On June 9, 2017, the FDA announced that high-dose influenza vaccine was more effective at preventing post-influenza deaths among elderly individuals during the 2012-2013 influenza season than standard-dose vaccines—when the A(H3N2) influenza viruses were broadly circulating, according to the results of a joint study done by researchers at the FDA, CDC, and the Centers for Medicare and Medicaid Services.
Specifically, people who received the high-dose influenza vaccine during the 2012-2013 influenza season were 36.4% less likely to die in the 30 days following hospitalization or an emergency department visit that included an influenza diagnosis compared to the standard-dose vaccine. During the following season (2013-2014), when H1N1 viruses dominated and the standard-dose vaccine had better effectiveness than the previous season, the high-dose vaccine was not significantly better at preventing deaths among the Medicare patients studied.
The findings suggest that the high-dose influenza vaccine offers greater benefit to older adults than do standard-dose vaccines when A(H3N2) influenza viruses are widely circulating.
The study’s findings are important because the goal of expanding immunization programs in the US has been largely based on trying to reduce serious complications of influenza infections, including death. This is especially important in older persons who have long been recognized as being at greatest risk for severe influenza outcomes. Therefore, the availability and use of vaccines that provide better protection against H3N2 influenza viruses for older adults could significantly reduce influenza-associated morbidity and mortality.
In a previous study of older adults enrolled in Medicare who were vaccinated during the 2012–2013 influenza season with high-dose vs standard-dose vaccines in pharmacies, the high-dose vaccine was 22% more effective than the standard-dose vaccine in preventing influenza infections and 22% more effective in preventing influenza hospital admissions.
See the FDA Announcement
See also Medical Law Perspectives Report: Vaccines: An Ounce of Prevention May Lead to a Pound of Injury
See the Medical Law Perspectives Blog: Vaccination Decisions Have Legal Repercussions, Not Just Medical Ones