A panel of experts unanimously voted 19-0 to recommend 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 initial vaccination with the single-shot vaccine.
A study published by the CDC in September showed the J&J vaccine had an effectiveness of around 68% in keeping people out of the hospital for COVID-19 compared with more than 90% for Moderna’s vaccine and about 77% for the Pfizer-BioNTech after about four months. The panel recommended that the booster dose come at least two months after initial immunization with one shot of the J&J vaccine. It applies to people 18 years and older. During the meeting, J&J presented data that showed the protection of the single-shot remained largely stable over time but that a second dose pushed the protection to a higher level.
The vote was based on findings from two company clinical trials which evaluated a booster dose of the Johnson & Johnson COVID-19 vaccine administered two months after the single-shot, as well as a large and robust real-world evidence study. The company also presented data that support the increased potential of a booster when administered at six months. Phase 3 clinical data and real-world data both demonstrated the Johnson & Johnson single-shot COVID-19 vaccine was strong and long-lasting.
Q: Do I need a booster shot if I received the Johnson and Johnson vaccine?
A: It is likely that those who received the J&J vaccine will also be recommended for a booster. We expect more data in the next few weeks and will keep the public informed.
— The White House (@WhiteHouse) August 20, 2021
The FDA panel said that the J&J vaccine’s protection was substantially lower than the mRNA vaccines made by Moderna and Pfizer — even when waning of their protection is taken into account.
The @US_FDA Advisory Committee voted unanimously to recommend the FDA grant Emergency Use Authorization for a #booster dose of the Johnson & Johnson #COVID19 #vaccine.
The Janssen COVID-19 Vaccine has not been approved/licensed by the FDA. https://t.co/Xnh5QXScdQ pic.twitter.com/46O7xOUnmj
— Johnson & Johnson (@JNJNews) October 15, 2021