The COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday approved the phase 3 efficacy data of Bharat Biotech's COVID-19 vaccine Covaxin.
Covaxin has shown efficacy of 77.8 percent in the phase 3 trial conducted on 25,800 subjects.
The company had submitted the phase 3 trial efficacy data results of Covaxin to the Drug Controller General of India (DCGI) over the weekend
SEC recommendations have been sent to the DCGI now, a source said. Bharat Biotech is also expected to attend a "pre-submission" meeting on July 23 with the World Health Organisation (WHO), which will take the vaccine-maker closer to a WHO Emergency Use Listing (EUL).
Though the meeting will not be a detailed review of the product, the vaccine-maker will have an opportunity to submit a summary on the overall quality of the jab, according to the WHO.
Last month, the firm had said that it expects Emergency Use Authorisation (EUA) approval from the WHO in July-September.“Application for Emergency Use Listing submitted to WHO-Geneva, regulatory approvals are expected Jul-Sept 2021,” Bharat Biotech had said in a statement.
Covaxin is one of the three vaccines approved by the DGCI for emergency use and is being deployed in India's COVID-19 vaccination programme.
(With inputs from PTI)
(Edited by : Aditi Gautam)
First Published: IST