FDA approves Sanofi’s Fluzone High Dose Quadrivalent

Sanofi has received the Food and Drug Administration’s clearance for Fluzone High-Dose Quadrivalent (influenza vaccine) for use in adults 65 years of age and older.

Fluzone High-Dose (influenza vaccine) was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.

"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 United States. and anticipate approval in the European Union next spring."

This approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.

"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," said John Shiver, Sanofi Pasteur senior vice president, global research and development. "We are committed to helping protect as many people as possible from influenza and look forward to introducing this new formulation."