USA – J&J’s COVID vaccine headed for VRBPAC on 26 February

A third vaccine against COVID-19 is headed for review by the US Food and Drug Administration (FDA). On Thursday, the Janssen group of Johnson & Johnson submitted an application for emergency use authorization of its single-dose recombinant human adenovirus vaccine; FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to review the application on 26 February.

“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” said acting FDA commissioner Janet Woodcock, MD in a press release announcing the VRBPAC meeting. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”..