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The administration sees pediatricians and primary care physicians taking the lead in the push.
The Biden administration is making pediatricians and primary care physicians the cornerstone of their plan to vaccinate children aged 5 to 11 against COVID-19.
According to a fact sheet from the White House, 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 fact sheet 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, according to the fact sheet.
In other news, the Food and Drug Administration (FDA) authorized booster shots for the Moderna and Johnson and Johnson COVID-19 vaccines, as well as the mixing and matching of booster doses.
According to a news release, 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 amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, says in the release. “We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”
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.
The committee will reconvene on Nov. 30 to discuss the Merck investigational antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults.