MONDAY, March 1, 2021 (HealthDay News) — The Janssen COVID-19 vaccine received the third emergency use authorization for a vaccine to prevent COVID-19, the U.S. Food and Drug Administration announced Saturday.
Following a recommendation for approval Friday from the FDA Vaccines and Related Biological Products Advisory Committee, the FDA determined the single-dose adenovirus type 26 (Ad26) vaccine has met the statutory criteria for an EUA to be used in individuals 18 years and older. “The emergency use authorization of a third vaccine against COVID-19 in the United States … just over a year since the virus was identified, demonstrates extraordinary scientific commitment and progress,” Barbara D. Alexander, M.D., president of the Infectious Diseases Society of America, said in a statement. “The availability of another safe and effective vaccine that requires only one dose and that can be stored with only basic refrigeration opens new opportunities for delivery and expanded access for millions of people.”
Efficacy data came from an analysis of 39,321 participants (19,630 randomly assigned to the vaccine and 19,691 randomly assigned to saline placebo) in an ongoing randomized, placebo-controlled study conducted in South Africa, South America, Mexico, and the United States. None of the participants had evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection before receiving the vaccine.
Data showed the vaccine was 67 percent effective overall in preventing moderate-to-severe COVID-19 at least 14 days after vaccination and 66 percent effective at least 28 days postvaccination. At 14 and 28 days after vaccination, respectively, the vaccine was 77 and 85 percent effective in preventing severe/critical COVID-19. At this time, the FDA said data are not available “to determine how long the vaccine will provide protection” or whether “the vaccine prevents transmission of SARS-CoV-2 from person to person.”
The safety data reviewed for the EUA came from 43,783 participants (21,895 randomly assigned to the vaccine and 21,888 randomly assigned to placebo) in the same ongoing randomized, placebo-controlled study. At a median of eight weeks following vaccination, side effects most commonly reported were pain at the injection site, headache, fatigue, muscle aches, and nausea, most of which were mild-to-moderate and resolved within one to two days.
The EUA was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. Janssen Biotech Inc. and vaccination providers are required to report any serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death to the Vaccine Adverse Event Reporting System. They must also report all vaccine administration errors.
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