DUBAI: Last week, Russia surprised the world by announcing that it had developed and authorized production of a vaccine — Sputnik V — to combat COVID-19. Many experts and media commentators criticized the Russians for being quick to claim credit for the first vaccine at the expense of sufficient testing, specifically phase 3 testing on humans.
The Russian Direct Investment Fund (RDIF) played a key role in developing Sputnik V. In an exclusive interview with Arab News, CEO Kirill Dmitriev explained the reason for the rapid registration of the vaccine, and why he thinks the West has been less than welcoming to this potential breakthrough against the pandemic.
AN: Have you been surprised by the reaction in some parts of the international media?
KD: We understood that the world would be divided. There has been a division between ordinary people who want the vaccine and who understand it’s good news in all countries. And also some politicians, some pharma companies and some media, there’s a division there.
Then there’s a division between countries. We’ve seen a very negative, I’d call it very jealous reaction in the US, the UK and some other places in Europe. But we’ve seen very positive reaction in the Middle East, in Asia, and extremely positive reaction in Latin America. I think the reaction is different in those geographies, and we were expecting this.
I think it’s very important to understand the position of Russia. We aren’t forcing our vaccine on anyone. As of now only Russians will be vaccinated, but we just want to share the fact we have this technology. There are some unique features. Maybe I can go into why we did it, how we did it so quickly and the science behind it.
We saw that some countries would want to explore it, would want to do it. But other countries, just because it’s Russian they have a mental block on anything that’s Russian. I have this analogy: If we were to offer to distribute water to the US, we’d get articles in the media that maybe it’s poisoned, or the recipe is stolen, or maybe it has some vodka in it.
AN: But some of the scientific criticism focused on the very rapid development of Sputnik V and lack of data.
KD: Some of the points are legitimate, and they’ll be answered by data we publish in August. In all the criticism, there’s a valid point about making data available, and I wish we could’ve done it earlier. But data will start to become available at the end of August, and it will be published — data about phase 1, phase 2, animal studies etc. And we’ve already started doing phase 3. So more data will be coming out, and it’s a fair criticism.
We know the technology works, and let me go into what’s unique about it. Russia has always been very strong in vaccines. Catherine the Great was vaccinated 30 years before the first American vaccine appeared — 1762 I think it was . And the Soviet Union was always strong in vaccines.
On this specific vaccine, basically our scientists had a head start. They were working on the Ebola vaccine, which got approved, then they used the same method — human adenovirus vector — on the MERS vaccine. When coronavirus appeared, they just happened to have this proven platform. MERS is very close to coronavirus, and they were able to use an already proven and researched platform.
This adenovirus vector stuff is basically the human adenovirus vector. It has been studied in the world the last 20 years. There have been dozens of studies, tens of thousands of people, and it has been proven that human adenovirus is safe and doesn’t have long-term consequences.
It’s very different from mRNA, very different from monkey adenovirus, which haven’t been studied for 20 years and haven’t been the subject of dozens of clinical studies. Frankly they’re novel approaches, and we hope they work, but they’re much less studied approaches. So the fact we had this proven platform allowed us to move forward.
AN: Why not wait until the end of August to announce it when all the data could be made available?
KD: There’s an ethical responsibility that once you have a technology that you know works, to make it available to people in a safe manner. It’s irresponsible to delay something that you know works and then deny it to people who need protection.
We want all countries to do all the necessary checks. Our Ministry of Health has done it for Russia, and they determined that the vaccine is safe and efficient. And when they determined that, they wanted to make it available to Russian people right away. People are dying from coronavirus and we want to protect them. There was a clinical and human need.
AN: What about the lack of phase 3 tests?
KD: We have a law in Russia that at a time of epidemic you’re allowed to do phase 3 concurrently while administering the vaccine to people. Basically it’s invoked only for technologies that’ve been proven to be safe before.
So if we were to try to use mRNA or monkey adenovirus, it has never been shown to be effective before, and we’d never have done it without phase 3. But we have the vaccine already approved, based on Ebola, so we have data for the last six years and the world has data for the last 20 years of studying human adenovirus vectors.
Let me try to explain it very simply. You can think of vaccines as just coming in two parts. You have a code for the spike of coronavirus that needs to be delivered to cells so that antibodies get produced. Pretty much all the vaccines, simplified, more or less, have the same spike.
So the only thing that matters and is different is the delivery mechanism. Our delivery mechanisms are based on human adenovirus, which has been proven before to be safe long term. There have been studies for example that show it doesn’t cause cancer, over the past 20 years.
So we used technology safe and proven before to deliver the spike of coronavirus. So once you understand the science, you basically say, ‘OK, what could go wrong?’ Most of the problems that could go wrong come from the delivery mechanism.
For example, AstraZeneca (the multinational pharmaceutical group also working on a vaccine) uses monkey adenovirus, which has never been studied long term in the human population. So that’s very different, which the West is missing. mRNA (an alternative vaccine technique under development in the West) had never been studied before.
So it shows that the stuff that was approved in Russia, safe and chosen before, just delivers a spike of coronavirus.
AN: Can you tell me more about the agreement you have with Saudi Arabia to do tests there?
KD: We have an agreement in principle to have clinical trials in Saudi Arabia. We’ll have a visit by the Saudi Health Ministry to the Gamaleya Institute, which is part of the process. We already have a partner in the Kingdom, a very good Saudi company. I shouldn’t name them. It’s an experienced pharma company that’s working with us, and we’ve already shared phase 1 and 2 data with our Saudi partners.
We believe in a real strategic partnership with Saudi Arabia on the vaccine. We know that lots of countries look up to the Saudi position and their approach, and we’ll really engage with Saudi scientists, the Saudi Health Ministry, in the very deep understanding of our technology. We believe that Saudi will be a very strong partner for our joint work on the Sputnik V vaccine.
We’ve also shared data with the UAE. We expect to start trials there in August.
We expect to have clinical trials in Saudi, the UAE, the Philippines and Brazil, as well as Russia.
AN: So you have your vaccine. Do you care whether the rest of the world takes it up or not?
KD: Of course, our priority is the safety and security of our people, and we have a safe vaccine. Vaccinating our people will start massively in October. If it’s just Russia that gets vaccinated, it’s a great accomplishment because we gave the vaccine earlier and saved more lives. It’s very important to save our people.
Our other responsibility is to share with the world, openly, what we have and what we know works. It’s up to individual countries to explore it. If they want to take it or not take it, we won’t care so much because we aren’t going to do this for profit.
It’s on a not-for-profit basis, just to cover our expenses on the vaccine and cover our costs. This isn’t a money maker. It’s a humanitarian initiative. It’s our responsibility to tell the world we have it, this is how it works, and you have Sputnik V that has all the information, and more will be published. With that, we feel our responsibility to the world is complete.
We have requests already for 1 billion doses of vaccine. It’s huge. If other people show interest, it’s our responsibility to make it available, then we’ll work with five other countries to produce the vaccine and make sure we distribute it to countries that want it.
We aren’t trying to convince the US. We aren’t trying to convince Europe. We fulfilled our responsibility by developing it, vaccinating Russian people, letting other people know we have it, and letting countries that want it manufacture it in partnership with them.
We’re trying to do as much as we can without forcing this on anybody or trying to convince anybody.
AN: How much will it cost per dose?
KD: We’ll be able to talk about that in September or October because we’re scaling up manufacturing outside Russia and we want to get to the lowest price point, and we need to get to manufacturing in scale. We need a couple more months to do this.
All I can say now is that pricing will be very competitive. From some other estimates we saw from other people, we expect our pricing will be lower than we saw others circulate.