H1N1 Vaccination Campaign Will Build Active Surveillance System To Monitor Guillian-Barres Syndrome
This article was originally published in The Pink Sheet Daily
Executive Summary
Multi-faceted effort includes text messages to vaccinees, a grant for Johns Hopkins, and extra funding for 10 state health departments.
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The federal government is setting up an active surveillance system to monitor for any potential link between the H1N1 flu vaccine and Guillian-Barres Syndrome, the rare neurological disorder found to be linked to the 1976 swine flu vaccine. Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases, said during a Sept. 11 media briefing that that is one of several surveillance methods the Centers for Disease Control and Prevention and the Department of Health and Human Services will use to monitor the safety of the vaccine once it is made available. "It's a very rare condition, but something that we want to be ready for," Schuchat said, adding that because Guillian-Barres syndrome can follow respiratory infections like influenza, "we may see more Guillian-Barres Syndrome this fall just because we may see a lot more flu than usual. But we want to know if the vaccine has any kind of link at all with that." Monitoring for Guillian-Barres syndrome is a multi-faceted approach. CDC is coordinated with 10 state health departments, which get extra funding to do surveillance. The 10 states - California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Tennessee and Oregon - will cover about 45 million potential vaccinees. CDC is also working with the American Academy of Neurology for the first time on a campaign to enhance reporting of Guillian-Barres syndrome post-vaccination. The last component will be run by Johns Hopkins University - it's called the Real-Time Monitoring System, in which follow-up will be conducted 42 days post-vaccination. About 100,000 patients will enroll to get text messages or emails at several time points, at which the researchers will check in to see how vaccinees are feeling. Those efforts are in addition to the passive surveillance available through the existing Vaccine Adverse Event Reporting System (VAERS), as well as the Vaccine Safety Data Link, which follows the electronic records of health plans. Surveillance efforts are also being coordinated through health records held by the Department of Defense and the Centers for Medicare and Medicaid Services. Early Data Show One Dose Immunogenic In Healthy Adults The briefing was held to underscore Sept. 10 reporting in the New England Journal of Medicine that early data from trials run by Sanofi Pasteur and CSL show the vaccines are well tolerated and induce a strong immune response in most healthy adults when administered in a single unadjuvanted 15 microgram dose. National Institute of Allergy and Infectious Diseases Director Anthony Fauci said preliminary analyses from trials NIAID is running align with those findings. In blood samples obtained eight to 10 days after the Sanofi vaccination, 96 percent of the adults aged 18 to 64 and 56 percent 65 years and older showed a robust immune response. Similar immunity was seen for the CSL vaccine in 80 percent of adults aged 18 to 64 and 60 percent of adults over 65. The preliminary results are good news for vaccine supply, as a need for two doses would have stretched availability, but perhaps bad news for the firms hoping supply limitations would help ease the first approvals of adjuvanted vaccines ( (Also see "Two-Dose H1N1 Vaccination Might Be Optimal, But Would Stress Supply" - Pink Sheet, 27 Jul, 2009.), p. 30). - Jamie Hammon ([email protected]) |