WASHINGTON (Pakistan Point News / Sputnik - 20th September, 2021) �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 �g doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 �g doses," the statement read. "The 10 �g 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 �g 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.
