FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the US
EUA granted for individuals 65 years of age and older, individuals ages 18 through 64 within certain high-risk groups
CAMBRIDGE, MA — Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people 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 booster dose is to be administered at least six months after completion of the primary series. The FDA also authorized a single booster dose of the Moderna COVID-19 Vaccine for individuals who have completed a primary vaccination with other authorized or approved COVID-19 vaccines.
“This emergency use authorization is supported by robust clinical evidence that a 50 µg booster dose induces a strong immune response against COVID-19. We thank the FDA for their review and for this EUA including for those people who have completed a primary vaccination with a different COVID-19 vaccine,” said Stéphane Bancel, chief executive officer of Moderna. “We believe that mRNA vaccines are uniquely positioned to adapt to the evolving epidemiology of SARS-CoV-2. We’re grateful for the opportunity to provide individuals with another layer of protection.”
The FDA based this EUA on the totality of scientific evidence shared by the company and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), 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 six–eight months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately six months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a booster dose, a similar level of neutralizing titers was achieved across age groups including in older adults (ages 65 and above). The safety profile following the booster dose was similar to that observed previously for dose two of mRNA-1273. The positive vote was unanimous with 19 VRBPAC members recommending EUA.
As a next step, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of COVID-19 boosters to Americans.
- This press release was originally published on the Moderna, Inc. website. It has been edited for length