The FDA has recently approved updated COVID-19 vaccines that target a commonly circulating coronavirus strain, but with restrictions on who in the U.S. can receive them. Health and Human Services Secretary Robert F. Kennedy Jr. announced on social media that Pfizer, Moderna, and Novavax vaccines are now cleared for use in individuals at higher risk for COVID-19. These vaccines are available for those who choose to receive them after consulting with their healthcare providers. Additionally, emergency use authorizations previously granted for certain groups have been rescinded.
Pfizer’s updated booster is approved for individuals between the ages of 5 and 64 with underlying health conditions that put them at high risk for severe illness. Moderna’s booster is approved for high-risk individuals between 6 months and 64 years old. Novavax’s protein-based vaccine, marketed by Sanofi under the name Nuvaxovid, is approved for high-risk individuals aged 12 to 64 years. These vaccines are also cleared for use in adults 65 years and older.
The FDA recommended that updated shots target a specific coronavirus subvariant known as LP.8.1 for the fall and winter seasons of 2025 and 2026. However, accessibility to boosters may be more limited as the FDA’s clearance only applies to most adults considered at higher risk. The Infectious Diseases Society of America expressed concerns about the narrowed approval, stating that it contradicts the evidence base and limits vaccine access.
The Centers for Disease Control and Prevention currently recommends COVID vaccines for most adults aged 18 and older. Parents of children are advised to discuss the benefits of vaccination with their healthcare providers. Despite recent changes in vaccine recommendations, the CDC panel is set to meet in September to possibly vote on COVID vaccine recommendations following the FDA’s approval.
In response to these developments, medical organizations have pushed back on efforts to restrict access to COVID shots. The American Academy of Pediatrics released updated vaccination guidelines, recommending a COVID vaccine for all children aged 6 through 23 months. This recommendation is based on the vulnerability of young children to severe COVID-19.
As Pfizer and Moderna prepare to distribute their updated vaccines, the debate surrounding COVID vaccine recommendations and access continues to evolve. It is essential for individuals to stay informed and consult with healthcare providers to make informed decisions about vaccination.