Feds shield swine-flu vaccine makers from lawsuits
Steve Rennie Canadian Press Canada September 30, 2009

OTTAWA — Canadians who suffer harmful side effects from the new swine-flu shot can take the vaccine maker to court - but the federal government would be on the hook for any damages. The chief public health officer, Dr. David Butler-Jones, said Wednesday that Canada has agreed to shield drug companies from lawsuits over the H1N1 pandemic vaccine. That means the federal government, not the vaccine manufacturers, would have to pay any damages awarded in court. That doesn't apply to cases of malpractice. ...

Pharmaceutical giant GlaxoSmithKline has a contract to produce 50.4 million doses of pandemic vaccine at its facility in Ste-Foy, Que. But there are concerns about the new vaccine, which contains adjuvants, or compounds that boost the immune system's response to vaccine, allowing smaller doses to be used. There are no data on the use of adjuvanted flu vaccine in pregnant women, which may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy. So Ottawa has ordered 1.8 million doses of vaccine that does not contain adjuvants for pregnant women and young children.

Canada will protect swine flu vaccine maker from lawsuits
Theresa Boyle Toronto Star Canada September 30, 2009

Canada is protecting the drugmaker of swine flu vaccine from lawsuits over potential side effects, Canada's top doctor has confirmed. Dr. David Butler-Jones told a media teleconference Wednesday that Canada will shield GalxoSmithKline in the unlikely event there are problems with the vaccine, but it will not shield health practitioners who make mistakes in administering the shot. "We're not obviously anticipating problems with it, but indemnification for a vaccine is important if someone does malpractice, basically injects someone the wrong way or causes harm because of their practice," he said. "That's not a vaccine issue, it's a practice issue," he added. The Public Health Agency of Canada had initially refused to say if Canada would shield drugmakers the way other G-8 governments have done.

Taxpayers on hook for any H1N1 vaccine damages
CBC News Canada September 30, 2009

If there are lawsuits over the H1N1 vaccine, it will be the federal government, not the vaccine maker, that picks up the tab for any damages awarded by courts. ...

Butler-Jones said there appears to be no increased risk of severe disease from the H1N1 virus among people who received seasonal flu shots. "Those who have severe disease have the same rate of having been immunized with seasonal vaccine as the general population," Butler-Jones said. "So the seasonal vaccine is not a contributor or a cause of severe disease or illness in those people." Still, the federal government, provinces, territories and researchers are reviewing preliminary, unpublished research that suggests people in three provinces who received seasonal flu shots may be at twice the risk of getting a case of swine flu that doesn't require hospitalization. He hypothesized that perhaps people who got seasonal flu shots may have been more likely to go to their doctor to get tested for H1N1. More information about an independent assessment of the research by international reviewers may be released to the public next week, Butler-Jones said. The sooner that the review and the study are made public and can be scrutinized, the better, said an infectious diseases expert in Ontario. "My opinion is it's already out there," said Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion. "It's out there, and I would say it's important to be as open and transparent as possible." ...

Some Canadians on the front lines of health care have expressed concerns about taking the H1N1 vaccine until more is known about it and the adjuvant it contains. The adjuvant is added to the vaccine to boost the immune response in people who are vaccinated. It may also provide some immunity if the virus mutates, said Butler-Jones, adding he has "no hesitancy" about the adjuvant. Federal health officials said the risks from the vaccine are theoretical while the risk of severe disease and even death from H1N1 are too real to ignore. "It's each individual's decision," Butler-Jones said. "But I'm not sure how I could counsel my family against getting something that would protect them and then watch one of my children die." ...