Lawsuit seeks to halt US swine flu vaccination campaign

New York medical workers took legal action Thursday to halt a massive swine flu inoculation program being rolled out across the United States, claiming the vaccines have not been properly tested.

Lawyers for the group filed a temporary restraining order in a Washington federal court against government medical regulators they claim rushed H1N1 vaccines to the public without adequately testing their safety and efficacy.

"None of the vaccines against H1N1 have been properly tested," attorney Jim Turner, one of half a dozen lawyers working on the case, told AFP.

The complaint filed Thursday argued that far from preventing a massive outbreak of swine flu, the "live attenuated influenza virus nasal mist vaccine could trigger" an H1N1 pandemic.

"I don't know of another live vaccine for flu. So you have immediately a new problem you don't have with a killed vaccine," Turner told AFP.

Officials at the National Institutes of Health have said that trials of swine flu vaccine began in August and delivered results last month, showing that the vaccine was well tolerated and produced a robust immune response in older children and adults in good health with just a single dose.

But Turner insisted that "the FDA did not do the proper testing to show safety and efficacy of this vaccine, which is under the law a new drug.

"When I say test data, I don't mean some professor at some medical school somewhere infected some students and said 'I don't see any problems.'

"What I mean is carefully conducted double blind placebo controlled studies trials done in accordance with FDA regulations, and a whole series of them to look at dosing... which are then reviewed by FDA scientists.

"None of that has been done on this vaccination and we're saying the law requires it to be done," Turner said.

The suit was brought on behalf of a group of doctors, nurses and other medical personnel in New York, where health care professionals who see patients are required to be vaccinated against H1N1, Turner said.

If the complaint is upheld, it would stop the roll-out of the H1N1 vaccine nationwide, said Turner, who accused public health officials of hyping the swine flu outbreak.

"Officials have said the virus is so much like the ordinary flu virus that they don't need to do special new drug testing on it because it's just the same old virus with a minor change to it," he said.

"We're saying, if that's the case, then all the hype about this thing being a worldwide threat is misplaced and they've stampeded the state of New York into taking an action they never would have taken if it were just another flu."

Last week, some 2.4 million doses of nasal spray vaccine made of greatly weakened, but live, H1N1 virus were delivered to state and local health authorities around the United States.

Karen Lancaster, a spokeswoman for the MedImmune, which manufactures the nasal spray H1N1 vaccine, told AFP that the the company has had a seasonal flu vaccine made with weakened live virus on the market since 2003.

This week, millions of doses stocks of injectable vaccine were delivered and administered to people in groups deemed to be at particular risk from swine flu, including children and health care professionals.

US public health officials want to vaccinate tens of millions of Americans by year's end against swine flu, which has claimed more than 4,500 lives worldwide since an outbreak of H1N1 was first reported in Mexico in April.

(c) 2009 AFP

   

• zak6482 - Oct 19, 2009
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  As one of those "public health officials" specializing in respiratory infections, I have to wonder if we are still teaching basic immunology and vaccinology in our schools. First, a minor change in a viral genome can translate to a very different pathology. Second, what they are talking is treating the vaccine as a "new" drug but the process of developing and manufacturing the vaccine is the same as any other flu strain. If we followed that logic, we would need to treat every change in the seasonal flu vaccine as new and spend a fortune in testing. No company would bother with the expense and the vaccine would not be made. The problem in 1976, which I'm sure is playing out in this, was due to errors in the manufacturing process and not the vaccine development itself. Personally, I plan to get the LAIV H1N1 vaccine as soon at it becomes available where I'm at.
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