Methodological challenges in post-licensure vaccine safety studies using large routinely collected datasets

Toffa-Stowe, Julia Margaret (2017) Methodological challenges in post-licensure vaccine safety studies using large routinely collected datasets. Doctoral thesis (PhD), Manchester Metropolitan University.

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Abstract

Robust and responsive epidemiological post-licensure vaccine safety studies are the backbone to having confidence in a vaccination programme. Consideration must be given to the unique methodological challenges inherent when assessing a potential causal association between a vaccine and the condition of interest; these can be present from setting up the study through to communicating the results. Public Health England (PHE) has addressed a number of vaccine safety concerns since the 1990’s using routinely collected healthcare data and methods specific to the disease and vaccine under scrutiny. This thesis comprises of seven published post-licensure vaccine safety studies which were carried out in response to a number of different pertinent safety concerns relevant to the UK’s immunisation schedule. As a background to these studies the history of routinely collected data is examined in the context of how we use the data today along with a description of the pre and post-licensure vaccine safety activities which often precede the epidemiological studies. By bringing together the methodological issues of these seven studies and demonstrating the different ways in which these issues have been handled it has created a blueprint for addressing vaccine safety concerns in the future. The seven studies are i) Intussusception and Rotavirus vaccination ii) Narcolepsy in adults and Pandemic Influenza vaccine iii) Convulsions and Pandemic and Seasonal Influenza vaccine iv) Bacterial and Viral Infections and Measles Mumps and Rubella vaccine v) Guillain-Barré syndrome and Seasonal Influenza vaccine vi) Idiopathic Thrombocytopenic Purpura and the second dose of Measles Mumps and Rubella vaccine vii) Bell’s Palsy and Seasonal Influenza vaccine. In conclusion the methodological approaches employed in these studies can be used in the future to assess potential adverse events and the access to routinely collected health data is an essential element of this.