The COVID-19 vaccines of the Serum Institute of India and Bharat Biotech have been granted permission for restricted use in an emergency situation.
World Health Organisation (WHO) has welcomed India's decision giving emergency use authorisation to COVID-19 vaccines, informed Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia on Sunday.
"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 the COVID-19 pandemic in the Region," WHO South-East Asia wrote in a tweet.
"The use of vaccine in prioritised populations, along with the continued implementation of other public health measures and community participation, will be important in reducing impact of COVID-19," WHO South-East Asia added in a tweet.
On Sunday, COVID-19 vaccines of the Serum Institute of India and Bharat Biotech have been granted permission for restricted use in an emergency situation, said Drugs Controller General of India (DCGI)."
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 emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial," said VG Somani, DCGI, during a media briefing on Sunday.
The Subject Expert Committee recommended a grant of permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune.
It also recommended the grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to Bharat Biotech International Ltd Hyderabad.
The recommendations were made for the consideration and final decision of the Drugs Controller General of India.
Covaxin is an indigenously developed coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Union Health Minister Dr Harsh Vardhan said earlier in the day that in the first phase of COVID-19 vaccination, free vaccine shall be provided across the nation to most prioritised beneficiaries that include one crore healthcare and two crore frontline workers.
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