Johnson & Johnson asks FDA to authorize booster dose of COVID-19 vaccine
Johnson & Johnson said Tuesday that it has asked the FDA to authorize a booster dose of its one-shot COVID-19 vaccine for people aged 18 years or older.
The company said its submission to the FDA included data from a late-stage study that found a second dose administered 56 days after the first shot boosted protection to 94% against symptomatic COVID-19 — and 100% against severe disease — at least 14 days after receiving the booster.
The FDA had already scheduled a 2-day meeting of its Vaccines and Related Biological Products Advisory Committee on Oct. 14 and 15 to discuss booster doses for the Moderna and Johnson & Johnson vaccines. Moderna submitted booster data to the FDA last month.
“The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement when the FDA announced the meetings.
The FDA has already authorized booster doses of the Pfizer-BioNTech vaccine for older patients and people at high risk for severe disease.
Health care workers are included in the latter group and are recommended to receive a booster — a guideline issued by CDC Director Rochelle P. Walensky, MD, MPH, on her own.
References:
CDC. Johnson & Johnson’s Janssen COVID-19 vaccine overview and safety. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html. Accessed Oct. 5, 2021.
Perspective
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It’s not surprising to see Johnson & Johnson filing for an emergency use authorization for its booster. Newer data has shown that a two-dose regimen may be superior when it comes to protection against serious disease — what matters — than the original one-dose regimen. It will be important to see how the FDA advisory committee will use the data because it is not likely that everyone will benefit from a booster, but those at high risk for serious disease — similar to the deliberations with the Pfizer vaccine — may.
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