The companies Pfizer and BioNTech announced on Monday the results of a phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children aged 5 to 11 years also with a two-dose regimen administered with 21 days. difference .
The dose was 10ug , a lower dose than the 30 ug dose used for people 12 years of age and older. Antibody responses in participants who received 10 ug doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 ug doses.
The 10 ug dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children 5 to 11 years of age. These are the first results of a pivotal trial of a COVID-19 vaccine in this age group.
«Over the past nine months, hundreds of millions of people 12 years and older around the world have received our COVID-19 vaccine. We are eager to extend the protection that the vaccine provides to this younger population, subject to regulatory clearance. especially as we track the spread of the Delta variant and the substantial threat it poses to children, «said Albert Bourla , President and CEO of Pfizer.
«Since July, pediatric COVID-19 cases have increased by approximately 240 percent in the US. Underscoring the need for public health vaccination. The results of these trials provide a solid basis for seeking approval from our vaccine for children 5 to 11 years, and we plan to send them to the FDA and other regulators urgently, «he added.
For his part, Ugur Sahin , CEO and co-founder of BioNTech, has highlighted that the safety profile and immunogenicity data in children aged 5 to 11 years vaccinated with a lower dose are consistent, so they plan to send this data to the US Medicines Agency (FDA), the European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible.
GOOD RESULTS ARE EXPECTED IN UNDER 5 YEARS OLD
The summary data from this phase 2/3 study, which includes children 6 months to 11 years of age, was from 2,268 participants who were 5 to 11 years of age and received a dose level of 10 ug in a regimen. of two doses. The top line readings for the other two age cohorts in the trial (children two to five years of age and children six months to two years of age) are expected in the fourth quarter of this year .
The phase 1/2/3 trial initially enrolled up to 4,500 children ages six months to 11 years in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine in a two-dose schedule (approximately 21 days apart) in three age groups: five to 11 years; ages two to five years; and ages six months to two years.
Based on the dose escalation portion of the phase 1 trial, children ages 5 to 11 received a two-dose schedule of 10 ug each , while children younger than 5 years received a lower dose of 3 ug for each injection in phase 2/3 study. The trial included children with or without prior evidence of SARS-CoV-2 infection.