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High-Dose Trivalent Flu Shot No Better for Patients With CVD

TUESDAY, Dec. 15, 2020 -- For patients with high-risk cardiovascular disease, high-dose trivalent inactivated influenza vaccination does not reduce cardiopulmonary hospitalization or all-cause mortality compared with standard-dose quadrivalent inactivated influenza vaccination, according to a study published online Dec. 4 in the Journal of the American Medical Association.

Orly Vardeny, Pharm.D., from the University of Minnesota in Minneapolis, and colleagues conducted an active comparator randomized clinical trial involving 5,260 high-risk patients with cardiovascular disease vaccinated for up to three influenza seasons at 157 sites in the United States and Canada between Sept. 21, 2016, and Jan. 31, 2019. Participants were randomly assigned to receive either high-dose trivalent or standard-dose quadrivalent inactivated influenza vaccine (2,630 to each group).

The researchers found that 7,154 total vaccinations were administered over three influenza seasons. There were 975 primary outcome events (883 hospitalizations of cardiovascular or pulmonary causes and 92 all-cause deaths) among 884 participants in the high-dose trivalent vaccine group (event rate, 45 per 100 patient-years) compared with 924 primary outcome events (846 hospitalizations and 78 deaths) among 837 participants in the standard-dose group (event rate, 42 per 100 patient-years; hazard ratio, 1.06; 95 percent confidence interval, 0.97 to 1.17; P = 0.21). Vaccine-related adverse reactions occurred in 40.5 and 34.4 percent of participants in the high- versus standard-dose groups, respectively.

"For reducing hospitalizations due to heart and lung complications, just getting vaccinated with any influenza vaccine may substantially lower risk in our high-risk patients," a coauthor said in a statement.

Several authors disclosed financial ties to pharmaceutical companies, including Sanofi Pasteur, which provided funding and vaccines.

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Posted: December 2020

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