India's drug controller clears Sputnik V vaccine for emergency use as states grapple with a shortage of vaccine doses. NDTV speaks to Dr Kirill Dmitriev, the CEO of the Russian Development Investment Fund, who says that the first batch of doses will be delivered to India latest by May.
NDTV: People who need to be vaccinated?
Dr Kirill Dmitriev: So, we believe that the first doses will be delivered either end of April or maybe more realistically early May, but definitely in May, India will be receiving the doses. And as you know, we also have five great manufacturers in India who will be producing doses as well. So, we see that May is the time when Sputnik will be launched in India, but of course it will take couple of months to really ramp up production capacity. So, we believe by June, we will really be at very good production capacity in India and will become a very meaningful player in vaccination programme in India. And before that we will be supplying doses, but definitely will be much smaller in market share versus the existing great Indian vaccines that you have.
NDTV: So how many doses are you going to start with and how many doses do you intend to get to?
Dr Kirill Dmitriev: Yes, so, in the end of ramp up, India will be manufacturing, you know, tens of millions of Sputnik amounts. So, we expect as the monthly production volumes in India to actually exceed 50 million doses a month, you know, in the summer. Now to get there, we are working on the amount that will only finalize up to the final approval comes, because we need to really prioritize the countries that gave us approval already. So right now, we expect that we will definitely have some doses ready for Indian market in May. This will not be, you know, a huge number. This will be something to get us started, but then eventually we will go to 50 plus million doses amounts in India of Sputnik Vaccines.
NDTV: So, would it be fair to say that if everything goes according to plan by June, you would be at 50 million doses a month in India?
Dr Kirill Dmitriev: June or July, you know, we are ramping it up, but definitely in the summer. And we also have a couple of additional agreements with a couple of other large manufacturers in India. So, if those come on line, you know, we could have capacity of hundred million a month, but once again, we're in the process of securing this and working very diligently. And once again, we really have a bold Prime Minister Modi and the government and private sector of India that really built those great vaccine production capacities, which is India is really number one now in the world in terms of capacity to produce vaccines for the world.
NDTV: And would the initial lot of vaccines which will be sent out in India, will they be imported or will they all be made in India?
Dr Kirill Dmitriev: We are still working on the final combination. I think we can send some vaccines from some other countries, but basically this will be just for the first couple of months. I think India will really become the production hub of Sputnik, serving India and other markets. And once again, mainly countries will be waiting for that vaccine produced in India because, you know, Sputnik has efficacy of more than 90%. It has really exceptional safety track record, not only in Russia, but also in Argentina and Mexico, where it has been used. So basically, we are really viewing Sputnik V as an Indian Russian vaccine and we'll ramp up production in India very quickly.
NDTV: Have you reached a price agreement by which you will sell to the government of India?
Dr Kirill Dmitriev: We are still in the process of discussions, we understand that there are some price control elements, to what Indian government has and there are some ideas of having a different price in the private market versus government contract. So, this is still subject to discussions that we are undertaking. I'm sure we'll find a solution. And by the way, Indian government has been really great to work with, we really overcame many of the issues that had to be solved. So, we have no doubt that we will find a good solution.
NDTV: Would you be able to price Sputnik at what AstraZeneca is, which is approximately $2 a dose in India?
Dr Kirill Dmitriev: Well, again, we'll see, realistically, AstraZeneca, has a vaccine, and Sputnik, are some of the most affordable vaccines in the world. If you look at all of the other vaccines, they cost double or triple the price still, I think Sputnik, you know, in other markets it's more expensive than AstraZeneca's vaccine and, I'm not sure that we can get exactly to that pricing, given our production, process. So again, we are in discussions with the government, I think the whole goal is not to really make, you know, huge return of investments. Of course, we want to return our capital, but the whole goal is to really be a solution to the world's that so much needs of vaccine.
NDTV: So, you are selling approximately at $10 a dose, as I understand it, on an average in many other countries, it would be less than that. Right?
Dr Kirill Dmitriev: Well, again, let's have discussions with the Indian government. So far, the pricing has been exactly the same for all of the countries. So, all of the countries and Africa and Asia and middle East, the price of Sputnik has been the same. And, we will just see how we can find a solution with Indian government, you know, the vaccine is one was the most affordable in the world and we will see how we can do it in India.
