'Countries With Leaders Supporting Science See Better Outcomes'

To discuss all this, we spoke with Rajeev Venkayya, M.D., a specialist in pulmonary and critical care medicine, now president of the Global Vaccine Business Unit at Takeda Pharmaceuticals and board member of the Coalition for Epidemic Preparedness Innovations (CEPI).

Edited excerpts:

How did the Bush administration find you and bring you into this role at the Biodefense Directorate under the Department of Homeland Security?

I actually came into the government through a White House Fellows Program; I had previously been working as a pulmonary and critical care physician and researcher in California. That brought me into government. When I got there, I saw that there are ways that physicians with their technical background can contribute to government policy, particularly in areas like biodefense and preparing for pandemics.

What's transpired since then? You wrote a document that led to $7 billion (about Rs 52,000 crore) being put aside to prepare to fight pandemics. Did things move the way you thought they would?

The infectious disease Covid-19 moved the way that we would have expected a flu virus to move. What didn't work the way we had hoped is that governments did not respond the way that they could have. And we found that because of the social media dynamic, we saw a lack of and loss of trust among the public because the science was moving so fast and frankly, leaders were not doing an effective job at communicating the science as it was developing. As a result, we had a disconnect between the reality of the epidemiology, what actions leaders were taking, and how the public generally understood it.

I do think that the mitigation measures that were identified back in 2005-06, i.e. to buy time until a vaccine would become available, were very much in the right direction. The challenge was that these things need to be done early, they have to be coordinated and they have to be done with strong leadership because in many cases, it's hard to ask people to do the things that we've asked them to do.

In other presentations you've made, you've talked about this disconnect between science and leadership. In India, we are now seeing the ebbing of the second Covid-19 wave and are now seemingly preparing for a third wave. Of course, we don't yet know how it's going to be. So how does leadership play a better role in transmitting scientific knowledge, or responding to changes in scientific understanding?

Certainly, leaders in many countries have access to the best science and the most up-to-date information about something like a pandemic. And it's one critical responsibility of a leader to be a bridge between the complexity of science and what it means for individuals, what actions they can take to protect themselves and their families.

But another key role of leaders is to manage risk. So when we think about the Covid-19 pandemic and the experience of 2020, many countries developed a sense of complacency, for various reasons. They believed that their population was somehow special, or the climate was such that it would be hard for a virus to be transmitted. Now, it's okay as a leader to hope that that's going to be the case, but as a leader, it's your job to manage the risk that it is not going to be the case, and in fact, prepare for the worst.

Now, this is hard. The great thing, though, is that governments have the resources that you need to do that kind of preparation. This is the trust we put in governments, to plan for the low-probability but high-consequence events, and there are lots of things governments can do in that regard.

You talked about the exception to the rule syndrome. In India, for instance, some of us thought not too long ago that because we are Indian, because of the environment we're in, we perhaps have more resistance to diseases or viruses like Covid-19. What is your reaction to that, as someone who understands a little bit of this environment and as a person of science?

Let me first say that it is not just the non-experts that believed that. There were many experts that didn't quite understand why things were not developing in India the way they were in places like Italy and in the US. And so many, including scientists and experts, came up with theories to explain that. So this was not a perception that was limited to people that were not scientists. The reality is we just don't know enough about this virus and how it's transmitted. And frankly, in many cases, we've been a bit overconfident about what we know and don't know.

But now that the world has been given notice, that even the places we thought would be spared might not be spared, this is a time when all countries need to redouble their preparedness efforts. That extends across a spectrum of activities, including vaccines but also public health infrastructure and, very importantly, building trust with the public--so that when a leader says you need to do certain things, like stop large public gatherings, people will trust them and listen and do exactly that to reduce transmission in the community.

What you're saying is that while science has a responsibility, it is equally incumbent on leadership to manage and drive the public response, and this is how the impact of this virus will be decided?

That's right. Leaders need to project a sense that they understand as much as is possible to understand at a moment, to share that information with the public in an actionable way, so that the public knows what they should be doing, but also to mentally prepare them for the different scenarios that can unfold. Of course, say that 'we hope that it's going to go in this direction, but if it's not, there are things that we (the government) and you can do to prepare for that negative outcome, to mitigate the illness, the suffering and death that could occur if that happens'.

In India, we're picking up the pace of vaccination. Other countries including the US and the United Kingdom, have progressed much further, particularly when it comes to vulnerable populations. From your vantage point at a vaccine company as well as someone who's part of CEPI, how are you seeing the demand-supply of vaccines at this point and in coming months? And what is likely to happen in the period that we are not able to vaccinate as fast as we should be?

Well, first of all, let me say that it's not a race between countries. It's easy to look at this as a race because we have access to data that shows how many people are vaccinated in one country versus another. What we should all be working toward--and when I say 'all', I am looking to the leaders of governments that have the financial resources to invest in vaccines and manufacture them--is equity and ensuring that there is some fairness in the timing of availability of vaccines in different parts of the world.

