FDA may pull Pfizer’s COVID vaccine for young children
The U.S. Food and Drug Administration is considering revoking emergency use authorization for Pfizer’s COVID-19 vaccine for healthy children under 5, Pfizer confirmed this week. The potential move could limit vaccine access for this age group, especially for healthy children without underlying medical conditions.
Pfizer said it is in active discussions with the FDA to maintain authorization through the upcoming fall and winter season.
“The FDA’s deliberations are not related to the safety and efficacy of the shot, which continues to demonstrate a favorable profile,” the company stated.
If authorization is withdrawn, Moderna’s COVID vaccine would remain available — but only for children at higher risk of severe illness due to preexisting conditions. Novavax’s vaccine is not authorized for children under 12.
The development comes amid broader changes to U.S. vaccine policy since Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, took office. In recent months, federal health agencies have shifted guidance on COVID-19 vaccination, including the Center for Disease Control and Prevention’s removal of its recommendation for healthy children and pregnant women.
Pfizer emphasized that it is seeking to keep its vaccine available for young children as part of ongoing pandemic preparedness efforts.
Read more: CNBC
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