The U.S. vaccine safety monitoring systems for the H1N1 vaccine report mostly “non-serious” adverse effects, a federal official says.
Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration, said federal government agencies have enhanced and expanded the vaccine safety monitoring systems to detect and quickly investigate any unexpected, rare, or serious adverse events.
“We are continuing robust efforts to monitor the safety of these vaccines and I would like to reassure you that, to date, the safety assessment is very encouraging,” Hamburg says in a statement.
As of Jan. 8 more than 110 million doses of H1N1 vaccine had been shipped to vaccination providers in the United States, the report says.
The FDA and the Centers for Disease Control and Prevention provide weekly updates on vaccine safety monitoring activities through the Vaccine Adverse Event Reporting System. An adverse event is a health problem that is reported after someone gets a vaccine or medicine but people may experience adverse events shortly after vaccination which may or may not be caused by the vaccine.
As of Jan. 8, VAERS had received 7,814 adverse event reports following monovalent H1N1 vaccination, and 94 percent of adverse events reported to VAERS are classified as “non-serious,” including soreness at the vaccine injection site.
Of the 7,814 reports, 6 percent were classified as “serious” health events – life threatening or resulting in death, major disability, abnormal conditions at birth, hospitalization, or extension of an existing hospitalization.
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