India’s home-grown COVID vaccine hits another block

Covaxin seems to be waiting a rather long wait before it gets approval from the World Health Organization (WHO). The much-awaited approval for India’s home-grown coronavirus vaccine is likely to be delayed by a few more weeks as WHO has raised more questions and queries that have been sent to the Hyderabad-based manufacturer Bharat Biotech for further clarification.

So what exactly is causing the delay?
The process for approval of a vaccine by WHO comprises four steps. First, there must be an acceptance of the manufacturer’s expression of interest (EOI). Then comes the pre-submission meeting between WHO officials and the manufacturer. After this is the stage of acceptance of the dossier for review by WHO. And finally, the decision on the status of the assessment and the final decision on approval is taken.

Covaxin is stuck on the very first step itself. Bharat Biotech had submitted its EOI on April 19 but WHO has not accepted it yet. In its status report, the health organisation has indicated that “more information is required”.

According to a News 18 report that quotes a source in the WHO, there is no concern in the matter. “It’s the usual process. Experts raise queries, which need to be answered by the company,” the source said. On being asked if the fresh set of queries will delay the approval further, the WHO source clarified that it may not cause much delay. “No, it should not be delayed… Maybe a few weeks,” the official said.

Last month, Health Minister Mansukh Mandaviya had met WHO chief scientist Soumya Swaminathan to discuss the international health body’s approval for Covaxin. The Health Ministry has indicated that Emergency Use Authorization (EUA) from the WHO is imminent. As of now, Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the use of Covaxin on their citizens.

This delay raises further concerns for those intending to travel abroad. Even as Covaxin is waiting for WHO approval, the other Indian vaccine — SII’s Covishield — was up in controversy after the new UK travel rules said that those who have taken both the Covishield jabs would still be considered “unvaccinated”. However, the UK government revised its travel advisory days later after drawing severe diplomatic flak from India. New Delhi had pulled up UK for ‘discriminating’ against Covishield by not including it in the list of approved COVID-19 vaccines, even though it has WHO’s approval.

Coming back to Covaxin, the Strategic Advisory Group of Experts on Immunization (SAGE) — charged with advising WHO on overall global policies and strategies — are scheduled to meet on October 5 to discuss granting the EUA to Covaxin. Any decision on the emergency use listing of the vaccine will be taken only after the meeting. TIMES NOW