Approval from the World Health Organisation for Bharat Biotech’s vaccine Covaxin is likely to come in mid-September. A WHO panel is scheduled to meet this week to review Covaxin’s application for emergency use listing that will allow people inoculated with Bharat Biotech’s vaccine to travel without restrictions.
The WHO panel will assess immunogenicity, vaccine safety and vaccine effectiveness of Covaxin. WHO’s approval will also allow Bharat Biotech to export Covaxin and enable easy international travel for people who have received the vaccine.
Covaxin will undergo a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality and risk management plan.
The homegrown company had submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO). In June, a pre-submission meeting for EUL was held that provides guidance and advice before the submission of the final dossier.
So far, the WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca-SK Bio or Serum Institute of India, Johnson and Johnson, Moderna, and Sinopharm. Covaxin is one of the vaccines that are currently being administered in India.
Meanwhile, Bharat Biotech said it was exploring opportunities with its international partners who have expertise in commercial-scale manufacturing of inactivated viral vaccines. "We want to ensure that Bharat Biotech can ably meet the demand for Covaxin such that individuals across the country, and the globe, have access to the vaccine," chairman and managing director Krishna Ella said in a statement. On Sunday, the company rolled out the first batch of Covaxin shots from a facility in Ankleshwar that has the capacity to produce more than 10 million doses per month.
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