A government-appointed panel of experts has approved the Serum Institute of India’s coronavirus vaccine Covishield and Bharat Biotech’s Covaxin for emergency use in the country. The final call on the efficacy of a vaccine will be taken by the Drugs Controller General of India.
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 Ministry of Health and Family Affairs said in a statement.
The panel also recommended that the DCGI grant 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. Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
Bharat Biotech is yet to release efficacy data of its vaccine, reported NDTV. However, 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 had requested more time to present its data.
Emergency use authorisation paves the way for vaccine roll out 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.
A dry run for vaccination took place in all the states and Union Territories on Saturday. Before this, authorities in the four states of Assam, Andhra Pradesh, Punjab and Gujarat had also assessed technology platforms to the storage infrastructure that will be required to inoculate millions of citizens.
Health Minister Harsh Vardhan has directed officials to ensure that vaccination sites abide by the detailed checklist and standard operating procedure for vaccination, which has been prepared by the health ministry.
Meanwhile, India’s coronavirus case count on Saturday rose to 1,03,05,788 after 19,079 new infections were reported in 24 hours. The toll stood at 1,49,218, with 224 deaths in a day. There are 2,50,183 active cases and 99,06,387 people have recovered from Covid-19 so far. The active cases include at least 29 cases of the new mutated coronavirus as well.