About BioNTech SE - American Depositary Shares (BNTX)
BioNTech SE is a biotechnology company focused on developing and providing transformative therapies for patients suffering from serious diseases. It is primarily known for its pioneering work in mRNA-based vaccines, particularly in the field of infectious diseases and cancer immunotherapy. By leveraging its proprietary technology platform, BioNTech aims to create personalized and innovative treatments that harness the body’s natural immune response. The company is committed to advancing scientific research and bringing novel therapeutics to market, working collaboratively with partners in the pharmaceutical industry and academic institutions to address unmet medical needs globally. Read More
FDA approves Pfizer, Moderna, and Novavax Covid vaccines for high-risk groups as emergency authorizations end and vaccines transition to full marketing.
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2
NEW YORK and MAINZ, GERMANY, AUGUST 27, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2
The Trump administration may remove COVID-19 vaccines from the U.S. market as RFK Jr.'s allies gain influence at HHS, with a new vaccine task force led by a known skeptic.
In a notable shift, shares of Pfizer (NYSE: PFE) have recently edged higher, reflecting a burgeoning strength within the broader health sector. This uptick signals a renewed investor confidence in the pharmaceutical giant and the wider healthcare industry, which has been navigating a complex landscape of regulatory scrutiny, patent expirations,
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is pledging a major overhaul of the National Vaccine Injury Compensation Program (VICP), describing the system as fundamentally broken and failing its intended purpose.
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”2
