Latest novel medicines recommended for approval by EMA’s CHMP

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its February 2024 meeting.

The committee adopted positive opinions for two vaccines intended for active immunization against the H5N1 subtype of influenza A virus, also referred to as avian influenza or bird flu. One of them, from Seqirus, part of Australian CSL Limited (ASX: CSL), Celldemic (zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunization during outbreaks of influenza coming from animals, including when public health authorities anticipate a possible pandemic.

The other, also from Seqirus, is Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, also from Seqirus, prepared in cell cultures)), is a pandemic preparedness vaccine intended for use only if a flu pandemic has been officially declared. In the event of a pandemic, once the virus strain causing the pandemic is identified, the manufacturer can include this strain in the authorized pandemic preparedness vaccine and apply for the vaccine to be authorized as a 'final' pandemic vaccine. Because the quality, safety and efficacy of the vaccine has already been assessed with other potential pandemic strains, the authorization of the final pandemic vaccine can be accelerated.