Quote:
Originally Posted by Bagor
Question:
When compared to normal flu vaccines is there any difference in timeline/ amount of clinical trials that this vaccine has been subjected to. i.e. has it had:
the same types of clinical trials with the same sample size and replications over the same time
the same types of clinical trials with smaller sample sizes and replications over less time or
Less types of clinical trials overall.
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Hmm...I should check with the public health docs to make sure I give you the right answer. However, I will say that this vaccine is different than the usual season vaccine.
Regular seasonal vaccines start their development right after the flu season when scientist can analyze the most predominant strain that year and pick the parts of the virus that the immune system reacted to. In the summer, scientist start surveying the environment to make a prediction how it will mutate into the coming influenza strain and put together a mix of strains from years past that they think will most likely resemble the coming flu virus.
Because it is a yearly process, production of the vaccine doesn't differ very much year to year, only the antigenic compound does. Therefore, clinical trials smaller, and mainly focused to see if the immune system accepts it and builds an immunity.
With H1N1, this is a totally new virus so everything has to be start from scratch. It also appeared quite rapidly so there was little warning it was becoming pandemic. I believe Canada's vaccine is coming from a strain isolated in California.
If I had to guess, I would say that there were probably less clinical trials and smaller sample size than traditional vaccine production for other new viruses, but still more than the yearly seasonal influenza. Testing is still on going, only today was it announced that a study has been completed that the vaccine is safe on pregnant women. I would also say that I think that while there are a multitude of trials and studies right now, there probably wouldn't be many that would get thoroughly peer reviewed
However, unlike the usual vaccine production, we have major countries all working together in the study and production of this vaccine. Every country is doing their own research for their population and choosing which vaccine (remember, there are 3 companies making H1N1 vaccines) to use for their citizens. There will also be large scale world wide monitoring and in real time, so any adverse effects will be noticed immediately
Anyways, I can ask for more details when I get back to work on Monday (day off today
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