Pfizer and BioNTech said Thursday they are seeking Food and Drug Administration emergency use authorization for their COVID-19 vaccine for children ages 5 to 11.
If authorized, this would be the first COVID-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.
Last month, Pfizer released details of a Phase 2/3 trial that showed its COVID-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10-microgram dose — smaller than the 30-microgram dose that has been used for those 12 and older.
Participants' immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a "strong immune response in this cohort of children one month after the second dose."
Pfizer began submitting its data on the vaccine for younger children to the FDA late last month, but had not formally requested authorization until now.
FDA officials had said that once vaccine data for younger children was submitted, the agency could authorize a vaccine for younger children in a matter of weeks — not months — but it would depend on the timing and quality of the data provided.
In anticipation of the request, the FDA last week scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the vaccine in children ages 5 to 11 on Oct. 26. If the FDA OKs it, a panel of CDC vaccine advisers will meet to consider whether to recommend its use.
"We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults," Acting FDA Commissioner Dr. Janet Woodcock said in a statement about the Oct. 26 meeting.