DCGI Approves Oxford Covishield Vaccine & Bharat Biotech’s Covaxin

On Sunday, 3 January, the Drugs Controller General of India (DCGI) granted permission to Bharat Biotech’s indigenous COVID vaccine ‘Covaxin’ and Oxford-AstraZeneca’s Covishield vaccine for restricted use in emergency situation.

“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare for conduct of the Phase III clinical trial,” DCGI said in a press briefing.

It further said that the vaccine of Serum Institute and Bharat Biotech have to be administered in two doses. Further, all the vaccines have to be stored at a temperature of 2-8 degree celsius.

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VG Somani, Drug Controller General of India told ANI, “We’ll never approve anything if there’s slightest of safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish.”

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Meanwhile, Serum Institute’s Adar Poonawalla tweeted about the approval saying, “All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”

Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK

— Adar Poonawalla (@adarpoonawalla) January 3, 2021

AIIMS Director Dr Randeep Guleria said that both the vaccines are cost-effective and easy to administer.

"It's a great day for our country and it's a very good way to start the new year. Both the vaccines are made in India. They are cost-effective and easy to administer. We should, in a very short period, start rolling out vaccine,” ANI quoted him as saying.

WHO Welcomes COVID-19 Vaccine Authorisation

Further, Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia Region, said that the organisation welcomed the approval.

“WHO welcomes the first emergency use authorisation given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region,” Singh said.

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Covaxin: Have Clinical Trials Concluded? How Safe Is the Vaccine?

On Saturday, the Central Drugs Standard Control Organisation (CDSCO) panel had recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID vaccine ‘Covaxin’ in India.

This is the second vaccine to have got approval from experts. The Subject Expert Committee (SEC) set up by the Drugs Controller General of India (DCGI) has reportedly been reviewing Covaxin’s application for emergency use.

A government press note said that the CDSCO recommended for granting permission to Bharat Biotech for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in context of mutant strain infection.”

The Oxford-AstraZeneca COVID-19 vaccine, which is called Covishield in India, had also received recommendation for emergency use “subject to multiple regulatory conditions” in the country.