FDA: Johnson & Johnson COVID-19 Vaccine is Safe and Effective

The FDA announced today that Johnson & Johnson's single-dose COVID-19 vaccine was found to be safe and effective against the novel disease.

Johnson & Johnson’s single-dose coronavirus disease 2019 (COVID-19) vaccine was found to be safe and effective against COVID-19, according to a new analysis by the US Food and Drug Administration (FDA) that may set the stage for a decision on granting the vaccine emergency use authorization (EUA).

The FDA confirmed that overall, the vaccine is approximately 66% effective at preventing moderate-to-severe COVID-19, and about 85% effective against severe/critical COVID-19, according to the February 24, 2021 analysis.

The agency also stated that the vaccine demonstrated, “a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.”

Johnson & Johnson’s vaccine, known as Ad26.COV2.S, was tested in approximately 40 000 adults aged ≥18 years in the US, Latin America, and South Africa. Approximately half of the participants received the vaccine and half received a placebo.

The results showed that the vaccine was 66.9% (95% confidence interval [CI]: 59.0-73.4) effective against moderate-to-severe COVID-19 when considering cases occurring at least 14 days after vaccination and 66.1% effective (95% CI: 55-74.8) when considering cases occurring at least 28 days after vaccination.

Analyses of secondary endpoints showed vaccine efficacy against severe/critical COVID-19 occurring at least 14 days and 28 days after vaccination of 76.7% (95% CI: 54.6-89.1) and 85.4% (95% CI: 54.2-96.9), respectively.

Also, none of the participants in the vaccine group required hospitalization or died once the vaccine took full effect, which was 28 days after vaccination.

The most common adverse reactions associated with the vaccine among a subset of participants (n=6736) who were asked about their experience, were injection site pain (48.6%), headache (38.9%), fatigue (38.2%) and myalgia (33.2%). These adverse reactions were predominately mild and moderate, according to the analysis.

On Friday, a panel of advisors to the FDA are set to meet to evaluate the vaccine and make a recommendation about whether the vaccine should receive an EUA.

In a congressional testimony on February 23, 2021, a Johnson & Johnson executive did state that 4 million doses of the vaccine would be available in the US if, and when, the FDA grants an EUA. The executive also said that 20 million vaccine doses would be ready by the end of March, and that the company would be able to deliver 100 million doses by the end of June.


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