(CNN) — Pfizer and BioNTech said Thursday that they are requesting emergency use authorization from the US Food and Drug Administration 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 persons 16 years of age and older and has an emergency use authorization for persons 12 to 15 years of age.
Last month, Pfizer released details of a phase 2/3 trial that showed its COVID-19 vaccine was safe and elicited a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants aged 5 to 11 years and used a two-dose regimen of the vaccine given 21 days apart. This trial used a 10-microgram dose, lower than the 30-microgram dose that has been used for those over 12 years of age.
Participants’ immune responses were measured by looking at the levels of neutralizing antibodies in their blood and comparing those levels with a control group of people aged 16 to 25 who received a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compare well to those of older people who received the higher dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”
Pfizer began submitting the data to the FDA late last month, but has not formally requested authorization so far.
FDA officials had said that once the vaccine data for younger children were 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 shots. data provided.
In anticipation of the request, the FDA scheduled a meeting of its Vaccine and Related Biologics Advisory Committee to discuss the vaccine in children ages 5 to 11 on October 26. If approved by the FDA, a CDC vaccine advisory panel will meet to consider whether to recommend its use.
“We know from our vast experience with other pediatric vaccines that children are not young adults, and we will conduct a comprehensive evaluation of the clinical trial data presented to support the safety and efficacy of the vaccine used in a younger pediatric population, which may need a different dosage or formulation than that used in an elderly pediatric population or in adults, ”said Acting FDA Commissioner Dr. Janet Woodcock in a statement regarding the October 26 meeting.
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