The US Food and Drug Administration (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, The Guardian reported yesterday, based on a Centers for Disease Control and Prevention (CDC) email it obtained that the agency sent on August 8 to state and local vaccine grantees.
Pulling the Pfizer EUA would remove 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 email told health officials that the CDC was in talks with Moderna about rapidly increasing its vaccine supply for young children.
The potential developments follow sweeping, unilateral changes to US COVID vaccine policy that Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in May, which removed the COVID vaccine recommendation for healthy children and pregnant women. A few days later, the CDC updated its immunization schedule without input of its vaccine advisory group to partly reflect the new position, saying that children ages 6 months to 17 years may receive the COVID vaccine based on parent preference and the clinical judgment of healthcare providers.
Young kids see notable impact, but vaccine uptake low
Children continue to be affected by COVID, and, during last winter's rise in cases, emergency department visits were elevated for young children, similar to a pattern for respiratory syncytial virus (RSV).
Pfizer first received the EUA for use of the vaccine in the youngest age-group in June 2022, but uptake has been low. The CDC estimates that coverage for kids as old as 4 years was 5.6% for the most recent season. Ahead of the last year's respiratory virus season, the FDA approved and authorized updated mRNA COVID vaccines on August 22 and authorized the updated Novavax vaccine on August 30.
An HHS spokesperson told The Guardian 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.
