FDA approves Sanofi’s quadrivalent flu vaccine for over-65s

pharmafile | November 6, 2019 | News story | Research and Development, Sales and Marketing |  FDA, Fluzone, Sanofi, flu, influenza, pharma 

Sanofi’s quadrivalent influenza vaccine Fluzone High Dose has secured FDA approval in adult patients over the age of 65 for the prevention of two A and two B strains of the virus.

The approval was based on Phase 3 data in which the quadrivalent Fluzone formulation proved itself non-inferior to two trivalent formulations of the therapy in terms of immunogenicity, meeting the trial’s primary endpoint.

The approval follows the decision from the FDA in 2009 to authorise the High Dose formulation as a trivalent vaccine, covering two strains of influenza A and one of influenza B. It means that Sanofi has now fully transitioned to quadrivalent flu products in the US market.

“Increasing protection and delivering improved influenza vaccines are critical to public health,” said David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur. “We are excited to build upon the success of trivalent Fluzone High-Dose with this FDA approval to expand protection for an additional B strain. We have submitted filings with additional regulatory bodies outside the US and anticipate approval in the European Union next spring.”

Matt Fellows