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Swine flu vaccine passes safety test

Still, some wary about side effects

By Stephen Smith
Globe Staff / October 9, 2009

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Shortly before noon yesterday, Dr. Benjamin Kruskal was tapping out an e-mail to his wife. The topic: the safety of swine flu vaccine.

“A large group of her friends on Facebook are discussing it,’’ said Kruskal, a pediatrician and infectious disease specialist at Harvard Vanguard Medical Associates. “There were three or four people who said, ‘My pediatrician said not to get it because it’s too new, it’s untested.’ ’’

Kruskal’s message to his wife, as well as to his patients: You can get the vaccine. It’s safe.

While the H1N1 virus that causes swine flu is new, the vaccine brewed to stop it follows the same tried-and-true laboratory and production methods used to churn out millions of doses each year against the seasonal strain. And, so far, clinical trials of the vaccine have not turned up any side effects more worrisome than the mild variety associated with annual flu immunizations.

But that message clearly is not reaching everyone, as evidenced by chatter in the blogosphere and a series of recent polls exposing significant pockets of ambivalence about the vaccine, even as an expected 195 million doses begin to trickle into physician offices, clinics, and hospitals in Massachusetts and nationwide.

In part, specialists said, that reflects an entirely understandable response to the uncertain threat posed by this year’s swine flu strain, first identified in people in April. Message board postings from some people suggest that because the H1N1 virus has not ignited widespread, severe illness, they are unwilling to tolerate the side effects of a vaccine, no matter how transient.

In part, wariness about the 2009 swine flu vaccine may find echoes in the last time the federal government embarked on a major inoculation campaign against swine flu. Thirty-three years ago, a different strain of swine flu erupted on the Fort Dix Army base in New Jersey.

But the outbreak was almost completely contained to that base. So when side effects previously unseen with any other flu vaccine were linked to the 1976 inoculation, including a rare neurological complication, the risk-benefit calculus simply did not favor getting vaccinated.

This year is different. Swine flu, even if it is not as bad as initially feared, is still leaving lots of people with coughs, fevers, and chills. In a small number of cases, it has resulted in severe illness, particularly among pregnant women. Twelve deaths have been reported in Massachusetts, and at least several hundred nationwide. Plus, vaccine production techniques have changed since 1976 in ways that make the vaccine safer, with no signs so far of unusual reactions to the H1N1 vaccine, specialists said.

It is clear, though, that health authorities are rattled by the rumors ricocheting across the Internet about the vaccine. This week, both US Secretary of Health and Human Services Kathleen Sebelius and the director of the nation’s main disease-fighting agency took pains to reassure Americans.

Dr. Thomas Frieden, chief of the US Centers for Disease Control and Prevention, went so far as to announce that his own children are being vaccinated.

“We have cut no corners,’’ Frieden said. “This flu vaccine is made as flu vaccine is made each year, by the same companies, in the same production facilities, with the same procedures, with the same safety safeguards.’’

That, more than anything, is the cornerstone of assurances that the vaccine is safe. Additionally, clinical trials are being conducted, even though drug companies were not technically required to conduct additional research because they have standing licenses to produce flu vaccine.

Studies published last month in The New England Journal of Medicine show the vaccine marshals a robust platoon of disease-fighting cells against the virus. Side effects mirror those blamed on the seasonal vaccine: soreness at the spot where the shot is given, headaches, and, in a few people, slight fevers.

“With the fever, it’s always hard to know whether that’s related to the vaccine or not,’’ said Dr. Richard Wenzel, past president of the International Society for Infectious Diseases. “You’re administering something foreign, and some people have an active inflammatory response, and fever’s part of it. But it’s also a time of year when people get fevers for lots of reasons.’’

Safety studies - expected to include more than 1,000 adults, children, and pregnant women - should largely be completed this month, said Dr. Susan Lett, head of the Massachusetts immunization program. Federal disease trackers have also expanded monitoring for serious side effects, enlisting health plans and the military to report any problems and using Internet and text-messaging tools.

Most vaccine doses will be shots made from virus biologically defanged so that it cannot cause the flu, but shipments of the injections will not begin widely for another week or two.

A mercury-containing preservative called thimerosal is present in multidose vials of injectable flu vaccine. The substance, which has for years been used to preserve the seasonal flu vaccine as well, has proved controversial, with some activists implicating it in the increased incidence of autism. An independent panel of scientists, commissioned by the federal government, concluded in 2004 that there was no link between thimerosal in childhood vaccines and neurological disorders.

Still, swine flu vaccine will be available in individual doses free of thimerosal, and patients who want that should ask for it.

There is also a nasal spray version, and the first batch of vaccine that arrived this week in Massachusetts, about 36,800 doses, was exclusively the spray. It is made from a substantially weakened form of the virus. But, because it does contain bits of live virus, specialists recommend it not be given to pregnant women or patients with compromised immune systems, asthma, diabetes, heart disease, or other chronic conditions.

Yesterday, at the Martha Eliot Health Center, a Children’s Hospital Boston affiliate in Jamaica Plain, Anelsy Martinez made sure her 4-year-old daughter got the spray vaccine.

“Everyone is doing it,’’ she said, “because [swine flu] can kill people or make them sick.’’

Bill Greene of the Globe staff contributed to this report. Stephen Smith can be reached at stsmith@globe.com.