[LChoy]

Sorry for for being absent from the thread. As you can imagine, we have been pretty busy

For Vaccine safety question, I spoke to someone in Public Health and refered me to the same FAQ I've been referring to.

The H1N1 vaccine in Canada is very similar to the season vaccine in production. The main thing about the vaccine is the strain itself (novel strain)

Alberta, as part of Canada's national pandemic plan has already done a lot of the work to support approval of the pandemic vaccine. The remaining data requirements necessary for authorization of the H1N1 flu vaccine are similar to what is required each year to support the seasonal flu vaccine in Canada.

Seasonal influenza vaccines have a special approval process. The seasonal influenza vaccine is licensed each year via the filing of manufacturing and quality data and revised labelling material together with clinical trial data from a small clinical trial that assesses the tolerance and immune response to the vaccine. Therefore to answers Bagor's original question, testing for seasonal vaccines are pretty short in nature since it's the same thing pretty much year to year, and the safety issue is already established. It is just the testing to make sure a proper immunlogical support is established.

Because H1N1 is caused by completely novel strains of virus that have not previously circulated in humans there are no historical data that vaccines against the strain are effective. This is the cause of the concern some of you have. However, the basic recipe for the vaccine remains same. The adjuvant used by GSK has been tested in approximately 45,000 people around the world and has been evaluated by Health Canada and other regulatory authorities as part of the review of the H5N1 vaccine in the pre-pandemic period. No significant safety concerns regarding the use of the adjuvanted vaccine were detected. It has also satisfied Health Canada's preliminary clinical trial standards. What is missing now is the data from a larger sample group, which for seasonal vaccinations, would not normally be available until after the influenza season is over.

Because H1N1 hit pandemic status so quickly, a vaccine had to be created rather quickly for it. As mentioned above, much of the regulatory work has already been completed before the Pandemic hit. The evaluation process will continue concurrent with production of the vaccine. Also due to the nature of a pandemic, more testing has put into this vaccine through cooperation between countries than a regular seasonal vaccine.
In the larger scope, in terms of safety testing, H1N1 has undergone more testing and scrutiny than the season flu shot, but less than a vaccine for a totally new vaccine.

Novel vaccine > H1N1 vaccine > Seasonal Flu vaccine

The other new thing about the H1N1 vaccine is the use of an adjuvant vaccine.

Adjuvant vaccines aren't new as it is available in other vaccinations. However, it's the first time it is available for a influenza vaccine.

As part of how seriously the government is treating this pandemic, Clinical trials have indicated that the unadjuvanted H1N1 flu vaccine does not deliver as strong of an immune response as was observed in previous trials with the adjuvanted H5N1 (avian or bird) flu vaccine. Studies show that even the best unadjuvanted flu vaccines only protect six out of 10 people who get the shot. Experts believe an adjuvanted flu vaccine could boost protection rates to as high as nine in 10. The adjuvanted vaccine provides much stronger cross-protection against virus drift, which is common in influenza viruses. Adjuvanted vaccine provides a broader spectrum of immunity as it protects against infection and severe disease even when the virus begins to change. Another reason for adjuvant use is that the entire world is developing vaccines for H1N1, and that adjuvant allows for more of the strain to go around. Therefore Adjuvanted vaccines could also be developed faster and immunization can begin sooner, which is relevant to the current spread of H1N1

However, because the evaluation was taking place in conjuction with production, it was only recently that it got Health Canada's approval for use. For Pregnant women, Health Canada was waiting for further study to make sure that adjuvant was okay for pregnant women (as you can imagine, it's a longer process to do clinical trials for this population). Just in case, and to reduce fears that the government is giving pregnant women untested adjuvant vaccine, the government ordered a small quantity of non-adjuvant vaccine just for pregnant women. It was suppose to be the first thing to arrive, but the quicker than expect approval of the adjuvant vaccine meant that Alberta started immunization of using adjuvant first, even though Pregnant women is one of the high risk groups

Because adjuvant boosts the immune response, there is the chance we'll see some more adverse reactions than the general flu shot. You may get a one day fever or feel a little sick. This is also why an elaborate monitoring system is in place and the increase testing scrutiny

I hope I answer most of your questions.
Pm me or msg me if I forgot anything