An FDA advisory committee voted unanimously Friday to recommend the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S) for use in adults 18 and older.
Based on the totality of scientific evidence available, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22-0 that benefits of the vaccine “outweigh its risks for use in individuals 18 years of age and older,” so the vaccine should qualify for FDA emergency use authorization (EUA).
FDA staff found few faults with the vaccine, and most of the issues raised by the committee were not deemed important enough to affect support for the EUA.
Data supporting the EUA application (the same as presented in pre-meeting briefing documents) were primarily from the phase III multi-national randomized, placebo-controlled trial dubbed ENSEMBLE by Johnson and Johnson, and sponsored in part by the National Institute of Allergy and Infectious Diseases. They showed 66.9% efficacy (95% CI 59.0%-73.4%) against moderate to severe COVID-19 at 14 days and 66.1% (95% CI 55.0-74.8%) at 28 days following vaccination. Vaccine efficacy in the U.S., which was 74.4% at 14 days following vaccination and 72% at 28 days following vaccination.
Efficacy against severe COVID-19 for the entire cohort was 76.7% (95% CI 54.6%-89.1%) 14 days after vaccination and 85.4% (95% CI 54.2%-96.9%) at least 28 days after vaccination. A post-hoc analysis found two COVID-related hospitalizations in the vaccine group and 29 in the placebo group after 14 days, with 0 and 16 cases after 28 days, respectively.
Examining safety, injection site pain was the most common local adverse reaction in the vaccine group (49%), while headache (39%) and fatigue (38%) were the most common systemic reactions. As with other vaccines, these were reported more frequently by younger participants.
The FDA does not have to follow the advice of its advisory committees, but it often does.
Source: MedicalNewsToday.com
