H1N1 vaccine study investigating hints of complications from vaccine

Washington Post

By Rob Stein
Washington Post Staff Writer

Saturday, April 24, 2010

Federal health officials are investigating the first hints of any possible significant complications from the H1N1 vaccine, but stressed that the concerns will probably turn out to be a false alarm.

The latest analysis of data has detected what could be a somewhat elevated rate of Guillain-Barré syndrome, which can cause paralysis and death; Bell’s palsy, a temporary facial paralysis; and thrombocytopenia, which is a low level of blood platelets, officials reported Friday. The data is being collected through five of the networks the government is using to monitor people who were inoculated against the swine flu.

Officials stressed that it is far too early to know whether the vaccine was increasing the risk of those conditions or whether there is some other explanation, such as doctors identifying more cases because of the intensive effort to pinpoint any safety problems with the vaccine.

Based on the preliminary report, the Health and Human Services Department’s National Vaccine Advisory Committee, which has been charged with monitoring the vaccine’s safety, voted unanimously to follow up on the findings. “We’re at the first step of determining whether there is a problem,” Guthrie S. Birkhead, who chairs the committee, said during a teleconference in which a subcommittee of experts presented its latest findings on the data. “There’s a lot more work to determine whether there is.”

Marie McCormick, who led the subcommittee, said there was a good chance the indications of problems could disappear with further analysis. Even if the link with Guillain-Barrésyndrome is confirmed, the committee calculated the vaccine at most could be causing one extra case per 1 million people vaccinated.

“We have categorized this as a potential, not even a weak, signal,” McCormick said, adding that no signs of problems have been seen in the other networks of data the government has been analyzing.

Even if the possible risks turn out to be real, officials stressed that the danger of the flu remains far greater.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.