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High-dose influenza vaccine approved for people 65 and older
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The FDA approved an inactivated influenza vaccine designed to stimulate a stronger immune response in patients aged 65 and older that may provide greater protection against influenza types A and B.
Like other currently licensed adult influenza vaccines, Fluzone High-Dose (Sanofi Pasteur) contains influenza hemagglutinin from three strains of virus, but at higher concentrations — 60 mcg from each strain for a total of 180 mcg in each 0.5 mL dose vs. 15 mcg from each strain for a total of 45 mcg.
“As people grow older, their immune systems typically become weaker,” Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza.”
The vaccine is available in single-dose, preservative-free pre-filled syringes.
As expected, nonserious adverse events were more frequent with the high-dose formulation due to the higher hemagglutinin content, with the most common including pain, redness, muscle aches, fever, malaise and swelling at the injection site. Rates of serious adverse events were similar to those that occur with lower-dose influenza vaccines.
The FDA does not recommend the new vaccine for people with egg allergies or those who have experienced life-threatening reactions after previous influenza vaccination.
Licensure was granted using the FDA’s accelerated approval pathway after clinical studies demonstrated an enhanced immune response among participants who received the high-dose formulation. Further post-licensure studies are planned to verify the vaccine’s beneficial effect on seasonal influenza prevalence.