Johnson & Johnson was issued Emergency Use Authorization (EUA) from the FDA for a booster dose of the its COVID-19 vaccine for adults 18 and older at least two months following primary vaccination; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot.
 
The EUA is 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 J&J 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.
 
In the U.S., there is sufficient supply to support boosting to those who have received the J&J COVID-19 vaccine. More than 15.2 million doses of the company’s COVID-19 vaccine have been administered as primary vaccinations in the U.S.