BIONTECH - BNTX STOCK NEWS

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.

BioNTech (Nasdaq: BNTX) is set to announce its financial results for the fourth quarter of 2020 on March 30, 2021. An investor call and webcast will take place at 8:00 a.m. EDT (2:00 p.m. CET) to discuss the results and provide a corporate update. The event will be accessible via the company’s website. BioNTech specializes in immunotherapy for cancer and serious diseases, leveraging mRNA technology and collaborating with major pharmaceutical companies.

The Israel Ministry of Health, Pfizer, and BioNTech released data showing significantly lower COVID-19 incidences in fully vaccinated individuals with the Pfizer-BioNTech vaccine. Findings indicate vaccinated individuals were 44 times less likely to develop symptomatic COVID-19 and 29 times less likely to die. Vaccine effectiveness was measured at 97% against symptomatic cases and severe outcomes, and 94% against asymptomatic infections. This comprehensive evidence supports ongoing global vaccination efforts amidst the pandemic.

The Israel Ministry of Health, Pfizer, and BioNTech announced significant findings from a real-world study showing a 97% effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in preventing symptomatic COVID-19, severe cases, and deaths. This data, derived from health surveillance from January to March 2021, showcases the impact of Israel's vaccination efforts, particularly against the B.1.1.7 variant. Further, the vaccine demonstrated 94% effectiveness against asymptomatic infections, emphasizing its role in controlling the pandemic and supporting ongoing immunization campaigns globally.

Pfizer and BioNTech have initiated a Phase 1/2/3 trial to evaluate a third dose of their COVID-19 vaccine, BNT162b2, aimed at studying safety and immunogenicity against evolving SARS-CoV-2 variants. Participants who received the initial two doses will be offered a booster dose 6 to 12 months later. They are also in discussions with regulatory authorities for a variant-specific mRNA vaccine, potentially targeting the B.1.351 lineage. The companies seek to ensure robust immunity and prepare for possible future vaccine adaptations, with ongoing assessments expected over two years.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) are evaluating a third dose of their COVID-19 vaccine, BNT162b2, to assess safety and immunity against circulating and emerging SARS-CoV-2 variants. This study will involve participants from a previous Phase 1 trial, who will receive the booster 6 to 12 months post-initial vaccination. Additionally, the companies are in talks with the FDA and EMA for a clinical study on a variant-specific vaccine. The goal is to ensure preparedness against future variants while maintaining current vaccine effectiveness.

BioNTech (BNTX) and Pfizer have submitted data to the FDA to update the Emergency Use Authorization for their COVID-19 vaccine. The proposed change would allow the vaccine to be stored at -25°C to -15°C for up to two weeks, providing better logistical flexibility for pharmacies and vaccination centers. This submission includes stability data from the last nine months of development. The current storage requirement necessitates ultra-cold temperatures between -80ºC and -60ºC. If approved, the updated storage guidelines would enhance accessibility for vaccine distribution.

Pfizer and BioNTech have initiated a global Phase 2/3 trial for their COVID-19 vaccine (BNT162b2) involving about 4,000 healthy pregnant women in several countries, including the U.S. and U.K. The trial aims to assess the vaccine's safety and immunogenicity in this vulnerable group. Participants will be unblinded post-delivery, allowing those who received a placebo to be vaccinated. The trial follows prior studies indicating no reproductive toxicity in animals. This initiative marks a step towards ensuring vaccine safety for crucial populations.