Soaring Elderly Flu Death: What Role Did the Stronger New Flu Vaccine Play?

On December 23, 2009, the U.S. Food and Drug Administration (FDA) approved use of Fluzone High-Dose flu vaccine for the elderly. This new product is four times more powerful, that is, contains four times the amount of flu virus antigen per dose as the product used previously (Fluzone). The vaccine is given as a single injection. FDA approval was given even though its Advisory Committee on Immunization Practices made no indication it was better than the previously-used Fluzone after reviewing studies of safety and effectiveness. The Centers for Disease Control and Prevention stated, “Data demonstrating greater protection against influenza illness after vaccination with Fluzone High-Dose are needed to evaluate whether Fluzone High-Dose is a more effective vaccine for patients age 65 years.” The largest study reviewed by the FDA committee showed that the new high-dose vaccine had a 50% higher rate of side effects within the first week after the injection, and four times the chance that patients would develop fever after the shot. The approval was given even though a large three-year study of effectiveness and safety had just begun (U.S. Centers for Disease Control and Prevention, 2010). Prior to 2013, fewer than 1,000 elderly Americans died from the flu in all but one year. But in the most recent five years available, the average jumped to over 3,000 per year, exceeding 5,000 in the most recent year (2017). The 2013-2017 flu death rate among Americans over 65 jumped 328.6%, or more than four times than it was in the period 2006-2012. The influenza death rate did not change among Americans age under 35, while it rose 132.4% (more than doubled) among those age 35-64. The recent mortality rise in elderly flu deaths should be taken seriously, and future trends should be monitored by health officials.