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September 24, 1997

Lessons From the Influenza Vaccine Recall of 1996-1997

Author Affiliations

From the Mayo Vaccine Research Group, Mayo Clinic, Rochester, Minn.

JAMA. 1997;278(12):1022-1023. doi:10.1001/jama.1997.03550120082039

INFLUENZA IS a major killer of persons aged 65 years and older, particularly those who are frail or debilitated with chronic cardiac and/or pulmonary conditions, and results in 10 000 to 40 000 deaths each year in the United States. The economic cost is considerable, with Medicare reimbursing hospitals $1 billion for excess hospitalizations during the 1989 flu season1 and an overall societal cost in excess of $10 billion.2 To prevent illness and death, there has been a sustained and ongoing campaign to enhance the annual delivery of influenza vaccine to persons aged 65 years and older. For this reason, public concerns regarding "recalled" vaccine may negatively affect the success of these campaigns.

Three times during November 1996, Parke-Davis voluntarily recalled 11 lots of influenza vaccine (Fluogen, lots 00176P, 00276P, 00576P, 00586P, 00676P, 00686P, 00786P, 00886P, 00966P, 00986P, and 01066P). Based on information available, neither the Centers for