1 research outputs found
Methodological challenges in post-licensure vaccine safety studies using large routinely collected datasets
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