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FDA Approves BioNTech and Pfizer’s New COVID-19 Vaccine for High-Risk Groups

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FDA Approves BioNTech and Pfizer’s New COVID-19 Vaccine for High-Risk Groups

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BioNTech SE ( (BNTX) ) has provided an announcement.

On August 27, 2025, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration approved their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY® LP.8.1, for adults aged 65 and older, and individuals aged 5 through 64 with underlying conditions at high risk for severe COVID-19 outcomes. This approval is based on extensive clinical and real-world data demonstrating the vaccine’s safety and efficacy. The vaccine targets the SARS-CoV-2 sublineage LP.8.1, aligning with FDA guidance to address circulating strains. Shipping of the vaccine will commence immediately to ensure availability in pharmacies, hospitals, and clinics across the U.S., reinforcing BioNTech’s and Pfizer’s positions in the vaccine market and their commitment to addressing public health needs.

The most recent analyst rating on (BNTX) stock is a Hold with a $120.00 price target. To see the full list of analyst forecasts on BioNTech SE stock, see the BNTX Stock Forecast page.

Spark’s Take on BNTX Stock

According to Spark, TipRanks’ AI Analyst, BNTX is a Neutral.

BioNTech’s overall stock score reflects significant financial and technical challenges. While strategic collaborations and revenue growth are positives, the company’s profitability issues and bearish technical indicators weigh heavily on the score. The negative valuation metrics further contribute to a cautious outlook.

To see Spark’s full report on BNTX stock, click here.

More about BioNTech SE

BioNTech SE is a biotechnology company that specializes in developing and manufacturing immunotherapies for cancer and infectious diseases. The company is known for its mRNA-based vaccines, including the widely used COVID-19 vaccine developed in collaboration with Pfizer.

Average Trading Volume: 844,112

Technical Sentiment Signal: Sell

Current Market Cap: $25.19B

Find detailed analytics on BNTX stock on TipRanks’ Stock Analysis page.

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