June Raine: A Prepared Mind

A Prepared Mind

Few people played a more decisive role in the UK’s response to Covid-19 than June Raine. As Interim CEO of the MHRA (she was confirmed in the role in Feb 2021), June steered the vaccines through testing and manufacture to achieve a mass rollout that set the pace for the rest of the world. Here she tells the story of an extraordinary year and the scientific training that prepared her for it.

Everything I do scientifically comes back to those first principles I learned at Somerville.

What first sparked your interest in a position in medicine regulation and how did your career take you there?

Well, I qualified back in 1976, at a time when the main pathways available to women doctors were radiology, pathology, anaesthetics or general practice. After an MSc in pharmacology and some reflection, I chose to start in general practice. But I still had a penchant for the research world – one which Oxford kept alive for me thanks to that real sense you have, when living there, of research and academia being all around you.

Serendipity stepped in next when David Graham Smith, the Professor of Clinical Pharmacology, suggested I consider regulation. He told me it was at the cutting edge scientifically and I might find the process of developing new drugs a good way of having a direct impact on public health. As he predicted, I saw the value of the work almost as soon as I started. At that time HIV was just becoming a global threat, and I witnessed first-hand how these new antiretroviral cocktails turned HIV from a death sentence into a disease you could live with and even, in time, cure.

Right from the beginning, regulation captured my imagination as a means of translating robust scientific methodologies into tangible health benefits – and I’ve been here ever since!

June Raine

You mention the atmosphere in Oxford as having influenced your decision to pursue regulation. To what extent, if any, did Somerville prepare you for that path?

Oh, it was everything! Like many others, I’m sure I couldn’t do what I do now without Somerville’s influence; it really did shape my intellectual and ethical disposition fundamentally. First of all, I think there’s an idea that, if you’re a Somervillian, you have an open mind; you ask questions, never take things at face value and, when the situation arises, you’re there to be counted.

The second thing Somerville gave me was scientific rigour. I was fortunate enough to be taught by Jean Bannister – and what a paragon she was! We all respected her work on cardiovascular physiology immensely, but it

Showing Prime Minister Boris Johnson around the National Institute for Biological Standards and Control (NIBSC) in June 2021

was her emphasis on evidence-based practice that really influenced me. She taught us not only to rely on evidence, but also that evidence isn’t something you just wait for; you generate evidence, you prepare for evidence.

Everything I do scientifically comes back to those first principles I learned at Somerville. Miss Bannister’s model was Louis Pasteur’s concept of the prepared mind – you know, ‘In the field of observation, chance favours only the prepared mind.’ I used to recite that to myself quietly in French, and it’s stayed with me ever since. The methodology I learned back then – of hypothesis, testing one’s hypothesis, repeating it, refining it, and then using that evidence to make robust decisions – that’s the absolute heart of what I do today, the heart of good regulation.

Vaccines have been the one real success story in a very challenging time – can you tell us about your role in getting them out there?

I believe there were three key aspects to our response. The first was starting early. We all knew that something like this was going to happen sooner or later, so our preparations had begun even before the virus emerged. In particular, the National Institute for Biological Standards and Control (which is part of the MHRA and rejoices in the acronym NIBSC) had done a good deal of work on emerging viruses and understood coronaviruses such as MERS and SARS-CoV-2 pretty well.

The next landmark was the call I took from the WHO early in 2020, wanting our Head of Virology to start preparing standards. Even without further confirmation of the virus’ spread, we acted on that immediately, because if you’re going to manufacture a vaccine, you need standards to test against.

Once lockdown hit in March 2020, our preparations moved up a pace. Early planning on how to manufacture at scale was absolutely vital, because it doesn’t matter how good your vaccine is – if you’ve got insufficient supply or an inability to deploy, your asset doesn’t have the benefits you think. So we started looking at manufacturing very early on.

Evidence isn’t something you just wait for; you generate evidence, you prepare for evidence

We never create these entities in a vacuum: it’s always people who matter and drive our best work.

What was the second key element in the MHRA’s response?

Here I must come back to the concept of the prepared mind scientifically – and it is where I myself pay most tribute to Somerville. But I was also tremendously fortunate to have a great many ‘prepared minds’ working alongside me.

I knew, for example, that I could consult the doctoral researchers working on emerging viruses at NIBSC, as well as the MHRA’s expertise as a global centre for the eradication of polio. All of this research and the minds that produced it were tools in our toolkit.

And the final stage?

The final element in our response was our ability to establish dialogue with developers and partnership with healthcare providers while maintaining strict independence.

By emphasising the need for regulatory independence in our interactions with these colleagues, we were able to build an accurate picture of vaccine safety and efficacy very early on – this was around June to October 2020. So, by November 2020, when the major global regulators had set the bar at 50% efficacy for vaccines, we knew we were ahead of the curve.

It was at this point that all our preparations began to pay off. We knew the vaccines worked and were safe, we knew the manufacturing and ongoing testing were in hand and we knew the NHS had fleets of vehicles with the requisite minus-75 degree refrigeration. We even knew we had a plan for hard-to-reach constituencies, such as care homes, who could store the AZ vaccine in a domestic fridge. Everything was ready to go.

Is there any sense that the UK’s recordbreaking vaccine authorisation has ushered in a new era for the regulation and deployment of medicines?

I hope so. Certainly, the last eighteen months have resulted in a range of innovations we can build upon. First and foremost, we proved that the emergency authorisation route works. Given the fundamental maxim that time is

health, there’s no question that we can and should make use of the same process for other urgently needed vaccines and medications in future.

I also believe that the model of international cooperation we’ve pioneered over the last year is a significant development. On the one hand, the ground-breaking work of Somerville’s former Principal, Fiona Caldicott on safeguarding patient data means the UK can use clinical data to test hypotheses and produce insights that we can share with countries that don’t have a regulatory regime like our own.

Perhaps even more importantly, the UK has set an example in dealing with the very important issue of global vaccine equity. Oxford’s links with the Serum Institute of India are an enduring example of moral leadership, with the Institute currently committed to manufacturing and delivering 1 billion doses of the AZ vaccine to India and other low and middle-income countries. I very much hope that the international community will shortly join us in a global strategy to tackle this disease and not let the grass grow under our feet.

The last and perhaps most important point to make is that this pandemic reminded us we never create these entities in a vacuum. It’s always people that matter and who drive our best work. Public support for the vaccines has been phenomenal. Our initial projections anticipated 40% or even 50% vaccine hesitancy, but uptake among the older vaccinated population is now at 9495%. I also pay tribute to all the people who volunteered for the studies. We thought a few thousand would come forward, but when the vaccine register opened, it was half a million who enrolled.

I find the continuing evidence of such altruism incredibly moving. It proves yet again what the belief in science can achieve.

This interview benefitted from questions suggested by Professor Marc Feldmann, Professor Patricia Owens and Abi Punt (2019, Medicine). An extended version can be found on the Somerville website.