FDA advisory committee unanimously recommends Johnson & Johnson COVID-19 vaccine booster for emergency use authorization

Adults at least 18 years old could soon gain access to a Johnson & Johnson COVID-19 vaccine booster shot if the U.S. Food and Drug Administration (FDA) agrees with the unanimous recommendation of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Last week, in a 19-0 vote, VRBPAC voted to recommend emergency use authorization for the booster among those who had waited at least two months after initial vaccination by the single-shot vaccine. Its recommendation was based on findings from two J&J-led trials, which determined the enhanced capabilities of a booster, finding them to be strong and long-lasting. In the Phase 3 ENSEMBLE 2 study, for example, a booster dose at two months out provided 94 percent protection against symptomatic, moderate-severe cases of COVID-19 and full protection against severe-critical COVID-19 at least 14 days after vaccination.

“Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” said Dr. Paul Stoffels, vice chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.

The booster shot was also well-tolerated, providing no new concerns that were not already seen in the primary dosage.

Johnson & Johnson said it expects a decision from the FDA soon. The CDC will gather an advisory committee to discuss boosters and provide recommendations as well on Oct. 21. The company has already indicated that it would provide the same data to regulatory bodies and advisory groups worldwide in seeking further authorization.