1. United States
2. N.Y.
3. Letter

The FDA must urgently approve the updated Moderna and Novavax COVID-19 vaccines for an earlier release between mid-July and early August. Delaying the rollout until the typical fall timeline is unacceptable given the significant mutations we have seen that require updating our immune memory responses. An earlier release would allow people to get fully vaccinated before the start of the school year, reducing transmission risks. It also provides a window for individuals to receive a two-dose primary series ahead of an expected winter surge. Furthermore, expediting approval enables access through the Bridge Access Program ending in August, ensuring equitable vaccine availability for underserved communities. Both mRNA and protein-based vaccine options must be made available concurrently to accommodate personal needs and preferences. Clearer guidance allowing two vaccine doses separated by two months should accompany the release to avoid confusion among providers and the public. Urgent action is needed to provide updated protection against COVID-19 as the situation rapidly evolves.