Sanofi’s Fluzone High-Dose Quadrivalent (Influenza Vaccine) has secured approval from the US Food and Drug Administration (FDA) for its use in adults, aged 65 and over.
Fluzone High-Dose (Influenza Vaccine) was approved as a trivalent influenza vaccine by the US regulator in 2009, which covered the two influenza A strains and one influenza B strain.
The quadrivalent formulation of the vaccine, which has now been approved for older people, contains an additional influenza B strain. Following the approval of its supplemental biologics license application, Fluzone High-Dose Quadrivalent can be used in the US to protect older people from influenza disease caused by influenza A and B strains present in the vaccine.
Sanofi executive vice president and Sanofi Pasteur head David Loew said: “Increasing protection and delivering improved influenza vaccines are critical to public health.
“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 U.S. and anticipate approval in the European Union next spring.”
The FDA approval for the quadrivalent formulation of the Sanofi vaccine was driven by the results of a phase 3 immunogenicity and safety study.
The late-stage trial saw Fluzone High-Dose Quadrivalent achieve the primary endpoint of non-inferior immunogenicity. This was in comparison to two trivalent formulations of Fluzone High-Dose with each having one of the two influenza B strains recommended to be included in the vaccine for the 2017-2018 influenza season.
In a secondary endpoint of the phase 3 trial, each B strain in the quadrivalent formulation of the vaccine triggered a superior immune response, in comparison to the trivalent formulation that did not have the corresponding B strain.
Sanofi Pasteur global research and development senior vice president John Shiver said: “Influenza is a serious threat, especially for older adults who are more vulnerable to serious complications and even death. For the past 10 years, Fluzone High-Dose has helped protect millions of people 65 years of age and older from seasonal influenza.
“We are committed to helping protect as many people as possible from influenza and look forward to introducing this new formulation.”