Can standard vaccine development and regulatory processes be used to authorize the H1N1 pandemic vaccine?
Development of a pandemic vaccine cannot begin until the pandemic strain has been identified and vaccine may be needed almost immediately after it has been manufactured in order to be useful. Unlike the situation with the seasonal influenza vaccine, influenza pandemics are caused by completely novel strains of virus that have not previously circulated in humans; therefore, the human population does not have any immunity against the virus, and there are no historical data that vaccines against the strain are effective. As a result, standard vaccine development and regulatory processes cannot be used in a pandemic situation.
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