India’s Central Drugs Standard Control Organization (CDSCO) panel on Saturday recommended granting approval for restricted emergency use of Bharat Biotech’s indigenous COVID vaccine Covaxin in India, according to sources.
The Indian drug regulator DCGI’s Subject Expert Committee today reviewed the appliance for emergency use authorisation of Covaxinm which is jointly developed by Hyderabad-based vaccine manufacturer Bharat Biotech and Indian Council of Medical Research (ICMR).
This is the second Covid-19 vaccine which has been recommended for emergency use approval after Serum’s locally produced Oxford Covid-19 vaccine ‘Covishield’.
The Drug Controller General of India (DCGI) will give the ultimate approval to both the vaccine candidates.
According to a PTI report, the SEC had on Friday recommended ‘interim efficacy analysis for Covaxin’.
While considering Bharat Biotech’s application, the SEC had noted that the” ongoing clinical test may be a large one with 25,800 subjects of which 22,000 are enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated.”
On Friday, the expert panel orecommended granting emergency use authorization to Serum Institute of India’s (SII’s) Covishield, according to Mint’s report, while the Govt prepared to roll out the shots as early as next week.
The independent subject expert committee (SEC) gave its recommendations to Drugs Controller General of India (DCGI) V.G. Somani for emergency licence for Covishield subject to certain conditions, the persons said, requesting anonymity. a proper clearance from the DCGI is probably going to follow soon.
However, Information and Broadcasting Minister Prakash Javadekar confirmed the news and told reporters on Saturday the vaccine had been given the green light on Friday.
Javadekar said a minimum of three more vaccines were waiting to be approved – local company Bharat Biotch’s COVAXIN, Zydus Cadila’s ZyCoV-D and Russia’s Sputnik-V.
“India is perhaps the only country where at least four vaccines are getting ready,” he said.
“One was approved yesterday for emergency use, Serum’s COVISHIELD.” he said, referring to the fact that the AstraZeneca/Oxford shot is being made locally by the Serum Institute of India (SII)
