Bharat Biotech asked to submit the effectiveness data of Covaxin Phase 3 before trying it on kidsTuesday March 2, 2021 at 6:19 pm
Hyderabad: The Subject Expert Committee (SEC), which is entrusted with the duty of advising the Indian drug regulator Drugs Controller General of India (DCGI), has ordered Bharat Biotech to produce the effectiveness and safety data from its continual Phase 3 Covaxin trials before getting approval for trying it on infants.
Bharat Biotech is also required to revise the trial protocol for kids until the Phase 3 study and then submit it to the committee. In order to conduct the Phase 3 trials of Covaxin on the children aged in between 5-18 along with the clinical trial protocol, Bharat Biotech has applied for approval to the drug regulator.
At a meeting conducted on Wednesday, SEC told, “Firm should submit efficacy and safety data of the ongoing Phase 3 clinical trial in adults along with the age subgroup analysis. The design of trial should be revised to Phase 2/3. Sample size and other consequential changes should be made to the protocol, accordingly…firm shall submit revised clinical trial protocol for review of the committee”.
Moreover, the minute details pertaining to the meeting got uploaded on the CDSCO (Central Drugs Standard Control Organisation) website on Friday itself.
Across 11 sites in the country, Bharat Biotech had conducted the Phase 1 trials of Covaxin on 375 volunteers aged in between 18-55 years. This was followed by Phase 2 trials on 380 individuals aged in between 12-65 years across 9 sites in the country.
The Phase 3 trials of Covaxin is presently being undertaken on 25,800 people over the age of 18 years across 25 sites in the country.
According to the chairman and managing director of Bharat Biotech, Dr Krishna Ella, the company is expecting the interim efficacy data from the Phase 3 study to be available in the next two weeks.
Covaxin is a whole-viron, inactivated SARS-CoV-2 vaccine, two doses of which shall have a gap of 28 days. In the early days of January, the vaccine candidate received DCGI approval for restricted EUA (emergency use authorization) in clinical trial.