Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older

Moderna stock surged 4% in premarket trading after announcing FDA authorization of booster dose of COVID-19 Vaccine in the U.S. for adults 18 years and older.

Moderna, Inc. today announced that theU.S. Food and Drug Administration(FDA) has extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg 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.

“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,” saidStéphane Bancel, Chief Executive Officer ofModerna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

The booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. OnOctober 20th, the FDAauthorizedfor emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg 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 µg 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 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.

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