The Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously Friday to recommend approval for a booster of Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine.
The recommendation occurred despite the fact that FDA officials haven’t yet conducted an independent review of Johnson & Johnson’s clinical data, which would have taken months, according to Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research. Still, VRBPAC determined that a two-month booster for Americans aged 18 and over is safe and effective enough for emergency use authorization.
Johnson & Johnson conducted clinical trials on about 30,000 participants and presented data showing that its vaccine efficacy increased from 74% to 94% against severe disease with a booster dose. While data shows the J&J jab did not wane in protection over time to the degree of mRNA vaccines from Pfizer and Moderna, the initial dose offers a lower baseline level of protection, thereby making the case that boosters are needed.
some gaps in J&J’s data:
J&J studied just 17 people getting a boost at 6 months
J&J only collected safety data from people getting a boost at 2 months for 36 days pic.twitter.com/7lqWnK0ib6
— Emily Kopp (@emilyakopp) October 15, 2021
VRBPAC members pointed out that the J&J shot did not seem to lose much efficacy over time. They also raised concern over the lack of an independent review of the company’s data by the FDA. Dr. Paul Offit, a panel member and attending physician at the Division of Infectious Diseases at Children’s Hospital of Philadelphia, argued that most people received their J&J shot more than two months ago and that the vaccine may be better off as a two-dose series with an updated emergency use authorization than as a separate single dose and booster. (RELATED: Even Without Vaccines, Kids Are Still Safer From COVID-19 Than Their Vaccinated Grandparents)
The panel voted Thursday to recommend approval for Moderna’s booster shot for its two-dose vaccine. Both recommendations will now be reviewed by FDA leadership, and if approved, rollout guidelines for the boosters will then fall to the determination of the Centers for Disease Control and Prevention.