Flu Vaccines Linked to Higher Nerve-Disorder Risk, Study Says By John Lauerman Nov. 13 (Bloomberg) -- Vaccines against influenza that the U.S. government is pushing to cut annual deaths and prepare for a possible pandemic may be linked to slightly higher rates of a paralyzing nerve disorder, a study found. Patients with the disorder, called Guillain-Barre syndrome, were more likely to have been diagnosed in the seven weeks after vaccination than in a comparison period four to six months later, Canadian researchers said in today's issue of the Archives of Internal Medicine. The results of the study are consistent with earlier research on flu vaccine, and won't change federal recommendations, said Jeanne Santoli, a vaccination expert with the U.S. Centers for Disease Control and Prevention, in a teleconference today. Federal officials are encouraging the production and use of flu shots to cut an estimated 36,000 deaths and more than 200,000 hospitalizations each year from influenza. ``The risk is real. You don't want to have this blindside you,' said Canadian researcher David Juurlink, who led the study, in a telephone interview, ``But the benefits of vaccination are really substantial.' Sanofi-Aventis SA, GlaxoSmithKline Plc, Novartis AG and MedImmune Inc. make flu vaccine for the U.S. market, based on strains that public-health officials identify each year as the most common currently circulating. The CDC has expanded its guidelines for flu vaccine in recent years, and the agency now recommends immunization for almost two-thirds of Americans. While the risk of Guillain-Barre is so small that rates of the disease didn't increase when a vaccination program began in Ontario, patients should be informed, Juurlink said. Ontario Program Increasing flu vaccine use will also help the U.S. prepare for mass immunizations in the event of a worldwide outbreak of lethal flu, which government health officials have said is inevitable. Ontario began a universal flu vaccination program in 2000 after a severe outbreak the previous year overloaded hospitals with patients. The program also presented flu experts with a way to examine suspected complications of the vaccine, such as Guillain-Barre. Concerns about the mysterious, paralyzing disorder, which is usually temporary, arose in 1976 during an outbreak of the so- called swine flu that U.S. health officials warned might cause a pandemic. While the pandemic never materialized, the link raised long-standing fears about the safety of flu vaccine. A 1998 study in the New England Journal of Medicine found that flu vaccination raised the risk of Guillain-Barre 70 percent. However, a 2003 review of other studies by the U.S. Institute of Medicine, the agency that creates volunteer expert panels to advise the government on health issues, found no association between Guillian-Barre and seasonal flu vaccination. Timing Juurlink, a researcher at Canada's Institute of Clinical Evaluative Sciences in Toronto, and his team found 269 patients diagnosed from April 1992 through March 2004 who developed the nerve disease within a six-month period after vaccination. Patients were 45 percent more likely to develop the disease in the first two months after vaccination than in the fifth and sixth months, the researchers said. Ontario also had begun a large immunization program against pneumococcal disease, a bacterial infection, that may have been responsible for some complications, said David Fedson, a former vaccine developer and University of Virginia professor of medicine, in an e-mailed response to questions. ``The association is there,' with flu vaccine, Fedson said, ``but the increase in risk is very small.' Benefits, Risks Young children and people who are at least 65 years old are at highest risk of complications from flu vaccination. More studies in these age groups, along with teens and young adults, are needed to show the benefits of vaccination against potential risks, he said. ``Only in this way can people balance the benefit and risks of vaccination,' he said. Juurlink said he would continue to recommend vaccination for his patients and family. ``It's a no-brainer,' he said. ``Literally tens of thousands of Americans don't get hospitalized or die each year because they've had flu vaccine, and to me it's worth the trade- off.'