DCGI to take final call on mass use of Covaxin, Covishield; vaccination free of cost across India, says Govt
India inched closer to launching a country-wide vaccination drive against coronavirus with a Government-appointed panel of experts on Saturday approving two vaccine candidates for emergency use in the country.
The final call on approval of these vaccines — the Serum Institute of India’s coronavirus vaccine Covishield and Bharat Biotech’s Covaxin — for mass use will be taken by the Drugs Controller General of India (DCGI).
Union Health Minister Harsh Vardhan announced that vaccination will be free across the country.
“In 1st phase of #Covid19 vaccination, free vaccine shall be provided across the nation to most prioritised beneficiaries that include 1 crore healthcare & 2 crore frontline workers,” the Minister tweeted.
However, he later on said that modalities to vaccinate 27 crore people will be worked out soon.
Covaxin, which is still in the clinical trial phase, was granted approval in “public interest as an abundant precaution” in connection with the mutated strain of the coronavirus, the Union Health Ministry said in a statement.
“Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech International,” the Centre said in a statement.
The Subject Expert Committee of the DCGI also recommended approval to Cadila Healthcare for conducting the third phase trials of its vaccine.
The Serum Institute is the local maker of the vaccine developed by Oxford University and pharmaceuticals company AstraZeneca.
The UK has already given nod for vaccination to the shot developed there. Bharat Biotech’s Covaxin is India’s first indigenous vaccine for coronavirus. The inactivated virus vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
Bharat Biotech’s interim findings of Phase I trials showed the drug induced an immune response and led to no serious side effects. Data from Phase II trials showed “tolerable safety outcomes”, suggesting antibodies may persist for six to 12 months.
The Subject Expert Committee met for the second time this week on Friday to review the applications of the vaccine candidates. Both Serum Institute and Bharat Biotech had made presentations before the expert panel on Wednesday. Meanwhile, biopharmaceutical company Pfizer has requested more time to present its data.
Emergency use authorisation will pave the way for vaccine rollout in India, which is the world’s second-worst affected country by the virus after the United States.
Adar Poonawalla, chief executive officer of the Serum Institute of India, had on Monday said that the company has already made 40 million to 50 million doses of the vaccine. However, the Government has not yet signed a deal with the firm.
Sunday, 03 January 2021 | PNS | New Delhi
