High-Dose Flu Vaccine: The Evidence Is In

Sandra Adamson Fryhofer, MD


January 03, 2014

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Hello. I'm Dr. Sandra Fryhofer. Welcome to Medicine Matters. The topic: the high-dose flu vaccine is more effective for seniors, according to new evidence presented at the October meeting of the Advisory Committee on Immunization Practices (ACIP). Here's why it matters.

In December 2009, high-dose seasonal flu vaccine for seniors aged 65 years or older (Fluzone® High-Dose; Sanofi Pasteur, Inc.) was granted accelerated approval by the US Food and Drug Administration (FDA). It contains 4 times more hemagglutinin per dose than the standard flu vaccine.

But it has downsides: more injection site reactions, and it is more than double the price.

It was designed to help improve immune response. And finally, there is proof it does just that. The study was presented by vaccine manufacturer Sanofi Pasteur at the October ACIP meeting. It included 32,000 adults 65 years and older living in the United States and in Canada. It followed them for the past 2 flu seasons. All received flu vaccination randomly: either the standard or high-dose flu version.

The results: case closed. The high-dose shot was more effective in seniors. It was 24% better at preventing flu than the standard flu shot. For seniors, the high-dose flu shot is clinically superior to standard formulations. The company is in the process of submitting revised labeling language to the FDA touting this clinical superiority.

Note that many companies are now transitioning to quadrivalent formulations. There is only 1 high-dose flu shot currently available, and it's still trivalent.

For Medicine Matters, I'm Dr. Sandra Fryhofer.


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