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DCGI authorises vaccines by Bharat Biotech, SII; WHO hails vaccine breakthrough

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Published : Jan 3, 2021, 11:15 AM IST

Updated : Jan 3, 2021, 12:16 PM IST

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11:08 January 03

New Delhi: India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

The approval by the Drugs Controller General of India (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). 

After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in an emergency situation," DCGI Dr V G Somani told a press conference here.

This paves the way for the roll-out of at least two vaccines in India in the coming days. 

The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. 

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). 

Serum Institute of India's CEO Adar Poonawalla tweeted, Happy new year, everyone! All the risks Serum Institute of India 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.

Also, the authority granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said. 

Meanwhile, Prime Minister Narendra Modi praised the COVID-19 frontline workers and scientists who held extensive researches to make the vaccine possible.

"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," Modi tweeted.

WHO hails India's vaccine breakthrough

The World Health Organisation also hailed India's efforts towards the development of vaccines.

“WHO welcomes the first emergency use authorization 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.

The use of the vaccines in prioritized populations, along with the continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19," said Dr. Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region. 

(With inputs from agencies)

Also read: COVID-19 vaccination drive based on election process at booth level: Harsh Vardhan

11:08 January 03

New Delhi: India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

The approval by the Drugs Controller General of India (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). 

After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in an emergency situation," DCGI Dr V G Somani told a press conference here.

This paves the way for the roll-out of at least two vaccines in India in the coming days. 

The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. 

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). 

Serum Institute of India's CEO Adar Poonawalla tweeted, Happy new year, everyone! All the risks Serum Institute of India 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.

Also, the authority granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said. 

Meanwhile, Prime Minister Narendra Modi praised the COVID-19 frontline workers and scientists who held extensive researches to make the vaccine possible.

"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," Modi tweeted.

WHO hails India's vaccine breakthrough

The World Health Organisation also hailed India's efforts towards the development of vaccines.

“WHO welcomes the first emergency use authorization 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.

The use of the vaccines in prioritized populations, along with the continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19," said Dr. Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region. 

(With inputs from agencies)

Also read: COVID-19 vaccination drive based on election process at booth level: Harsh Vardhan

Last Updated : Jan 3, 2021, 12:16 PM IST
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