Safety issues associated with pandemic influenza vaccines
In the event of an influenza pandemic, protective influenza vaccines will be urgently required. WHO is promoting vaccination strategies that economize on the use of antigens to address the current global shortage of influenza vaccines for epidemics and pandemics. That would entail development and licensing of novel antigen-sparing vaccine formulations. Evaluation of safety and efficacy of new vaccines is likely to be especially challenging since the vaccines might not be available until after the pandemic had started. There would be public health demand for a vaccine to be made available as soon as possible. Advanced planning of safety and efficacy evaluation would be essential, with collaborative collection and evaluation of data, and rapid communication of conclusions.
The GACVS agreed to act as a resource for WHO if such a situation were to arise. The Committee made the following recommendations: develop pharmacovigilance guidelines to enable rapid assessment of pandemic influenza vaccines; promote the extension of such guidelines to evaluate seasonal influenza vaccines; develop an authoritative review of the safety and efficacy of inactivated influenza vaccines with adjuvants. It would be assured that regulators from developing countries are included in WHO meetings to promote regulatory collaboration on pandemic influenza vaccine issues and that lessons from the past, such as those from swine influenza vaccine, are taken into account.