BioNTech SE American Depositary Share - BNTX STOCK NEWS

The U.S. FDA has granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for children aged 5 to 11 years. This milestone is supported by clinical data indicating a 90.7% vaccine efficacy among participants when Delta was the prevalent strain. The vaccine demonstrates a favorable safety profile and will be administered in two 10-µg doses. With this authorization, Pfizer-BioNTech's vaccine is now the only option for this age group in the U.S., aiming to protect millions of school-aged children from COVID-19.

Pfizer and BioNTech announce the U.S. government's purchase of 50 million additional COVID-19 vaccine doses, bringing the total under their agreement to 600 million. This aims to support pediatric vaccinations, particularly for children under 5, pending regulatory authorization. The companies plan to deliver the doses by April 2022 and have committed to providing 1 billion doses to low and lower-middle-income countries at not-for-profit prices. Pfizer and BioNTech have already distributed over 1.8 billion doses globally, reflecting their commitment to equitable vaccine access.

Pfizer and BioNTech announced the U.S. government's purchase of an additional 50 million COVID-19 vaccine doses, bringing the total to 600 million under the existing supply agreement. This move supports pediatric vaccination efforts, particularly for children under 5, pending regulatory authorization. Deliveries are anticipated by April 30, 2022. Furthermore, the companies aim to manufacture 4 billion doses worldwide in 2022, with a commitment to provide vaccines to low-income countries. The FDA has been approached for Emergency Use Authorization for children aged 5 to under 12 years.

BioNTech SE (Nasdaq: BNTX) will announce its Q3 2021 financial results on November 9, 2021. A conference call and webcast for investors and analysts will be held at 8:00 a.m. ET (2:00 p.m. CET) the same day. Participants can access the presentation and audio via a provided link and will receive conference call details, including dial-in numbers and Conference ID. BioNTech continues to focus on immunotherapy development, having established partnerships with major pharmaceutical companies like Pfizer, Sanofi, and Bayer. Further information is available on their website.

Pfizer and BioNTech announced FDA's Vaccines Advisory Committee voted 17-0, with 1 abstention, to recommend Emergency Use Authorization (EUA) for their COVID-19 vaccine for children aged 5 to <12 years. This vaccine demonstrated a 90.7% efficacy rate in clinical trials conducted during the Delta variant surge, using a 10-µg dosage. If authorized, this will be the first COVID-19 vaccine approved for this age group in the U.S. The companies anticipate starting vaccine distribution immediately upon authorization, ensuring free access for eligible children.

Pfizer and BioNTech announced that the FDA advisory committee voted 17-0, with 1 abstention, to recommend Emergency Use Authorization for their COVID-19 vaccine in children aged 5 to <12 years. The clinical trial data showed a favorable safety profile and a high efficacy rate of 90.7% against COVID-19 during the Delta variant prevalence. The vaccine, to be administered as a two-dose regimen of 10-µg doses, could be the first authorized for this age group in the U.S. If approved, pediatric vaccine doses are expected to ship immediately, maintaining free access for eligible residents.

BioNTech has signed a Memorandum of Understanding with the Rwandan Government and Institut Pasteur de Dakar to construct Africa's first mRNA vaccine manufacturing facility, beginning in mid-2022. This facility aims to create a decentralized manufacturing network capable of producing hundreds of millions of mRNA vaccine doses annually. BioNTech plans to staff and operate the facility initially while transferring operational responsibilities to local partners. The project is expected to enhance vaccine access and build local capacity in Africa.

Pfizer and BioNTech announced results from a Phase 3 randomized trial for their COVID-19 vaccine booster, demonstrating a relative vaccine efficacy of 95.6% against disease during a period dominated by the Delta variant. The trial involved over 10,000 participants aged 16 and older, showing a favorable safety profile. The companies plan to submit these findings to the FDA, EMA, and other regulators to support licensure in the U.S. and abroad, highlighting the importance of booster shots in combating COVID-19.

Pfizer and BioNTech have announced the first results from a Phase 3 trial for a COVID-19 vaccine booster, revealing a relative efficacy of 95.6% against disease during Delta's prevalence. The trial included over 10,000 participants aged 16 and older, showing the booster restored vaccine protection to levels seen after the initial two doses and had a favorable safety profile. The companies plan to submit these results to regulatory agencies for licensure in the U.S. and globally.