The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (BLA) for the Fluzone high-dose quadrivalent influenza vaccine for use by adults 65 years of age and older. Fluzone is manufactured by Sanofi Pasteur, Inc. of France.1 2
The Fluzone high-dose influenza vaccine was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A virus strains and one influenza B virus strain. The quadrivalent version of the vaccine contains an additional influenza B strain.1 2
A BLA is a request for “permission to introduce, or deliver for introduction, a biologic product into interstate commerce.” It affirms that the product is “safe, pure, and potent” and that the production facilities have been qualified for inspection and each package of the product carries the license number.3 4
According to a Sanofi Pasteur press release, “This approval is the final step toward the company’s complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season.”1
The press release notes that the rates of “local and systemic reactions” to the Fluzone quadrivalent have been “similar” to those caused by Fluzone trivalent and that the “most common reactions occurring after administration were injection-site pain (41.3 percent), myalgia (22.7 percent), headache (14.4 percent), and malaise (13.2 percent).”1
The onset of adverse reactions to Fluzone quadrivalent usually occur within three days after vaccination.1
The Fluzone quadrivalent vaccine contains egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose vials), and sucrose.5
Numerous studies, including a major one by the U.S. National Institutes of Health (NIH), have provided data showing that flu shots provide no benefit to the elderly and, in most flu seasons during the past 15 years, flu shots were less than 50 percent effective in preventing influenza in children and adults of all ages.6 In an article reprinted in The Vaccine Reaction, investigative report Sharyl Attkisson referenced the NIH study saying that “no matter how they crunched the numbers, the data kept telling the same story: flu shots were of no benefit to the elderly.”7
“Quite the opposite,” wrote Attkisson. “The death rate had increased markedly since widespread flu vaccination among older Americans. The scientists finally had to acknowledge that decades of public health thought had been mistaken.”8
The Centers for Disease Control and Prevention (CDC) estimate that the influenza vaccine for last year’s flu season (2018-2019) had an adjusted effectiveness rating of negative 29 to 41 percent for people over 65 years of age—meaning that for this segment of the population getting the flu shot made them more susceptible to infection.8 9
1 Press Release. FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older. Sanofi Nov. 4, 2019.
2 Brooks M. FDA OKs Fluzone High-Dose Quadrivalent Influenza Vaccine for Older Adults. Medscape Nov. 5, 2019.
3 U.S. Food and Drug Administration. Biologics License Applications (BLA) Process (CBER). FDA.gov.
4 Biologics license application. Wikipedia.
5 Centers for Disease Control and Prevention. Vaccine Excipient & Media Summary. CDC.gov.
6 National Vaccine Information Center. How Effective Is Influenza Vaccine? NVIC.org 2019.
7 Attkisson S. NIH Research: Flu Shots Not Effective in Elderly. The Vaccine Reaction Nov. 13, 2015.
8 Mercola J. Flu Shot Fails to Protect Seniors and May Increase Miscarriages. The Vaccine Reaction Oct. 9, 2019.
9 Centers for Disease Control and Prevention. US Flu VE Data for 2018-2019 CDC.gov Sept. 10, 2019.