The Benefits and Risks of Pandemic Influenza Vaccines

In 2009 and 2010 the world experienced the first influenza pandemic of the 21st century. As the new influenza A(H1N1)pdm09 virus spread across the world, vaccines were being produced and licensed at an unprecedented scale and speed. In Europe, adjuvanted and non-adjuvanted H1N1pdm09 vaccines were licensed through fast track procedures with the first centrally registered vaccines authorized at the end of September 2009. Due to the nature of pandemic influenza, uncertainties surrounding the benefit risk balance for pandemic influenza vaccines remained at the time of licensing. These uncertainties were addressed in the post-licensure phase through additional studies and alternative monitoring efforts. Whilst the monitoring of effectiveness and safety of vaccines is challenging under most circumstances it is particularly so when vaccination is rolled out within a developing pandemic at the scale seen in 2009 and 2010.

The work described in this thesis was conducted in the wake of the 2009/2010 pandemic. It consists of several studies that evaluate the benefits and risks of pandemic influenza vaccines used across Europe. The experience with pandemic influenza vaccines is collated and lessons drawn to improve the future monitoring of the benefits and risks of influenza vaccines.