CHMP positive for Incellipan an active immunisation against influenza in an officially declared pandemic . -Seqirus/CSL
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1marketing authorisation for the medicinal product Incellipan, intended for active immunisation against influenza in an officially declared pandemic .
The applicant for this medicinal product is Seqirus Netherlands B.V.
Incellipan will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Incellipan 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.1. The Incellipan vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.
The benefits of Incellipan are a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks apart, as measured by haemagglutinin 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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