When it comes to protecting yourself against this fall's swine flu (or H1N1 virus) outbreak, you know the drill. Wash your hands frequently. Cover your cough or sneeze. Stay home if you or your child is sick. But, if government officials approve a vaccination effort, should you participate?
Thanks to planning by President George W. Bush's administration for the avian flu pandemic that never materialized in 2005, the Obama administration had a strong foundation from which to respond to the swine flu outbreak in April. Among other things, contracts were in place with manufacturers to get started on a vaccine for the fall. According to the Department of Health and Human Services, one reason most of the vaccine won't be ready until the mid-October peak is that H1N1 doesn't yield as much material in the lab as seasonal flu does. So the process is taking a little longer. But news that only one dose might be needed could speed up the timetable.
Sufferers of regular seasonal flu tend to be those with weak immune systems, such as the elderly. But it's different with H1N1. Otherwise healthy young people are becoming infected with swine flu. This is one of the driving forces behind the rush for a vaccine. The other is the efficiency with which the virus has spread. Since H1N1 roared to life in Mexico in the spring, it has appeared in more than 190 countries. Overall, the Centers for Disease Control and Prevention (CDC) and the World Health Organization classify the pandemic as "moderate" in its severity. According to the CDC, 9,079 hospitalizations and 593 deaths have been attributed to swine flu in the United States this year. To put this in perspective, the average number of deaths from seasonal flu each year is 36,000.
Concern about the forthcoming vaccine is understandable and centers on the experience during the 1976-77 flu season. That's when a swine flu outbreak at Fort Dix, N.J., led the federal government to expedite vaccine production. Some 40 million people were vaccinated, including President Ford, by the time Guillain-Barre syndrome (GBS), a rare neurological disorder, was identified as a side effect. It is estimated that more than 500 people developed GBS and 25 people died after receiving the vaccine.
Given that history and the distrust that it bred, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases since 1984, understands the public's concern. He told us that a risk-benefit analysis is always done with vaccinations. Where federal officials erred then was in green-lighting the massive vaccination effort "before seeing whether the cases would go beyond Fort Dix," Dr. Fauci said. "A pandemic never materialized; there was only the risk of the vaccine. Today, the pandemic is a reality. The benefit of the vaccine far outweighs the risks."
Dr. Fauci also said that the risks of the vaccine will be small because "the way you make this vaccine is essentially the same for seasonal flu vaccines we've made for decades." And what about the emergence of a serious side effect after a mass vaccination? Dr. Fauci told us, "No clinical trial in the world can be large enough to definitively detect a very rare adverse event," such as the GBS side effects in 1976. But, he added that surveillance mechanisms today are much better than in 1976. The CDC has set up a post-vaccination program to catch severe side effects and reactions as quickly as possible.
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