BIONTECH - BNTX STOCK NEWS

On May 6, 2021, Pfizer and BioNTech announced a Memorandum of Understanding with the International Olympic Committee to provide COVID-19 vaccines to athletes participating in the Tokyo 2020 Olympic and Paralympic Games. The initial vaccine doses are expected to be delivered by the end of May, ensuring athletes receive both doses prior to arriving in Tokyo. This initiative aims to enhance the safety of the Games while demonstrating solidarity with host Japan. The vaccine is authorized for emergency use in individuals aged 16 and older but remains unlicensed by the FDA.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) signed a Memorandum of Understanding with the IOC to donate COVID-19 vaccine doses to athletes participating in the Tokyo 2020 Olympic and Paralympic Games, starting July 23, 2021. Initial doses are set for delivery by the end of May. The agreement ensures that vaccine doses provided will not detract from national supply agreements. IOC President emphasized the donation's role in promoting safety and solidarity. Pfizer's Chairman stated that the initiative represents a unifying moment post-pandemic, while BioNTech's CEO highlighted the importance of vaccines for a successful Games.

BioNTech SE (Nasdaq: BNTX) will announce its Q1 2021 financial results on May 10, 2021. The company invites investors and the public to join a conference call and webcast at 8:00 a.m. EDT (2:00 p.m. CEST) for the financial update and corporate insights. Access to the slide presentation and audio will be provided online.

BioNTech focuses on innovative immunotherapy solutions targeting serious diseases, leveraging advanced mRNA technology and collaborating with major pharmaceutical partners.

BioNTech (Nasdaq: BNTX) and Pfizer (NYSE: PFE) have submitted a variation for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their vaccine COMIRNATY (BNT162b2) to extend its use for adolescents aged 12 to 15. This follows a pivotal Phase 3 clinical trial with 2,260 participants showing 100% vaccine efficacy and robust antibody responses. The companies also seek Emergency Use Authorization in the U.S. and plan similar submissions globally, aiming for broader vaccine access.

BioNTech (BNTX) and Pfizer announced an agreement to supply 100 million additional doses of COMIRNATY to the European Union, increasing total doses to 600 million for 27 member states. All doses are expected to be delivered in 2021. The European Commission exercised this option under an expanded Advanced Purchase Agreement signed on February 17, 2021. Pfizer plans to deliver 250 million doses in Q2, which is a 400% increase compared to Q1.

Pfizer and BioNTech announced updated results from their Phase 3 study of the COVID-19 vaccine, BNT162b2, indicating a 91.3% efficacy against symptomatic COVID-19 up to six months post-second dose. The vaccine demonstrated 100% effectiveness in preventing severe disease per CDC guidelines and 95.3% effectiveness according to FDA standards. Over 44,000 participants were evaluated for safety, with favorable outcomes reported. The companies plan to submit a Biologics License Application to the FDA soon, bolstering confidence in the vaccine's ability to combat variants.

Pfizer and BioNTech released updated topline results from their pivotal Phase 3 study on the BNT162b2 COVID-19 vaccine, reporting a 91.3% efficacy rate in preventing symptomatic COVID-19. The vaccine showed 100% effectiveness against severe disease according to the CDC and 95.3% against severe COVID-19 per the FDA. Safety data indicated a favorable profile from over 12,000 participants monitored for at least six months post-vaccination. These results bolster plans for a Biologics License Application to the FDA.

BioNTech (Nasdaq: BNTX) and Pfizer released positive results from a Phase 3 trial showing BNT162b2 vaccine achieved 100% efficacy in adolescents aged 12-15, exceeding the results of the 16-25 age group. The trial involved 2,260 participants, with no COVID-19 cases in the vaccinated group. The companies plan to submit the data to the FDA and EMA for Emergency Use Authorization expansion. Additionally, they initiated a Phase 1/2/3 study for children aged 6 months to 11 years, aiming to assess vaccine safety and immunogenicity.

Pfizer (PFE) and BioNTech (BNTX) announced the successful results of a Phase 3 trial for their COVID-19 vaccine BNT162b2, showing 100% efficacy in adolescents aged 12 to 15. The trial, involving 2,260 participants, indicated no COVID-19 cases in the vaccinated group compared to 18 in the placebo group. The companies intend to submit these findings for Emergency Use Authorization (EUA) modification in the US and similar requests globally. They are also advancing studies in younger children, with the goal of public vaccination before the next school year.