NEW DELHI: Hours after the UK approved the Oxford-AstraZeneca Covid vaccine for human use on Wednesday, India’s drug regulator met on Wednesday to review the applications by Serum Institute of India and Bharat Biotech. However, the meeting remained inconclusive as the Drugs Controller General of India’s Subject Expert Committee was not satisfied with the applications of either of the companies.
The next meeting will be held on January 1. “SII has been asked to submit more data from AstraZeneca trial globally, while Bharat Biotech will have to submit the interim analysis of phase 3 trial,” said a source. Serum Institute is conducting a bridging phase-three clinical trial of the AstraZeneca vaccine Covishield on 1,700 volunteers in India.
Bharat Biotech, whose homegrown Covaxin has been developed in collaboration with the ICMR, is being tested on 26,000 people in late-stage trial. Covishield has been found to be 70% effective in multi-country phase-3 trials, while a recent scientific paper published on Covaxin’s phase-1 and phase-2 trials said it could lead to generation of antibodies lasting up to 6-12 months.
Pfizer, the first company to apply for its Covid-19 vaccine in India, has sought for more time to submit data for its vaccine’s consideration. The UK’s drug regulator, Medicines and Healthcare products Regulatory Agency said the second dose of the vaccine will be given 12 weeks later as a longer interval between two doses could produce better results.
Meanwhile, Chinese vaccine maker Sinopharm has claimed to have 79% efficacy rate. India’s daily number of Covid- 19 cases jumped 6.88% to touch 20,021 on Wednesday.