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FDA Recommends Booster Dose of Moderna’s COVID-19 Vaccine
An FDA committee unanimously voted to recommend the booster dose for adults at least six months following the primary series.
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended a booster dose of Moderna’s COVID-19 vaccine, mRNA-1273, at the 50 microgram level.
VRBPAC unanimously voted 19-0 to recommend the booster dose for individuals 65 years of age and older, 18 to 64 who are at high risk of severe COVID-19, and individuals aged 18 to 64 whose exposure to the coronavirus puts them at risk for complications or severe illness.
The booster dose will be administered at least six months after completion of the primary series.
“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. We thank the committee for their review and for their positive recommendation in support of Emergency Use Authorization,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“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,” Bancel continued.
The committee based its recommendation on various scientific data, including Phase 2 study data of mRNA-1273. Researchers amended the trial to offer a booster dose of mRNA-1273 at the 50-microgram dose level to participants six to eight months following their second dose.
The trial found that a booster dose increased neutralizing antibody titers across all age groups, notably those 65 years and older. The safety profile following the booster dose was also similar to the one observed previously for the second dose of mRNA-1273.
In August, FDA approved an update to the emergency use authorization for mRNA-1273 to include a third dose at the 100-microgram level for immunocompromised adults in the US who have undergone organ transplantation or are diagnosed with chronic conditions.
Moderna believes that the positive vote supporting mRNA-1273 at the 50-microgram dose level and approval could result in up to 1 billion extra doses available for distribution in 2022.
