Source: United Kingdom – Executive Government & Departments
An editorial published in Anaesthesia looks at the global COVID-19 vaccination program.
Dr Andrew Garrett, Executive Vice President of Scientific Operations, ICON, said:
“Cook & Farrar highlight the global response to the pandemic and describe the organizations that have collaborated to mobilize the global effort to date. They also highlight the need for post-administration monitoring of approved vaccines and the challenges of vaccine deployment. The authors note that there are many unanswered questions and the need for further vaccine development and refinement. It is important therefore to consider which experimental methods could be used to generate the data that could be used to help answer some of these questions.
“One approach would be to use a platform trial design to study approved vaccines head-to-head, including dose modifications and combinations. This type of design has been adopted by the UK Recovery study that successfully demonstrated the benefit of dexamethasone in the treatment of COVID-19. Like the Recovery trial, the platform design could also be used to evaluate new candidates. Taking advantage of global collaboration, this study could be set-up as an international trial – like most phase III drug development programs. This would undoubtedly be an efficient use of resources and provide much needed direct comparisons of different vaccines.
“Closer to home in the UK, experimental data could also be generated through vaccine deployment using a randomized stepped-wedge type design. Care homes are the obvious unit, and since roll out will take a number of weeks, it would be straightforward to select care homes at random within a region and roll-out through time, using the lagged time to vaccination as the control. Other units could, at a later date, include university halls of residence, or schools. Vaccination would of course remain voluntary.
“Given so much remains unknown, and many questions remain unanswered, it is imperative that international and national organizations mobilize to create an experimental framework to generate empirical evidence.”
Professor Andrew Morris, Director of Health Data Research UK, and chair of the ICODA Executive Team, said:
“Now that vaccination distribution programmes are about to begin, attention must turn to effective monitoring and evaluation of the vaccine in practice. It will be essential to gather real world evidence to understand more about the safety and efficacy of the vaccine, and to inform the design of the best possible vaccination strategy. To deliver an effective monitoring programme will require investment, expertise and strong support from Governments across the world, working in partnership with vaccine manufacturers, the WHO, national health authorities and regulatory bodies.”
‘COVID-19 vaccines: one step towards the beginning of the end of the global impact of the pandemic’ by Cook et al. was published in Anaesthesia at 23:01 UK time on Monday 14 December 2020.
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Dr Andrew Garrett: “I am employed by ICON which is a Contract Research Organization . ICON provides pharmaceutical services to the pharmaceutical and biotechnology industries. ICON conducts clinical trials on behalf of Sponsors, including vaccine trials.”
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