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Vaccine review and reassurance

Last updated on 3 Dec 2020

The Medicine and Healthcare products Regulatory Agency has approved a COVID-19 vaccine for roll-out in the UK starting next week. The MHRA concluded that the Pfizer BioNTech vaccine met its strict standards of safety, quality and effectiveness.

As he fronts a new government campaign to reassure the public about vaccine development, our Chair Professor Sir Terence Stephenson reflects on the role of the HRA in the race from lab to jab.

Professor Sir Terence Stephenson

Yesterday brought news that some of the UK’s most vulnerable people will soon be offered a vaccine to protect them from COVID-19. The news arrived in line with the end of the second national lockdown in England, and brought with it the hope of a brighter Spring. Although logistical challenges lie ahead, hearing that the vaccine will be offered from next week to older adults and those living and working in care homes was roundly welcomed.

But alongside praise for the scientific community which has delivered results at great pace is a concern, increasing in volume, that to achieve a vaccine in under 12 months from the start of the pandemic, corners must have been cut.

Expert reassurance

Today, along with Dr June Raine from MHRA, Dr Mary Ramsay from Public Health England, Deputy Chief Medical Officer Jonathan Van-Tam and Professor Wei Shen Lim from the Joint Committee on Vaccination and Immunisation, I’ve lent my voice to a campaign to encourage those who will be offered the jab to take reassurance from the work of organisations like the HRA which ensures that all health research, including on vaccines, is subject to robust scrutiny.

The message from all of the experts involved is that coronavirus vaccines in clinical trials or which have been submitted for licensing approval by MHRA, have been held to the same standards as those which are reviewed in ‘peace time’.

Some people have asked me how this has been possible. The HRA has approved nine COVID19 vaccine studies since March, involving eight separate candidates, and these studies are only a small portion of the almost 700 which have passed through our fast-track process. Our approval timelines for these studies have been as little as 48 hours, far quicker than the standard timescales.

Corners have not been cut

Speed does not come at the expense of scrutiny – corners have not been cut. Each study has still been assessed by HRA staff and subject to review by a Research Ethics Committee, albeit one meeting virtually, but these staff and volunteers have worked around the clock to ensure that their part of the process can be completed as quickly as possible.

There is little point in speeding away from the traffic lights only to reach a queue of cars in the road ahead. The pace which has enabled two other vaccine candidates to reveal results from phase three trials, and one to have been licensed, has also required every other part of the study timeline to proceed without delay. In normal times for example, applications submitted to the HRA for ethics review may be delayed as we wait for responses to follow-up questions put to researchers. During the pandemic, responses have been almost instant. And once approvals were granted there has been no delay in recruiting to studies as volunteers signed up in the tens of thousands. Combined, these factors mean that research has been able to race along. This isn’t Oxford Street at rush hour, this is Silverstone, solo.

Money and healthy competition have also driven development of course, with massive investment made into the people, facilities and work needed to trial potential vaccines. This, along with the number of studies reporting strong results, should be seen as a positive. The government has been clear that a portfolio of vaccines will be needed to ensure as many people as possible can be protected from the virus, and whilst this week’s result should be celebrated, more research is needed to generate evidence to inform a long-term vaccination strategy. This may include new candidates, or new types of study, for example a human vaccine challenge approach where healthy volunteers are deliberately infected with coronavirus to test the efficacy of a particular vaccine. Whatever the approach, our Research Ethics Committees offer protection for patients and the public, by ensuring that all studies are legal, ethical and fair. We are gatekeepers, and we take our responsibility seriously.

The HRA is proud to have an important role to play in vaccine research, and I am proud of the staff and volunteers who have given so much this year to do this at speed.

Interest in health research has never been higher, and everyone is deeply invested in the studies that offer potential to help us return to our pre-COVID lives. Now that research has delivered results, effective communication and engagement, transparency and reassurance can help to build understanding and confidence in the vaccines that can help us to emerge from this pandemic.

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