India's drugs regulator DCGI on Sunday approved Oxford's COVID-19 vaccine Covishield, manufactured by Pune-based Serum Institute, as well as indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive. Welcoming India's decision, the World Health Organization (WHO) has said it will help "intensify and strengthen the fight against COVID-19 pandemic in the South-East Asia Region."
"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 vaccine 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 in a statement.
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 emergency situation," DCGI Dr V G Somani told a press conference in New Delhi.
Also, the authority granted Ahmedabad-based Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said. 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).
Prime Minister Narendra Modi congratulated the country as Drugs Controller General of India (DCGI) granted emergency use approval to Serum Institute of India and Bharat Biotech for their COVID-19 vaccines on Sunday.
A decisive turning point to strengthen a spirited fight!— Narendra Modi (@narendramodi) January 3, 2021
DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.
Congratulations to our hardworking scientists and innovators.
It would make every Indian proud that the two vaccines that have been given emergency use approval 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.— Narendra Modi (@narendramodi) January 3, 2021
We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.— Narendra Modi (@narendramodi) January 3, 2021
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."
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