On Oct. 20, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot was the same formulation and dosage as the primary shot.

The EUA follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) based on data provided by the Company, including efficacy, safety and immunogenicity data from its clinical trials and real-world evidence data. When administered as a primary or booster dose, following initial vaccination with the Company’s COVID-19 single-shot vaccine, it provided protection against symptomatic disease and was generally well-tolerated, highlighting the favorable benefit-risk profile of a booster dose in light of the ongoing pandemic.

A single booster dose of the Johnson & Johnson COVID-19 vaccine may also be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.

Editor Note: On Jun. 1, 2023, the FDA revoked the J&j booster vaccine. The remaining U.S. government-purchased vaccine lots had expired, and there was no ongoing demand for new lots in the United States, and the manufacturer did not plan to update the vaccine to target emerging variants.