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Hyderabad Bharat Biotech's Covaxin gets SEC nod
Hyderabad Bharat Biotech's Covaxin gets SEC nod
The Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended granting approval for the restricted emergency use of Bharat Biotech's indigenous Covid-19 vaccine Covaxin.
New Delhi/ Hyderabad: The Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended granting approval for the restricted emergency use of Bharat Biotech's indigenous Covid-19 vaccine Covaxin.
This is the second Covid vaccine, which has been recommended for emergency use authorisation to the DCGI after Oxford-AstraZeneca's 'Covishield' Covid-19 vaccine.
The Indian drug regulator DCGI's Subject Expert Committee (SEC) reviewed the application for emergency use authorisation of Covaxin, which is jointly developed by Hyderabad-based vaccine manufacturer Bharat Biotech and Indian Council of Medical Research (ICMR).
The committee on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting.
The Drug Controller General of India (DCGI) will give the final approval to both the vaccine candidates.
While considering Bharat Biotech's application, the SEC had noted that the 'ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated.'
On Friday, the expert panel recommended granting emergency use authorization to Serum Institute of India's (SII's) Covishield, according to Mint report, while the government prepared to roll out the shots as early as next week. The SEC gave its recommendations to Drugs Controller General of India (DCGI) VG Somani for emergency licence for Covishield subject to certain conditions, sources said, requesting anonymity.
A formal clearance from the DCGI is likely to follow soon.
However, Information and Broadcasting Minister Prakash Javadekar confirmed the new reports and told reporters on Saturday that the vaccine had been given the green light on Friday.
Javadekar said at least three more vaccines were waiting to be approved - local company Bharat Biotech's COVAXIN, Zydus Cadila's ZyCoV-D and Russia's Sputnik-V.
