Even as COVID-19 continues its worldwide rampage, many countries have eased lockdowns due to the stress on their economies. While the fight against the pandemic continues, the fact remains that the only way to truly eradicate the virus is to discover a viable vaccine.
The route to new drug discovery (called a ‘candidate’ at the early stages) is complex and fraught with uncertainties. Typically, almost 12 years (global average) pass before a drug candidate reaches commercial production (when it can be termed a ‘drug’ or ‘vaccine’). The candidate must successfully complete many steps before it can see the light of day.
The drug discovery process and timeline involves the following steps:
Basic research to understand the illness and its underlying reasons (2–3 years)
Non-clinical studies (3–5 years)
Clinical studies, including confirmation of safety, efficiency, efficacy (3–7 years)
New drug application and review (1 year)
Approval and commercial launch
Post-market surveillance and clinical studies
Route for COVID-19
Due to the humanitarian and economic crisis resulting from the COVID-19 situation, there is now an urgency to accelerate the process of discovery and bring out a solution. Although many countries are now reporting a reduced number of cases, the fear of a second wave is ever-present.
India has already taken steps to accelerate its search for a vaccine. The Drugs Controller General of India (DCGI) has fast-tracked approvals for all companies working on drugs or vaccine to battle the pandemic. Apart from speedy approvals, the DCGI has approved other measures, such as waiving off animal studies and providing flexible pathways.
Two Indian pharma companies currently leading the race for a vaccine – Zydus Cadila (Zydus) and Bharat Biotech International – will now begin phases one and two of human clinical trials. The companies are working with the Indian Council of Medical Research (ICMR) and have readied sites to conduct clinical studies on about 1,000 volunteers each at these sites.
India’s large-scale manufacturing capabilities
India’s large-scale drug-manufacturing capability is already well-known and appreciated globally. The country has always played a vital role in manufacturing and supplying medicines worldwide. India currently supplies 50 per cent of the global demand for certain vaccines, about 25 per cent of all medicines distributed in the UK and 40 per cent of the generic drugs needed in the US.
With India’ pharma prowess, even if another country discovers a vaccine, commercial manufacturing of the drug may still come to India. In fact, the UK government recently announced that it entered a manufacturing pact with Wockhardt, a Mumbai-based global biotech and pharma company. The contract would ensure the supply of millions of doses of a COVID-19 vaccine whenever it becomes available. The 18-month agreement focuses on the crucial ‘fill and finish’ stage of the manufacturing process. It includes filling the manufactured vaccine into vials ready for distribution.
The challenges ahead
While several countries are gearing up to start production as soon as a vaccine is discovered, this in itself would not be the end of the road. There are several challenges associated with the accelerated approval of any vaccine.
The most critical challenge encompasses ethical and safety concerns as accelerated approvals bypass some crucial steps in the drug testing process. Fast-tracking a scientific process may have serious repercussions. In India, the human trials that Zydus and Bharat Biotech have begun are for a short period. This timeframe is not enough to confirm the efficacy of the drug. If the vaccine has any serious side-effects and harms even one individual among 1,000, it would seriously dent public confidence in the drug.
Perceived side-effects would adversely affect the community’s acceptance of a vaccine later on. Will the general populace accept being injected with a vaccine that has not completed all trials? Such an attempt could be potentially dangerous for the poor and malnouris...
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