NDTV: All right, tell us a little bit about global acceptance of Sputnik. How many countries have accepted Sputnik and where does the World Health Organization stand with it?
Dr Kirill Dmitriev: So, we already had 59 registrations before India. So, India will become the 60th country and with India, we will have, more than 3 billion people living in countries as a registered as emergency authorization of Sputnik V. And we see great effects that Sputnik V is having not only in Russia, but on many other nations. So, Argentina released data where it shows that people who receive two shots of Sputnik, they only 0.1 - 5% of them had light COVID, no severe COVID, really no symptoms and very good safety record. Mexico released data that Sputnik is, frankly you know the best vaccine from the safety perspective, if you look at the reported side effects, that the other vaccines have. So, we really have been very successful in countries with Sputnik V is use it is because it's based on the safe human adenoviral platform, that have been tested for decades. You know, as we discussed, it's quite affordable and then it's easy to transport because it's plus two plus eight and because efficacy with more than 90%. So, combination of those factors makes it a very compelling proposition to different countries.
NDTV: I have read the Lancet report, which, you know, says that it's a fantastic vaccine. Where does the World Health Organization stand on Sputnik right now?
Dr Kirill Dmitriev: So, World Health Organization is reviewing all of the manufacturing capacity we have. And I think they come for an inspection, I think, in the next couple of weeks. So, we have no doubts, that WHO approve Sputnik, you know, in the next couple of months, but frankly for us its much less relevant because we already working with 59 other nations that already approved Sputnik so for us just sort of a check mark will do but the key thing for us is to ramp up production, including production in India and continue saving lives with Sputnik in India and other places
NDTV: One or two more questions. Firstly, the importance of this vaccine is also the easy transportability. You can transport it, not necessarily in a liquid form, but also in a powdered form. Tell us a little bit about that. How is that significant in a country as hot as India?
Dr Kirill Dmitriev: Yes, exactly. So, the original formulation we had had to have temperature of -18, but then we proved the stability of this liquid formulation at +2 +8 for two months. So basically, we will have, +2 +8 degrees, which is regular refrigerator, last mile solution in India. But in addition, we have what's called life for life dry form that can be stored in, you know, dry form for six or more months. So, this will also be I think, a part of the solution for particular remote areas in the world. So, we definitely are much better than some of the vaccines that require very significant investment in cold chain infrastructure. And we believe that, current Indian vaccines are also great because they really put logistics at the core of the solution. And that is very important. And by the way, we intend to work in partnership with existing vaccine manufacturers in India, we believe they have great vaccines and we will be just a part of the comprehensive Indian vaccine solution.
NDTV: What is the efficacy against mutant strains? We have a, probably have a different strain now in India, much more transmissible. The clinical evidence is clear, will Sputnik work effectively against this?
Dr Kirill Dmitriev: So, we have shown that we have the same efficacy against British strain as against the original virus. And we have shown the same efficacy against many other strains. Now we believe that the efficacy against South Africa strain may be a little bit lower, but still protecting people from severe cases of COVID. And as the reason we are so confident on mutations is that Sputnik is the only vaccine in the world it uses two different shots of the vaccine. So basically, it's the result of having two different shots. We believe we produce higher immune response that lasts longer. And basically, we have a vaccine cocktail having two different shots. So, this vaccine cocktail proves to work very effectively against mutations, but also very soon we'll have a modification that will include all of the existing mutations in this Sputnik V vaccine. And this will come out in the next couple of months. So, we are very cognizant of mutations. We believe we have one of the best solutions against mutations and that will only become stronger going forward.
NDTV: Last question, the trials in India, how big were they? How significant were they?
Dr Kirill Dmitriev: So, trials in India were very significant for us, you know, they involve more than thousand people and they showed very high, immunogenicity and very high safety in India. And it's very important to us that this decision by the expert committee has taken also based on this Indian data. And they have seen vaccine functions themselves and seen real exceptional results that vaccine produces. So, I think this is particularly important for us that Indian data and phase three has been used and produced really stellar results that expert committee used to basically recommend the approval of Sputnik V vaccine in India.
NDTV: Dr. Dimitri, wonderful speaking to you. Thank you so much!