The FDA has approved a supplemental Biologics License Application for a Fluzone (Sanofi) High-Dose Quadrivalent Influenza Vaccine for the prevention of influenza disease caused by Influenza A subtype viruses and type B viruses in adults 65 years of age and older.
"Increasing protection and delivering improved influenza vaccines are critical to public health," said David Loew, Sanofi executive vice president and head of Sanofi Pasteur, in a statement. "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."
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The approval is based upon results of a phase 3 immunogenicity and safety study published in Vaccine, in which researchers observed an improved immunogenicity with the addition of a B strain to the previous trivalent vaccine. Immunogenicity against other viruses previously contained in the trivalent vaccine remained the same even with the new addition, the study says.
Contraindications for Fluzone High-Dose Quadrivalent include patients that have experienced a secere allergic reaction to any component of the vaccine, including egg protein, or after the previous dose of any influenza vaccine.
Warnings and precautions issued with the High-Dose Quadrivalent vaccine include the risk of Guillian-Barré syndrome, which reportedly occurred within five weeks following the previous influenza vaccination.
Adverse reactions reported with the use of Fluzone High-Dose Quadrivalent include injection site pain and myalgia.