The Subject Expert Committee under Central Drugs Standard Control Organisation (CDSCO) has sought more data for Bharat Biotech's Covaxin before granting marketing approvals. The expert panel earlier today recommended Serum Institute of India's Covishield for emergency use, with certain conditions.
The expert panel also asked the Hyderabad-based firm to expedite volunteer recruitment for the ongoing Covaxin clinical trial and recommended it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for Covaxin.
Covishield has become the first coronavirus vaccine to receive a regulatory nod in India. Now, Drug Controller General of India (DCGI) will take a final call on rolling out the inoculation. The expert panel also deliberated over the modalities of rolling out the vaccine into the country.
Covishield is the name given to the COVID-19 vaccine jointly developed by Oxford University and AstraZeneca. Serum Institute of India (SII), the biggest vaccine manufacturer in the world by volume, has partnered with AstraZeneca to manufacture and distribute the jab in India and other countries.
Earlier this week, UK's Medicines and Healthcare products Regulatory Agency (MHRA) had approved emergency supply of the Oxford-AstraZeneca COVID-19 vaccine. It was expected that India would approve the shot shortly after UK.
The vaccine has shown efficacy of 70 per cent, and can go up to 90 per cent under certain conditions. Serum Institute has said that it has stockpiled 50 million doses of the vaccine, most of which will be provided to the Indian government at a reduced price of Rs 220 per dose. However, the government is yet to disclose a plan to procure this vaccine from the company.
While granting the restricted emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.
Serum Institue will also have to submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest. Also, the Pune-based firm should submit the safety data including the data on adverse event following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country.
Covaxin, India's first indigenous COVID-19 vaccine, is being developed by Bharat Biotech in collaboration with Indian Council of Medical Research and the National Institute of Virology. The vaccine is undergoing Phase 3 trials.
The SEC noted that the ongoing clinical trial for Covaxin is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with co-morbidities, which has demonstrated safety till date but efficacy is yet to be demonstrated.
"After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval," an official source said.
The development comes a day before a nationwide test run of vaccine delivery network is scheduled to take place. The exercise is meant to check the feasibility of the vaccination plan involving real-time monitoring via Co-WIN app and will not involve vaccine administration. Aspects like management of probable side effects after vaccination, checks on cold storage, and plugging the leaks in transportation arrangements will also be evaluated.
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