09:07 AM EDT, 09/20/2024 (MT Newswires) -- Pfizer ( PFE ) and BioNTech (BNTX) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for an updated Comirnaty Covid-19 vaccine targeting the Omicron KP.2 subvariant in individuals six months and older.
The recommendation is based on non-clinical data showing the updated vaccine draws a "substantially improved response" against KP.2 and other Omicron JN.1 sublineages compared with the companies' Omicron XBB.1.5-adapted vaccine, the companies said.
Pfizer ( PFE ) and BioNTech said they were ready to ship out the vaccine as soon as the European Commission renders a final decision.
Separately, the committee said its positive opinion for the Comirnaty vaccine targeting KP.2 is in line with the EMA's Emergency Task Force recommendation to update the vaccines for the 2024/2025 vaccination campaign.