The WHO considers vaccines to be an important medical intervention for reducing illness and deaths during a pandemic, but during the previous 1957 and 1968 pandemics, vaccines arrived too late. So as part of preparedness for an influenza pandemic the WHO Expert Committee on Biological Standardisation (ECBS) met in October 8-12, 2007, after which they released their report “Regulatory Preparedness for Human Pandemic Influenza Vaccines“.
ECBS worked together with health officials, regulatory authorities, and vaccine manufacturers to explore a broad range of issues surrounding the regulatory approval of pandemic vaccines, with the objective to approve “fast-track procedures” to “shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines.”
“In some cases, pandemic vaccines are not regarded by regulatory authorities as entirely “new” vaccines, as they build on the technology used to produce vaccines for seasonal influenza….[such as is] applied to “strain changes””
Expedited approval can be given in the US when the manufacturer “intends to use the same manufacturing process” for an already licensed vaccine. The EU has a “rolling review procedure” or they use studies from “mock-up” vaccines, thus negating the “need” for going through the evaluation process.
A pandemic vaccine can only be legally considered when there is a pandemic, or more specifically when there is a public health of international concern declared. 19 months later the WHO changed the definition of a pandemic, just before the 2009 influenza pandemic was declared!