Even while pediatric COVID-19 cases remain high in the United States, there remains significant resistance by parents to vaccinate their children. Amid this reluctance, Pfizer and BioNTech have asked the FDA to authorize their vaccine for children aged 5 to 11, the companies revealed on Thursday.
An FDA advisory committee has scheduled a meeting on Oct. 26 to discuss authorization. The submission potentially sets up the vaccine for emergency use approval late October or early November, but the companies may face a tough sell trying to convince parents that the shot is safe.
Last month, only 34% of parents in the U.S. with children ages 5 to 11 said they would vaccinate them “right away,” according to a Kaiser Family Foundation poll. The survey was taken after Pfizer and BioNTech revealed that their vaccine was safe and effective in children of this age group.
In the late-stage study of 2,268 children ages 5 to 11, doses a third of the size given to adults provided antibody responses comparable to those seen in people aged 16 to 25. Side effects for the age group also were comparable to those observed in those aged 16 to 25.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer said on Twitter.
Even if the companies secure an authorization, it seems many parents will not be on board. In the KFF poll, 24% of those with kids ages 5 to 11 said they definitely would not vaccinate them, while 32% said they would “wait and see” how the vaccine is working.
Although the risk is very small, myocarditis, an inflammation of the heart, has been seen in adolescents and young adults, mostly male, after a second dose of the vaccine.
The Pfizer vaccine is fully authorized for people 16 and older. Those age 12 to 15 are authorized to use it on an emergency basis. Since the rise of the delta variant, children under age 18 have become more readily infected, accounting for one in four cases in the U.S. in September, said (PDF) the CDC. Since the beginning of the pandemic, the rate of child infection for children was one in six.