Health officials greenlight Moderna, Pfizer and Novavax shots while limiting access for youngest children
The Food and Drug Administration granted approval for three updated COVID-19 vaccines today, marking a significant shift in the nation's approach to pandemic prevention while creating new barriers for America's youngest children.
The newly approved vaccines from 1. Moderna, 2. Pfizer, and 3. Novavax are specifically designed to combat the LP.8.1 sublineage of the JN.1 virus variant. This scientific update comes as COVID activity climbs across most states, though current levels remain below last summer's peak.
Health and Human Services Secretary Robert F. Kennedy Jr. announced the approvals through social media, emphasizing that the decision fulfills several of his administration's priorities. The authorization removes previous emergency use designations that Kennedy criticized for enabling widespread vaccine mandates.
Moderna's vaccine received approval for individuals 6 months and older, while Pfizer's shot is now authorized for those 5 years and up. Novavax, which produces a protein-based alternative, gained clearance for people 12 and older. Kennedy stressed that these vaccines remain available for patients who choose them after consulting with their healthcare providers.
The Infectious Diseases Society of America issued a sharp rebuke of the FDA's narrowed approach, with president Dr. Tina Tan arguing that the restricted labeling ignores established science and endangers American lives.
The medical organization is collaborating with other health societies to develop comprehensive respiratory virus guidance for fall and winter, expected to launch in September. Dr. Tan emphasized that physicians retain the ability to provide COVID vaccines off-label and urged doctors to continue recommending vaccination based on current scientific evidence.
However, pharmacists face severe constraints when providing off-label vaccines, placing greater responsibility on physicians and clinicians to maintain patient access. The IDSA called on insurance companies to continue covering COVID vaccines in line with medical society recommendations.
The elimination of Pfizer's emergency use authorization removes the only COVID vaccine previously available to all children from the American market. Under the new rules, Pfizer's vaccine is restricted to children 5 and older, while Moderna's shot is approved only for children with underlying health conditions.
This change creates particular concern since children ages 6 to 23 months experience the highest rates of severe COVID disease, despite low overall vaccination rates in pediatric populations. The restrictions could strain supplies of Moderna's vaccine, as it becomes the sole option for many young children with health conditions.
The American Academy of Pediatrics recently updated its childhood immunization recommendations, breaking from new CDC guidelines by emphasizing that all children in the youngest age group should receive vaccination. The pediatric organization also recommends single doses for children ages 2 through 18 who belong to certain risk groups or whose parents desire vaccine protection.
Current federal recommendations favor vaccination for seniors while limiting use in adults under 65 to those with underlying health conditions, subject to shared decision-making with healthcare providers. The administration previously announced that COVID vaccination is no longer recommended for healthy children and pregnant women, a decision made without input from vaccine advisory committees.
Pfizer announced immediate shipping to ensure widespread availability across pharmacies, hospitals, and clinics nationwide. The company emphasized its commitment to robust supply chains and rapid access for healthcare facilities.
Moderna confirmed that approvals apply to both its traditional Spikevax vaccine and the newer mNexspike formulation. The next-generation mNexspike, approved in June, requires smaller doses than the original vaccine and maintains stability under standard refrigeration, potentially expanding immunization opportunities in diverse healthcare settings.
Novavax plans to work with partner Sanofi to provide access for eligible individuals this fall. The protein-based vaccine targets people 65 and older, plus those ages 12 to 64 with underlying health conditions that increase severe COVID risk.
The updated vaccines should reach patients within days as the nation prepares for another respiratory virus season amid evolving public health policies.