The roles of the MHRA and JCVI in COVID-19 vaccines



The roles of the MHRA and JCVI in COVID-19 vaccines 1

A generic vaccine image.

We are currently receiving lots of updates and seeing regular news stories on COVID-19 vaccines as well as articles on vaccines in general.

There is a lot of interest in how they are made, approved and rolled out to the public. You may have seen mentions of the Joint Committee on Vaccination and Immunisation (JCVI) and the Medicines and Healthcare Regulatory Authority (MHRA) when reading about how we will approve and roll out a vaccine in the United Kingdom.

What does the MHRA do?

The MHRA is an executive department of the Department of Health and Social Care and is the body that regulates medicines, medical devices and blood components for transfusion in the UK.

Until the end of December, and as part of the transition period, COVID-19 vaccine candidates can be licensed via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK.

If a suitable COVID-19 vaccine candidate – with strong supporting evidence of safety, quality and effectiveness from clinical trials – becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.

In the event of a temporary authorisation for supply, the MHRA will evaluate the data rigorously for quality, safety and effectiveness to reach an independent, scientifically robust opinion. The data must include, for example, results from lab and clinical trials in humans, manufacturing and quality controls, product sampling, and testing of the final product.

Once the MHRA has thoroughly reviewed the data, they will seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will critically assess the data too before advising the UK government on the safety, quality and effectiveness of any potential vaccine.

Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA.

The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine. It has responsibility in law to continuously evaluate all products on the UK market.

Following COVID-19 vaccine approval, the MHRA has in place a robust and proactive safety monitoring strategy which allows for near real-time safety monitoring at population level.

What is the JCVI?

This committee is an independent group of experts who advise the Government health departments in the four UK nations on immunisations and the prevention of infectious disease. They consider vaccine safety, efficacy and look at the impact and cost effectiveness of immunisation strategies.

The JCVI looks at data on the impact of a disease, data from clinical trials and modelled data, then advises on the best way to get these vaccines to the public.

This is how we come to have the vaccine schedule, which tells us when you need certain vaccines – for example, why young children need their MMR and 6-in-1 vaccines at certain ages, and why we start vaccinating people against flu from September every year.

They also look for any gaps in the information presented where further research or surveillance may be required.

The underlying principles of the JCVI’s advice on the first phase of any COVID-19 vaccination programme are to reduce mortality and serious disease and protect the NHS and social care system.

Essentially, they make sure our vaccines meet robust standards of safety, that they work as effectively as possible and that the NHS and wider care system has the right strategy in place to give them to us. Their work has fed into us getting new and important updates to our vaccination schedule, such as expanding the HPV vaccine to include boys as of 2019.

Right now, the JCVI COVID-19 sub-committee is in regular contact with manufacturers of COVID-19 vaccines, keeping up to date on the progress of each one, so the JCVI is ready to consider the data as it becomes available and can advise on a COVID-19 vaccination strategy as fast as possible.

They are currently considering the COVID-19 vaccine prioritisation, meaning who should receive the vaccine first.

The current evidence tells us that people over the age of 50 are at greater risk of COVID-19, with the risk rising exponentially with increasing age. Frontline health and social care workers are also at increased risk of becoming infected and passing it on to vulnerable people.

Therefore, in its advice, the current JCVI recommendation is that the oldest people get the vaccine first, as well as older residents of care homes who are at greatest risk of getting COVID-19 and their workers and frontline health and social care workers.

The roles of the MHRA and JCVI in COVID-19 vaccines 2

Both the MHRA and the JCVI are playing a critical role in getting COVID-19 vaccines approved and rolled out to the public. Safety is the number one priority.

It is down to unprecedented resource, funding and collaboration that we are seeing vaccine projects move at a much faster pace than we usually do.