- Russian vaccine Sputnik V is 91.6% efficacious against symptomatic COVID-19
- Efficacy results are based on the data of around 20,000 trial participants
- One dose of vaccine will cost $10, can be stored at +2 to +8 degrees
New Delhi: On February 2, The Lancet medical journal published the interim analysis of the phase 3 trial of Russian COVID-19 vaccine called Sputnik V. As per the peer-reviewed study, recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V) is 91.6 per cent efficacious against symptomatic COVID-19. The results are based on data from around 20,000 participants. The results also showed that the vaccine was 100 per cent efficacious against severe COVID-19, although this was a secondary outcome so the results are preliminary. The vaccine was well tolerated, with no serious adverse events deemed to be associated with vaccination.
The latest findings raise a lot of hope of India potentially getting its third COVID-19 vaccine for emergency use after Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin. Dr Reddy’s Laboratories has partnered with the Russian Direct Investment Fund (RDIF) for the trials and distribution of Sputnik V in India. Currently, phase 3 clinical trials are underway in India involving 1,600 participants and parallelly in three other countries. In an exclusive conversation with NDTV, Kirill Dmitriev, CEO of Russian Direct Investment Fund shared details of the Sputnik V rollout in India.
At the start of the interview, elated Mr Dmitriev shared the highlights of Sputnik V and said,
There are only four vaccines in the world that have published results of phase 3 interim results. Sputnik V is one of the three vaccines in the world with an efficacy of more than 90 per cent. Not only efficacy of 90 per cent is important but also the fact that our vaccine can be stored at +2 to +8 degrees vs -70 degrees required for some mRNA vaccines and also much affordable than mRNA vaccines.
NDTV: What are your plans for scaling up the production so that it is available?
Kirill Dmitriev: India is a great partner for Russia and Sputnik V is the Russian-Indian vaccine. It will be manufactured in India. We have five manufacturers and partners in India who are already producing the vaccine and we will supply more than 700 million people doses so more than 1.4 billion doses of Sputnik V vaccine. We actually are willing to partner with vaccines that have an efficacy of less than 90 per cent so for example, AstraZeneca’s vaccine has efficacy of 62.1 per cent and Serum Institute is producing this. We are now doing a clinical trial to help AstraZeneca increase the efficacy of their vaccine closer to 90 per cent by giving them one shot of Sputnik V. So, we will definitely be producing lots of our vaccine including in India but we are also going to be partnering with other vaccines that have efficacy less than 90 per cent to help them increase their efficacy and then it will mean that we will be producing some of these vaccines jointly.
NDTV: What is the cost of your vaccine?
Kirill Dmitriev: The cost is less than $10 per shot and jointly with AstraZeneca we are two of the most affordable vaccines in the world. And that is very important because when we set up to develop Sputnik V we wanted it to be a vaccine for the whole of mankind and it means it had to be safe and is based on a safe human adenoviral platform that has been studied for decades. We already saw the efficacy numbers which are very high and then we wanted to make sure it is affordable and can also be delivered easily in India and other countries using +2 to +8 temperatures. We have a combination of all of this and that puts Sputnik V on top of the vaccine list in terms of safety, efficacy, price and delivery. It is really a vaccine for mankind.
NDTV: There is a process in India for this vaccine to be rolled out but do you have your mechanism that is the necessary supply chain and production capabilities in place? Would you like to tell us how soon can we expect a rollout once approved?
Kirill Dmitriev: We are working very closely with our partner Dr Reddy’s and we are already doing phase 3 trial in India. We will also be applying for emergency use authorisation soon. We will apply for emergency approval either this month or next month and we will be able to start deliveries of Sputnik V vaccine to India right after that. Sputnik V is already authorised and registered in 16 countries around the world including Europe, Hungary, Latin America, Argentina, Bolivia, Africa, Middle East, UAE, and others.
NDTV: We have seen that whether it is Pfizer’s or AstraZeneca’s or Bharat Biotech’s vaccine, one always has to take two jabs? What about Sputnik V?
Kirill Dmitriev: Our Sputnik V is also a shot vaccine given 21 days apart. In March, we will also introduce a vaccine that is just one shot and it will have an efficacy of close to 80 per cent. Even the one shot vaccine we have will have higher efficacy than some of the existing vaccines. I think based on the circumstances and age, countries will be able to choose which vaccine and for what age group they would like to use.
NDTV: As a company, are you looking at Sputnik V to be the main vaccine?
Kirill Dmitriev: Sputnik V is our main vaccine and we will be producing it in India and supply to many other markets and as I mentioned, India is really our co-partner. India has built a great production hub for vaccines and that is why many manufacturers want to produce in India. So we will be supplying Sputnik V to Indian people with Dr Reddy as well as we will be exporting Sputnik V from India to many other nations around the world.
NDTV: In one of the answers you said this is going to be the vaccine for the people. Are you looking at the correct price and right amount of doses for Sputnik V to become the main vaccine and not say the ones that have already got emergency approval?
Kirill Dmitriev: Well again, we advocate the concept of a portfolio of vaccines. I think not one vaccine can really be the only solution. We definitely believe our vaccine is the best given safety, efficacy, price and logistics but we cannot supply the whole market and all the countries. Basically, India is doing right to have different vaccines that can be provided and as I mentioned we are happy to work with vaccines of efficacy less than 90 per cent to given them one of our shots to help them with the efficacy. But going forward, I believe, in two to four months, most countries will try to focus on vaccines that have 90 per cent efficacy because how do you justify giving somebody a vaccine with 60 per cent efficacy if you have a 90 per cent efficacy vaccine as well.
NDTV: You seem to suggest that vaccines be mixed which means that there is a jab of another vaccine and then topped up with your vaccine which reportedly has greater efficacy. How exactly will this be done and what is the study behind this? According to the government, both the shots need to be of the same vaccine.
Kirill Dmitriev: We are officially starting clinical trials with AstraZeneca in UAE and we have an agreement with AstraZeneca to test exactly this. We believe if we use one AstraZeneca component, one sputnik component, this will increase the efficacy of AstraZeneca. This will start a clinical trial and of course, we will share results of a clinical trial but we do believe particularly in light of mutations that combining vaccines is important and will have better results than for some of the low efficacy vaccines.
We believe it is similar technology; it is based on adenoviral vectors and particularly the ones that we use based on human adenovirus has been proven to be safe over decades and this is why we are also starting clinical trials jointly with AstraZeneca. We will start them as soon as next week.
NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.