Pfizer seeks FDA clearance for Covid-19 vaccine for children ages 5-11

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If authorized, it would be the first vaccine against Covid-19 for young 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 of age.

Pfizer submits data on Covid-19 vaccine for children aged 5-11 to FDA, not yet seeking EUA

Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine to be safe and generated a “robust” antibody response in children aged 5 to 11. The trial included 2268 participants aged 5 to 11 years and used two – dosing regimens of the vaccine administered 21 days apart. This trial used a 10 microgram dose – smaller than the 30 microgram dose used for ages 12 and older.

The participants’ immune responses were measured by examining the levels of neutralizing antibodies in their blood and comparing these levels to a control group of 16 to 25 years old who were given a two-dose regimen with the highest dose of 30 micrograms. . Pfizer said the levels compared well with older people who received the highest dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

Pfizer began submitting its vaccine data for young children to the FDA at the end of last month, but had not formally applied for clearance until now.

FDA officials have said that once vaccine data for young children is submitted, the agency could clear a vaccine for young children in weeks – not months – but that would depend on when and how. quality of data provided.

In anticipation of demand, the FDA scheduled a meeting of its Vaccines and Related Biologics Advisory Committee last week to discuss the vaccine in children aged 5 to 11 on October 26. If the FDA agrees, a group of CDC vaccine advisers will meet. consider whether to recommend its use.

“We know from our extensive experience with other pediatric vaccines that children are not little adults, and we will be conducting a comprehensive evaluation of the submitted clinical trial data to support the safety and the effectiveness of the vaccine used in a younger pediatric population, which may need a different strength or formulation than that used in an older pediatric population or in adults, ”said Acting FDA Commissioner Dr. Janet Woodcock, in a statement about the October 26 meeting.

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