The FDA may not renew Pfizer’s pediatric Covid vaccine — the only one available to kids without health conditions

On Saturday, I published a scoop: The FDA reportedly told Pfizer it may not renew the emergency use authorization for its Covid vaccine for children aged 6 months to four years.

That’s the only Covid vaccine available for young children without health conditions.

When they were fully licensed last month, the Moderna and Novavax vaccines came with new restrictions: The Moderna vaccine is only approved for children with one or more health conditions, and the pediatric Covid vaccine from Novavax is only available for children aged 12 and up with health conditions.

These shots are used in the initial vaccination series as well as boosters.

That means children over the age of 6 months without health conditions could lose access to Covid vaccination this fall.

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What constitutes a “health condition” may be at the discretion of pediatricians, but many of the conditions previously mentioned by FDA officials, like a lack of physical exercise, rarely apply to infants and very young children.

Even children who qualify could face supply gaps, since some pediatricians and health centers have only stocked Pfizer vaccines in the past. (Our pediatrician, for instance, always tries to order Moderna, but it never arrives.)

And it’s very late in the season to make these changes, since the updated vaccines are due to roll out in a matter of weeks.

“We already have a low number of people using the vaccines to start with,” said Georges Benjamin, the executive director of the American Public Health Association.

“There hasn’t been enough promotion of vaccinations for kids, and then you have Mr [Robert F] Kennedy’s [Jr] unscientific statements about the safety and efficacy of vaccines, particularly Covid vaccines, for both pregnant women and kids. It has muddied the waters of what people know about the safety and efficacy of the vaccine.”

–Pfizer Covid vaccine for young children may not be renewed by FDA, The Guardian

A Moderna spokesperson told me they are now preparing to expand the supply of their Covid vaccine.

I will continue following this story. If you ever have tips like these or ideas for what I might cover, please get in touch securely via email (melodyschreiber@pm.me) or Signal (melodyschreiber.06).

Top image: EU-Ukraine Cooperation