Incellipan

Opinion

EMA has issued an opinion on this medicine

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Overview

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.

The full indication is:

Incellipan is indicated for active immunisation against influenza in an officially declared pandemic.

Incellipan should be used in accordance with official recommendations.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

 

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 ¹ A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.

CHMP summary of positive opinion for Incellipan

AdoptedReference Number: EMA/71759/2024

Product details

• Name of medicine:
  Incellipan
• Active substance:
  Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
• International non-proprietary name (INN) or common name:
  influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutic chemical (ATC) code:
  J07BB02
• EMA product number:
  EMEA/H/C/006051
• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation applicant:
  Seqirus Netherlands B.V.
• Opinion adopted:
  22/02/2024
• Opinion status:
  Positive