RTTNews | Nov 19, 2021 08:33AM EST

08:33 Friday, November 19, 2021 (RTTNews.com) - Biotechnology company Moderna, Inc. (MRNA) announced Friday that the U.S. Food and Drug Administration (FDA) has extended the emergency use authorization (EUA) of a booster dose of the Moderna COVID-19 vaccine at the 50 g dose level to all adults aged 18 and older.

This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine. It can be administered at least six months after completion of any primary series COVID-19 vaccination.

On October 20, the FDA granted EUA to the booster dose of the Moderna COVID-19 vaccine at the 50 g dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.

The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 g mRNA 1273 third dose in immunocompromised individuals.

The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 g dose level to interested participants 6-8 months following their second dose

The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.

As a next step, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.

Read the original article on RTTNews ( https://www.rttnews.com/3243773/fda-extends-eua-of-moderna-s-covid-19-vaccine-booster-to-the-50-g-dose-level-quick-facts.aspx)

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