Germany-based biotechnology company Biopharmaceutical New Technologies SE "BioNTech" (BNTX:NASDAQ) and global pharmaceutical firm Pfizer Inc. (PFE:NYSE) announced that they have "submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY® (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age."
The companies noted that in the event that the EMA grants approval for expanded use for these lower age groups, then the amended use authorization will be valid in each of the 27 EU member states.
The report advised that BioNTech and Pfizer have previously submitted a request the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA), which was virtually similar to that filed with the EMA, and that the two firms intend to file additional requests as needed with other worldwide regulatory governing authorities.
The companies reported that the expanded use submission was based upon the data from a pivotal Phase 3 clinical trial that enrolled a total of 2,260 individuals between the ages of 12 to 15. The firms pointed out that the topline data from this trial were announced at the end of March 2021 and indicated that the results demonstrated "a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses."
The report stated that the Pfizer-BioNTech COVID-19 vaccine was jointly developed by BioNTech and Pfizer and was based upon BioNTech's proprietary mRNA technology.
Pfizer is a global research-based biopharmaceutical company based in New York. The firm is active in the discovery, development and manufacture of healthcare products. Its global medicine portfolio is composed of many well-known brand prescription medications including Celebrex, Eliquis, Lipitor, Prevnar 13, Xeljanz, Pristiq and Viagra. The firm's shares trade on the NYSE and it has a market cap of about $215 billion.
BioNTech is headquartered in Mainz, Germany, and concentrates its efforts on providing next generation immunotherapies for cancer and other serious diseases. The firm noted that "its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules." Along with its oncology pipeline, the company is utilizing its strong expertise in mRNA vaccine development and manufacturing capabilities to create multiple mRNA vaccine candidates for infectious diseases. In addition to its close work with Pfizer on its mRNA-based COVID-19 vaccine, the company also partners and collaborates with many other leading pharmaceutical firms including Bayer Animal Health, Fosun Pharma, Genevant, Genmab, Regeneron, Sanofi and Genentech, which is a member of the Roche Group.
BioNTech started the week with a market capitalization of around $45.5 billion with approximately 241.50 million shares outstanding. BNTX shares opened more than 7% higher today at $202.25 (+$13.97, +7.42%) over Friday's $188.28 closing price reached a new 52-week high price today of $211.65. The firm's U.S. ADR shares have traded today between $196.00 to $211.65 per share and closed for trading at $208.90 (+$20.62, +10.95%).[NLINSERT]
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