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
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.
Topic: R Package Basics.
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, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.