BIONTECH - BNTX STOCK NEWS

Pfizer and BioNTech have signed a new agreement with Turkey’s Ministry of Health to supply an additional 60 million doses of their COVID-19 vaccine, bringing the total to 120 million doses for 2021. This collaboration aims to enhance Turkey’s vaccination efforts against COVID-19. The vaccine is based on BioNTech’s mRNA technology, with both companies committed to public health initiatives. CEO Ugur Sahin emphasized their goal to deliver vaccines globally to combat the pandemic effectively.

Pfizer and BioNTech announced a new agreement with the European Commission to supply 900 million doses of their COVID-19 vaccine, COMIRNATY, with an option for an additional 900 million doses. Deliveries are scheduled to begin in December 2021 and continue through 2023. This agreement brings the total commitment to 2.4 billion doses since the pandemic began. The companies emphasize the ongoing need for vaccination as COVID-19 persists and highlight their dedication to adapting the vaccine for emerging variants.

Pfizer and BioNTech have entered a new agreement with the European Commission to supply 900 million doses of the COVID-19 vaccine COMIRNATY® to the EU, with an optional additional 900 million doses. This follows a prior commitment of 600 million doses for 2021. Deliveries are set to start in December 2021 and continue into 2023, potentially totaling 2.4 billion doses. Both companies emphasize the importance of ongoing vaccinations due to the continued spread of COVID-19 and are committed to adapting their vaccine for emerging variants.

BioNTech announced the appointment of Jens Holstein as the new Chief Financial Officer (CFO), effective July 1, 2021. Holstein brings over 25 years of experience in the pharmaceutical sector, previously serving as CFO at MorphoSys AG. This transition allows Sierk Poetting, the current CFO, to concentrate on his role as Chief Operating Officer (COO). Under Poetting's leadership, BioNTech expanded significantly, growing from 300 to over 2,000 employees. The company aims to leverage Holstein's expertise to accelerate its research pipeline and bolster its global manufacturing capabilities.

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.