WHO to review Covaxin; emergency use approval may come by mid-September

A World Health Organization panel will meet this week to review Covaxin for granting emergency use listing (EUL), a move that will allow people inoculated with Bharat Biotech’s Covid-19 vaccine to travel abroad without restrictions, people aware of the development said.

The WHO global advisory committee on vaccine safety will assess immunogenicity, vaccine safety and vaccine effectiveness of Covaxin, a crucial step for granting EUL, they told ET.

The regulatory approvals are expected by mid-September, they said.

An emergency approval from the WHO will allow Bharat Biotech to export Covaxin and enable easy international travel of people who have received this vaccine. “A series of meetings are taking place to assess pre-clinical and clinical data, leading to a crucial decision which is likely by September mid,” said one of the persons cited above.

The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality, and a risk management plan. Bharat Biotech had in June presented its phase-3 clinical trials data, demonstrating 77.8% efficacy, to the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Submission of phase-3 data is a key to obtain prequalification from the WHO. A pre-submission meeting for EUL was held in June. The pre-submission meeting provides 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.

An email sent to Bharat Biotech did not elicit any response as of press time on Tuesday. The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.