Advisers to the Food and Drug Administration voted, 19-0, to authorize a Johnson & Johnson COVID-19 booster shot at least two months after the first dose, providing some reassurance to the 14 million Americans who received its vaccine and face a higher risk of mild cases than other vaccinated people.
The Vaccines and Related Biological Products Advisory Committee recommended the second shot after parsing the data for five hours. The panel also showed some support at its meeting Friday for allowing people to get a booster shot made by a different manufacturer than the vaccine they originally received.
FDA and Centers for Disease Control and Prevention officials said at the meeting that real-world evidence suggests the single dose shot is less effective than the Pfizer-BioNTech and Moderna vaccines, including against hospitalization. Johnson & Johnson argued two doses of its vaccine would ramp up efficacy to 94 percent, comparable to those other authorized vaccines.
The company also said its vaccine provided more durable immunity than the mRNA vaccines, but that immunity has seen a dangerous decline due to variants like delta.
The company’s studies suggested a second dose of the vaccine would boost antibody levels by 1.5-fold to 4.5-fold.
The committee found evidence suggesting declining immunity and the safety of a second shot compelling, while also critiquing major gaps in the data and FDA’s analysis.
The next step in making a booster available is for the FDA to formally issue an emergency use authorization. The agency usually follows its advisers’ recommendations. After that, independent advisers to the CDC will evaluate the FDA’s emergency use authorization, and CDC Director Rochelle Walensky will offer guidance after hearing her own advisers’ recommendations.
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