The MHRA and Covid vaccine approval: everything you need to know

What is the UK regulator’s role in assessing the quality, safety and effectiveness of vaccines?

Oxford Vaccine Group researchers working on the coronavirus vaccine developed by AstraZeneca and Oxford University
Oxford Vaccine Group researchers working on the coronavirus vaccine developed by AstraZeneca and Oxford University. Photograph: John Cairns/University of Oxford/PA

The Medicines and Healthcare products Regulatory Agency (MHRA) was not previously an organisation many of us gave much thought to. But positive results from trials of three Covid vaccine candidates, which will need its approval, mean it has been thrust to centre stage, standing between us and a semblance of normality.

What is the MHRA?

As its name suggests, the MHRA, an independent executive agency, is responsible for regulating medicines, medical devices and blood components for transfusion in the UK. The regulator, the closest equivalent the UK has to the FDA (Food and Drug Administration) in the US, assesses the quality, safety and effectiveness of products.

How long does it take the MHRA to approve vaccines?

It can take years. The MenB (Meningitis B vaccine), took nearly 20 years from the first idea to the vaccine being licensed for use, according to the University of Oxford’s Vaccine Knowledge Project, although that includes development and testing prior to the approval process.

Drug and vaccine licensing procedures in the UK have frequently been criticised as slow and cumbersome, but approvals have been sped up in recent years. For obvious reasons, the MHRA has prioritised review of Covid vaccines. It has also sought to streamline approval by receiving rolling data on the vaccine candidates as they go through trials.

Additionally, in October, the government changed the law to enable the MHRA to grant temporary approval for a vaccine before it has been given a licence by the European authorities. This brought forward arrangements that will be in place from January next year when the UK leaves the EU, ending Brussels’ involvement in the UK approval process.

Commenting on data received on the Pfizer vaccine, Dr June Raine, the MHRA chief executive, said the regulator would “aim to make a decision in the shortest time possible, without compromising the thoroughness of our review”. It will be assisted in the process by the UK government’s independent advisory body, the Commission on Human Medicines.

How is it funded?

The MHRA receives most of its income from fee-charging activities, including fees for assessing medicines developed by private companies. In 2019-20, £104.6m came from this stream, out of total income of £166.7m. The Department for Health and Social Care (DHSC) also provides funding, which amounted to £43.5m in the last financial year. The medicines regulation part of the body’s remit is funded entirely from fees, whereas funding for medical devices comes from the DHSC. Other sources of income include research funding.

Anti-vaxxers propagating conspiracy theories that Bill Gates is promoting vaccines to implant microchips in people or solely to make profit have highlighted donations made by the Bill and Melinda Gates Foundation to the MHRA. The cash has variously been provided for research work on oral polio vaccines internationally, research to support safer use of medicines during pregnancy, and work to improve the safety monitoring of medicines in low- and middle-income countries.

Does the MHRA involvement end after approval?

The MHRA is also involved in pharmacovigilance – monitoring the safety of all medicines throughout their marketed life. Clinical trials involve a relatively small number of patients for a limited length of time whereas vaccines responding to a pandemic such as coronavirus will be rolled out to very large populations and adverse drug reactions (ADRs) may emerge.

The swine flu vaccine, Pandemrix, made by GlaxoSmithKline, is a case in point. It was given to 6 million people in Britain during the 2009-10 swine flu pandemic but was withdrawn after doctors noticed a sharp rise in narcolepsy among those who received it. The regulator said because the sleep disorder was so rare in people vaccinated – approximately 100 are believed to have been affected in the UK – it could not have been detected in any clinical trial.