Pfizer, BioNtech announce positive results of COVID-19 vaccine trial for small children

Washington, Sep 20 (FN Bureau) Pfizer and BioNTech announced on Monday positive results of a major trial for their low-dose COVID-19 vaccine designed for children between the ages of five and 11. “In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses,” a joint statement said, adding that they plan to submit data to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A two-dose regimen of 10 micrograms, three times lower than the vaccine for people age 12 and older, is administered 21 days apart.

“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 statement read. “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 CEO Albert Bourla expressed confidence that these results provide a strong foundation for seeking authorization of vaccine for children 5 to 11 years old.

“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,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “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.” About 4,500 children from 6 months to 11 years of age in the United States, Finland, Poland, and Spain were initially enrolled in the trial, over 2,200 of them were 4 to 11 years and received a 10 µg dose level in a two-dose regimen. US Surgeon General Vivek Murthy said in late August that COVID-19 vaccines for children under the age of 12 may be approved this year.