FDA-approved Pfizer vaccine not OK for off-label use in kids, official says

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ABC News

Pfizer, Moderna and Johnson & Johnson are running vaccine trials with kids.

When the Food and Drug Administration (FDA) granted full approval of the Pfizer COVID-19 vaccine for people ages 16 and older Monday, it did so with a warning to parents and medical providers.

The vaccine — the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval — should not be given to young children as off-label use, according to FDA commissioner Janet Woodcock.

“We do not have data on the proper dose, nor do we have the full data on the safety in children younger than what is in the EUA, and so that would be a great concern that people would vaccinate children,” Woodcock said. “We are not recommending that children younger than age 12 be vaccinated with this vaccine, it would not be appropriate.”

“They are not just small adults,” she said of kids. “And we’ve learned that time and time again and so we really would have to have the data and the appropriate dose before recommending that children be vaccinated.”

Dr. Robert Frenck, lead investigator of the COVID-19 vaccine trials at Cincinnati Children’s Hospital, emphasized that clinical testing has not yet been done in 5 to 12-year-olds.

It’s likely that young children ages 5 to 12 will get a smaller vaccine dose. That’s not only because children are smaller, but also because they tend to have stronger immune responses than adults, Frenck said.

“In kids 5-12, we found that 10 micrograms, so one-third of the [adult] dose, gives you the same immune response,” Frenck said. “If they give it off label, and they give the 30 mg, I think they’re going to have kids in the 5 to 12 year olds that are going to have a lot more reactogenicity. That means they’re going to have kids with fevers, headaches, and they’re going to feel bad.”

“As scientists we want to know,” Frenck said. “You don’t want to guess.”

The American Academy of Pediatrics (AAP) also urged caution, noting that while it is now “legally permissible” for doctors to administer the vaccine off-label for kids ages 11 and younger, the AAP “strongly discourages that practice.”

Pfizer’s COVID-19 vaccine was authorized for use in children ages 12 to 15 in May by the U.S. Food and Drug Administration (FDA).

The two other COVID-19 vaccines available in the United States, Moderna and Johnson & Johnson, are currently available for anyone 18 years and older in the U.S. Moderna filed for emergency use authorization with the FDA for its vaccine in adolescents in June but is still awaiting a decision.