With over one crore confirmed Covid-19 cases and more than six lakh deaths across the world, the fear of contracting the virus is only increasing in a big way. In such a situation, countries are racing to develop a vaccine. But empirical data shows that it typically takes many decades to develop a reliable vaccine.

A vaccine has still not been found for pandemics such as the Spanish flu that took away millions of lives. On the other hand, it took over 40 years to develop a vaccine for human use for the measles and polio pathogens.

Long-drawn process

The conventional stages in vaccine development include the exploratory or drug discovery stage where the potential vaccine candidates are identified and profiled. This is followed by the pre-clinical stage, wherein researchers study the vaccines thoroughly to understand the safety profile. The clinical-development stage comes next and comprises three phases, where the vaccine is tested upon groups of people, and aspects such as its immunogenicity, safety, efficacy, and method of delivery are determined.

Upon successful completion of trials in the clinical development stage, the vaccine is sent for regulatory review and approval, post which it is given the go-ahead for manufacturing and administration on a large scale. These five stages together take at least 10 years to bring out a vaccine that is long-lasting.

“Pathogens such as viruses change too fast and are able to infect even people who may have developed immunity against an earlier version of the virus. It takes a very long time for scientists to identify those regions of the virus that do not change much and at the same time are still essential for the ability of the virus to infect and replicate in our cells,” said L S Shashidhara, Dean of Research and Professor of Biology, Ashoka University, adding, “Only vaccines developed using those regions would be most effective among diverse populations and long-lasting. This requires enormous amounts of funding, human resources, human subjects from diverse backgrounds for clinical trials and it takes years to achieve all this and then test, re-test and validate the efficacy of the vaccines.”

Is it different this time?

Apart from the aspects of safety and efficacy, another aspect that acquires equal significance under pandemic conditions is the race against time, said Monica Gulati, Senior Dean, Faculty of Applied Medical Sciences, Lovely Professional University. “While under normal conditions, financial investment is avoided till substantial claims of safety and efficacy of a product are widely proven, under the current situation where vaccine seems to be the only saviour; all promising candidates have been given a green signal,” Gulati added.

Among the domestic pharma firms that are working towards developing a vaccine in the country are Bharat Biotech, Serum Institute of India, Indian Immunologicals, Mynvax and Biological E. The World Health Organization’s draft landscape of Covid-19 vaccines showed that there are already 25 candidate vaccines in the clinical evaluation stage and 141 candidate vaccines in the preclinical evaluation stage (as on July 24). Experts said though the development, its large-scale production and distribution to the masses take a very long time, they are still positive about projected goal of 18 months for a coronavirus vaccine.

The whole scientific community of the world working together as one unit, information being exchanged freely and in real-time about various aspects of the virus and huge financial resources being made available by governments, philanthropists and pharmaceutical companies are reasons why they are hopeful of the 18-month duration, said Shashidhara, adding, “People are ready to take risks even while knowing that chances of their successes are low. The fact that nearly 150 vaccine ideas are being tried simultaneously makes the 18-month timeline realistic and achievable.”

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