Vaccine nears marketing authorisation approval in Europe
Maidenhead, 1 April 2020
Seqirus, a global leader in influenza prevention, today 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.1
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.2
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.
“This positive CHMP opinion takes us one step closer to fulfilling our commitment to bring our adjuvanted quadrivalent vaccine to Europe,” said Dr Raja Rajaram, Head of EMEA Medical Affairs for Seqirus. “Our current adjuvanted trivalent vaccine is supported by a large body of evidence – generated from both clinical trials and real world studies – and is recommended for use in patients over 65 years of age in many countries across the globe.
“We know that influenza causes a significant burden each year and that vaccination is the best method of prevention. The impact of the current coronavirus emergency underscores the importance of influenza vaccination in protecting those most at risk and reducing pressure on vital health services.3”
Influenza vaccine effectiveness tends to be low in the 65 and over population due to age-related immune decline, which reduces the body’s ability to produce a sufficient, protective immune response to the vaccine.4 The aQIV vaccine utilises the same adjuvant found in the aTIV vaccine – MF59® – which is designed to create a strong, broad and durable immune response.5,6,7 The aQIV vaccine will be produced in the UK at Seqirus’ Speke, Liverpool, manufacturing site.