EMA/CHMP recommends six novel meds following March meeting

At its March 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) came up with positive recommendations for six novel medicines.

These include the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.

Bimervax, developed by HIPRA Human Health, contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the Alpha and Beta virus variants. The CHMP concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorization in the European Union. The CHMP concluded that a booster dose of Bimervax is expected to be at least as effective as Comirnaty, the world’s best-selling covid vaccine from Pfizer (NYSE: PFE) and BioNTech (Euronext: BNTX), at restoring protection against COVID-19 in people aged 16 years and older.