R&D for an indigenous vaccine must consider India-specific factors, such as the need for stability at high temperatures, a long shelf life, ease of administration, etc
By Dr Jyotsna R Bapat
The World Health Organisation’s latest data reports a total of 62,195,274 Covid-19 cases: Americas (26,452,055), Europe (18,498,145), South-East Asia (10,788,704), Eastern Mediterranean (4,080,243), Africa (1,494,524) and Western Pacific (880,862). There is also news about the development of SARS-CoV-2 vaccines by Pfizer, Moderna, and Oxford University & AstraZeneca and emergency authorisation for release. Each of these vaccines has some positive features and some challenges. The Pfizer vaccine needs to be stored at minus 75-80 degree Celsius and is effective for 4-6 hours at room temperature. It needs trained staff, special vaccination centres, and two doses are needed within a gap of 21 days. The Moderna vaccine is modified to remain stable at minus 20 degree Celsius—the same temperature as inside a deep freezer of a general practitioner’s dispensary—and has a 30-day storage time. The Oxford vaccine is more effective on older people, but Phase III trials are awaited.
There is a false notion about these vaccines. They are considered a magic bullet—i.e. the disease will disappear and that will end the pandemic. These vaccines only stop infection and not the disease. The Covid-19 virus is not just going to disappear due to these vaccines. There is no permanent solution, only permanent infection. Like other infectious diseases, where the vaccine is available, people still get infected and a few of them die. Tuberculosis, for example, has a vaccine, and yet globally 10 million get infected annually and 1 million die, even today.
A pandemic is a natural disaster. For any disaster management, the policy should focus not just on disease (disaster) prevention, but simultaneously on access to and availability of preventive measures. The management strategy for access and availability should be part of R&D for developing a vaccine—to be done simultaneously and not sequentially.
The right dosage of a vaccine needs to be determined before making it available to target population. There is also a need for spreading information and awareness, about what a vaccine can and cannot achieve. There are still over 40% people unwilling to get inoculated in the US.
Distribution of a vaccine can be done as per various criteria. It is a political decision. One can decide that it be given to the ‘highest bidder first’. Thus, the rich—people or countries—get it first. Other criteria could be vulnerability to the disease, in this case the frontline workers—doctors, nurses and health service providers—get it first, followed by senior citizens with co-morbidity, and then the rest. But, in a democracy, equitable access to distribution is ideal. Access to vaccine requires that everyone who demands it gets it, no matter their status. But given limited supply, due to production constraints, priority of access will have to be a political decision across countries and within countries.
Availability challenges are there—it should exist in large supplies in appropriate doses, distributed easily in all climates. In the current vaccines that have emerged, there is a need for a supply chain of super-cool freezers, trained medical specialists and special vaccine centres—these networks need to be created or explored. The special supply chain is needed to carry the vaccine over large distances—as storage temperatures needed could be far quite low and shelf life may be limited. Specially-trained medical personnel are needed to vaccinate the population—in addition to limited shelf life, some candidates need repeat doses. Finally, special vaccination centres should be set up in adequate numbers to reach all, irrespective of location. These challenges have to be thought through, at the stage of R&D related to vaccine discovery and not sequentially.
Economic cost includes cost of manufacturing of vaccine, cost of setting up new facilities or upgrading existing facilities, transport, and immunisation training.
Access is a challenge in India, given the various kinds of inequalities—rural-urban, rich-poor, caste-tribe, etc. As in all disaster management strategies, coordinated efforts are required between people who need it and the supply of the vaccine.
Availability is a distribution challenge in India, with geographical spread and inadequate transport, power issues, and cold storage infrastructure in rural and urban areas. Pharma companies that have developed these vaccines are focused on distribution mainly in their own regions and Europe by mid-2021. For low- and middle-income countries (including India), R&D of a vaccine suited to local climate and storage infrastructure needs to be explored. It will help if we consider the design-to-cost concept used in management of new products for vaccine manufactured in India. Is there a network for distribution of product, are there skills to deliver the product and is the product affordable for the consumer? R&D needs take into account the need for a long shelf life, stability at high temperatures, simplicity of administration, right doses so that more doses are available, etc. This will bring down the supply-chain cost.
An indigenous vaccine must take into account all these factors at the R&D stage itself; such weighted R&D will be helpful. In India, both the rate of deaths and infections is declining; Indian companies have entered Phase III stage and are expected to enter the market early in 2021, while imported vaccines are not likely to reach by end-2021. The cost of vaccination is still an estimate. Currently, per dose cost of a Covid-19 vaccine manufactured in India is estimated to be Rs 250, quoted by the CEO of Serum Institute of India (the Oxford vaccine may cost Rs 1,000 per dose). Thus, being atmanirbhar in vaccine development may be India’s best option.
(The author, a PhD from IIT Bombay, is an environmental social scientist.)