India is in a unique position because there is a vibrant, incredibly capable industry with great companies that have a lot of experience in supplying vaccines to the entire world, and in large volumes. India is the most significant supplier of vaccines in the world. So there is an opportunity here for the government to really partner with industry to scale up the manufacturing as quickly as possible. Importantly, it has to be done in a way that recognises the technical difficulties in doing that. Vaccines are not like HIV medicines. You can't flip a switch and have 10 different companies making the same medicine overnight. It takes months to transfer the process for making a vaccine from one company or facility to another. And if you don't get it right, you risk having a vaccine that either doesn't work or, in the worst case, is not safe. That's why a lot of effort has to be put into those transfer timelines.

I think this is where, in retrospect for many governments, there probably could have been more partnership early on, at risk, to make some investments, just in case huge volumes of vaccines needed to be made available very quickly. If you recognise a situation in a moment, that's not the time when you can make a difference. You have to actually take action months in advance in order to be prepared for that moment.

If you look at the Covid-19 vaccine demand-supply dynamics, where are we today versus what we need to achieve our desired outcomes?

We're in a very difficult place right now. About 2.5 billion doses of Covid-19 vaccines have been distributed worldwide. The vast majority of doses have gone to the wealthiest countries. The problem is scarcity. As I've said, scarcity is the enemy of equity. You need to generate volumes of vaccine very, very quickly so you don't have to deal with these difficult equity challenges. But, as I said, it's not easy to scale up very quickly.

We are in a much better position today than we were a year ago because the good news is that vaccines actually work and the reality is that Covid-19, or the SARS-CoV-2 virus, is not as hard a virus target for vaccines as perhaps it could have been. And we had some good science before the pandemic began to inform our vaccine development efforts. So there are a lot of good things. The fact that we have multiple companies around the world with vaccines that work is a great thing. That means that we have more capacity to apply to this challenge.

Now we need to do the hard work of the transfer of technology to as many manufacturers as possible to make high-quality vaccines for the world. Some estimates are optimistic, that by the end of this year, we could have over 10 billion doses of vaccines available. I'm a little sceptical about some of those investments. But if we can actually achieve even three-quarters or half of that and ensure some level of equity, we'll be in a much better place in terms of managing the situation at the beginning of 2022, than we were at the beginning of 2021.

What do you understand about the efficacy of the Covid-19 vaccines and your confidence in them, particularly from India's point of view and fears about both the Delta variant and the newer Delta Plus variant which has cropped up?

The good news is that most of the vaccines for which we have data available show that they are safe and that they are highly effective against preventing the more severe forms of the disease that could put a person in the hospital or even lead to their demise. And that applies to the mRNA vaccines, the vector-based vaccines like the Johnson & Johnson and AstraZeneca vaccine [branded Covishield in India], and the vaccines that used inactivated virus [like Covaxin], i.e virus that has been grown and killed. There are some differences in the efficacy of these vaccines at preventing illness, and that's notable and important, but the most important thing in my view is the prevention of severe disease and there the news is very good. The news is also very positive when it comes to the variants in terms of vaccine efficacy. We do see that though there is some reduction in the ability of vaccines to prevent the illness itself, [but] the prevention of severe disease still appears to be very high. So that's very good news.

Now the Delta variant that you're talking about is concerning. When we see a new variant, there are really three things that we worry about. One, is it more transmissible? Two, does it have the ability to cause more severe disease than the virus we were dealing with? And three, does it evade vaccine protection? If I had to choose between the three of those from a public health standpoint, the worst one is transmissibility, because if you have a virus that is more transmissible, because transmission is exponential in nature, you can see huge differences in the number of cases that a virus can generate. And that is exactly the challenge that healthcare systems have, the surge of patients coming in and the ability to provide them with beds, ventilators, oxygen and trained healthcare personnel.

So I'm very concerned that the Delta variant appears to be about 50-60% more transmissible than the previous variants we were facing. There are also some reports that it can cause more severe disease and it appears to have some ability to evade vaccine protection. Not completely, but there is some reduction in the efficacy of vaccines and preventing illness against the Delta variant. So it really emphasises the importance of making vaccines available as quickly as possible.

In the meantime, while we're waiting for vaccines in many places, ensure the critical public health measures to reduce transmission, such as wearing masks and cancelling public gatherings. By the way, this has been an issue in India. There is no uniform set of directions across states on how to do these public health measures. I think that's so important for leaders to emphasise so that the weddings, the religious gatherings, the sports matches, the election rallies... those are not the kinds of things that you should be doing when you have a pandemic virus circulating. That is exactly the kind of thing that leads to explosive outbreaks of a virus.

Many of us in India have now been vaccinated in the last three to five months. As new variants emerge, assuming that the vaccine-makers are also working hard on these, is it feasible that the next round of doses we get will be better prepared for new variants? How does that work?

