Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the U.S. 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 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. 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 2 of mRNA-1273. The positive vote was unanimous with 19 VRBPAC members recommending EUA.
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 the use and rollout of COVID-19 boosters to Americans.
About Moderna
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.
