An Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended the Johnson & Johnson COVID-19 vaccine booster shot for adults 18 and older at least two months after the initial vaccination.

On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 recommending the Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 vaccine booster shot.

The FDA panel’s decision was based on data from Johnson & Johnson’s two clinical trials showing that its single-shot COVID-19 vaccine provides “strong and long-lasting protection. The data also provided evidence that a booster shot increases protection particularly against symptomatic COVID-19, according to Paul Stoffels, M.D., Vice Chairman of the Executive Committee, and Chief Scientific Officer, Johnson & Johnson.

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Johnson & Johnson’s Phase 3 ENSEMBLE 2 study showed that a booster dose given two months after the initial vaccination, provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the United States and 100 percent protection against severe/critical COVID-19, at least 14 days post-booster vaccination.

The company’s Phase 1/2a study showed that a booster dose given six months after the first vaccination increased a person’s antibody levels by nine-fold a week after the booster. The antibody levels continued to increase to 12-fold four weeks after the booster.

Johnson & Jonhson said its COVID-19 vaccine when given as a primary or booster dose is “well-tolerated” by those who received it based on the data from the ENSEMBLE 2 trial. The company added that no new safety signal was observed.

“Today’s recommendation by the VRBPAC is another step toward ensuring that those who have received the single-shot Johnson & Johnson vaccine – or will receive it in the future – are provided the opportunity to increase their protection against COVID-19,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

In the United States, 15.1 million people received the Johnson & Johnson COVID-19 vaccine as a primary vaccination. The company said it has a sufficient supply of booster shots for them.

On Thursday, the same FDA Advisory Committee recommended the Moderna COVID-19 booster shot for individuals ages 65 and older and other high-risk adults. Last month, the panel also recommended Pfizer-BioNTech COVID-19 Vaccine booster shot for people 65 years and older and for other high-risk adults. Both Moderna and Pfizer-BioNTech COVID-19 Vaccine booster shots are recommended six months after a person completed his/her primary doses.


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