CHMP positive for Celldemic vaccine, intended for active immunisation against the H5N1 subtype of Influenza A virus in adults and infants .Seqirus/CSL
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Celldemic, intended for active immunisation against the H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above.
The applicant for this medicinal product is Seqirus Netherlands B.V.
Celldemic will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Celldemic is an influenza vaccine (ATC code J07BB02). It contains haemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) viruses produced in MDCK cell cultures and the adjuvant M59C.. The Celldemic vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.
The benefit of Celldemic is a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks appart, as measured by haemagglutination inhibition titres against H5N1. The most common side effects in adults are pain at the injection site, fatigue, headache, malaise, myalgia and arthralgia. In children aged between 6 and 18 years, the most common side effects are injection site pain, myalgia, fatigue, malaise, headache, loss of appetite, nausea, and arthralgia. In children 6 months to less than 6 years of age, the most common side effects are tenderness at the injection site, irritability, sleepiness, change in eating habits and fever.
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