Sputnik V- Developed in Russia, Produced in Hyderabad

By M Somasekhar

When Hyderabad-based Pharma major, Dr Reddy’s announced that it was partnering the RIDF, Moscow to undertake clinical trials and distribute the Sputnik V vaccine in India in the September 2020, as the global pandemic was spreading fast, it raised both public and market interest. 

In March 2021, Dr Reddy’s says, its just weeks before the Vaccine could get clearance from Indian regulators for use. In the meantime, atleast half a dozen Indian drug majors have entered into tie-ups with the RIDF, the Russian Sovereign Fund for production. 

Interestingly, with four of these drug companies located in Hyderabad, the city is fast turning out to be the biggest Hub for the Russian Vaccine. Dr Reddy’s with its bold step is leading the pack with the others being Hetero Biopharma, Gland Pharma and Virchow Biotech. Each of these three companies will produce the vaccine. It may be noted that the representatives of the RIDF had met several companies in India, specially in Hyderabad, from September to November

The Sputnik V Vaccine has been developed by the Gemaleya National Research Institute of Epidemiology and Microbiology. It has an efficacy of 91.6 percent as per global reports. It is also the first to be authorised in August 2020. At present, about 59 nations have agreements for its manufacturing and use globally.

At a parallel level, Hyderabad is already the major producer of COVID 19 vaccines, led by the Bharat Biotech with its Covaxin. Biological E, Aurobindo Pharma, Indian Immunological Ltd., etc., with their existing production facilities, are all readying to produce the vaccines through their tie ups. 

Demand for Vaccines shoots up with the huge spike in cases:

In the last 10 days, the spike in cases, with the last one of 1.34 lakh in a single day has pushed up the call and demand for accelerating the vaccination drive. The Prime Minister, Mr. Narendra Modi also announced a ‘ Tika Utsav’ between April 11-14, after a detailed review of the situation with chief ministers of states. 

However, the main vaccine suppliers as of today- the Serum Institute of India ( SII), Pune which makes ‘Covishield’ of Oxford-Astra Zeneca and Bharat Biotech, the maker of the indigenous Covaxin are facing production and supply challenges in the face of the sudden and huge demand staring at them.

While, the Chief of the SII, Mr Adar Poonawala has openly expressed the need for financial support of Rs 3000 cr to meet demands and accelerate production, Bharat Biotech has been searching for funds and is joining hands with Indian manufacturers to raise its production capacities. 

Meanwhile, shortages are being reported by various states. A political slugfest seems to be emerging with chief ministers of Maharastra, Andhra Pradesh etc stating very little supply and inventory while the Union Health Minister, Dr Harsh Vardhan is claiming no shortages and supplies were being ensured. 

At the scientific level too, the vaccines are still to complete large-scale human rials across different geographies and obtain comprehensive data about the overall benefits. The lack of which and the continuous learning’s as the vaccination now has entered the fourth month is the recommendation that the second dose for Covishield is extended from 4-8 weeks. There are reports of adverse events, though the number reported in India is low so far.

The two companies, also have export obligations as per WHO & GAVI requirements to meet. The Indian Govt’s goodwill moves to present vaccines as well as commercial if any to fulfill. All these add up to a huge challenge in the short term. The Govt., which has encouraged the developers in the regulatory mechanisms more than providing funding support or huge purchases for vaccination has to act fast. 

A big push similar to the universal immunization programme, where the governments procure huge volumes and implement the vaccination programme perhaps is the way out now given the surge in the second wave and sudden demand hike. Even then, the existing two vaccines might not meet the demand and the portfolio has to be expanded. Pfizer, which has the vaccine developed by BioNTech of Germany had applied for emergency authorisation in December 2020. But, it’s demand is huge in the developed nations and priced higher. Given, its presence in India, the company might also enter in the future.

Scope for New Vaccines grows: 

Given this scenario, the chances of Sputnik V getting the nod have gone up. "We expect to get the approval in the next few weeks. It is a two-dose vaccine. You take the first dose on day zero and the second one on day 21. The peak immunity develops somewhere between day 28 to day 42. So, it is a two-dose vaccine. The data on trials is currently with the Indian regulator and the company expects it to get approved in the next few weeks”,  said Deepak Sapra, CEO, APIs and Services of Dr Reddy’s at a recent webinar on "India's vaccination journey and the second wave of COVID-19' conducted by the All India Professional Congress (AIPC), Telangana.

The RIDF has also reached agreements with three more Indian firms—Panacea Biotec, Stelis Biopharma, and Zydus Cadila. Zydus also has its own vaccine in an advanced stage of development. 

Overall, nearly 1000 million doses of Sputnik V can be made as per the agreements so far. According to the disclosed information, Hetero Biopharma (100 m), Panacea (100 m); Gland Pharma (250m); Virchow Biotech (200 m), Stelis Biopharma (200 m), and Dr Reddy’s too can produce later. 

The advantage with the Russian vaccine is that it requires a storage temperature at 2-8°C, a favourable feature for the Indian realities of vaccination in rural areas.  

The Sputnik V vaccine uses an approach slightly different from the one used by Oxford-AstraZeneca. While AstraZeneca uses the same adenovirus vector to carry the genetic material into cells, the Sputnik V vaccine uses two different adenovirus vectors, to give a better immunity and protection. 

( The Author is an Independent Journalist and Science Writer)