Clinical trials with adults and the new swine flu vaccine have been underway for two weeks. These trials are reporting no serious side effects from these first injections, according to US Federal Health officials. Dr Anthony S Fauci of the National Institute of Allergy and Infectious Diseases was quoted as saying, “There are no red flags regarding safety.”

If trials continue well, nearly 200 million doses could be produced by the end of 2009.

Given the fact that the only reported side effects in adults have been sore arms, trials on children have been approved. These trials will begin shortly. Assuming that all goes well, trials with pregnant women will begin early in September.

The vaccine will only be tested on 4,500 people. This small sample size will not identify subtle side effects; however, officials believe that the H1N1 virus strain is close enough to at least one seasonal strain of flu, that any side effects should be similar. However, only wide-spread vaccination will reveal if any subtle side effects are significant in impact.

The trials are designed to help health officials decide how many doses of the vaccine are necessary for proper protection. It is possible that 2 doses of the vaccine will be required in order to get a protective immune response.

At this point, the vaccine does not contain adjuvants. Adjuvants are substance added to vaccines to enhance the immune response. Often this means oil-water emulsions or aluminum salts added to the vaccine – which also tend to increase side effects. In some cases, the full toxicity of adjuvants is unknown or only partially studied. For instance, aluminum salts have been shown to cross the blood-brain barrier and are linked with neurotoxicity and yet these salts may be added to vaccines.

For seriously allergic individuals, it will still be necessary to know what is in the vaccine. Most seasonal flu vaccines are cultivated in eggs and some trace egg may remain. If someone with an allergy still wants the vaccine, proper precautions should be taken – including waiting after the shot and having an autoinjector available in case of reaction.

H1N1 has spread around the world, but has not resulted in wide-spread fatality. The virus has not developed any deadly mutations at this point, nor produced proteins that could make it more lethal. However, it is now turning up in turkeys. This has not lead to any concerns, as the seasonal flu virus is often found in birds, pigs and humans.

Source: The New York Times