- India's expert panel has recommended SII’s Oxford-AstraZeneca COVID-19 vaccine dubbed Covishield in India for emergency use with 'restrictions.'
- The SEC recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon.
- The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
The SEC recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon.
The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.
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.
Further, the SII should 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 events 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.
The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
The approval comes at a time when the Indian government is wary of the new strain of COVID-19, which has been wreaking havoc in the UK. So far 29 cases of the new mutant variant have been detected in India.
As compared to Pfizer and Moderna vaccines, the Oxford-AstraZeneca COVID-19 vaccine is more suited to India’s requirements with storage temperature requirements of between two to eight degrees Celsius.
COVID-19 vaccine candidates and the temperatures they need to survive:
The government is also reportedly in favour of Covishield because it's considerably cheaper than Pfizer and Moderna. According to the SII, the vaccine will only cost the government $3 per dose. Pfizer, on the other hand, is selling its vaccine at $37 per dose.
Cost of COVID-19 vaccines:
SII CEO Adar Poonawalla told reporters on December 28 that it has 40 to 50 million vaccine doses stockpiled so far, most of which are intended for the Indian market. “We will get some good news this New Year’s… All the data has been submitted and we must respect the process as regulators evaluate data,” he said.
The Indian government is also ready to roll out the vaccine having run a two-day dry run of its vaccination drive. The mock exercise was aimed at end-to-end testing of Covid-19 vaccination process, including planning and preparations as per the operational guidelines.
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