FDA advisory committee to assess Moderna’s COVID-19 vaccine candidate this month

The U.S. Food and Drug Administration (FDA) has tapped the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to investigate a second COVID-19 on December 17: mRNA-1273, a Moderna, Inc. candidate that fared well in clinical testing.

Moderna recently announced the vaccine had managed a 94.1 percent efficacy rate among a phase three clinical trial of more than 30,000 people. Following those results, Moderna filed for emergency use authorization (EUA). VRBPAC members will assess this request and its associated data, advising the FDA on whether to approve.

According to FDA Commissioner Stephen Hahn, this committee will consist of outside scientific and public health experts from around the United States. In turn, the FDA will quickly make background materials — such as the meeting agenda and roster — available to the public within two days after the meeting.

“The FDA understands there is tremendous public interest regarding vaccines for COVID-19,” Hahn said. “We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”

The VRBPAC meeting will be live-streamed, and a Federal Register notice will be published with details of the meeting. Public comments are welcome. The mid-December date was established to give the FDA time to evaluate the data and information submitted before the meeting.