Press release
In participants aged 12 to 15 years , BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in a trial of vaccinated participants aged 16 to 25 years in a previous analysis, and was well tolerated.
The companies plan to submit this data to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the emergency use authorization (EUA) and the EU conditional marketing authorization for BNT162b2.
The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children ages 6 months to 11 years.
NEW YORK AND MAINZ, Germany - (BUSINESS WIRE) - Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that, in a Phase 3 trial in adolescents ages 12 to 15 with or without evidence prior SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, surpassing those previously recorded in vaccinated participants aged 16 to 25 years, and was well tolerated . These are the main results from a pivotal phase 3 trial in 2,260 adolescents.
“We share the urgency of expanding the authorization of our vaccine for use in younger populations and are encouraged by clinical trial data in adolescents ages 12 to 15,” said Albert Bourla, president and CEO of Pfizer. "We plan to submit this data to the FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of beginning to vaccinate this age group before the start of the next school year ".
“All over the world, we long for a normal life. This is especially true for our children. The initial results we have seen in adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1 variant. 7 in the UK. It is very important to allow them to return to daily school life and meet friends and family while protecting them and their loved ones,” said Ugur Sahin, CEO and co-founder of BioNTech.
About Phase 3 Data for Adolescents 12 to 15 Years of Age
The trial recruited 2,260 adolescents ages 12 to 15 in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n = 1,129) versus none in the vaccinated group (n = 1,131).
Vaccination with BNT162b2 resulted in geometric mean SARS-CoV-2 neutralizing antibody titers (GMT) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was not inferior) to GMTs obtained by participants aged 16 to 25 years (705.1 GMT) in a previous analysis. Furthermore, BNT162b2 administration was well tolerated , with side effects generally consistent with those seen in participants 16 to 25 years of age.
The companies plan to submit these data to the FDA and EMA to request an amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY® to expand use in adolescents 12 to 15 years of age. as fast as possible. All trial participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Pfizer and BioNTech plan to submit the data for scientific peer review for possible publication.
Update on Phase 1/2/3 Study in Children 6 Months to 11 Years
Last week, Pfizer and BioNTech dosed the first healthy children in an ongoing global Phase 1/2/3 study to further evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children aged 6 months at 11 years of age.
The study is evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in a two-dose schedule (approximately 21 days apart) in three age groups: children 5 to 11 years, 2 to 5 years and 6 months to 2 years. The 5-11 year old cohort began administration last week and companies plan to start the 2-5 year old cohort next week.
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, has not been approved or authorized by the US Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA under a US Food and Drug Administration (FDA). emergency (USA) to prevent coronavirus disease 2019 (COVID-19) for use in people over 16 years of age .
Emergency use of this product is only authorized for the duration of a declaration that circumstances exist that justify authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is canceled or authorization revoked earlier.
The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the holder of marketing authorizations in the European Union and the holder of emergency use authorizations or equivalent in the United States, the United Kingdom, Canada and other countries prior to a planned application for full marketing authorizations in these countries.
AUTHORIZED USE IN USA
The Pfizer-BioNTech COVID-19 vaccine is authorized for use under an emergency use authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS). -CoV-2) in individuals 16 years of age or older.
