In a pandemic, a specific vaccine will have to be rapidly produced to vaccinate people against the new virus. Such a vaccine, like all biological medical products, has to be checked for safety and efficacy (that is, does it work as claimed by the manufacturer) and approved for use. Usually this process takes several months but during a pandemic it must be done in a matter of days or at most, weeks. Countries receiving vaccine are responsible for the safety of their citizens and must make very quick decisions on whether to grant a licence, ask for more data or reject the application for a licence.
The Regulatory Capacity Building Outcome is defined as “countries with weak or no regulatory capacity will be able to regulate influenza products including vaccines, antivirals and diagnostics, and to accelerate national approval of these commodities in case of an influenza pandemic”. This Outcome is articulated across three Outputs, and seven Key Deliverables. Objectives to be achieved by 2016 will be measured against detailed global level indicators of success.