DCGI’s Subject Expert Committee is also currently reviewing an application by Bharat Biotech for its vaccine candidate Covaxin.
Serum Institute of India’s vaccine candidate, Covishield, is set for approval by Subject Expert Committee, of the Drug Controller General of India, an informed source confirmed to The Hindu.
SII has partnered with AstraZeneca to bring to market the Oxford vaccine, which has been approved by health authorities in the United Kingdom on Wednesday.
The committee meeting, which is ongoing is also currently reviewing an application by Bharat Biotech for its vaccine candidate Covaxin.
A formal statement by the health ministry is expected later today.
Both SII had Bharat Biotech are testing the vaccine in ongoing phases-3 trials in India, the results of which have not been publicised yet.
For Covishield’s appraisal process, the source said, it was the nod by the UK regulator and the immunogenicity data from a phase -2 trial on 100 volunteers in India were relied on to accord emergency use approval.
Covishield is currently being tested in 1,600 volunteers as part of its phase 2/3 trial.However, the results from these trials haven’t been published or publicised in scientific journals.
“The phase 3 trial is ongoing and we will continuously keep reviewing the data,” the source added, “Other than the case from Chennai of a reported severe adverse event from the vaccine, no other safety events have been reported. We’ve also conclusively ruled out that the said reaction was directly linked to the vaccine.”
V.G. Somani, DCGI, at a webinar on Thursday indicated that India was close to approving a COVID-19 vaccine.
Mr. Somani was participating in a webinar, organised by the Department of Biotechnology, that saw vaccine experts, infectious disease experts and representatives of companies developing vaccines discussing COVID vaccine development and India’s preparation.
“We will probably have a Happy New Year with something in hand,” he said while discussing the regulatory process as well as the participation by academicians, industry and infectious disease experts in working towards developing vaccine candidates.