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Pfizer and BioNTech Seeks FDA Authorization for Children Vaccinations

Pfizer and BioNTech announced on Thursday that they are seeking emergency use authorization from the US Food and Drug Administration for their Covid-19 vaccine for children aged 5 to 11. This will be the first Covid-19 vaccine for younger children if it is approved. The Pfizer/BioNTech vaccine is licensed for those 16 and over, with a EUA for those 12 to 15. Pfizer announced last month that its Covid-19 vaccine was safe and exhibited a “robust” antibody response in children aged 5 to 11 in a Phase 2/3 trial.

The vaccine was provided in two doses, 21 days apart, to 2,268 participants ranging in age from 5 to 11. This study used a 10-microgram amount, which is lower than the 30-microgram dose previously used in children aged 12 and up. The immunological responses of the participants were assessed by comparing neutralizing antibody levels in their blood to a control group of 16 to 25-year-olds who were given a two-dose regimen with the bigger 30-microgram dosage.

According to Pfizer, the levels were comparable to older persons who received the higher dose, indicating a robust immune response in this group of youngsters one month after the second treatment. Late last month, Pfizer began submitting data on the vaccination for younger children to the FDA but had not formally requested approval until recently.

Officials with the FDA previously stated that once vaccine data for younger children was submitted, the agency may approve a vaccine for them in a matter of weeks rather than months, depending on the timing and quality of the data supplied. However, in response to the request, the FDA announced this week that its Vaccines and Related Biological Products Advisory Committee would meet on October 26 to discuss the vaccination in children aged 5 to 11.

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