New Delhi: The central drugs standard control organisation (CDSCO) has put a halt from giving emergency use authorisation (EUA) approval to the Russian vaccine, SputnikV in India.
A subject expert committee (SEC) of India's national regulatory body for pharmaceuticals and medical devices, CDSCO, in its meeting held recently in New Delhi has asked for additional data from Dr Reddy's Laboratories for getting EUA. The CDSCO comes under India's apex drug regulator, Drug Controller General of India (DCGI).
It may be mentioned here that Hyderabad based Dr Reddy's Laboratories Limited had approached India's drug controller general for the emergency use approval following the clinical trial of the SputnikV vaccine. Dr Reddy's has been conducting the clinical trial of SputnikV in India.
As per a CDSCO note, Dr Reddy's presented interim safety and immunogenicity data of Gam Covid Vac Combined vector vaccine (SputnikV) generated in India along with the interim data from the ongoing Russian study.
After detailed deliberations, the committee recommended that the firm should present additional data and clarifications for further evaluations.
The committee has asked Dr Reddy's to submit six additional data including data pertaining to all immunogenicity parameters including GMT titres for virus-neutralizing antibody and SARS-CoV-2 glycoprotein specific antibodies on day 42 as per protocol.
The committee has also asked to submit unblinded data of all serious adverse events and RTPCR positive cases along with casualty analysis reported to date for further examination.
The committee has asked for clarification regarding the correlation of immunogenicity data including cell-based response between phase II and phase III trials. The expert committee in its meeting held recently also asked Dr Reddy's for a comparative analysis of phase III immunogenicity data generated on Indian and Russian studies at various time points.
In a related development, the subject expert committee of the CDSCO recommended approval of the amendments proposed in the ongoing phase III clinical trial of Bharat Biotech International Limited's whole virion, inactivated coronavirus vaccine (BBV152).
The SEC has also recommended approval of the amendments proposed in the ongoing phase II clinical trial protocol of BBV152 for the administration of booster dose after 6 months after the second dose.
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