Few people have 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, in which she also received an Honorary Fellowship from Somerville, and the scientific training which prepared her for it.

This interview offers an extended version of the print interview which appeared in this year’s edition of the Somerville Magazine, incorporating additional questions posed by the students and Fellows of Somerville College.

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!

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 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.

What was the second element of the MHRA’s response?

That comes back to the concept of the prepared mind scientifically, and is where I personally pay most tribute to Somerville. I was also 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 part of our response was our ability to establish dialogue with developers and partnerships 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% vaccine efficacy, we knew we were way 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, 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 record-breaking 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 issues of global vaccine inequality. Oxford’s links with the Serum Institute of India are a shining 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. It’s time now that the international community joined us in a global strategy to tackle this disease and not let the grass grow under our feet – an objective which is entirely possible given the positive start we made with the Pandemic Preparedness Plan signed at the G7 in June 2021.

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 who matter and 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 94-95%. 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 close to half a million who enrolled.

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

WEBSITE-ONLY QUESTIONS

Professor Patricia Owens (Professor of International Relations): What do you make of the fact that Britain became, for a while at least, a major outlier in not vaccinating children and teenagers under the age of 18 despite the MHRA’s approval of the Pfizer vaccine for 12 years and up?

(N.B. This question was suggested in June 2021 and is retained for the insight it provides into vaccine deployment strategy, rather than its topical relevance.)

As Professor Owens notes, we’ve always advised COVID-19 vaccination for children who are vulnerable, for example those with neuro-disability. It’s important to remember that has always been part of the immunisation programme and provision has been made for that.

I think it’s appropriate that JCVI is taking a very careful approach to deployment down to the age 16s and below, and at that age informed decisions can be made with suitable information and discussion. So I think it is a matter for children and parents to discuss carefully.

The other element that has come to the fore is our concern for access to COVID-19 vaccines by the rest of the world. The COVAX initiative is perhaps still reaching its maximum potential, and you might argue that there are many adults around the world, where the chance of being vaccinated might still be a couple of years away. I think it’s absolutely appropriate that it’s not just science but ethics that policy decisions are based on.

Abi Punt (2019, Medicine): What do you think of the JVCI’s decision to advise under 40s be given an alternative to the AstraZeneca vaccine?

The age gradient in risk and benefit has been a really important evidence-based principle. And, yes, JCVI made a very good and timely decision to advise that the under 40s be given an alternative to the AZ vaccine, because at that time our best data showed an age gradient – and we know that the younger you are, the less likely you are to have serious morbidity or even mortality associated with COVID-19 infection. So it was very right that we looked at not just risk, but risk and benefit according to age.

At the heart of vaccination, people are making an informed decision about what is right for them. The graphics produced by Professor David Spiegelhalter and his team at the Winton Centre are a really helpful way to support this. What’s so effective about what David Spiegelhalter’s group constructed is graphical representation of high, moderate and low infection incidence scenarios.

So if you’re trying as a young person to get your head round the right course of action – and everybody quite rightly wants to make that decision for themselves – then these graphics are a great decision tool. They lay out so clearly the benefits of vaccination versus the risk of a side effect at various ages.

Professor Marc Feldmann FRS (Kennedy Institute, Oxford University): Were there any concerns about the Astra-Zeneca or Pfizer vaccines from the limited data presented for approval?

Actually, the data sets and analyses we had for vaccine approval were really robust. For the Pfizer vaccine, we were looking at studies around the 40,000+ and it was well into the 20,000s for the AZ, with a good demographic spread and in different countries. We had very comprehensive data and there was no doubt that the vaccine was highly effective and that the safety profile was one we would have anticipated.

We knew there would be much more work to do after approval because there are some suspected side-effects that are only detected when millions of people have been exposed. As well as safety surveillance,  we undertake batch release to ensure all vaccine batches being deployed are pure and the potency meets requirements.

The quality side obviously in some people’s minds should be taken as read, but for a biological product you’ve got to be sure for every batch that it is what it should be. We’ve tested about 100 million doses so far, so I would say the public can be fully confident on quality.

How was it to be nominated the first female Chief Executive of the MHRA?

People often talk about glass ceilings, but that hasn’t been my experience. Right now, at the same time as my appointment as Chief Executive of the MHRA, both the FDA and the European Medicines Agency have woman leaders. For me, that’s positive confirmation that, if you’re the right person and you’ve got the right skills, you’ll get the job. And that’s what I think is most important: that you are judged on your own merits.

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