India approves Serum Institute, Bharat Biotech vaccines for emergency use

Dry run for COVID-19 vaccination in begins in all Indian states
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken October 30, 2020. File Photo: REUTERS/Dado Ruvic

New Delhi: Eleven months after the first case of deadly coronavirus was detected in India, Drug Controller General of India (DCGI) V G Somani on Sunday approved Serum Institute of India's 'Covishield' vaccine and Bharat Biotech's 'Covaxin' for emergency use, paving the way for their roll-out and administration to millions.

This is a major relief for India which has the second highest number of infections in the world, after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.

The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

The Subject Expert Committee, tasked with vetting the vaccine proposals, had recommended Oxford-Astra Zeneca's 'Covishield' and Bharat Biotech's indigenous 'Covaxin' for emergency use approval on January 1 and 2, respectively. The final call was to be taken by the DCGI.

The expert panel recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains.

Pune-based Serum Institute of India has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield', while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.

Serum and Bharat Biotech Pfizer had applied for the accelerated approval on December 6 and 7, respectively.

The UK and Argentina have already approved the Oxford-AstraZeneca vaccine. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, Serum Institute of India.

Oxford-AstraZeneca vaccine will play a major role in India's plan to vaccinate its population against COVID-19 due to several factors – low-cost, ease of storage and transport.

Serum Institute of India this week said it has a stockpiled 40-50 million doses of its COVID-19 vaccine. India is likely to receive a majority of these 50 million doses.

As far as Bharat Biotech's Covaxin is concerned, it is India's first indigenous vaccine for coronavirus. The inactivated virus vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

Approval accelerates India's journey to be COVID-free: Modi

Hailing the approval given to two coronavirus vaccines as a "decisive turning point" in the spirited fight against the pandemic, Prime Minister Narendra Modi said on Sunday that this will accelerate the process for India to become a COVID-free nation.

In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.

"This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion," he said, congratulting the nation, scientists and innovators.

He once again extended his gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all 'Corona warriors' for the outstanding work they have done in adverse circumstances, and said the nation will remain eternally grateful to them for saving many lives.

"A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators," he tweeted.

'Covishield' ready to roll out in coming weeks: Poonawalla

Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' is 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," Poonawalla tweeted.

"Thank you Hon. Sri @narendramodi Ji, Hon. Sri @drharshvardhan Ji, @MoHFW_INDIA @ICMRDELHI @DBTIndia #DCGI_India @UniofOxford @AstraZeneca @gavi @GaviSeth @gatesfoundation and @BillGates for your support," he added.

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