FDA approves emergency booster dose of Moderna’s COVID-19 vaccine

pharmafile | October 15, 2021 | News story | Medical Communications  

The FDA Advisory Committee has unanimously voted in support of emergency use for a booster dose of Moderna’s COVID-19 vaccine in the US. This booster dose will be administered to individuals aged 65 and older, as well as individuals aged 18 through 64 who are at high risk of contracting COVID-19 at least six months after the completion of the primary series.

The positive vote was unanimous, with 19 Vaccines and Related Biological Products Advisory Committee (VRBPAC) members recommending EUA. The VRBPAC based its recommendation on an array of evidence, including a data analysis from the Phase II clinical study of mRNA-1273, and the FDA will take this recommendation into consideration when making a final decision on authorisation.

Moderna , a pioneer in messenger RNA vaccines, has a diverse clinical portfolio of vaccines and therapeutics, and their vaccine is one of the earliest and most effective vaccines against COVID-19.

Stéphane Bancel, CEO of Moderna, said: “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. 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.

“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.S. to help protect themselves against this ongoing public health emergency.”

Moderna says that the positive vote in support of mRNA-1273 at the 50-µg dose level, and subsequent market approval, could result in 1 billion extra doses becoming available for distribution in 2022.

Lina Adams

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