The Food and Drug Administration has approved a new influenza vaccine for people aged 65 or more years, biopharmaceutical company Sanofi announced Monday.
Fluzone High-Dose Quadrivalent will be available in fall 2020, the company said. It includes an additional influenza B strain compared with Fluzone High-Dose, which was approved by the FDA in 2009 as a trivalent influenza vaccine and includes two influenza A strains and one influenza B strain.
The older version will continue to be available through the current 2019-2020 flu season, according to Sanofi.
“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,” David Loew, Sanofi executive vice president and head of Sanofi Pasteur, said in a statement. “We have submitted filings with additional regulatory bodies outside the United States and anticipate approval in the European Union next spring.”
Fluzone High-Dose Quadrivalent induced a better immune response compared with the trivalent formulation in a study that produced data used by FDA in its approval decision, Sanofi said.