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 - 2026/2027
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.
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 webinar brings together three bitesize complementary sessions to help PSI contributors create conference presentations and posters that communicate clearly and inclusively. Participants will explore how to refine their message, prepare materials effectively, and adopt practical habits that support confident, accessible delivery. A focused, supportive session designed to elevate every contribution.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.
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.
Join our Health Technology Assessment (HTA) European Special Interest Group (ESIG) for a webinar on the strategic role of statisticians in the Joint Clinical Assessment (JCA). The introduction of the JCA marks a new era for evidence generation and market access in Europe. As HTA requirements become more harmonized and methodologically demanding, the role of statisticians has evolved far beyond data analysis. Today, statistical expertise is central to shaping clinical development strategies, designing robust comparative evidence, and ensuring that submissions withstand the scrutiny of EU-level assessors. In this webinar, we explore how statisticians contribute strategically to successful JCA outcomes.
Statisticians in the Age of AI: On Route to Strategic Partnership
A 90-minute webinar featuring two case studies from Bayer and Roche demonstrating how statisticians successfully integrated into AI programs, followed by interactive discussion on strategies for elevating statistical expertise in the AI era.
Enhancing Clinical Study Reporting with the Estimand Framework
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
• Understand the role of estimands in improving transparency and interpretation of trial results.
• Navigate common challenges in implementing the framework during reporting.
• Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
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 networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
GSK - Statistics Director - Vaccines and Infectious Disease
We are seeking an experienced and visionary Statistics Director to join our Team and lead strategic statistical innovation across GSK’s Vaccines and Infectious Disease portfolio.
As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
As a Statistical Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
We have an exciting opportunity for an Associate Director, Biostatistics to join a passionate team within Advanced Quantitative Sciences – Full Development.
: We have an exciting opportunity for an Associate Director (AD), Statistical Programming, to join a passionate team within Advanced Quantitative Sciences- Development.
Novartis - Senior Principal Statistical Programmer
We have an exciting opportunity for a Senior Principal Statistical Programmer, to join a passionate team within Advanced Quantitative Sciences – Development.
Pierre Fabre - Clinical Development Safety Statistics Expert M/F
We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92).
Pierre Fabre - Lead Statistician – Real World Evidence -CDI- M/F
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.
Pierre Fabre - Lead Statistician- Clinical Trials M/F
We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department based in Toulouse (31, Oncopole) or Boulogne (92).
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.