The Covid Suraksha Mission has taken off and India is almost there without having to knock at the doors of other nations. With right logistics, the country can meet the WHO’s estimate that a 65-70 per cent vaccine coverage rate is sufficient to reach population immunity, evaluates Aarti Asthana.
The Covid-19 pandemic provided India the perfect opportunity to play leader to the world that is rushing to find a ‘safe’ vaccine for the dreaded infection. India is not only leading the R&D of the Covid-19 vaccine, it is a crucial cog in the vaccination development process needed the world over.
On 12 November 2020, Finance Minister Nirmala Sitharaman announced Rs 900 crore funding for Covid-19 vaccine research in the country. This was a stimulus as part of the Atmanirbhar Bharat package. The union minister clarified that the funding will be released only for the research and development of Covid-19 vaccine and the actual cost of the vaccine, the distribution cost, etc. will be accounted for separately.
The minister said, “Rs 900 crore would be sanctioned for Covid Suraksha Mission for research and development of the Indian vaccine to the Department of Biotechnology.” At present, there are three candidates involved in the development of the Covid-19 vaccine in India and are at different stages of the human clinical trials. The human clinical trials of vaccines developed indigenously, one by Bharat Biotech and the other by Zydus Cadila Ltd. are under underway presently.
Proactive PM boosts morale, funds
The government too is leaving no stone unturned to ensure the timely development of the vaccine. On 28 November 2020, Prime Minister Narendra Modi visited Hyderabad, Ahmedabad and Pune in a day-long programme to review the coronavirus vaccine development work. The Prime Minster wanted a first-hand perspective and understanding of the preparations and preparedness of the vaccine development programme. He also wanted to understand the challenges and the roadmap of the programme when India reaches out the vaccine to its citizens. He visited the three biotechnology firms whose vaccine candidates are in advance stages of human trials.
He first visited pharma major Zydus Cadila manufacturing unit in Ahmedabad and reviewed the process at their research facility and interacted with the scientists and the vaccine developers. The company aims to complete the vaccine trial by March 2021 and is in the process of producing up to 100 million doses a year.
He also visited pharma major Bharat Biotech at Hyderabad and reviewed the progress of the vaccine Covaxin, a vaccine candidate being developed by the company. This vaccine is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology.
In the third leg of his visit, Modi stopped at the Serum Institute of India in Pune where he interacted with the scientists and reviewed the progress of the vaccine candidate for coronavirus. Serum Institute of India has trucked with AstraZeneca and Oxford University. PM Modi also reviewed the preparedness of the launch and production and distribution of the vaccine during his visit.
Reviewing the processes at every stage
If the vaccine development programme goes as planned and acquires the necessary regulatory approvals, then companies could be producing millions of doses of the Covid-19 vaccine by the next year. Prime Minister Narendra Modi also held a virtual conference with heads of three vaccine development and manufacturing companies: Gennova Biopharmaceuticals, Pune, Biological E Ltd and Dr. Reddy’s Laboratories Ltd., Hyderabad.
Biological E Ltd had procured permission to start human clinical trials of its vaccine candidate in October 2020. Gennova Biopharmaceuticals is scheduled to begin thehuman trials of its proprietary m-RNA vaccine in December 2020. This m-RNA vaccine is similar to that of Pfizer-BioNTech and Moderna. Dr. Reddy’s Laboratories Ltd. has tied up with Russian Direct Investment Fund (RDIF) and Gamaleya to test the Sputnik V vaccine on Indian volunteers. In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.
Dr Reddy’s Laboratories and the RDIF announced on 1 December 2020 the start of adaptive phase 2 and 3 clinical trials for vaccine Sputnik V in India after receiving necessary clearance from the Central Drugs Laboratory in Himachal Pradesh. JSS Medical Research will conduct the clinical trials as the clinical research partner of the company. The company will also undertake the safety and immunogenicity study in the process.Dr Reddy’s Laboratories has also partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory support and to use BIRAC’s clinical trial centres for the vaccine.
For the Phase 3 of Sputnik V clinical trials, 40,000 volunteers have participated of which over 22,000 have been administered the first dose and more than 19,000 with the first and second doses of the vaccine.
Domestic vaccine development
The phase 3 human clinical trial of India’s own vaccine, Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) began on 2 December 2020. The trials started at privately-run Vydehi multi-specialty hospital in Bengaluru.
Vydehi Institute of Medical Sciences and Research Centre official K. Ravi Babu said, “The ICMR has permitted our hospital to conduct the third phase trial for Covaxin developed by the Hyderabad-based Bharat Biotech.” The hospital has roped in Clintrac International Ltd for the trials that will involve 1,000 volunteers. Mr Babu explained the ‘vaccine will be given to the volunteers in two doses’ and will be ‘monitored daily through phone/video call for feedback and updates.’
Reaching vaccine to the masses
Once the vaccine is developed, it will be a humongous challenge to disseminate it to the 1.3 billion people in India. In a statement released on 1 December 2020, the Union Health Ministry said that ‘India does not need to vaccinate all of its 1.3 billion people if it manages to break the transmission of Corona virus’.
At the press conference, Director General of the state-run Indian Council of Medical Research Balram Bhargava said, “If we are able to vaccinate a critical mass of people, and break that virus transmission, then we may not have to vaccinate the entire population.” The World Health Organization experts believe that a 65-70 per cent vaccine coverage rate is sufficient to reach population immunity.
India is a country of more than a billion people. The Covid-19 fight will end only when an effective vaccine will reach the right proportion of the population to control the spread of the virus. India has run massive immunisation programmes and makes 60 per cent of the world’s vaccines. It is also home to major manufacturers of vaccine. This includes Serum Institute of India – the largest in the world. So, the country is prepared to vaccinate the 1.3 billion people against Covid-19. India is expecting to receive and use 500 million doses of vaccines against the novel coronavirus and in the process immunise up to 250 million people by July 2021.
The government has also prioritised the distribution of the vaccine: The first preference will be given to Covid warriors, including doctors, nurses, paramedics and all others who are on the frontline in the battle against the virus. In the next stage, the vaccine will be given to senior citizens, those who are co-morbid and other vulnerable sections of society.
India is not only prepared to satiate the domestic needs but also provide necessary support to neighbours. The Indian government is enhancing cold chain and storage capabilities for delivery of Covid-19 vaccine of neighbouring countries such as Nepal and Bangladesh.