The European Medicines Agency (EMA) has issued a positive opinion on two H5N1 influenza vaccines. The Incellipan vaccine has been granted “conditional” marketing authorization.
At a meeting held from February 19 to 22, the EMA’s Committee for Medicinal Products for Human Use gave a positive opinion to Celldemic and Incellipan, two vaccines for active immunization against the H5N1 avian influenza virus subtype. Both vaccines contain inactivated surface antigens.
Cell epidemic is an influenza vaccine for active immunization against the H5N1 subtype of avian influenza virus, supplied as an injectable suspension at 7.5 micrograms per 0.5 ml dose. In its adopted opinion, the committee noted that the vaccine guarantees people “an immune response within three weeks of two doses of the vaccine, three weeks apart.”
Although the vaccine incelipan “Conditional” marketing authorization has been granted and may only be used in the event of an official declaration of a pandemic.
The applicant for marketing authorization of these two vaccines is the Dutch company Seqirus.
Indications for use of Celldemic and Incellipan will be announced and made available upon grant of marketing authorization by the European Commission.