Date: Thursday 28th October 2021 Time: 16:00-17:00 BST Speaker: Prof. Dan-Yu Lin (Department of Biostatistics, University of North Carolina at Chapel Hill)
Who is this event intended for? Statisticians working on Vaccines or related topics to COVID-19. What is the benefit of attending? To learn how to evaluate the duration of protection of COVID -19 vaccines and about the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Overview
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. The COVID-19 vaccines currently in use were approved on the basis of efficacy and safety data from phase 3 trials with a median follow-up time of only about two months. Because of crossover, the phase 3 trials provided little information about the efficacy of these vaccines beyond 6 months. Typically, estimates of vaccine efficacy over broad time intervals are reported, which are not informative about the level of waning at the end of the observation period. Observational studies can potentially provide information about long-term vaccine effectiveness, but they are more difficult to be analysed. In this talk, I will discuss how to properly measure and estimate vaccine efficacy/effectiveness as a function of time elapsed since vaccination while properly accounting for changing transmission rates over calendar time. I will present results on the long-term effectiveness of the Pfizer, Moderna, and Janssen vaccines against Covid-19, hospitalisation, and death in the United States.
Registration
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Speaker Details
Speaker
Abstract
Prof. Dan-Yu Lin
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Scientific Meetings
PSI Vaccine SIG Webinar: Evaluating the Durability of Protection for COVID-19 Vaccines
Date: Thursday 28th October 2021 Time: 16:00-17:00 BST Speaker: Prof. Dan-Yu Lin (Department of Biostatistics, University of North Carolina at Chapel Hill)
Who is this event intended for? Statisticians working on Vaccines or related topics to COVID-19. What is the benefit of attending? To learn how to evaluate the duration of protection of COVID -19 vaccines and about the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Overview
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. The COVID-19 vaccines currently in use were approved on the basis of efficacy and safety data from phase 3 trials with a median follow-up time of only about two months. Because of crossover, the phase 3 trials provided little information about the efficacy of these vaccines beyond 6 months. Typically, estimates of vaccine efficacy over broad time intervals are reported, which are not informative about the level of waning at the end of the observation period. Observational studies can potentially provide information about long-term vaccine effectiveness, but they are more difficult to be analysed. In this talk, I will discuss how to properly measure and estimate vaccine efficacy/effectiveness as a function of time elapsed since vaccination while properly accounting for changing transmission rates over calendar time. I will present results on the long-term effectiveness of the Pfizer, Moderna, and Janssen vaccines against Covid-19, hospitalisation, and death in the United States.
Registration
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Speaker Details
Speaker
Abstract
Prof. Dan-Yu Lin
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Training Courses
PSI Vaccine SIG Webinar: Evaluating the Durability of Protection for COVID-19 Vaccines
Date: Thursday 28th October 2021 Time: 16:00-17:00 BST Speaker: Prof. Dan-Yu Lin (Department of Biostatistics, University of North Carolina at Chapel Hill)
Who is this event intended for? Statisticians working on Vaccines or related topics to COVID-19. What is the benefit of attending? To learn how to evaluate the duration of protection of COVID -19 vaccines and about the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Overview
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. The COVID-19 vaccines currently in use were approved on the basis of efficacy and safety data from phase 3 trials with a median follow-up time of only about two months. Because of crossover, the phase 3 trials provided little information about the efficacy of these vaccines beyond 6 months. Typically, estimates of vaccine efficacy over broad time intervals are reported, which are not informative about the level of waning at the end of the observation period. Observational studies can potentially provide information about long-term vaccine effectiveness, but they are more difficult to be analysed. In this talk, I will discuss how to properly measure and estimate vaccine efficacy/effectiveness as a function of time elapsed since vaccination while properly accounting for changing transmission rates over calendar time. I will present results on the long-term effectiveness of the Pfizer, Moderna, and Janssen vaccines against Covid-19, hospitalisation, and death in the United States.
