Pfizer Inc. [NYSE: PFE] and BioNTech SE [NASDAQ: BNTX] disclosed that its COVID-19 vaccine has got the FDA approval for its COVID-19 vaccine. After the approval, firms will be allowed to inoculate the vaccine in individuals between the age of 12 to 15 years. This is the first COVID-19 vaccine certified in the U.S. for use in this age group.
This is the greatest achievement of the firms. The firm will now be able to help the government in expanding its vaccination program. It also assists the government in safeguarding young people before the beginning of the next school year. The authorization of the FDA is dependent on data from a pivotal Phase 3 clinical trial. The study has registered 2,260 attendees between the ages of 12 to 15 years.
Furthermore, the results from the study demonstrated a vaccine efficacy of 100% in participants with or without any previous infection. Pfizer and BioNTech have lodged the data of 12 to 15 years of age for scientific peer assessment.
The data also have been lodged to other watchdogs around the globe, involving the European Medicines Agency (EMA). Additionally, studies assessing the safety of the Vaccine in children of 6 months to 11 years of age are underway. The Pfizer-BioNTech COVID-19 Vaccine, which is dependent on BioNTech patented mRNA technology, was created by both BioNTech and Pfizer. The PFE-BNTX COVID-19 Vaccine has not been authorized by the U.S. but FDA has approved it for EUA to avert COVID-19.