FDA Clears New Covid Vaccines with Eligibility Limits Under RFK Jr.

The U.S. Food and Drug Administration (FDA) approved a new round of Covid-19 vaccines on Wednesday but imposed significant restrictions on who is eligible to receive them, marking a sharp departure from the broad vaccination policies of recent years. Unlike previous guidance that recommended annual Covid shots for nearly all Americans aged six months and older, the FDA has now limited authorization to individuals at higher risk of severe illness. These include adults 65 and older, as well as younger people with underlying health conditions such as cancer, obesity, diabetes, chronic kidney disease, heart disease, or compromised immune systems.

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, framed the decision as a return to “science, safety, and common sense.” In a post on X, Kennedy noted that the emergency use authorizations (EUAs) for Covid vaccines—once used to justify broad public mandates during the Biden administration—have been rescinded. While he emphasized that patients can still receive the shots after consulting with their doctors, it remains unclear how accessible vaccines will be for people outside the high-risk categories.

The FDA authorized Moderna’s updated vaccine for individuals aged six months and up, Pfizer’s for those five and older, and Novavax’s for those 12 and older—but only if they fall within high-risk groups. This change effectively removes Pfizer’s authorization for children aged six months to four years, despite the company’s request in August to maintain it for the fall and winter seasons. Both Pfizer and Moderna confirmed that they will begin immediate distribution of their updated vaccines, which will be available in pharmacies, hospitals, and clinics across the country.

The decision could complicate access for millions of Americans, raising questions about whether insurance providers will continue to cover vaccines for healthy adults and children. It also comes after the Centers for Disease Control and Prevention (CDC) in May dropped its recommendation that pregnant women and healthy children receive Covid shots. However, the American Academy of Pediatrics (AAP) diverged from that guidance earlier this month, continuing to recommend vaccines for children between six months and two years old.

Following the FDA’s announcement, AAP President Dr. Susan Kressly criticized the agency’s more limited approval, calling it “deeply troubling.” She stressed that Covid and other respiratory illnesses pose particular risks to infants and toddlers because of their small and developing airways. Kressly warned that removing broad access to vaccines could increase vulnerability among the youngest populations, while also creating confusion and stress for parents trying to make the best health decisions for their children. The AAP urged that decisions regarding vaccine eligibility remain with medical experts and families rather than policymakers.

Similarly, the American College of Obstetricians and Gynecologists reiterated its advice that pregnant women receive Covid vaccines to protect themselves and their infants, who cannot be immunized until at least six months of age.

On Wall Street, Pfizer and Moderna shares saw a modest rise following the FDA announcement, while Novavax shares dipped slightly.

The new policy highlights a major shift in U.S. vaccine strategy, narrowing eligibility to only high-risk groups and moving away from the universal vaccine access that had characterized earlier stages of the pandemic response. This shift has sparked debate over public health, parental choice, and the balance between safety, science, and access.