Video-on-Demand Library

02 December 2021

The first talk is about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Introduction to Statistical Methods and Challenges in Vaccine Development.
Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.
The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed. A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

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