CHMP recommends approval of Fluad Tetra adjuvanted quadrivalent influenza vaccine.- Seqirus

Seqirus, a global leader in influenza prevention, announced that its adjuvanted quadrivalent influenza vaccine (aQIV) – launching as Fluad Tetra – has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of the marketing authorisation application (MAA) for use in people aged 65 years and above.

The CHMP positive opinion is a scientific recommendation for marketing authorisation which is referred to the European Commission for a final decision on the Company’s MAA. Subject to final approval, the decision will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein. The European Commission MAA approval is also applicable in the UK. During the Brexit transition period the UK is still subject to EU legislation and regulatory decisions.

Seqirus’ adjuvanted trivalent vaccine (aTIV) – Fluad – offers protection against three strains of influenza. The aQIV vaccine includes an additional B strain, offering protection against four seasonal influenza virus strains – A(H3N2), A(H1N1) and two B virus strains.