Pfizer (PFE) Announces FDA Approval of sBLA for Pfizer-BioNTech COVID-19 Vaccine

Pfizer Inc. (NYSE:PFE) is one of the top most undervalued low volatility stocks to buy now. Pfizer Inc. (NYSE:PFE) announced on August 27 the US Food and Drug Administration’s (FDA) approval of 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).

The vaccine is to be used in adults aged 65 years and older, along with individuals aged 5 to 64 years with at least one underlying condition putting them at high risk for severe outcomes from COVID-19.

Management reported that the FDA based the approval on “the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including clinical trial data supporting the approval for children 5 through 11 years of age.”

It added that the application also encompassed data from pre-clinical models showing that “the LP.8.1-adapted monovalent COVID-19 vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines.”

Pfizer Inc. (NYSE:PFE) is a global biopharmaceutical company that manufactures, develops, markets, and sells biopharmaceutical products worldwide. It advances wellness, prevention, treatment, and cures in developing and emerging markets.

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Disclosure: None. This article is originally published at Insider Monkey.