Will Russia’s Sputnik V Be India’s Third COVID-19 Vaccine? Dr Reddy’s Laboratories Answers

New Delhi: Sputnik V, the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform, has been peer reviewed by The Lancet medical journal. Russia’s COVID-19 vaccine Sputnik V (Gam-COVID-Vac) has been rated 91.6 per cent efficacious against symptomatic COVID-19 based on the interim analysis of the phase 3 trial data of 19,866 volunteers. The phase 3 clinical trials of Sputnik V are underway in the UAE, India, Venezuela and Belarus. Dr Reddy’s Laboratories has partnered with the Russian Direct Investment Fund (RDIF) for the trials and distribution of Sputnik V in India. The vaccine is named after the first Soviet space satellite and will cost less than $10 per dose in international markets. Sputnik V is expected to apply for an emergency use license in India as early as next month. Ahead of that, NDTV spoke to Deepak Sapra, CEO, API and Pharmaceuticals Services at Dr Reddy’s Laboratories to know more about the vaccine.

Also Read: Russia’s COVID-19 Vaccine 91.6% Effective, Soon To Apply For Emergency Use In India

NDTV: How soon before you start manufacturing in India and in what quantity?

Deepak Sapra: We believe that we should be able to apply for emergency use authorisation in India in the month of March. We believe that the vaccine should be available in India from March –April. As far as quantities are concerned, we have an agreement with RDIF, our partners in Russia, for 125 million people doses that translate to 250 million vaccines which will be sufficient for 2.5 crore people or 125 million people in India. This we expect to accomplish over the period of the next 12 months.

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NDTV: You have also got phase 3 trials in India of Sputnik V. At what stage are you and when will Dr Reddy’s, which is the part of the process, will be in a position to go to the government with the documentation and say look this is what we have for you. Let’s know the progress.

Deepak Sapra: The trials for Sputnik V in the world are being conducted on about 36,000 people out of which over 3,300 people are in Russia. In addition to the Russian trial, there is a bridging study being conducted in some other countries like India, and the UAE. In India we are conducting a bridging study which is a phase 2 and 3 clinical trials on 1,600 patients. Phase 2 was completed in December and the data showed excellent safety and immunogenicity results. Phase 3 is currently underway and is expected to be completed in the month of February after which we will make a submission to the Drugs Controller General of India (DCGI) which is likely to happen in the month of March.

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NDTV: Sputnik V can be transported in a powder form in temperatures between 2 to 8 degrees and it can be used in a combination with other vaccines. Could you tell us a little bit more about that?

Deepak Sapra: This vaccine has two forms – liquid form and a lyophilised form. The liquid form originally is in the -18 storage condition. In addition to the -18 storage condition, there is also a version which is currently under stability testing at 2 to 8 degrees. Once we have 2 to 8 degrees stability data available, we will also be able to get the vaccine transported across the world at 2 to 8 degrees.

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NDTV: The efficacy would remain the same?

Deepak Sapra: Yes, the efficacy is 91.6 per cent as part of the interim results which have come in from The Lancet study. This 91.6 per cent is for the entire population on whom this interim data is available. This cuts across age groups and comorbidity conditions. For example, in the age group of 60 plus, this vaccine has demonstrated an efficacy of 91.8 per cent. This shows there is consistency in the efficacy across age groups and across conditions of comorbidity which gives us a tremendous amount of hope and confidence that this vaccine will be a vaccine which will be suitable for the entire adult population of the world.

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NDTV: What is it going to cost?

Deepak Sapra: We have not yet determined the cost; however, it is important to mention that we are working very closely with the government in India and also with our partners in the private sector to determine what should be the right price point at which this will be available. Needless to say, our goal is going to be ensuring access for as large a segment of the population as possible. Accessibility and affordability is going to be the mantra. And I am sure it will compare favourably with regards to some of the other vaccine pricing that we have in other parts of the world.

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NDTV: Would you say that if there are government regulations in place that you are allowed to sell it to private players then maybe after July sometime this drug would be available?

Deepak Sapra: Our objective is to operate in consultation with the government and as per the guidelines of the government. As of now, we are waiting for the government guidelines on allowing this vaccine for the private sector. We will operate as per that. However, once the government allows us to take this vaccine to the private sector, we would definitely take it to the private sector and we have a very large and extensive reach throughout the country and we will be able to make it accessible to a larger number of people around India once it opens up for the private sector as well in addition to the government.

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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.