FDA: Efficacy of J&J Vaccine
Johnson & Johnson’s single-dose vaccine, known as Ad26.COV2.S, offers significant protection against COVID-19, according to an FDA analysis posted in advance of Friday’s vaccine advisory committee meeting. The vaccine is a replication-incompetent adenovirus-vectored vaccine encoding a stabilized variant of the SARS-CoV-2 spike protein.
Friday’s meeting is to determine whether the benefits of the vaccine outweigh the risks. The company is seeking an emergency use authorization for vaccination in people ages 18 and over.
In a trial of 40,000 participants, the vaccine’s overall efficacy against moderate-to-severe/critical COVID-19 was 67% for cases occurring at least 2 weeks after vaccine receipt. Vaccine efficacy was somewhat higher in the U.S. (74%) than South Africa (52%), where the dominant strain has been the B.1.351 variant.
The most commonly reported adverse reactions were injection site pain (49%), headache (39%), fatigue (38%), and myalgia (33%). The FDA details several serious adverse events likely related to the vaccine, including a hypersensitivity reaction that didn’t meet the criteria for anaphylaxis and a case of severe systemic reactogenicity