Quadrivalent adjuvanted influenza vaccine (aQIV) Fluad TetraThe drug developed by CSL Seqirus received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and can be used in people aged 50 years or older. Just two years ago, it had received CHMP approval for use in people 65 and older.
“We are pleased with the positive opinion from CHMP, which marks an important milestone in our mission to expand access to quadrivalent adjuvanted vaccines “Fluad Tetra is a medicine that fights the flu,” said Lorna Meldrum, vice president of international business operations and pandemic response for CSL Seqirus. “By expanding indications to people aged 50 and older, we are taking an important step toward our goal of protecting more people from influenza and reducing the medical and economic burden of influenza on society and health systems,” Meldrum said. “
Research supporting the decision found that the MF59-adjuvanted influenza vaccine showed a positive benefit-risk profile for preventing influenza in people aged 50 to 64 years.Compared with the licensed non-adjuvanted influenza vaccine in this randomized trial, immunogenicity was non-inferior against all strains, with higher responses against A(H1N1) and A(H3N2) strains. Type A strains cause the greatest disease burden in adults.
“Adjuvanted vaccines provide Protect people with weakened immune systems“Expanding the availability of Fluad Tetra to those aged 50 and over will help protect Spain’s wider population and health resources,” said Pepe Meseguer, CSL Seqirus Spain country manager. Meseguer said: “We will continue to work with health authorities to Expand access to adjuvanted vaccines to eligible groups. “
Positive comments allowed Submission of application for marketing authorization to the European Commission’s decision-making trust procedure The Medicines and Healthcare products Regulatory Agency (MHRA) has the power to approve medicines in England, Wales and Scotland after Brexit. The MHRA and EMA are expected to make a final decision in the coming months.