Johnson & Johnson's single-dose COVID-19 vaccine effective, safe: FDA

Drug maker Johnson & Johnson's single-shot COVID-19 vaccine is safe and effective as per the data submitted from its ongoing multi-national Phase 3 randomised, double-blind and placebo-controlled trials, a briefing document published by the US Food and Drug Administration (FDA) said.

Johnson & Johnson had sought emergency use authorisation for its vaccine on February 4. FDA's advisory committee for approving the vaccine will meet on Friday to take a decision on the issue.

The vaccine, known as Ad26.COV2.S, is a replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding a stabilised variant of the SARS-CoV-2 S protein.

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"Vaccine efficacy (VE) against central laboratory-confirmed moderate to severe/critical COVID-19 across all geographic areas in which the trial was conducted was 66.9 per cent when considering cases occurring at least 14 days after the single-dose vaccination and 66.1 per cent when considering cases occurring at least 28 days after vaccination," the documents showed.

The vaccine's effectiveness varied from 72 per cent in the US to 66 per cent in Latin America and 57 per cent in South Africa, but it was 85 per cent effective overall in stopping severe cases of disease.

Three vaccine recipients had severe side effects in the trial, but the FDA said its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorisation.

(With inputs from Reuters)

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