ARTICLE | Regulation
COVID vaccine booster decision hinges on sense of urgency
FDA advisory committee will assess data on booster efficacy, risks of acting or waiting
September 16, 2021 1:29 AM UTC
The outcome of Friday’s advisory committee meeting on Pfizer’s application for approval of a booster dose of its Comirnaty COVID-19 vaccine is likely to turn on the committee’s confidence in observational data from Israel, as well as calculations of the potential harms and benefits of waiting for more definitive data.
In a paper published in Lancet ahead of the advisory committee meeting, the agency’s top vaccine scientists questioned the reliability of the Israeli observational data. ...