FDA Advisory Council Unanimously Supports Moderna COVID-19 Booster EUA

Published on: 

The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.

Moderna announced on Oct. 14, 2021, that FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended that FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273). In a 19–0 vote, the VRBPAC recommended a 50 ug booster shot should be made available to three populations:

  • People aged 65 or older
  • People aged 18 to 64 who are at high risk for severe COVID-19
  • People aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness.

Additionally, this booster dose is to be administered only after at least six months have passed since their original vaccination series.

A recent Phase II study of mRNA-1273 was conducted wherein 344 interested participants were given a 50-ug booster dose six to eight months following their second dose. According to the study, neutralizing antibody titers, particularly against variants of concern, had waned prior to this study. However, following a booster dose, neutralizing titers were raised significantly to the Phase III benchmark level.

“We thank the committee for their review and for their positive recommendation in support of [EUA]. This positive recommendation is supported by data on the 50-µg booster dose of our COVID-19 vaccine, which shows robust antibody responses against the original virus, but also against the Delta variant,” said Stéphane Bancel, CEO of Moderna, in a company press release. “We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We look forward to making our booster available to people in the U[nited] S[tates] to help protect themselves against this ongoing public health emergency.”

This recommendation is non-binding but will be taken into consideration as it concerns an EUA. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will also meet to discuss a recommendation on a booster shot.

Source: Moderna