The Subject Expert Committee (SEC) has approved the Phase -3 trial data of Bharat Biotech's Covaxin that was performed on 25,800 subjects.
The data on India's only homegrown Covid-19 vaccine has displayed 77.8% efficacy.
Prior this month, Bharat Biotech had said phase 3 data would first be submitted to the Central Drugs Standard Control Organisation and then to peer-reviewed journals. It also said it was directing phase 4 trials to check the “real-world effectiveness of the vaccines” and to encounter
scientifically approved standards for safety and efficacy. The Hyderabad-based vaccine maker would also hold a ‘pre-submission’ meeting on Wednesday with the World Health Organization, regarding the approval for Covaxin.
A pre-submission meeting would offer an opportunity to the company to receive advice and guidance before submission of the final dossier, as well as an opportunity to meet WHO assessors who would be involved in examining their product.
In May, Bharat Biotech said an emergency use listing (EUL) application had been submitted to WHO, with regulatory approvals likely between July and September. The EUL pathway includes a rigorous assessment of clinical trial data — as well as additional data on safety, efficacy and quality — and a risk management proposal.
An emergency approval from WHO would permit Bharat Biotech to export vaccines and enable easy international travel of Indian citizens who have been administered Covaxin.
Covaxin is an inactivated vaccine invented by chemically treating novel coronavirus samples to make them incompetent of reproduction. This procedure leaves viral proteins, including the spike protein of the coronavirus which it uses to enter the human cells, intact.