FDA approves Fluzone for older adults
The FDA approved a supplemental Biologic License Application for the Fluzone High-Dose Quadrivalent vaccine for the prevention of influenza in adults aged 65 years or older, Sanofi announced.
“Increasing protection and delivering improved influenza vaccines are critical to public health,” David Loew, executive vice president of Sanofi and head of Sanofi Pasteur, said in a press release.
In 2009, the FDA approved Fluzone as a trivalent influenza vaccine. This included two strains of influenza A and one strain of influenza B, according to the press release. The new, quadrivalent formulation includes an additional strain of influenza B.
Fluzone is marketed as a nasal spray influenza vaccine, which gives individuals who are reluctant to receive needles an alternative option for influenza protection.
The company said the quadrivalent vaccine will be available for use during the 2020-2021 influenza season, and the trivalent vaccine will continue to be offered through the end of the current influenza season.
A phase 3 study investigated the immunogenicity and safety of the Fluzone High-Dose Quadrivalent vaccine. The findings, which the FDA approval was based on, demonstrated that the quadrivalent formulation was immunogenetically noninferior compared with two different trivalent formulations of the vaccine.
“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,” John Shiver, PhD, senior vice president of global research and development at Sanofi Pasteur, said in the release. “We are committed to helping protect as many people as possible from influenza and look forward to introducing this new formulation.” – by Marley Ghizzone
Disclosures: Loew is the executive vice president of Sanofi and the head of Sanofi Pasteur. Shiver is the senior vice president of global research and development at Sanofi Pasteur.