Research & Development
Moderna expects the FDA advisory committee to support emergency use of booster COVID-19 Vaccine dose in the US
15 October 2021 -

Biotechnology company Moderna Inc (Nasdaq:MRNA) said on Thursday that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) is in favour of its Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level at least six months after completion of the primary series.

The US FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommends the Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older, 18 to 64 at high risk of severe COVID-19, 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness.

Following the positive vote in support of mRNA-1273 at the 50 µg dose level and subsequent approval, the company expects up to 1bn extra doses being available for distribution in 2022.

This VRBPAC is based its recommendation of data analysis from the company's Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants following their second dose.

Additionally, the neutralizing antibody titers had waned prior to boosting against variants of concern at approximately six months. The safety profile following the booster dose was similar to that observed previously for dose two of mRNA-1273, said the company.

On 13 August 2021, the U.S. FDA approved an update to the emergency use authorization for the Moderna COVID-19 vaccine to include a third dose at the 100 µg dose level for immunocompromised individuals 18 years of age or older in the US who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

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