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.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
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 Introduction to Industry Training (ITIT) Course - 2024/2025
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.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK