Moderna, Inc. received emergency use authorization for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) 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.
 
The EUA is based 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 to interested participants 6-8 months following their second dose. Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 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.