Promise and delivery: On India’s first COVID-19 vaccine

Even partially effective vaccines will be in demand, but the safety aspect is paramount

Updated - July 02, 2020 01:17 am IST

Published - July 02, 2020 12:02 am IST

India’s first indigenous COVID-19 vaccine (COVAXIN) developed by a Hyderabad-based company in collaboration with the ICMR is all set to be tested on humans. The permission from the Drugs Controller General of India to carry out phase-1 and phase-2 human clinical trials was based on the safety and efficacy results of studies on mice, rats and rabbits. The phase-1 trial of the candidate vaccine using inactivated (killed) novel coronavirus will begin this month to test its safety. The virus used for developing the vaccine was isolated by the Pune-based National Institute of Virology from samples collected in India. Meanwhile, a Pune-based company is all set to manufacture two-three million doses of the University of Oxford vaccine if the results of its phase-1 clinical trial, which are expected in the first week of July, are encouraging. Millions of doses more will be manufactured if the results of the combined phase-2/3 trial are reassuring. In addition, the two companies are collaborating with universities and a biotechnology company to develop three more vaccines. With the pandemic raging and no antivirals available to treat severe COVID-19 patients, a vaccine that is even partially effective and protects for about a year will be in demand. Thus, an indigenous vaccine will mean guaranteed availability for Indians, while a significant percentage of the Oxford vaccine manufactured in India will be earmarked for local consumption. This is one reason why many countries are earnestly attempting to develop a vaccine. According to WHO, 17 candidate vaccines are in various stages of a human clinical trial, while 132 are in a pre-clinical trial stage.

On June 25, China’s CanSino Biologics COVID-19 vaccine, became the first off the block when it was approved for use by the military for a period of one year. The phase-1 and phase-2 trials found the vaccine to be safe with a “potential to protect” against the disease. It is unclear if the vaccination will be optional or mandatory. While this is not the first time that countries have made vaccines under development available to the military even before the completion of the trial, there is growing concern that speeding up vaccine development by bypassing certain crucial stages of the trial process may prove counterproductive. In a poll in the U.S., one-third have said they would not get immunised against COVID-19 even if a vaccine was widely available and affordable. While many expect science to find a quick-fix, experts envisage 12-18 months to get a vaccine commercialised, if at all. But that timeline is already seen as aggressive. If scientists develop a safe, efficacious vaccine soon, public trust in science could grow substantially but there would be serious consequences if it fails, particularly on the safety aspect. Regulatory agencies have a responsibility to ensure COVID-19 vaccines deliver what they promise.

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