By Julie Stachowiak, PhD
Multiple Sclerosis Guide; Guest blogger
There seems to be a lot of confusion around whether the H1N1 (swine flu) vaccine is "new" - people are wondering how it was developed and tested in clinical trials so quickly after the virus was discovered. This has led to many people concluding that the H1N1 vaccine is still in the "experimental" stages.
Here's the deal: As I have mentioned before, the vaccine for H1N1 is basically the same thing as the seasonal flu vaccine, except the virus used is different (actually, the H1N1 vaccine is monovalent, containing only one virus, whereas seasonal flu vaccines are trivalent, containing 3 viruses). The process to make the vaccines is the same, the ingredients are the same (except for the virus itself), the delivery is the same.
Because of all of these similarities, the Food and Drug Administration treats the H1N1 vaccine just like they treat the yearly seasonal flu vaccine - they make sure that the oversight is the same to ensure the same level of quality and safety. The FDA approval of the H1N1 vaccine is based on the fact that all of these things are consistent and on small trials to see how much antigen (virus) needs to be included in each dose to confer immunity.
To repeat, clinical trials have been and are in the process of being conducted on the H1N1 vaccine. Some of the more interesting trials are:
- in children to compare two doses of the vaccine and to figure out if timing of seasonal flu vaccine plus H1N1 vaccine matters;
- in pregnant women to compare the effectiveness of two different doses; and
- in HIV-positive pregnant women and children.
If you are interested in finding out what other clinical trials are happening around the H1N1 vaccine (or anything else, for that matter), visit ClinicalTrials.gov and enter "H1N1" into the search field. At the time of this writing, 92 results were returned, meaning that research around this virus is certainly taking place. Who knows, you may just find a trial that is a good fit for you...
