increased protection to 94%, according to Dr. Penny Heaton, global therapeutic area head at Janssen. However, studies indicated ranging efficacies, and surveillance data found the initial shot was 68% effective against hospitalization among adults without immunocompromising conditions.

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Protection from the initial dose was durable over time, Heaton said, which contrasts to the fading protection seen with the mRNA COVID-19 vaccines. However, the J&J vaccine offers less protection compared to the mRNA shots, even with their waning, Cohn noted.

"The reality is that your vaccine does seem to be holding up actually quite well in terms of durability, so the immediate need for a booster is not apparent," panel member Dr. Michael Kurilla told J&J officials, but he noted some potential benefit against emerging variants.

Of note, panel members noted concern that the FDA hadn’t yet conducted full independent analyses or verification of the company-submitted data including thousands of patients, which would have taken months to review, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

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Uptake of the one-shot J&J vaccine has lagged far behind vaccines developed by Pfizer-BioNTech and Moderna, at 15.2 million doses administered, versus 236 million and 153 million shots in arms, respectively, per CDC data. In April, federal health officials lifted an 11-day pause on use of the J&J COVID-19 vaccine  following a review and the recommendation of a panel of experts who determined it met safety standards despite rare instances of severe blood clots.

In an updated safety analysis Friday, J&J officials noted not a single case of the rare clotting syndrome, thrombosis with thrombocytopenia syndrome (TTS), was detected in the booster shot trials.

Finally, Dr. Paul Offit, voting member and attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia, noted that most people who received the initial J&J one-shot vaccine received it more than two months ago, and the panel on Friday declined to recommend the booster when administered after six months due to insufficient data and a small sample size of 17 participants. What’s more, panel members suggested the J&J vaccine is better fit as a two-dose series with an amended emergency use authorization, instead of a single dose and a follow-up booster shot.