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.
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.