Pfizer seeks FDA clearance for COVID vaccine for children ages 5 to 11 – CBS Philly
NEW YORK (CNN) — Pfizer and BioNTech said Thursday they are seeking emergency use authorization from the U.S. Food and Drug Administration for a Covid-19 vaccine for children ages 5 to 11.
If licensed, it would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people 16 years of age and older and has an EUA for people 12 to 15 years old.
Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and produced a “strong” antibody response in children ages 5 to 11. The trial included 2,268 participants between the ages of 5 and 11 and used a two-vaccine dose regimen given 21 days apart. This trial used a 10 mcg dose – smaller than the 30 mcg dose that was used for those age 12 and older.
The participants’ immune responses were measured by looking at the levels of neutralizing antibodies in their blood and comparing those levels to a 16- to 25-year-old control group given a two-dose regimen with a larger 30-microgram dose. Levels compared well with older adults who received a larger dose, Pfizer said, showing “a robust immune response in this group of children a month after the second dose.”
Pfizer began submitting its vaccine data for younger children to the Food and Drug Administration late last month, but has not formally requested permission yet.
FDA officials said that once vaccine data for younger children is provided, the agency can authorize a vaccine for younger children within weeks — not months — but that it will depend on the timing and quality of the data provided.
In anticipation of the request, the Food and Drug Administration (FDA) last week scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the vaccine in children ages 5 to 11 for October 26. To consider recommending its use.
“We know from our extensive experience with other childhood vaccines that children are not young adults, and we will conduct a comprehensive evaluation of clinical trial data provided to support the safety and efficacy of the vaccine used in the population of younger children, who may need to,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement about Meeting October 26 The dose or formulation is different from that used in older children or adults.
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