Legal Challenge to H1N1 Vaccine Expands

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By BRIAN TUMULTY
Gannett Washington Bureau

WASHINGTON - A group that's challenging a state requirement that all health care workers in New York get vaccinated for swine flu said Thursday that it's seeking a federal injunction to halt nationwide distribution of the vaccine.

"We are arguing this is a new drug and it must go through the proper testing for safety and efficacy,'' said attorney Jim Turner, who wants to stop other states from following New York's lead in mandating vaccinations.

The Food and Drug Administration, which announced Sept. 15 that it had approved the H1N1 vaccine for distribution, says the vaccine is merely a change in strain from the typical seasonal flu vaccine and doesn't require testing as a new drug.

U.S. District Judge Reggie Turner of the District of Columbia has not set a hearing date. Attorney Turner argues that if H1N1 is just a seasonal variation in the flu, the federal government shouldn't have treated it as a national health emergency and set out to buy 250 million doses.

"The Catch-22 argument is that the FDA is putting out the message that this flu that is walking across the world ... is so unique and so deadly that we must buy millions of doses,'' he said.

The Obama administration began distributing the H1N1 vaccine nationwide this month, with plans to make the first 40 million doses available by Oct. 31. Four firms - CSL Limited, MedImmune LLC, Sanofi Pasteur Inc., and Novartus Vaccines and Diagnostics Limited - have been approved to produce the vaccine under federal contract.

The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends that pregnant women, health care workers, people aged 25-64 with chronic illnesses, and people working with children under 6 months old should be first in line for the vaccine.

But Cherryl Robbins, a patient care technician at St. Francis Hospital in Poughkeepsie who is 24 weeks pregnant, doesn't plan to get vaccinated. "The state declared an emergency in order to get this drug through,'' said Robbins, a plaintiff in the lawsuit seeking to overturn New York's mandatory vaccination requirement for health care workers. "Personally, I don't think there is a crisis.''

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