Janssen jab closes in on FDA approval

25 February 2021

The US Food and Drug Administration (FDA) looks closer to granting Emergency Use Authorization (EUA) for the single-dose Janssen COVID-19 vaccine candidate.

Briefing documents prepared ahead of an FDA advisory panel meeting on Friday state that the jab appears safe and effective against SARS-CoV-2 infection based on available data.

The Phase III ENSEMBLE clinical trial demonstrated that the vaccine met all primary and key secondary endpoints and had a strong rate of preventing infections.

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