New safety data published on High-dose Trivalent Influenza Vaccine

Post-licensure safety surveillance for high-dose trivalent influenza vaccine in the Vaccine Adverse Event Reporting System (VAERS)

A safety study of the high-dose influenza vaccine, licensed in December 2009, was published in the Clinical Infectious Diseases journal on March 23, 2012. This study reviewed reports to VAERS among adults age 65 years and older who received the high-dose trivalent influenza vaccine (or TIV-HD) or standard dose trivalent influenza vaccine (TIV) from July 2010 through December 2010.

The article informs there was no new serious vaccine safety concerns following TIV-HD identified in VAERS during the first year after licensure. Findings were consistent with conditions found from pre-licensure studies (e.g., fever and pain) that were more frequently reported after TIV-HD than after receipt of standard dose TIV. The analysis also showed a higher proportion of gastrointestinal events reported after TIV-HD than expected. CDC will continue further monitoring of adverse event reports following TIV-HD vaccine as the use of the vaccine increases during future influenza seasons.

For more information on influenza vaccine safety, visit

For more information about the Vaccine Adverse Event Reporting System:


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