The science is happening as we speak. Companies and scientists are looking to see whether you can use the same original vaccine and give an extra booster dose and maintain protection against the new variants. There are also efforts to develop vaccines that are specifically tailored to these new variants, and comparing between the approaches to see what's better. The good news is that every company that is developing a Covid vaccine is looking at this. So my hope is that once we know what the science supports, we'll quickly be able to develop the supply to target the challenges presented by that variant.

One question is what will happen with variant development once a lot of people are vaccinated in the community. We may see that the virus evolves further to reduce vaccine protection. I'm not too concerned about that, because I think we've shown that we can quickly pivot and develop different versions of the vaccine that target specific variants if they appear to be a big problem.

Do you see more dangerous variants emerging? How could this Delta variant evolve? What could be the response to that, medical or otherwise?

Let me come back to a comment I made earlier, that we have to be humble about what we know and what we don't know about this virus. A year ago, a lot of people including very smart scientists were saying that this virus would not mutate much, and that would not lead to many problems, the way we see with influenza. That proved to not be the case, the virus actually does mutate and it can get around some level of vaccine protection.

So I don't have my crystal ball but, as I also said before, we can hope for the best that not much serious mutation happens that reduces the effectiveness of vaccines, but we have to be prepared for the worst. To me, the worst is that a more serious variant emerges for which the current vaccines do not work very well. Then we will have to have the science to support different vaccine approaches that can target that specific variant.

But there are also some guardrails here for viruses, I don't think that this is going to turn into something that we just can't do anything about. That seems highly unlikely. I think we have a great set of tools in vaccines and platforms that we've now proven will allow us to address whatever we face with this particular virus in the future.

If you were to go back 15 years and were asked to write a fresh document trying to anticipate what might lie ahead, not just for the US but for the planet as a whole, what would you write today?

The first thing I would say is that the science has delivered well beyond our wildest dreams. Traditionally, vaccines take between seven and 15 years to develop. We developed them for [Covid-19] in less than a year. And it wasn't just the mRNA vaccines. Other platforms showed that they could move quickly. And our clinical and regulatory development strategies can move very quickly. So that's great news.

The organisation you mentioned at the beginning, the Coalition for Epidemic Preparedness Innovations, or CEPI, is a global organisation that is funding vaccine development for epidemic viruses. It's now turning its attention to the pandemic threat and is proposing, as we speak, to develop vaccines against all 25 families of viruses that could cause pandemics in the future and to do that in advance of the next pandemic, so that we're ready with vaccines that can go right into current clinical trials. So instead of it taking 300 days to get a vaccine, which is still incredibly fast, we shrink that further down to 100 days. For the first time in history, we have the technology, the power to do that for many pandemic threats. So that is going to be a critical element of our strategy going forward. I really hope that governments will support CEPI, which has only asked for $3.5 billion (about Rs 26,000 crore) to get started. It will take more down the line. But I think that's a very small investment, given the threat and the opportunity.

The other challenge that we did not anticipate 15 years ago was social media. Social media can be a tool for good but, as we've seen, it can cause huge misunderstandings, misperceptions. There's a lot of misinformation out there that has really gotten in the way of science-driven public health responses. And I think in the future, we'll have to be much better prepared to deal with this kind of dispersal of information and the echo chambers that can develop through social media.

Finally, I would say that we now have confirmation that leadership matters a lot. You can take two countries that are identical in every way, put a good leader that is behind the science, is proactive, communicates well to the public [in one], and a leader that doesn't have those skills in the other country, and they'll have vastly different performances in the next pandemic. We need to work on our leadership skills to ensure that they get behind the science, that they know how to communicate actionable information to the public, that they maintain the trust of the public, and that they make the necessary steps and investments to get ready for that worst case, that low-probability but high-consequence event on behalf of their people who have entrusted them with that power.

If you have a mental dashboard of the progression of this Covid-19 disease, vaccine production, scientific efforts and scientific papers, how is that dashboard looking right now? What are you tracking personally, what gives you comfort and what are you concerned about?

I think we have some very promising news in places where you've seen high levels of vaccine uptake. One of the great examples that gives me hope is when I look at a small town in Brazil called Serrana, where one of the vaccines from China was rolled out, called CoronaVac, which has about 50% efficacy against preventing illness. When a lot of people in that community received the vaccine, the transmission plummeted and we saw an almost elimination of deaths and a massive reduction in illnesses. So the great equaliser across vaccines is getting high uptake in communities. I really expect and believe that we're going to see that eventually around the globe. So that gives me a lot of hope that we will develop some population immunity through vaccines and natural immunity. That really makes it hard for the virus to be transmitted.

I do see light at the end of the tunnel. I do think we're going to come out of this. It's just a question of how long it's going to take based on vaccine availability. And eventually, I think we'll get to a place where the disease is more like a serious influenza, if that, or maybe like the common cold. It will take some time and a lot of vaccines that are equitably distributed around the world, but I think that's where we're going with this virus.

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