Vaccine Safety Monitoring Ensures Continued Safety, Part 1 of 3

October 26, 2010

By Claudia Vellozzi, M.D., M.P.H., Deputy Director, Immunization Safety Office, Centers for Disease Control and Prevention, HHS

For the 2010-11 influenza season, vaccination is recommended for all people aged 6 months and older to protect them from influenza, or “the flu.”  Because the formulation of seasonal influenza vaccines changes nearly every year, we closely monitor for any potential change in safety every influenza season.  As a doctor and scientist specializing in vaccine safety, I get questions about influenza vaccine and its safety record.  In this three-part series. I will share a few points that I try to get across when answering these questions.

The United States sets very high standards for vaccine safety.  Before vaccines are licensed (approved) for use, they are evaluated by the Food and Drug Administration (FDA).  The influenza vaccines approved by FDA have a long and successful track record of safety in the United States.

After vaccines are licensed, CDC and FDA, along with other partners, closely monitor their use to look for rare or unexpected patterns of adverse events (or health problems) following vaccination. An adverse event after vaccination might be caused by a vaccine, but it also can occur coincidentally at any time following vaccination.  In following up on such reports, our job is to help distinguish between these two situations.

In my next post, I will share more about how our vaccine safety monitoring program helps to identify possible safety concerns.