Vaccinating younger children against COVID-19 might prove to be a more difficult task during this respiratory virus season.
The Food and Drug Administration (FDA) is considering discontinuing the emergency use authorization (EUA) for Pfizer's COVID-19 vaccine in children under 5 years old for the 2025-2026 season. This decision could leave healthy children in this age group without an officially sanctioned vaccine option, as Moderna's vaccine is currently only approved for children at increased risk for COVID-19.
The FDA's potential decision contradicts the availability of COVID-19 vaccines, which first became available to the American public during the pandemic under emergency use authorization. This move has raised concerns among health professionals, including Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children's Hospital of Philadelphia, who believes this decision goes against the intent of shared clinical decision-making.
Pfizer is actively seeking to maintain or extend authorization for the upcoming respiratory virus season, but the FDA has not yet made a final decision. If the authorization is not renewed or fully approved, Pfizer's vaccine would no longer be available to any children younger than 5.
In such a scenario, Moderna's COVID-19 vaccine would have to be administered "off label" by a willing pharmacist or physician to children in this age group without underlying conditions. It's worth noting that Moderna's vaccine is currently only approved for children at increased risk for COVID-19.
The FDA has not yet approved the formulation for the 2025-2026 season. To mitigate any potential supply gap, Moderna is planning to increase vaccine supply for children. The specific volume and timing of the increased vaccine supply are still being determined by Moderna.
Last respiratory virus season, there were 48 Covid-19 hospitalizations for every 100,000 children under 5, making this age group particularly vulnerable. The CDC's National Center for Immunization and Respiratory Diseases has stated that this decision would affect Pfizer's pediatric COVID-19 vaccine for children aged 6m-4y for the 2025-2026 season.
Pfizer has had full FDA approval for its Covid-19 vaccine for individuals age 12 and older since 2022. The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023. The US Department of Health and Human Services does not comment on potential regulatory changes.
As the COVID-19 levels continue to rise in the US, with transmission increasing in at least 45 states, according to the CDC, the importance of vaccination for all eligible individuals remains crucial in the fight against the virus. It is hoped that the FDA will make a decision soon regarding the authorization of Pfizer's vaccine for children under 5, ensuring that all children have access to a safe and effective vaccine.
[1] Moderna's Covid-19 vaccine for children aged 11 and younger received full FDA approval in July, but only for those at increased risk for COVID-19 disease. [2] In May, US Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would no longer recommend Covid-19 vaccines for healthy children or pregnant women. [3] As of August 2025, the FDA is considering discontinuing the emergency use authorization (EUA) for Pfizer's COVID-19 vaccine in children under 5 years old for the 2025–2026 season. Pfizer is in discussions with the FDA and has requested that the authorization remain in place for the upcoming respiratory virus season, but there is no confirmed renewal yet. [4] Pfizer anticipates that this approval will expand to children ages 5 to 11 for the upcoming respiratory virus season. [5] The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023.
