This fall, it may not be possible for many parents to have a healthy child under age 5 immunized against Covid.
Pfizer’s vaccine has long been available to these children under so-called emergency use authorization. But the Food and Drug Administration is considering discontinuing the authorization for that age group, according to an email sent by the Centers for Disease Control and Prevention to state and local health departments.
Pfizer confirmed the possibility on Monday evening and said that the company was “currently in discussions with the agency on potential paths forward.” For children 5 to 11 years old, the Pfizer vaccine is expected to be approved and available, according to the C.D.C.’s email, which was reviewed by The New York Times.
In July, the F.D.A. granted full approval to Moderna’s Covid vaccine for children — but only for those who have health conditions that may put them at increased risk should they become infected. Novavax’s Covid vaccine has never been available for children under 12.
The upshot is that if the F.D.A. does not renew Pfizer’s authorization for children 6 months to 4 years, or fully approve the vaccine, healthy children in that age group will have no officially sanctioned options — although doctors may still choose to provide the vaccine “off label.”
That the F.D.A. might rescind the authorization was first reported by The Guardian.
“Unfortunately, this leaves one of the vulnerable groups, specifically healthy children less than 2 years old, without access to a safe vaccine that’s known to prevent hospitalization and death,” said Dr. Lakshmi Panagiotakopoulos, who oversaw the C.D.C.’s work group on the Covid vaccine before she resigned in June.
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The post Why Young Children May Not Get Covid Shots This Fall appeared first on New York Times.
