FDA approves flu vaccine for use on patients over 65

November 6, 2019

Fluzone High-Dose Quadrivalent has been approved for use in patients over 65 to help prevent A and B strains of influenza.

The FDA has approved a new flu vaccine for people over the age of 65, according to a news release.

Fluzone High-Dose Quadrivalent is meant to protect people over the age of 65 to prevent their contracting influenza from influenza A and B strains.

In 2009, Fluzone High-Dose was approved by the FDA as a trivalent influenza vaccine which included two A strains and a single B strain. The new drug contains an additional B strain, according to the release.

"Increasing protection and delivering improved influenza vaccines are critical to public health,"  David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur, says in the release. "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."

This is the final step toward the Sanofi’s full transition to quadrivalent flu vaccines in the U.S. and the new drug will be available for immunizations for the 2020 to 2021 flu season. The trivalent Fluzone High-Dose will continue to be produced through the end of the 2019 to 2020 flu season, the release says.

"Influenza is a serious threat, especially for older adults who are more vulnerable to serious complications and even death,” says John Shiver, senior vice president Global Research and Development of Sanofi Pasteur.  “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."

In a study on Fluzone High-Dose, researchers found the drug prevented 24 percent more cases of the flu caused by any of the circulating influenza strains and 51 percent more cases of influenza caused by strains similar to those in the vaccine better than normal Fluzone, the release said.

At the end of the 2018 to 2019 flu season, over 112 million doses of Fluzone High-Dose had been distributed throughout the country and during that season nearly 60 percent of U.S. adults over 65 who received a flu vaccine had received Fluzone High-Dose.