BioNTech SE American Depositary Share - BNTX STOCK NEWS

BioNTech and Pfizer have received a significant recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, COMIRNATY, aimed at children aged 5 to 11 years. This follows existing authorization for those aged 12 and above. Clinical trials indicated a strong immune response and a favorable safety profile. The final decision from the European Commission is anticipated soon, which could expand vaccination options for younger populations amidst ongoing COVID-19 challenges.

BioNTech announced financial results for the nine months ending September 30, 2022, reporting revenues of €13.0 billion, slightly down from €13.4 billion in 2021. Net profit increased to €7.2 billion, up from €7.1 billion, with diluted EPS at €27.70. The company raised its 2022 COVID-19 vaccine revenue guidance to €16-17 billion, reflecting the successful launch of its Omicron-adapted bivalent vaccines. BioNTech also expanded its oncology pipeline, starting three new clinical trials, and continues to lead in COVID-19 vaccine distribution, with approximately 300 million doses invoiced by mid-October 2022.

BioNTech and Pfizer announced promising results from a Phase 2/3 trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (BNTX). The study revealed that, one month post a 30-µg booster, antibody levels increased 13.2-fold in individuals older than 55 and 9.5-fold in adults aged 18-55, significantly outpacing the original vaccine's 2.9-fold increase. The safety profile remained favorable, resembling that of the original vaccine. The companies plan to share findings with regulatory bodies and continue examining the vaccine’s performance against emerging variants.

Pfizer and BioNTech announced robust results from a Phase 2/3 clinical trial for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. A 30-µg booster significantly increased neutralizing antibody titers—13.2-fold in adults over 55 and 9.5-fold for those aged 18 to 55 compared to the original vaccine. The safety profile remains favorable, similar to the original vaccine. These findings suggest enhanced protection against Omicron variants and support ongoing evaluations of the vaccine's effectiveness against emerging strains.

BioNTech SE (Nasdaq: BNTX) announced it will release its third quarter 2022 financial results on November 7, 2022. The company invites investors and the public to a conference call and webcast on the same day at 8:00 AM EDT (2:00 PM CEST) to discuss the results and provide a corporate update. Registration for the call is required, and the presentation will be accessible on BioNTech's Investor Relations website. A replay will be available post-call for 30 days.

Pfizer and BioNTech announced on October 19, 2022, that the European Medicines Agency's (EMA) CHMP recommended marketing authorization for a 3-µg dose of COMIRNATY (COVID-19 vaccine) for children aged 6 months to under 5 years. The decision is based on a Phase 2/3 trial with 4,526 participants where the vaccine showed a 73.2% efficacy against COVID-19 with a safety profile similar to placebo. The European Commission is expected to review this recommendation soon. Ongoing discussions regarding potential authorization of an adapted bivalent vaccine for younger children are also in progress.

Pfizer and BioNTech announced early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, showing substantial increases in neutralizing antibody responses. Participants receiving a 30-µg booster demonstrated significantly improved immunity against Omicron variants. The vaccine showed a favorable safety profile similar to the original vaccine. Further data on responses one month post-administration are expected soon, aiding potential full licensure and global registration efforts.

Pfizer and BioNTech have announced encouraging early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Following a 30-µg booster dose, participants exhibited a significant increase in neutralizing antibodies against the Omicron BA.4/BA.5 variants. Both younger and older adults demonstrated similar responses. Notably, the bivalent vaccine is expected to outperform the original vaccine in providing protection against these variants. The vaccine was well tolerated, with safety profiles resembling that of the original formulation. Additional data is forthcoming.

Pfizer and BioNTech have received Emergency Use Authorization (EUA) from the FDA for their 10-µg bivalent COVID-19 vaccine targeting the Omicron BA.4/BA.5 variants for children aged 5-11. This booster is intended to increase protection as the Omicron variant accounts for over 80% of COVID-19 cases in the U.S. The companies have manufactured millions of doses and will initiate shipping pending CDC recommendations. Clinical trials are also underway for younger children. The authorization is based on supportive safety and immunogenicity data from previous vaccine studies.