Bharat Biotech’s Covaxin gets SEC approval on its Phase 3 trials efficacy data – ET HealthWorld

The Subject Expert Committee (SEC) has approved the Phase-3 trial data of Bharat Biotech‘s Covaxin that was conducted on 25,800 subjects.

The data on India’s only homegrown Covid-19 vaccine has shown 77.8% efficacy.

Earlier this month, Bharat Biotech had said phase 3 data will first be submitted to the Central Drugs Standard Control Organization and then to peer-reviewed journals. It also said it was conducting phase 4 trials to check the “real-world effectiveness of the vaccines” and to meet scientifically approved standards for safety and efficacy.

The Hyderabad-based vaccine maker will also hold a ‘pre-submission’ meeting on Wednesday with the World Health Organization, regarding the approval for Covaxin.

A pre-submission meeting will provide 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 will 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 expected between July and September. The EUL pathway involves a rigorous assessment of clinical trial data — as well as additional data on safety, efficacy and quality — and a risk management plan.

An emergency approval from WHO will allow Bharat Biotech to export vaccines and enable easy international travel of Indian citizens who have been administered Covaxin.

Covaxin is an inactivated vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction. This process leaves viral proteins, including the spike protein of the coronavirus which it uses to enter the human cells, intact.


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