US biopharmaceutical company Pfizer Inc (NYSE:PFE) and German biotechnology company BioNTech SE ADR (NASDAQ:BNTX) have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending marketing authorisation for their LP.8.1-adapted COVID-19 vaccine, BioNTech announced on Friday.

The updated monovalent vaccine targets the LP.8.1 variant and is intended for individuals aged six months and older.

Clinical and non-clinical data show the vaccine generates stronger immune responses against circulating variants such as XFG, NB.1.8.1, and LF.7, outperforming prior JN.1- and KP.2-based formulations.

The European Commission is expected to decide soon, after which Pfizer and BioNTech are prepared to immediately supply doses to European Union member states. Manufacturing has already commenced at risk to ensure readiness ahead of the fall and winter immunisation campaigns.

To date, over one billion people globally have received Pfizer-BioNTech COVID-19 vaccines, which maintain a favourable safety and efficacy profile based on comprehensive real-world and clinical data. The companies have also submitted the updated vaccine for regulatory review in other global markets.