Vaccines have been in the news this week - but when you dig into the stories, it turns out that the hype is about phase 1 trials. We're a long way from being sure any of the 150 possible vaccines being developed actually work.
In this talk evidence we're talking to a researcher, a regulator, and a manufacturer about the way in covid-19 is upending normal vaccine development, which hurdles they'll have to reach to get onto the market, and how we'll know which one to choose when they are...
Vaccines have been in the news this week - but when you dig into the stories, it turns out that the hype is about phase 1 trials. We're a long way from being sure any of the 150 possible vaccines being developed actually work.
In this talk evidence we're talking to a researcher, a regulator, and a manufacturer about the way in covid-19 is upending normal vaccine development, which hurdles they'll have to reach to get onto the market, and how we'll know which one to choose when they are there.
This week
(1.10) We said that covid would have a knock-on effect on other treatments, and Helen looks at some research into acute coronary syndrome admissions in the UK.
(6.53) Peter Doshi, assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and an editor for The BMJ, tells us what to watch out for in the PICO for a vaccine study.
(15.20) Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the European Medicines Agency, explains what regulators are looking for when thinking about licencing a vaccine - and how covid has made different agencies around the world align their requirements.
(22.22) Philip Cruz, UK head of vaccines at GSK, explains how a manufacturer tests their vaccines, and how they use adaptive study design to past regulatory hurdles and provide information for those choosing which vaccine to use.
Reading list
Lancet paper - COVID-19 pandemic and admission rates for and management of acute coronary syndromes in England
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31356-8/fulltext
ONS Data - Deaths registered weekly in England and Wales, provisional: week ending 3 July 2020
https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsregisteredweeklyinenglandandwalesprovisional/latest
The BMJ editorial - Vaccines, convalescent plasma, and monoclonal antibodies for covid-19
https://www.bmj.com/content/370/bmj.m2722
WHO report - Draft landscape of COVID-19 candidate vaccines
https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
Research Methods & Reporting
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
https://www.bmj.com/content/369/bmj.m115
