Biopharmaceutical New Technologies Inc. (NASDAQ: BNTX) stock declined by 8.64% in the current market trading session. Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing innovative cancer and other critical disease treatments.
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BNTX stock’ Major Update
The FDA has extended the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to also include anyone who is 16 years of age and older, according to Pfizer Inc. and BioNTech. The booster dose should be given at least 6 months after the main series is finished, and it has the same composition and dosage potency as the main series doses.
The FDA previously approved a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for urgent use in people 18 years of age and above who have finished the main series, as well as for selected individuals who have finished primary vaccination with a different authorized COVID-19 vaccine.
Pfizer and BioNTech intend to apply for a supplemental Biologics License Application (sBLA) to the FDA for authorization of a booster dose of their COVID-19 vaccination in people aged 16 and up. The sBLA will include safety and effectiveness data from a Phase 3 trial. It found that a 30-g booster dose given to people 16 and older who had previously gotten the Pfizer-BioNTech initial two series had a relative vaccination efficacy of 95% when contrasted to those who did not. This is the first time efficacy data from a randomized, controlled COVID-19 vaccination booster experiment has been released. The effects of the vaccine were broadly compared with other clinical safety data, indicating a positive safety profile.
Following their current supply deal with the US government, Pfizer and BioNTech will keep supplying the vaccine, plus booster doses, until April 2022. The corporations believe that today’s disclosure will have no effect on current contracts with authorities and international health companies around the globe.