FDA pulls clearance of Pfizer, BioNTech COVID-19 vaccine for children under 5

FDA pulls clearance of Pfizer, BioNTech COVID-19 vaccine for children under 5 | Image Credit: © myskin - stock.adobe.com.

On August 27, the FDA authorized updated formulations of COVID-19 vaccines for the 2025–2026 season, but significantly tightened restrictions on their use in younger populations.¹

The changes coincide with the Department of Health and Human Services’ decision to withdraw Emergency Use Authorizations for several vaccines, including Pfizer-BioNTech’s Comirnaty, Moderna’s Spikevax, and Novavax’s protein-based option. The move eliminates broad pediatric access that had previously been in place.¹

Pfizer announced that the new Comirnaty formulation received approval for adults 65 and older and for individuals aged 5 to 64 with underlying health conditions. However, it is no longer authorized for children under 5 years of age, marking a major shift from earlier allowances.²

The FDA has gradually reduced vaccine access under Secretary Robert F. Kennedy Jr.’s leadership, narrowing indications to higher-risk groups and older adults. Novavax’s Nuvaxovid was cleared in May for individuals 12 and older with medical risk factors, while Moderna’s Spikevax received approval in July for children between 6 months and 11 years old who face increased susceptibility to severe illness.¹

These decisions collectively mark a transition from widespread pediatric use of COVID-19 vaccines to a more targeted approach centered on older adults and those with underlying vulnerabilities.

Susan J. Kressly, MD, FAAP, president of the American Academy of Pediatrics, stated, "Today’s announcement from U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., proposing to limit the availability of COVID-19 vaccines for children and young adults is deeply troubling. The American Academy of Pediatrics remains focused on increasing access to vaccines for all children, in all communities. As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing."³

According to Kressly, the AAP advises that all children from 6 months to 23 months receive the COVID-19 vaccine. For children 2 years and older, annual vaccination is recommended for those with underlying conditions that heighten the risk of severe illness.³

Both Kressly and the AAP emphasized that families should continue to have the option to vaccinate their children, noting that the recent HHS decision removes this choice for many and creates additional uncertainty for parents seeking to safeguard their children’s health. Additionally, she stressed that vaccination decisions are best made jointly by parents and pediatricians and urged federal officials to preserve this role for medical professionals and families.³

References:

1. Eaton ES. FDA approves updated COVID-19 jabs, with strict limitations for young people. First Word Pharma. August 27, 2025. Accessed August 27, 2025. FDA approves updated COVID-19 jabs, with strict limitations for young people
2. Pfizer and BioNTech’s COMIRNATY^® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19. Busineswire. August 27, 2025. Accessed August 27, 2025. https://www.businesswire.com/news/home/20250822994391/en/Pfizer-and-BioNTechs-COMIRNATY-Receives-U.S.-FDA-Approval-for-Adults-65-and-Older-and-Individuals-Ages-5-through-64-at-Increased-Risk-for-Severe-COVID-19
3. American Academy of Pediatrics. AAP SAYS DECISION TO LIMIT CHILDREN’S ACCESS TO VACCINES IS DEEPLY TROUBLING. AAP. Press release. August 27, 2025.