Pfizer-BioNTech vaccine demonstrated 100 efficacity against COVID-19 in longer- term analysis, with no serious safety enterprises linked
. Data will support planned cessions for full nonsupervisory blessing of the vaccine in this age group in theU.S. and worldwide
NEW YORK & MAINZ, Germany– (BUSINESS WIRE)– PfizerInc. (NYSEPFE) and BioNTech SE (NasdaqBNTX) moment blazoned topline results from a longer- term analysis of the safety and efficacity of their COVID-19 vaccine in individualities 12 through 15 times of age. The streamlined findings from the companies’ vital Phase 3 trial show that a two- cure series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per cure) was 100 effective against COVID-19, measured seven days through over four months after the alternate cure.
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The adverse event profile was generally harmonious with other clinical safety data for the vaccine, with no serious safety enterprises observed in individualities with at least 6 months of safety follow-up after the alternate cure.
“ As the global health community works to increase the number of vaccinated people around the world, these fresh data give farther confidence in our vaccine’s safety and effectiveness profile in adolescents. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has braked,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “ We look forward to participating these data with the FDA and other controllers.”
“ These are the first and only bared longer- term data demonstrating the safety and efficacity of a COVID-19 vaccine in individualities 12 through 15 times of age,” said Ugur Sahin, CEO andCo-founder of BioNTech. “ The growing body of data we’ve collected from clinical trials and real- world surveillance to date strengthen the base of substantiation supporting the strong efficacity and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations.”
These longer- term follow-up data will form the base for a planned supplemental Biologics License Operation (sBLA) to be submitted to the FDA to expand blessing of the vaccine for use in individualities 12 times and aged. The vaccine is presently available for individualities 12 through 15 times of age under Emergency Use Authorization (EUA), granted by the FDA in May 2021. The companies also plan to submit these data to pursue nonsupervisory blessings for this age group in other countries where exigency use authorizations or coequals were originally granted.
About the Analysis in Adolescents 12-15 Times of Age
The streamlined analysis of the Phase 3 clinical trial in individualities periods 12 through 15 times was conducted in agreement with guidance from the FDA for all companies probing COVID-19 vaccines to review safety and efficacity at crucial mileposts. Data through up to six months after the primary vaccination series are needed for licensure. These data were collected from November 2020 to September 2021.
Results from this analysis of trial actors make upon and confirm preliminarily released data and demonstrate strong protection against COVID-19. From the 30 verified characteristic cases of COVID-19 in the trial with and without substantiation of previous infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo group and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacity of 100 (95 confidence interval (CI,87.5,100.0)).
Efficacity was constantly high across gender, race and race demographics, rotundity and comorbidity status. Pfizer and BioNTech plan to submit these data for scientific peer review for implicit publication.
The Pfizer-BioNTech COVID-19 Vaccine, which is grounded on BioNTech’s personal mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and other countries, and the holder of exigency use authorizations or coequals in the United States ( concertedly with Pfizer) and other countries. Cessions to pursue nonsupervisory blessings in those countries where exigency use authorizations or original were originally granted are planned.
About Pfizer Improvements That Change Cases’Lives
At Pfizer, we apply wisdom and our global coffers to bring curatives to people that extend and significantly ameliorate their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative drugs and vaccines. Every day, Pfizer associates work across developed and arising requests to advance heartiness, forestallment, treatments and cures that challenge the most stressed conditions of our time. Harmonious with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we unite with health care providers, governments and original communities to support and expand access to dependable, affordable health care around the world. For further than 170 times, we’ve worked to make a difference for all who calculate on us.
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