FDA advisory committee rejects COVID-19 unblinding

Several members of an FDA advisory committee Thursday suggested that the agency has set the bar too low for emergency authorization of a COVID-19 vaccine, expressing concerns about the duration of safety and efficacy data and stringency of the efficacy endpoints. The committee did not, however, reject FDA’s proposed approach to COVID-19 vaccines.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was not asked to vote on any questions. ...