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Andre Picard (John Morstad)
Andre Picard (John Morstad)

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Your H1N1 vaccine questions answered Add to ...

Today, we a number of questions related to legal liability and vaccination:

Q: Is it true that I can't sue if the swine flu vaccine makes me sick or kills me?

Q: I've read some pretty frightening things about vaccines on the Internet. How many people do they actually kill?

Q: I read that in the U.S. vaccine makers can't be sued. Is that true in Canada too?

Q: Why have the vaccine producers been given blanket immunity shielding them from any adverse reaction lawsuits?

Q: When I got the H1N1 vaccine, I had to sign a waiver that said I couldn't sue. Is that valid?

A: In the U.S., federal legislation has, since the 1980s, protected vaccine makers against lawsuits related to childhood vaccines. In July, that protection was extended to makers of H1N1 vaccine. This was done because, in the litigious U.S., drug companies had essentially threatened to stop producing childhood vaccines, which are not particularly profitable and there were fears that production of the flu vaccine would be delayed by legal concerns.

The inability to sue manufacturers does not mean those who are vaccine-damaged cannot receive compensation. The U.S. has a "vaccine court" that hears cases and awards compensation.

In Canada, vaccine manufacturers do not have blanket protection from lawsuits and suits related to harm caused by vaccine are usually settled out-of-court. One province, Quebec, has a no-fault insurance program that operates in a manner similar to the U.S. vaccine court. Over two decades, there have been about 100 claims and a couple of dozen substantial awards.

The Canadian Paediatric Society estimates that about five children a year will potentially suffer a serious adverse event from vaccination. Bear in mind that there are almost 400,000 children born a year and they get approximately two dozen shots by the time they hit kindergarten.

Health officials describe the number of severe adverse reactions to influenza vaccines as "very rare." The biggest danger is a life-threatening allergic reaction to a component of the vaccine such as egg proteins. In rare instances - again, numbers are hard to come by - a person can suffer from Guillain-Barré syndrome after vaccination. The autoimmune condition, which is characterized by paralysis that can be reversed, is related to fever. The disastrous 1976 swine flu vaccination campaign was derailed by reports of numerous cases of Guillain-Barré. But infectious disease experts note that the flu itself triggers far more cases of Guillain-Barré than the vaccine.

On the question of "immunity" from H1N1 vaccine lawsuits (a clever play on words), the reality is a bit more complex. In the contract between the government of Canada and GlaxoSmithKline, Ottawa promises to "indemnify" anyone harmed by the vaccine. Practically, what this means is that, if you suffer harm from the vaccine, you can sue and the government, not GSK, will be responsible for paying the settlement.

Many have argued that this is an unnecessary gift to a big, wealthy pharmaceutical company. But the underlying philosophy - as articulated in a landmark 1985 Supreme Court judgment - is that people exposed to a potential harm while undergoing an intervention that is in the greater public good, particularly at the urging of the state, should be compensated by the state if they are harmed in the process.

Finally, when you get a H1N1 vaccine you will be asked to sign a waiver. The wording of these waivers varies a lot across the country but most say that you waive the right to sue those administering the vaccine - principally nurses. Lawyers consulted said that these waivers would in no way limit your ability to sue the vaccine maker of the government.

Q: Is the non-adjuvanted vaccine available now for pregnant women? And can we get non-adjuvanted vaccine for our kids too?

A: By week's end (Nov. 10) one million doses of non-adjuvanted vaccine have been distributed to the provinces and territories. However, the vaccine, called Panvax, has not yet been approved by Health Canada. Approval is imminent so the vaccine should be available to any pregnant woman who asks by week's end.

The formal recommendation is that only pregnant women get the non-adjuvanted form of the vaccine. But some parents have safety concerns because there has been limited testing of the adjuvant, particularly in younger children.

So the question becomes: Should you demand the non-adjuvanted vaccine?

The vast majority of pediatricians and public health officials will tell you that the adjuvanted vaccine is safe and that it actually works better than the non-adjuvanted vaccine - meaning it generates a better immune response, including in children and pregnant women.

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