10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
The committee adopted positive opinions for two vaccines intended for active immunisation against the H5N1 subtype of influenza A virus, also refered to as avian influenza or bird flu. One of them, Celldemic (zoonotic influenza vaccine (H5N1)(surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunisation during outbreaks of influenza coming from animals, including when public health authorities anticipate a possible pandemic. The other, Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, 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 authorised pandemic preparedness vaccine and apply for the vaccine to be authorised as a ‘final’ pandemic vaccine. Because the quality, safety and efficacy of the vaccine has already been assessed with other potential pandemic strains, the authorisation of the final pandemic vaccine can be accelerated…
