The Medical Letter on Drugs and Therapeutics
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In Brief: FDA to Review Johnson and Johnson COVID-19 Vaccine
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The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review a request by Johnson & Johnson (Janssen) for Emergency Use Authorization (EUA) of their adenovirus-based COVID-19 vaccine candidate on February 26. The meeting will be webcast from the FDA's website and streamed on Facebook, Twitter, and YouTube.1 Two mRNA-based vaccines, produced by Pfizer/BioNTech and Moderna, received EUAs for prevention of COVID-19 in December 2020.2,3

CLINICAL STUDIES — In a double-blind trial (ENSEMBLE; summarized in a press release), 43,783 adults were randomized to receive a single dose of the Johnson & Johnson vaccine or placebo. The vaccine efficacy rate for prevention of moderate to severe COVID-19 from day 28 was 66% overall (based on 468 reported cases); it was 72% in the US, 66% in Central and South America, and 57% in South Africa, where a SARS-CoV-2 variant from the B.1.351 lineage caused 95% of all COVID-19 cases. The vaccine efficacy rate for prevention of severe COVID-19 from day 28 was 85% overall. No patients who received the vaccine were hospitalized or died because of COVID-19.4

A trial evaluating a two-dose regimen of the Johnson & Johnson vaccine (ENSEMBLE 2) is underway.5

ADVERSE EFFECTS — Fever occurred in 9% of patients who received the vaccine in ENSEMBLE; 0.2% had grade 3 fever. Serious adverse events were more common in the placebo group than among those who received the vaccine. No cases of anaphylaxis were reported.4

ADMINISTRATION AND STORAGE — The Janssen vaccine is to be supplied in vials containing five doses. It will not require dilution before administration. The product can be stored in a standard freezer for up to 2 years or in a refrigerator for up to 3 months. Johnson & Johnson claims that it can deliver 100 million doses to the US by June 2021.

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