Pfizer and BioNTech are seeking emergency regulatory authorization for their SARS-CoV-2 vaccine for children between the ages of 5 and 11 years old, the New York Times reports.
The Pfizer-BioNTech mRNA-based vaccine, called Comirnaty, was approved by the US Food and Drug Administration in August for people 16 years old and older and is available for adolescents and teens between the ages of 12 and 15 years old under an emergency use authorization. A booster has also been authorized for individuals 65 years old and older as well as for other high-risk individuals.
Last month, Pfizer and BioNTech announced that a lower-dose version of their vaccine generated an immune response among children. They noted that kids had similar antibody levels as adolescents who received the full dose.
According to the Times, the FDA has scheduled a meeting later this month to consider the data Pfizer and BioNTech have submitted and a ruling is then expected between Halloween and Thanksgiving in the US.
"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," Janet Woodcock, the acting FDA commissioner, says in a statement, according to CNN.