DCGI approves Covaxin and Covishield vaccines for emergency use in India

January 4, 2021 0 By FM

The Drugs Controller General of India (DCGI) has given approval to the Oxford/AstraZeneca’s COVID-19 vaccine Covishield, manufactured by the Serum Institute of India, and to the indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country.

The approval by the DCGI was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

This allows Covishield and Covaxin to be administered to the healthcare and frontline workers in India. The health ministry has said 3 crore individuals considered at highest risk for COVID-19, will be given the vaccine for free. It is not yet revealed which vaccines or when it will be made available to these personnel.

Neither Covishield nor Covaxin vaccine has completed its late stage/ phase-3 trial, under which the vaccine candidate has to be administered to volunteers at multiple locations across the country.

The health ministry in a press statement stated that the vaccine’s efficacy in Indian volunteers was “comparable” to that tested in overseas trials. Both vaccines have to be administered in two doses and stored at temperatures between 2 and 8 degrees Celsius. Covishield was found to be 70.42 per cent effective and Bharat Biotech’s Covaxin was “safe and provides a robust immune response, said V G Somani, DCGI.

Bharat Biotech whose vaccine candidate was being tested in a large phase-3 efficacy trial in India has provided safety and immunogenicity data — proof that the inoculation doesn’t harm and is capable of stimulating an immune response in the body — but no efficacy data, that shows the vaccine achieves its primary goal of protecting against disease. Doing such a trial would have, according to the company’s timeline, taken some more months. 

Covaxin has been developed based on an inactivated SARS-CoV-2 strain cultured at the National Institute of Virology, an ICMR body. The official reports said that its phase I and phase II trials of Covaxin were conducted in around 800 people and the results showed that it is “safe and provides a robust immune response”

However, Samiran Panda, Head of the epidemiology and communicable diseases division, ICMR, defended the emergency approval to the Covaxin on the ground that the existence of the pandemic, the detection of the UK strain and the vaccine’s safety profile meant that it could be approved in ‘clinical trial mode.’

“This isn’t the standard approval given to a vaccine. The scheduled trial on 26,000 will continue and every person who gets the vaccine will be followed up and monitored for risk as well as benefit. It can also be withdrawn. This vaccine, as of now is not for everybody, and is being given under restricted use condition,” he said.

Serum Institute has conducted phase 2 and phase 3 trials on 1,600 participants in India. The recent recommendation was made for restricted use and the trials will continue, said the DCGI. The vaccine, developed by the Oxford University and pharma giant AstraZeneca is already in use abroad.