The FDA has signaled that it “might not renew the emergency use authorization (EUA) for Pfizer's COVID-19 vaccine for children ages 6 months to 4 years old for the upcoming respiratory virus season, which may limit the supply of vaccines for the youngest kids.” CIDRAP has the news.
The report came from The Guardian based on a CDC email sent to state and local vaccine grantees on August 8. The Pfizer vaccine is “the only COVID-19 vaccine approved for all children from the US market. The Moderna vaccine is approved only for children with one or more health conditions, and the Novavax vaccine is cleared only for use in children ages 12 years and older.” The CDC email mentions the agency is in contact with Moderna about “rapidly increasing its vaccine supply for young children.”
Emergency department visits were elevated for young children last winter due to COVID. The CDC estimates, however, that vaccine uptake for the youngest age-group has been as low as 5.6%.
An HHS spokesperson said that the agency “doesn't comment on future regulatory changes and that discussion about future actions amounts to speculation. A Moderna representative confirmed that the company is working to ensure sufficient supply, and Pfizer did not respond to the newspaper's query by publication time.”
