New Delhi:
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.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The phase-III human clinical trials of Covaxin began mid-November. Bharat Biotech aims to recruit 26,000 volunteers across the country for the phase-III trials.
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.
The Serum Institute of India, the world''s largest vaccine manufacturer, has tied up with Oxford-AstraZeneca to manufacture Covishield.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The approval by the 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).
''The approval of COVAXIN for emergency use is a giant leap for innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India's scientific capability, a kickstart to the innovation ecosystem in India,'' Bharat Biotech Chairman and Managing Director Krishna Ella said in a statement.
While this vaccine addresses an unmet medical need during this pandemic, the company's goal is to provide global access to populations that need it the most, he added.
Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist, Ella noted. The DCGI approval for the vaccines 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. This paves the way for the roll-out of at least two vaccines in India in the coming days.
It has already crossed the 23,000-volunteers mark so far. The Hyderabad-based firm said Covaxin has been evaluated in around 1,000 subjects in phase-I and phase-II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.