Regulators have told the company they may not renew emergency authorization for the shot.
The Pfizer-BioNTech COVID-19 vaccine may become unavailable for some children, according to an email sent to state health officials.
The Food and Drug Administration, which has granted Emergency Use Authorization (EUA) for the vaccine for some children, “recently notified Pfizer of its intent to potentially NOT renew the EUA,” the Centers for Disease Control and Prevention said in an Aug. 8 memo, a copy of which was reviewed by The Epoch Times.
If the EUA is not renewed, the shot will no longer be available for children aged from 6 months to 4 years.
For children aged 5 to 11, Pfizer has told the CDC that it expects approval of its vaccine for the upcoming virus season, which starts in the fall and runs into the winter.
“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 Pfizer spokesperson told news outlets in a statement.
Inquiries sent to the FDA and CDC were referred to their parent agency, the Department of Health and Human Services (HHS).
“The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023,” Andrew Nixon, an HHS spokesman, told The Epoch Times via email.
“We do not comment on potential, future regulatory changes. Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.”
The CDC said in its email that officials are in discussion with Moderna, which manufactures a COVID-19 vaccine called Spikevax.
Pending FDA approval of an updated formulation for Moderna’s vaccine, the company has confirmed it plans to increase the supply of its vaccine for children aged 11 and younger, according to the CDC.
“Moderna is currently finalizing internal planning to determine specific volume and timing and is actively working to help mitigate any potential supply gap,” the CDC email stated.
A Moderna spokesman did not respond to a request for comment.
Novavax’s vaccine is only cleared for individuals 12 years of age and older.
State health officials said they are working with partners after learning Pfizer’s vaccine may not be available for younger children.
The Washington State Department of Health “will begin working with our vaccine providers across the state to update plans for orders given this information,” a spokesperson for the department told The Epoch Times in an email.
“Our goal is to ensure continuity of access to vaccines as we approach the winter respiratory virus season.”
