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Article

FDA panel recommends Pfizer COVID-19 vaccine for children

A previous analysis found the vaccine was 90.7 percent effective against severe COVID-19.

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee gave its blessing to administering smaller doses of the Pfizer COVID-19 vaccine, Comirnaty, to children from 5 to 11 years of age.

Once the vaccine secures a recommendation from the Centers for Disease Control and Prevention, it is expected to plug a hole in the nation’s mass vaccination efforts and stem the slow, but consistent flow of juvenile deaths due to COVID-19.

According to documents the committee reviewed at their Oct. 26 meeting, the dose would be a third the size of those given to adults and teens. At least two months after the two-dose regimen, the vaccine proved to produce more neutralizing titers against the original strain of COVID-19 and the Delta variant than the larger doses did in teenagers.

The vaccine was shown to be 90.7 percent effective against COVID-19 at least seven days after the second dose.

The Biden administration has already set its sights on an all-out push for juvenile vaccination against COVID-19.

As previously reported, the administration as well as local health authorities will make the vaccine available to more than 25,000 pediatricians’ offices and other primary care sites.

“Pediatricians, and other doctors, are some of the most trusted sources for families when it comes to COVID-19 vaccines for children,” the White House says. “These providers will play a critical role in the nationwide effort to get children vaccinated.”

The administration will also be supplying vaccines to more than 100 children’s hospitals and health systems, tens of thousands of pharmacies, hundreds of schools and community-based clinics, and hundreds of community health centers and rural health clinics.

Previously, the agency decided boosters of the Moderna vaccine may be administered to patients who are 65 years of age or older, 18 through 64 years of age and at high risk of severe COVID-19, and 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.

Boosters of the Johnson and Johnson vaccine should be administered at least two months after completion of the primary regimen to patients 18 years of age and older.

The agency also authorized patients who received one COVID-19 vaccine to receive a booster shot of a different authorized vaccine, a move that offers flexibility to both patients and physicians.

The boosters are still awaiting recommendations from the CDC before they can be administered to patients.


This article was initially published by our sister publication Medical Economics.

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