FDA Approves New High-Dose Flu Shot for Adults 65 Years of Age and Older with Many Side Effects and Unknown Efficacy

Earlier this month (November, 2019) the FDA approved the Fluzone® High-Dose Quadrivalent influenza vaccine produced by Sanofi Pasteur Inc. Fluzone is approved for adults 65 years old and above. The package insert for the new Fluzone®High-Dose Quadrivalent flu vaccine states that there was one clinical study conducted to evaluate the safety of this new high dose flu shot for seniors. The study did not compare the new flu vaccine to a placebo, but to previous versions of the Fluzone vaccine. Both study groups (the older flu vaccine and the newer one) suffered serious adverse events (SAEs). According to the package insert of the new Fluzone® High-Dose Quadrivalent influenza vaccine, there were no efficacy studies done on the new flu vaccine. The single study that was conducted compared the safety and immunogenicity of Fluzone High-Dose Quadrivalent to those of Fluzone High-Dose. For a measure of effectiveness, they simply quoted the results for the older Fluzone High-Dose vaccine. The relative efficacy of the older study for primary endpoints ranged from 11% to 27.4%. The secondary endpoint had an efficacy rate of 51%. Again, this study was not for the new flu vaccine just approved by the FDA, but for the older flu vaccine against specific virus strains. The new vaccine added a new strain, but this flu vaccine will not even be available until the 2020-2021 flu season. Everything here comes straight from the manufacturers package insert for the flu vaccine, a package insert you are not likely to have access to if you were to walk into a drug store like Walgreens, CVS, Rite Aid, and others and request to see before receiving a flu shot. And for simply printing facts like this that are easily found online (the FDA government website is required to have vaccine package inserts online), we have been branded by the corporate media watch dogs as "fake news." Health Impact News, and specifically our VaccineImpact.com website, generates a lot of traffic for readers searching for facts related to vaccines in general, and the flu vaccine specifically. If this particular article starts receiving too much traffic, Facebook and others will come in and label it as "fake news" to immediately reduce the amount of traffic it receives. This has already happened a few times during the current flu season.