Authorities Respond to H1N1 With Post-Vaccine Monitoring

Kathleen Sebelius, HHS chief, talks with Mayo Clinic vaccine expert Gregory Poland, center, and David Tayloe of the American Academy of Pediatrics.
Kathleen Sebelius, HHS chief, talks with Mayo Clinic vaccine expert Gregory Poland, center, and David Tayloe of the American Academy of Pediatrics. (By Luis M. Alvarez -- Associated Press)

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Associated Press
Monday, September 28, 2009

More than 3,000 people a day have a heart attack. If you're one of them the day after your swine flu shot, will you worry that the vaccine was to blame and not the more likely culprit, all those burgers and fries?

The government's system to track possible side effects of mass flu vaccinations will begin next month, aimed at detecting any rare but real problems quickly, and explaining the inevitable coincidences that are sure to cause some false alarms.

"Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone," said Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.

Health authorities hope to vaccinate more than half of the population in just a few months against swine flu, which doctors call the 2009 H1N1 strain. Vaccination is voluntary, and how many get it depends partly on confidence in its safety.

"The recurring question is, 'How do we know it's safe?' " said Gregory Poland of the Mayo Clinic.

Enter the intense new monitoring. On top of routine vaccine tracking, there are these government-sponsored projects:

-- Harvard Medical School scientists are linking large insurance databases that cover as many as 50 million people with vaccination registries around the country for real-time checks of whether people see a doctor in the weeks after a flu shot and why. The huge numbers make it possible to quickly compare rates of complaints among the vaccinated and unvaccinated, said the project leader, Richard Platt, Harvard's population medicine chief.

-- Johns Hopkins University will direct e-mails to at least 100,000 vaccine recipients to track how they're feeling, including the smaller complaints that wouldn't prompt a doctor visit. If anything seems connected, researchers can call to follow up with detailed questions.

-- The Centers for Disease Control and Prevention is preparing take-home cards that tell vaccine recipients how to report any suspected side effects to the nation's Vaccine Adverse Event Reporting system.


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