BIONTECH - BNTX STOCK NEWS

The European Medicines Agency (EMA) has provided a positive opinion recommending conditional marketing authorization for the Pfizer-BioNTech COVID-19 vaccine (BNT162b2). If authorized by the European Commission, it will be the first COVID-19 vaccine available in the EU. Based on extensive Phase 3 data, the vaccine aims to combat COVID-19 for individuals aged 16 and older. This positive opinion follows numerous emergency use authorizations globally, and the vaccine has already been approved in over 15 countries.

BioNTech (BNTX) and Fosun Pharma announced a supply agreement for 100 million doses of the BNT162 mRNA COVID-19 vaccine in China, pending regulatory approval. The initial supply will come from BioNTech's facilities in Germany. This collaboration aims to enhance vaccine accessibility and affordability in China. A Phase 2 clinical trial for BNT162b2 is ongoing in Jiangsu Province, involving 960 participants to assess safety and immunogenicity. Both companies express gratitude towards the Chinese authorities for their support in combating COVID-19.

BioNTech (Nasdaq: BNTX) and Pfizer announced significant findings from their Phase 1/2 trial of the COVID-19 vaccine BNT162b2. The study involving 37 participants showed a robust immune response, including broad SARS-CoV-2-specific neutralizing antibodies, CD4+ T cell responses, and strong CD8+ T cell activation. Notably, all participants produced neutralizing antibodies, and the vaccine effectively targeted multiple spike protein regions. These results affirm a strong safety profile and sustained immune response, indicating potential for broad protection against diverse virus variants.

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.