The Lung Centre

Covid 19 Vaccine race: Where does India stand?

Novel coronavirus or SARS CoV2 or COVID 19 has struck the entire globe with a vengeance and has resulted in huge numbers of morbidity and mortality amongst the human population. At the time of writing this article, there were 40 million cases worldwide with 1.1 million deaths and 9.1 million active cases. India is the second largest country with covid 19 cases after United States, with its active number growing steadily at around fifty thousand new cases per day. The policymakers in India are facing a daunting task to find strategies to protect its unaffected population by effective vaccination. India has faced an unprecedented loss of around US $ 120 billion in first six months of the lockdown besides the tragic loss of life. Introduction of a vaccine will prevent the loss of US$ 375 billion to the global economy every month. At the time of writing this paper, there are currently more than 164 COVID-19 vaccine candidates under development, with almost 24 of these in the human trial phase.
Indian scenario:
The Central Drugs Standard Control Organisation (CDSCO) in India has granted test license permission for manufacture of Covid-19 vaccine for preclinical test, examination and analysis to seven manufacturers. Most notable amongst them is the Serum Institute of India in Pune and Bharat Biotech. Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune has developed an inactivated whole virion candidate vaccine (BBV152) for Sars-CoV-2. It has shortly about to start phase-3 randomised double-blind placebo-controlled multicentre trial. Serum Institute of India (SII) has entered a manufacturing partnership with AstraZeneca to produce the AstraZeneca-Oxford vaccine candidate in India, for which it is conducting Phase 2/3 trials. The vaccines currently under trial in India are either two-dose or three-dose vaccines. DCGI has recently granted the proposal to conduct a phase-2/3 clinical trial of the Russian Sputnik V coronavirus vaccine to Dr Reddy’s Laboratories. India’s current access strategy relies heavily on the world’s largest vaccine producer in terms of volume, the SII. Officials of SII have said that most of the vaccines it manufactures will be for Indians before allowing shipping overseas. SII will invest approximately 80 million dollars on a manufacturing unit that will be dedicated to the production of COVID-19 vaccines and expects the government to share part of the costs.

Challenges for India:
After successful development and approval, the next biggest challenge for India will be production, procurement and distribution of the vaccine. They key question is whether India has enough infrastructure for at least one billion vaccine doses. The immunization programme may probably take years. One of the country’s largest vaccination campaigns so far — delivery of the measles–rubella vaccine to 405 million children, starting in 2017 — took 3 years8. Innovative and logical approaches will be needed to distribute vaccines in rural and remote regions. Cold chain and other logistics need to be planned appropriately to ensure no glitches occur in vaccine delivery even to the remotest of the places.
Road ahead for India:
A phase wise framework, central, state, district and municipal authorties, should be adopted in developing guidelines for equitable allocation of COVID-19 vaccine. First phase should cover the seven million healthcare workers, paramedical staff, allied health professionals, municipal, frontline staff and six million armed forces and the police in a “‘JumpStart’ Phase” of the vaccine rollout. Second phase should cover people above the age of fifty years and younger population below fifty with comorbidities that have been disproportionately affected by the pandemic, with higher transmission, morbidity, and mortality rates. This is approximately around 250 to 300 million population in India. For these two phases, India would require around 550 to 600 million doses of vaccines roughly. The SII has priced the Oxford vaccine at 225 rupees (US$3) a dose. That means the cost of vaccinating 600 million people will be at least $1.8 billion. Phase 3 should cover the largest group including young adults and workers in occupations and workplaces that are both important to the functioning of society but are moderately at high risk of exposure but not addressed in earlier phases. These include, for example, workers at colleges and universities, hotels, banks, health clubs, and factories. This should be approximately about 500 million population. Finally, in phase 4, everyone else in India who did not have access to the vaccine in earlier phases would be eligible for vaccination. This would occur once vaccine supplies are more robust. Also the government should consider setting up a reserve of certain quantities of vaccines for hotspots and to be used in areas of special needs. Additionally, the government should reiterate its global responsibility by joining the COVAX group and reaffirming its commitment as the worlds largest democracy towards the global allocation mechanism. India has already set up an Expert Committee of vaccine Administration under the aegis of the Union Ministry of Health and Family Welfare. We need to set up a scientific committee and a war room on the lines of Operation Warp Speed in United States.
Actionable next steps:
1. Develop and distribute a nationwide plan for vaccine distribution that balances effectiveness, efficiency and equity.
2. Develop and distribute a vaccine rationing “decision tree” for clinicians.
3. Develop and distribute protocols for reallocation if required to meet unexpected surge in demand.
4. Establish and maintain district-, state- and nationwide systematic databases of inoculation.
India has already paved its way in the vaccine race albeit on the shoulders of a private organization but with government funding. However, what remains to be seen is how will it ensure fair and equitable distribution among its large and diverse population if such a vaccine comes in the market with limited number of doses.
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Sahil Deo CPC Analytics Pune