The FDA is expected to act on an EUA application for the smaller doses next week.
Pfizer says that a smaller dose of their COVID-19 vaccine, Comirnaty, shows high efficacy in children between the ages of 5 and 11.
According to documents which will be reviewed as part of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee 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 vanilla 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.
Meanwhile, the FDA has been busy approving booster doses of authorized COVID-19 vaccines for populations who’ve already received initial doses.
Last week 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 Centers for Disease Control and Prevention before they can be administered to patients.
Previously, the FDA Vaccines and Related Biological Products Advisory Committee recommended the move.
Documents which the committee used to reach their determination show that, when administered six months after a second dose, the booster half-dose of the Moderna vaccine raise antibody titers 15 times a month after the additional shot and provides protection against the now-dominant Delta variation of the disease.
The documents also show that the booster shots appear safe, with the reactogenicity and adverse event profile similar to that seen after the second dose of the vaccine.
A Phase 3 ENSEMBLE 2 study found that a second dose of the Johnson and Johnson vaccine administered 56 days after the first provided 100 percent protection against severe or critical COVID-19, 75 percent protection against symptomatic COVID-19 globally, and 94 percent protection against symptomatic COVID-19 in the U.S. When the second shot is administered, it boosts antibody levels four to six times higher than what is observed after the initial dose.
When the booster shot was given six months after the initial dose antibody levels shot up nine-fold after a week and 12-fold after four weeks irrespective of the age of the patient.