BioNTech SE American Depositary Share - BNTX STOCK NEWS

Pfizer and BioNTech announced a favorable FDA advisory committee vote (17 to 4) supporting Emergency Use Authorization for their COVID-19 mRNA vaccine, BNT162b2. The decision is based on comprehensive Phase 3 efficacy and safety data, showing a 95% efficacy rate in study participants. If authorized, BNT162b2 will be the first COVID-19 vaccine available in the U.S. The FDA's final decision is pending, considering the advisory committee's recommendation.

BioNTech SE (Nasdaq: BNTX) and Pfizer Inc. (NYSE: PFE) announced the publication of final efficacy results from their Phase 3 trial of the mRNA-based COVID-19 vaccine BNT162b2, involving 43,448 participants. The results indicate a 95% efficacy in preventing COVID-19 among those without prior infection, with strong performance across demographic subgroups. The trial also noted early partial protection beginning 12 days post first dose. The data are crucial for regulatory submissions to agencies like the FDA and EMA.

Health Canada has authorized the emergency use of the mRNA COVID-19 vaccine BNT162b2 developed by BioNTech and Pfizer. The companies will supply a minimum of 20 million doses to Canada in 2021, with potential upward adjustment to 76 million doses. This decision follows similar approvals in the U.K. and Bahrain. The authorization is based on extensive clinical trial data involving approximately 44,000 participants. BioNTech holds the regulatory approval, while Pfizer manages commercialization in Canada.

BioNTech SE (Nasdaq: BNTX) is set to hold a press conference on December 2, 2020, focusing on the status of its lead COVID-19 vaccine candidate, BNT162b2. The conference, conducted in English, will begin at 12:30 PM CET (6:30 AM ET), and will allow journalists to submit questions online. BioNTech, a pioneer in next-generation immunotherapy, is developing various mRNA vaccine candidates for infectious diseases while continuing its oncology pipeline. More details can be found on BioNTech's official website.

The Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted emergency authorization for the COVID-19 mRNA vaccine (BNT162b2) developed by BioNTech (BNTX) and Pfizer. This marks the first authorization of a COVID-19 vaccine, indicating a significant step in fighting the pandemic. The companies plan to deliver 40 million doses to the U.K. by the end of 2021. Based on Phase 3 trial data, the vaccine shows an efficacy rate of 95%. Further regulatory reviews by the U.S. FDA and EU EMA are anticipated in December.

BioNTech (NASDAQ: BNTX) and Pfizer have successfully submitted an application for Conditional Marketing Authorization (CMA) of their COVID-19 vaccine, BNT162b2, to the European Medicines Agency (EMA) on November 30, 2020. The Phase 3 clinical trial demonstrated a vaccine efficacy rate of 95% with no safety issues reported. The companies plan to submit applications to various global regulatory agencies, including the FDA and authorities in Australia, Canada, and Japan. If approved, BNT162b2 could be available in Europe by the end of 2020.

BioNTech (BNTX) and InstaDeep have announced a multi-year strategic collaboration focusing on integrating artificial intelligence (AI) and machine learning (ML) into drug discovery and development. This partnership will establish a joint AI Innovation Lab in London and Mainz, enhancing BioNTech's capabilities in creating novel mRNA-based therapies. Key focus areas include novel drug design, advanced analytics, and supply chain optimization. The collaboration builds upon their existing relationship initiated in 2019, aiming to transform approaches to cancer and infectious disease treatments.

Pfizer and BioNTech have submitted a request for Emergency Use Authorization (EUA) from the FDA for their COVID-19 vaccine candidate, BNT162b2, which has shown a 95% efficacy rate in Phase 3 trials. The firms aim to produce up to 50 million doses in 2020 and 1.3 billion by the end of 2021, ready for distribution upon authorization. The submission is supported by extensive safety data from about 46,000 participants, with no serious safety concerns reported as of yet. The companies are also engaged in rolling submissions with international regulators to accelerate vaccine access globally.