COVAXIN, Covishield will now be available in hospitals and clinics
The Drugs Controller General of India (DCGI) on Thursday granted approval for regular market sale to India's two most prevalent COVID-19 vaccines—COVAXIN and Covishield. This means people will be able to buy the two shots from hospitals and clinics, though they would not be available at medical stores anytime soon. The nod has been given under the New Drugs and Clinical Trials Rules, 2019.
Why does this story matter?
Thursday's approval marks a significant step forward in India's battle against the coronavirus pandemic as it would make vaccine availability wider and cheaper. Under India's COVID-19 vaccination program, over 163 crore vaccine doses have already been administered to the eligible population. The nod comes as India witnesses the third wave of coronavirus infections and is currently reporting around three lakh daily new cases.
Key conditions for market sale approval
The approval from DCGI is only for the adult population. The vaccination data will have to be submitted to the DCGI every six months, after which it will be updated on the Co-WIN platform. Adverse events after inoculation would continue to be monitored. Notably, makers of Covishield and COVAXIN—Serum Institute of India and Bharat Biotech—had submitted data from clinical trials for market approval.
How much will the vaccines cost?
The central government is reportedly planning to cap the prices of COVAXIN and Covishield at Rs. 275 per dose under the market sale approval. The existing prices under emergency use authorization are Rs. 1,200 for COVAXIN and Rs. 780 for the latter.
Expert panel recommended approval last week
Officials at the Pune-based Serum Institute had given an application to the DCGI, seeking a market sale nod for their vaccine. A similar application had been filed by Bharat Biotech along with the required trial data. After reviewing the applications, a subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended approval for both the shots on January 19, 2022.
Both vaccines got emergency nod a year ago
Both COVAXIN and Covishield were the first vaccines to be granted emergency use authorization in India. The approval came on January 3, 2021. COVAXIN is an inactivated virus-based vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. It had been found 77.8% effective in trials. Covishield, on the other hand, is a viral vector vaccine with 63% efficacy.
India's vaccination drive
India has so far administered over 163.84 crore coronavirus vaccine doses. At least 72% of the country's adult population has been fully vaccinated. Further, more than 52% of children aged between 15 and 18 years have been inoculated with the first dose. The government is now mulling opening the vaccination drive for the 12-14 year age group in the next phase.
