MHRA COVID-19 Safety Monitoring System | Civil Service Awards 2021 | Prestigious cross-government programme to recognise the wealth of inspirational individuals

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MHRA COVID-19 Safety Monitoring System

Medicines and Healthcare Products Regulatory Agency

With the emergence of COVID-19, MHRA, responsible for authorising use of healthcare products and undertaking safety monitoring in the UK, anticipated increases in reporting of suspected adverse reactions and developed a comprehensive and proactive vigilance plan for COVID-19 vaccines, to ensure rapid detection of issues and protection of public health.

The Yellow Card scheme, where suspected side effects to healthcare products can be reported, is the ‘front door’ to safety monitoring at MHRA, making this data critical to the rapid detection of any safety concerns. Since the start of the immunisation programme, the systems have enabled analysis of over 355,000 Yellow Card reports for COVID-19 vaccines, compared with approximately 45,000 annually in a normal year. Over 80% of the Yellow Card reports have come from members of the public and over 31,000 people have registered for the active surveillance system enabling active monitoring of vaccinees who may have been underrepresented in clinical trials.

The implementation of new technology has not only allowed the management of unprecedented amounts of data, but also created a ‘first in kind' strategic platform for vigilance which has brought forward thinking on how the regulator will conduct vigilance across all healthcare products now and in the future.