FDA Expands EUA for Moderna COVID-19 Booster, CDC Votes to Recommend

The FDA has expanded the emergency use authorization (EUA) of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for those 18 years of age or older who have completed their primary vaccination with any other authorized or approved COVID-19 vaccine, regardless of occupational risk factors or severe risk of COVID-19.

Upon the FDA’s EUA expansion of eligibility for the vaccine booster dose, the CDC Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the Moderna COVID-19 vaccine booster for all adults aged 18 years or older.

The CDC ACIP vote was unanimous with 11 ACIP members recommending the booster.²

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” said Stéphane Bancel, chief executive officer of Moderna, in a statement.¹

The decision comes after data was provided on the results of a phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose. During the investigation, patients included in the study were found to have neutralizing antibody titers that had waned prior to boosting. After the third dose, the titers were significantly above the phase 3 benchmark.¹

The investigators also noted in the study results that the safety profile was similar to those previously observed for the second dose of the vaccine.

In the expanded Moderna vaccine EUA, the FDA explained that the booster dose is to be administered at least 6 months after the completion of any primary series of COVID-19 vaccines.

Previously, the FDA had issued an EUA for the Moderna booster dose for individuals aged 65 and older and those 18 to 64 who are at high risk of severe COVID-19, as well as for those aged 18 to 64 years with frequent institutional or occupational exposure to COVID-19.

The recommendation from the CDC ACIP will be forwarded to the director of the CDC and the US Department of Health and Human Services for review before adoption.

References

1. Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older. Business Wire. News release. November 19, 2021. Accessed November 22, 2021. https://www.businesswire.com/news/home/20211119005436/en
2. U.S. CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine. Business Wire. News release. November 19, 2021. Accessed November 22, 2021. https://www.businesswire.com/news/home/20211119005733/en