The One Million Study to monitor safety and effectiveness of COVID-19 vaccines

Our UK COVID-19 Vaccine Consortium has announced plans for the One Million Post-Authorisation Study to monitor the safety and effectiveness of the COVID-19 vaccine in real-life conditions.

The Consortium has been formed by the Drug Safety Research Unit (DSRU), led by Professor Saad Shakir, and includes Professor Stephen Holgate (University of Southampton), Professor Neena Modi (Imperial College), Professor Carmel Hughes (University of Belfast), Dr Paul Collini (University of Sheffield), Professor Paul Rutter (University of Portsmouth), Dr James Coulson (University of Cardiff), Dr Sufyan Shakir (North East Health Education England), Dr Emma Johnson (Queen Elizabeth University Hospital, Glasgow), Professor Frances Mair (University of Glasgow) and Dr Louise Berry (Nottingham University Hospitals Trust).

Developers of vaccines are required to demonstrate quality, safety and efficacy for their products before members of the public start receiving them. During the current pandemic, COVID-19 vaccines are being developed with unprecedented speed, with the development being reduced from 10-12 years to 12-18 months. Therefore it is necessary to conduct post marketing observational studies to monitor the safety and effectiveness of COVID-19 vaccines and that these studies report in real-time any safety or lack of effectiveness signals so that action can be taken in a timely way. The post-authorisation studies also fill any gaps in knowledge obtained from premarketing clinical trials.

The One Million Post-Authorisation Study will conduct essential monitoring at the ‘post marketing’ stage to ensure vaccines work and are safe as they should be.

The work of the Consortium will build on its experience in active surveillance of vaccines. The DSRU conducted monitoring of the safety of the H1N1 swine flu vaccine during the 2009 pandemic and has also conducted enhanced safety surveillance on a seasonal flu vaccine every year since 2014. For these studies, the DSRU team worked with the National Institute for Health Research (NIHR) Clinical Research Networks (CRNs), GP practices and other sites where the vaccine is administered.

Members of the Consortium bring decades of experience in epidemiology, vaccines research, primary and secondary NHS care and pharmacy, meaning that the Consortium is very well placed to conduct the post-authorisation surveillance that is so vital for new COVID-19 vaccines. The Consortium will also engage with stakeholders including experts in vaccines, general practice and pharmacoepidemiology, as well as manufacturers of COVID-19 vaccines.

Professor Saad Shakir, of the DSRU, said “It is well-known that a safe and effective vaccine is vital for protecting the public from COVID-19. The usual development process for a vaccine, including proving its safety and effectiveness, would normally take over a decade, but has been reduced to 12-18 months for COVID-19 vaccines. The methods of the One Million Study benefit from the structure of the NHS and have been developed to allow near real-time reporting of safety and effectiveness signals, which will be crucial for monitoring newly-licensed COVID-19 vaccines.

“This is a vital part of ensuring that any vaccine can be safely deployed around the world.”

For the One Million Study, the Consortium will invite one million members of the public who receive a COVID-19 vaccine to take part. Those who agree will be contacted at set points after the vaccine to check on their health. The study is designed to respond frequently, so that any concerns regarding safety or efficacy can be detected and acted upon quickly. It is hoped that this methodology will reassure people who are concerned about receiving a COVID-19 vaccination.