Pfizer and BioNTech have announced that results from a Phase II/III trial have shown that their COVID-19 vaccine is safe for use in children 5 to 11 years of age.
The first results from a pivotal trial of a COVID-19 vaccine in this age group, they showed a favourable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.
The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer said: “Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children. Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Dr. Ugur Sahin, CEO and co-founder of BioNTech said: “We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season. The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”