Pfizer Receives Conditional Approval from EMA for New COVID-19 Vaccine

Pfizer's COVID-19 vaccine receives conditional approval from the European Medicines Agency for the LP.8.1 variant. The vaccine is aimed at individuals aged six months and older. Pfizer and BioNTech have started manufacturing the vaccine, and regulatory submissions have been made to global bodies. Analysts forecast an average price target of $28.76 with a 13.46% upside from the current price.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for their LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1). The vaccine is aimed at individuals aged six months and older. The CHMP's recommendation is based on the cumulative body of evidence supporting the safety and efficacy of the vaccine, including clinical, non-clinical, and real-world data [1].

The adaptation of the vaccine to target the LP.8.1 variant is in response to the evolving epidemiology of COVID-19. The EMA's Emergency Task Force (ETF) recommended this adaptation to maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve. The CHMP's recommendation will be reviewed by the European Commission (EC), which is expected to make its final decision soon [1].

Pfizer and BioNTech have already initiated manufacturing of the LP.8.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season. The updated vaccine will be available to ship to applicable EU member states immediately following the EC decision. The CHMP's recommendation is based on data showing that the LP.8.1-adapted vaccine generates overall improved immune responses against multiple circulating SARS-CoV-2 lineages, including XFG and NB.1.8.1, compared to the companies' JN.1 and KP.2-adapted vaccines [1].

Analysts have forecasted an average price target of $28.76 with a 13.46% upside from the current price, reflecting the market's positive response to the vaccine's approval. The companies have also submitted data for the updated vaccine to regulatory authorities around the world. They are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs [1].

References:
[1] Pfizer Inc. (2025). Pfizer and BioNTech receive positive CHMP opinion for LP.8.1-adapted COVID-19 vaccine. Business Wire. Retrieved from [https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-lp81](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-lp81)