The Food and Drug Administration may revoke authorization for Pfizer’s COVID-19 vaccine for healthy children under age 5, the pharmaceutical company confirmed, which would limit parents' vaccine options ahead of the winter respiratory virus season.
The possibility comes several months after President Donald Trump’s Department of Health and Human Services began placing limits on COVID-19 vaccines. For the last four years, updated COVID-19 vaccines have been made available in the fall for most Americans before the cold sets in.
The federal agency told Pfizer that it might not renew the emergency use authorization, or EUA, for the Pfizer-BioNTech COVID-19 vaccine Comirnaty for children ages 6 months through 4 years, according to a statement sent to USA TODAY.
“We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,” a company spokesperson said. “It is important to note that these deliberations are not related to the safety and efficacy of the vaccine, which continues to demonstrate a favorable profile.”
HHS spokesperson Andrew Nixon declined to predict what the agency might do.
“We do not comment on potential, future regulatory changes,” Nixon said. “Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.”
In July, Moderna received full FDA approval for its COVID-19 vaccine for children 6 months to 11 years old who are at increased risk of contracting COVID-19. The vaccine, Spikevax, is expected to be available for eligible populations in the 2025-26 respiratory virus season.
The Centers for Disease Control and Prevention still recommends older patients get vaccinated against COVID-19, as well as people whose immune systems have been weakened by illness or medical treatments such as chemotherapy.
But if Pfizer loses its EUA, parents won't have the option to vaccinate their healthy young children.
HHS Secretary Robert F. Kennedy Jr. has long sown doubt about a wide range of vaccines, while saying parents should be able to choose which vaccines their children should get.
In late May, he announced that the COVID-19 vaccine for healthy children and healthy pregnant women was removed from the Centers for Disease Control and Prevention’s immunization schedule. “There’s no evidence healthy kids need it today," Dr. Marty Makary, FDA commissioner, said in the May 27 video announcement posted to X.
The American Academy of Pediatrics pushed back, saying at the time that the removal “ignores independent medical experts and leaves children at risk.”
Ending access to vaccination for healthy young children would strip families of choice, said Dr. Sean O’Leary, chair of the academy’s committee on infectious diseases, in a May statement.
“Those who want to vaccinate may no longer be able to, as the implications for insurance coverage and access remain unclear," he said.
This article originally appeared on USA TODAY: FDA might revoke Pfizer COVID-19 shot for children
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