BioNTech SE American Depositary Share - BNTX STOCK NEWS

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.

BioNTech SE (Nasdaq: BNTX) has achieved significant milestones with its BNT162b2 COVID-19 vaccine, now approved in over 65 countries. As of March 23, 2021, over 200 million doses have been supplied, with orders totaling 1.4 billion doses for 2021. The company anticipates expanding production capacity to 2.5 billion doses by year-end. Financially, BioNTech reported COVID-19 vaccine revenues of €270.5 million for the full year 2020 and ended the period with €1.2 billion in cash. The oncology pipeline is advancing with 13 candidates in 14 ongoing trials.

BioNTech SE announced the European Medicines Agency (EMA) approved its COVID-19 vaccine manufacturing at the Marburg facility, enhancing production capabilities to one billion doses annually. Due to operational efficiencies, an increase of 250 million doses is expected. 400 employees are currently at Marburg, with the first drug product batches anticipated for delivery in April. The facility is GMP-certified, ensuring high-quality drug production standards. BioNTech aims to produce up to 250 million doses of BNT162b2 in early 2021, catering to the growing global demand.

BioNTech (Nasdaq: BNTX) and Pfizer announced EMA approval for their COMIRNATY vaccine to be stored at -25°C to -15°C for two weeks. This flexibility enhances distribution, allowing storage in pharmacies and supporting decentralized vaccinations at general practitioners' offices across the EU. The approval aims to increase accessibility and reduce pressure on large vaccination centers.

Ugur Sahin, BioNTech's CEO, emphasized the importance of this milestone, while Albert Bourla, Pfizer's CEO, noted the collaborative efforts with regulatory agencies to enhance vaccine distribution.