Sputnik spoke to India’s leading pharmaceutical company, Dr. Reddy’s, in detail to understand what gave it the confidence to invest in a Russian-developed COVID-19 vaccine.
Deepak Sapra, Chief Executive Officer, (API and Pharmaceutical Services), Dr. Reddy’s Laboratories Ltd. revealed that the world’s first registered CoVID-19 vaccine has the potential to be “the vaccine” on basis of its science, adding that Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, had the motivation to make a positive impact on the world during times of crisis.
He underscored that the procurement of 100 million doses is subjected to successful final-stage trials and approval from the Indian drug regulator.
Kirill Dmitriev, the chief executive officer of RDIF, had revealed last week that by November the vaccine will hit the Indian market, following approvals from the authorities.
Sputnik: RDIF and Dr. Reddy’s collaboration is the first breakthrough for the Russian vaccine Sputnik V in India. How do you think a vaccine can help the second-worst hit nation India in its fight against COVID-19?
Dr. Reddy’s: As of today, 21 September, if we look at the global context, the world has about 30 million COVID-19 cases and about 959,528 deaths. Out of these 30 million cases, India has over 5 million cases and about 85,000 deaths, which is a very, very large proportion of the global numbers. More than 90,000 cases appear in India every single day. This is the magnitude of COVID-19’s impact on the world and India.
In a country like India, a potential vaccine would play a significant role to not only control the pandemic but also deal with the consequences it has for the people, and to get day-to-day life and the economy back on track. The pandemic has not only affected people who have been infected with the disease, it has had an impact across the spectrum of the population and on the economy as well.
Sputnik: Why is Dr. Reddy’s betting big on Sputnik V and not some other vaccine candidate?
Dr. Reddy’s: This is a question on which we deliberated a lot during our discussion on partnership. The vaccine stood out for us for some of its key factors: first, the vaccine candidate is based on the human adenovirus. The world has had decades of experience with the adenoviral vector technology and the vaccines based on this technology have been in existence for several years. Some of these vaccines are against Ebola, MERS and SARS. That is one very important consideration we had. One should note that it is not only based on adenovirus, but human adenovirus, that has lent itself to a good long-standing record for safety over several years.
The second key factor which really stood out during our evaluation process was that the initial data we received from RDIF, our partners, was very consistent. The data showed good antibody titers and a lot of this data was also commented upon by global journals, such as The Lancet. That really gave us an additional data point.
The third point, which I think is really the core of the ongoing activity at the moment, is that there is a very large global trial that is currently ongoing, with more than 40,000 subjects.
Another important reason I think is: Dr. Reddy’s is a global pharmaceutical company headquartered out of India. We are present in a very, very strong manner in India and in many countries around the world, including Russia, one of our most important geographies. We have been in Russia since 1993 and we are deeply committed to the Russian market as well. Since the COVID situation unfolded in the world, we have been at the forefront of our efforts across the therapeutic spectrum on the COVID-19 response.
Photo : Dr.Reddy’s
Sputnik: A lot of questions have been raised by sections of the media and medical community over the efficacy of Sputnik V since Russia announced itself as the first country to develop a COVID-19 vaccine. Did Dr. Reddy’s have any inhibitions?
Dr. Reddy’s: For us the safety and efficacy for the Indian population are paramount and our primary consideration. The RDIF has been very open and transparent in sharing the details and science behind their efforts. On the other hand, Dr. Reddy’s is a company which takes pride in itself, on its science and on its ability to understand the clinical and regulatory requirements around the world. We understand and respect that there is a lot of additional activity that has to be carried out for us to be able to fulfil the requirements of the Indian regulators, which we have jointly committed to do.
If everything goes well and trials are successful then it will give us a chance to make an impact in the world in the times of an unprecedented crisis. And this has really been the driving force for us to go into this collaboration with the RDIF. Our Russian partners are actually equally motivated about the cause that I spoke about, about making a difference, a positive impact.
Sputnik: If we talk about the timeline, when can we expect the phase 3 trials to start and when is Dr. Reddy’s expected to receive the 100 million doses of Sputnik V?
Dr. Reddy’s: The procurement of 100 million doses will be subject to successful clinical trials and regulatory approval from the government of India. After establishing the safety and efficacy on the Indian population during clinical trials, we will approach the Indian regulator and make a request for approval.
During these unprecedented times, we are doing things on a war footing. In a few weeks’ time, we will make a request for the approval of phase 3 trials. At the moment, it would be really difficult to give out a detailed timeline.
Sputnik: As we know, Serum Institute of India is conducting clinical trials for Oxford’s AstraZeneca and would be manufacturing the vaccine under the name Covishield in India. Will the partnership between RDIF and Dr. Reddy’s replace the Serum Institute of India’s Covishield as the forerunner in the Covid-19 vaccine race in India?
Dr. Reddy’s: We’re thinking this is more than a race, this is an opportunity for the entire healthcare community and the pharmaceutical industry and the vaccine industry to collaborate in a manner that it accelerates access to a vaccine. When we look at the macro picture, globally, and also the macro picture in India, at the end it has to be a combination of approaches, based on different vaccines and different platforms.
What AstraZeneca and Serum Institute have been doing, we have great respect for that. And, and I think all of us are really rooting for each other and praying for success because in the context of what’s going on in the world, we are at the end; we need a vaccine.
Sputnik: Can we expect any future deals with the GAVI (Global Alliance for Vaccines and Immunisation)?
Dr. Reddy’s: Currently, this arrangement is limited to India. We are open about expansion with other entities, especially those who are working in the public health space, to maximise access. That is something which we will be open to as a next step. But as of now, the arrangement we have is just with India.
Sputnik / Vladimir Pesnya
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