People in high-priority groups to receive the flu vaccine in the 2004-05 season were inoculated at rates similar to the previous flu season despite an unexpected shortage of vaccine,… CDC immunization expert Jeanne Santoli said Tuesday at the National Immunization Conference in Washington, D.C., the AP/Las Vegas Sun reports (Freking, AP/Las Vegas Sun, 3/22). A U.S. flu vaccine shortage developed after British Medicines and Healthcare Products Regulatory Agency officials in October 2004 suspended the manufacturing license for vaccine manufacturer Chiron’s Liverpool, England, plant because of contamination issues. Prior to the regulatory action, Chiron was expected to produce about half of the United States’ 100 million-dose flu vaccine supply for the 2004-05 season. MHRA in late February lifted the suspension, allowing the company to manufacture flu vaccine for the U.S. market next season if FDA gives approval. Despite making extensive improvements to its plant, Chiron CEO Howard Pien has said that the company likely will produce less flu vaccine than the 46 million to 48 million doses it manufactured but did not ship last year (Kaiser Daily Health Policy Report, 3/3). The U.S. flu season peaked in February and cases are now declining. Health officials have said that some states still have remaining vaccine.

Vaccination Rates
During the recent flu season, 43% of “priority adults” — people over age 65, those with illnesses and health care workers with direct patient contact — received the vaccine, compared with 47.8% of those in the high priority groups the previous season. About 8% of “nonpriority adults” received a flu vaccination this year, compared with about 20% of adults the previous flu season. According to Santoli, about 16 million to 17 million U.S. residents voluntarily did not receive a flu shot so that people with higher priority could be vaccinated (AP/Las Vegas Sun, 3/22). More than 57% of children ages six months to 23 months received flu shots, compared with 7.7% of children in the same group who received a shot the previous season. The 2004-05 season was the first time CDC recommended children in that age group receive the shot. According to USA Today, at the end of the flu season, , 4.5 million doses were not used (Manning, USA Today, 3/23).

Comments
Santoli said that a “slight increase” in production by other vaccine makers, an “intense” public relations campaign by health officials and cooperation of U.S. residents averted a potential public health emergency. She said, “We ended up with a number of positive outcomes, despite the challenges” (AP/Las Vegas Sun, 3/22). Lance Rodewald, director of the National Immunization Program’s Immunization Services Division, said that the level of flu vaccine production for the upcoming season could be characterized as “rain, shine or hurricane.” The “rain” scenario would occur if Chiron does not receive FDA approval and only Sanofi Pasteur and MedImmune are licensed to sell vaccine in the U.S. market. The “shine” scenario would occur if Chiron and another manufacturer receive FDA approval in addition to Sanofi and MedImmune, generating ample supply of vaccine. The “hurricane” scenario would result if Sanofi experienced “some kind of production failure” and no additional flu shot manufacturers were licensed in the United States, resulting in less vaccine available than last season. Rodewald said that officials are confident that Chiron will re-enter the market. He added that CDC and other health agencies are working to improve communications. Rodewald said, “There are reasons for optimism. I think it’s going to be a tough, tough season this year, but everybody’s working together” (USA Today, 3/23).

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