BioNTech SE American Depositary Share - BNTX STOCK NEWS

BioNTech (BNTX) and Pfizer have received FDA's Emergency Use Authorization for their COVID-19 vaccine for individuals aged 12 to 15, marking it as the first vaccine approved for this group in the U.S.

The decision was based on a Phase 3 trial involving 2,260 participants, demonstrating 100% efficacy and robust antibody responses. The companies have also submitted data to the European Medicines Agency (EMA) and expect further global authorizations soon. Research continues into the vaccine's effectiveness in younger children, with data submissions anticipated in September.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced that the FDA has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals aged 12 to 15, making it the first vaccine authorized for this age group in the U.S. This decision follows a Phase 3 trial with 2,260 participants showing 100% efficacy and good tolerance of the vaccine. Monitoring for long-term safety will continue for two years post-vaccination. The CDC's Advisory Committee will shortly discuss recommendations for this age group.

BioNTech SE (BNTX) reported a substantial increase in revenues of €2.048 billion for Q1 2021, compared to €27.7 million in Q1 2020, driven by the global supply of its COVID-19 vaccine, BNT162b2. The company delivered over 450 million doses across 91 territories and secured orders for 1.8 billion doses in 2021. BioNTech's manufacturing capacity is projected to reach 3 billion doses by year-end. Additionally, BioNTech is advancing its oncology pipeline with 14 candidates in 15 trials, including the initiation of a Phase 1 trial for BNT221.

BioNTech is establishing its first regional hub in the Asia Pacific by planning a state-of-the-art mRNA manufacturing facility in Singapore. This expansion aims to enhance the global supply of mRNA-based vaccines and provide rapid response capabilities for Southeast Asia against potential pandemic threats. The initiative is supported by the Singapore Economic Development Board, with an anticipated operational start as early as 2023, creating up to 80 jobs.

Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the FDA for their COVID-19 mRNA vaccine for individuals 16 years and older. This BLA submission follows the delivery of over 170 million doses under Emergency Use Authorization (EUA). The companies aim to secure full regulatory approval by submitting clinical trial data and manufacturing information on a rolling basis. A supplemental BLA will also be submitted to expand the EUA to include individuals aged 12 to 15, following the availability of required data.

Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the FDA for their mRNA COVID-19 vaccine for individuals aged 16 and older. This submission supports their ongoing Emergency Use Authorization (EUA) since December 2020, during which over 170 million doses have been delivered in the U.S. The BLA aims for full regulatory approval, with data submitted on a rolling basis. The companies also seek to expand the EUA to include ages 12 to 15, followed by a supplemental BLA once data for this age group is available.

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.