Despite evidence of its safety, some people are worried about the new H1N1 swine flu vaccine. Out of caution, the government is running a massive effort to look for problems.
The military will be scanning its health care databases to see if there are any unusual flurries of disease among those who receive the H1N1 vaccine. A safety system also exists for the public. Called the Vaccine Adverse Events Reporting System (VAERS), it is run jointly by the Centers for Disease Control and Prevention, and the Food and Drug Administration. Both agencies will be paying special attention to the system, which relies on doctors and vaccine receivers to report any illness after vaccination. The system has been up and running for years, but agencies have assigned extra staff to pay closer attention.
'We Haven't Seen Any Causes For Concern'
The CDC does not expect any problems. "This vaccine is made in the same way we make seasonal flu vaccine," says Dr. Beth Bell, the associate director for science at the National Center for Immunization and Respiratory Diseases. The seasonal flu vaccine is used on more than 100 million people a year, and it has an excellent safety record — though there are problems in people with egg allergies. Bell says that with the new H1N1 vaccine, "We have done clinical trials, and we haven't seen any causes for concern."
By developing the vaccine, pushing it through FDA approval, and buying and distributing it, the government has put its public health reputation on the line.
In addition to the VAERS system, people getting the vaccine are given a phone number and Web site to contact if they have problems. In another project with Johns Hopkins University, the CDC is sending e-mails out to some vaccine recipients asking if they'd had any problems. And several health insurance plans are helping out with massive amounts of data. The CDC and other agencies will be looking at millions of health records to see if there's an increased incidence of some neurological conditions or stillbirths.
During the last swine flu vaccine campaign in 1976, several hundred people developed a rare muscular condition called Guillain-Barre syndrome. While a connection between the vaccine and the syndrome was never conclusively proven, new cases will be compared against the normal occurrence rate.
Any anomalies picked up by these surveillance systems will be analyzed against vaccine records, to see if these problems are occurring more often in people who've gotten vaccinated.
The media is likely to jump on any sudden health problem in the millions of people getting vaccinated, says Michael Osterholm, a virus expert at the University of Minnesota.
"I'm quite convinced you're going to see in the media headlines that say, 'Heart attacks associated with the swine flu vaccine,' because three people will have reported having a heart attack after receipt of the vaccine." But, he says, that doesn't mean anything about cause and effect, because heart attacks occur every day.
Osterholm says he thinks the vaccine is safe, and that the government's surveillance plans are good.