Registration
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Speaker Details
Speaker
Abstract
Prof. Dan-Yu Lin
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Journal Club
PSI Vaccine SIG Webinar: Evaluating the Durability of Protection for COVID-19 Vaccines
Date: Thursday 28th October 2021 Time: 16:00-17:00 BST Speaker: Prof. Dan-Yu Lin (Department of Biostatistics, University of North Carolina at Chapel Hill)
Who is this event intended for? Statisticians working on Vaccines or related topics to COVID-19. What is the benefit of attending? To learn how to evaluate the duration of protection of COVID -19 vaccines and about the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Overview
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. The COVID-19 vaccines currently in use were approved on the basis of efficacy and safety data from phase 3 trials with a median follow-up time of only about two months. Because of crossover, the phase 3 trials provided little information about the efficacy of these vaccines beyond 6 months. Typically, estimates of vaccine efficacy over broad time intervals are reported, which are not informative about the level of waning at the end of the observation period. Observational studies can potentially provide information about long-term vaccine effectiveness, but they are more difficult to be analysed. In this talk, I will discuss how to properly measure and estimate vaccine efficacy/effectiveness as a function of time elapsed since vaccination while properly accounting for changing transmission rates over calendar time. I will present results on the long-term effectiveness of the Pfizer, Moderna, and Janssen vaccines against Covid-19, hospitalisation, and death in the United States.
Registration
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Speaker Details
Speaker
Abstract
Prof. Dan-Yu Lin
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Webinars
PSI Vaccine SIG Webinar: Evaluating the Durability of Protection for COVID-19 Vaccines
Date: Thursday 28th October 2021 Time: 16:00-17:00 BST Speaker: Prof. Dan-Yu Lin (Department of Biostatistics, University of North Carolina at Chapel Hill)
Who is this event intended for? Statisticians working on Vaccines or related topics to COVID-19. What is the benefit of attending? To learn how to evaluate the duration of protection of COVID -19 vaccines and about the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Overview
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. The COVID-19 vaccines currently in use were approved on the basis of efficacy and safety data from phase 3 trials with a median follow-up time of only about two months. Because of crossover, the phase 3 trials provided little information about the efficacy of these vaccines beyond 6 months. Typically, estimates of vaccine efficacy over broad time intervals are reported, which are not informative about the level of waning at the end of the observation period. Observational studies can potentially provide information about long-term vaccine effectiveness, but they are more difficult to be analysed. In this talk, I will discuss how to properly measure and estimate vaccine efficacy/effectiveness as a function of time elapsed since vaccination while properly accounting for changing transmission rates over calendar time. I will present results on the long-term effectiveness of the Pfizer, Moderna, and Janssen vaccines against Covid-19, hospitalisation, and death in the United States.
Registration
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Speaker Details
Speaker
Abstract
Prof. Dan-Yu Lin
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Careers Meetings
PSI Vaccine SIG Webinar: Evaluating the Durability of Protection for COVID-19 Vaccines
Date: Thursday 28th October 2021 Time: 16:00-17:00 BST Speaker: Prof. Dan-Yu Lin (Department of Biostatistics, University of North Carolina at Chapel Hill)
Who is this event intended for? Statisticians working on Vaccines or related topics to COVID-19. What is the benefit of attending? To learn how to evaluate the duration of protection of COVID -19 vaccines and about the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Overview
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. The COVID-19 vaccines currently in use were approved on the basis of efficacy and safety data from phase 3 trials with a median follow-up time of only about two months. Because of crossover, the phase 3 trials provided little information about the efficacy of these vaccines beyond 6 months. Typically, estimates of vaccine efficacy over broad time intervals are reported, which are not informative about the level of waning at the end of the observation period. Observational studies can potentially provide information about long-term vaccine effectiveness, but they are more difficult to be analysed. In this talk, I will discuss how to properly measure and estimate vaccine efficacy/effectiveness as a function of time elapsed since vaccination while properly accounting for changing transmission rates over calendar time. I will present results on the long-term effectiveness of the Pfizer, Moderna, and Janssen vaccines against Covid-19, hospitalisation, and death in the United States.
Registration
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Speaker Details
Speaker
Abstract
Prof. Dan-Yu Lin
Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.
Upcoming Events
PSI Introduction to Industry Training (ITIT) Course - 2025/2026
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
PSI Book Club Webinar: Atomic Habits - The Science of Getting Your Act Together
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
PSI Webinar: Methods and tools integrating clinical trial evidence with historical or real-world data, Bayesian borrowing, and causal inference
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
One-day PSI/PHUSE Event: Change Management for Moving to R/Open-Source
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.