BioNTech, Pfizer Receive EMA Recommendation for COVID-19 Vaccine Approval

BioNTech SE and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for their LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1) for individuals 6 months of age and older. The vaccine is designed to prevent COVID-19 caused by SARS-CoV-2. The companies are developing a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2).

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Pfizer Inc. (PFE) and BioNTech SE (BNTX)'s LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY LP.8.1, for individuals aged 6 months and older [1]. The recommendation is based on the EMA's Emergency Task Force (ETF) recommendation to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season.

The LP.8.1-adapted vaccine has shown improved immune responses against currently dominant and emerging SARS-CoV-2 lineages compared to the 2024-2025 vaccine formulations [2]. This adaptation aims to maintain the effectiveness of the vaccines as the virus continues to evolve.

The CHMP's recommendation will be reviewed by the European Commission (EC), which is expected to make its final decision soon. Pfizer and BioNTech have already initiated manufacturing of the LP.8.1-adapted vaccine to ensure supply readiness ahead of the upcoming fall and winter season [3].

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and have demonstrated a favorable safety and efficacy profile supported by extensive real-world evidence, clinical, non-clinical, pharmacovigilance, and manufacturing data [3].

References:
[1] https://www.rttnews.com/3557477/pfizer-biontech-receive-positive-chmp-opinion-for-lp-8-1-adapted-covid-19-vaccine.aspx
[2] https://seekingalpha.com/news/4472112-pfizer-biontech-win-eu-backing-new-covid-shot
[3] https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-receive-positive-chmp-opinion-lp81-adapted-0?mobile=1