PSI Vaccines SIG Webinar: Statistical designs for assessment of vaccine safety in pregnancy

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This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

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