FDA Advisory Committee Unanimously Votes to Recommend Emergency Use Authorization of Moderna COVID-19 Booster Vaccine

Although the advisory committee’s recommendation is not binding, the FDA will take their recommendation into consideration when making a final decision on authorization of the 50-µg booster dose.

An advisory committee for the FDA voted unanimously in support of an emergency use authorization (EUA) for a booster dose of Moderna’s COVID-19 vaccine for adults 65 years of age and older or younger adults at high risk of contracting COVID-19.

Although the advisory committee’s recommendation is not binding, the FDA will take their recommendation into consideration when making a final decision on the authorization. The CDC Advisory Committee on Immunization Practices will also meet soon to discuss their recommendations for COVID-19 boosters.

The recommendation is for a 50-µg dose of the vaccine administered at least 6 months after completion of the primary 2-dose series. According to a press release from Moderna, if the booster dose were to be officially approved under EUA by the FDA, it could result in up to 1 billion extra doses available for distribution in 2022.

“We are grateful for the opportunity to present the clinical data package for our COVID-19 booster vaccine to the FDA’s advisory committee today,” said Moderna CEO Stephane Bancel, in the press release. “We thank the committee for their review and for their positive recommendation in support of emergency use authorization.”

The recommendation is based on the totality of available scientific evidence, including a data analysis from the phase 2 clinical study of the vaccine, called mRNA-1273. The phase 2 study was amended to offer a booster dose of the vaccine at the 50-µg dose level to interested participants between 6 and 8 months following their second dose.

In this study population, neutralizing antibody titers had waned prior to receiving the booster, particularly against COVID-19 variants of concern. Importantly, a booster dose of the vaccine at the 50-µg dose level increased neutralizing titers significantly above the phase 3 benchmark. After a booster dose, a similar level of neutralizing titers was achieved across age groups, and notably in older adults 65 years of age and above. The safety profile following the booster dose was similar to that observed for the second primary dose of the vaccine.

This new recommendation is separate from the earlier update to the EUA allowing a 100-µg booster dose for immunocompromised individuals 18 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that have an equivalent level of immunocompromise.

“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2,” Bancel said in the press release. “We look forward to making our booster available to people in the US to help protect themselves against this ongoing public health emergency.”

REFERENCE

Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the US. News release. Moderna; October 14, 2021. Accessed October 15, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-advisory-committee-unanimously-votes