With the World Health Organization (WHO) postponing the emergency use authorization (EUA) for Bharat Biotech’s covaccine, till October 5, many people looking to travel abroad from India may have to wait a long time.
According to a report in ANI news agency, the Strategic Advisory Group of Experts on Immunization (SAGE) will meet on October 5 to take a decision on granting EUA to Covaxin.
The Sage session of the UN special agency will recommend the EUA on a clinical basis on Covaxin from Phase 1, 2, and 3 trials, according to the report.
When it comes to approvals from countries and regulatory bodies, people vaccinating with certain COVID-19 vaccines are finding it difficult to be treated as vaccinated and allowed to cross international borders. And Covaxin happens to be one of them.
The vaccine has not yet been approved by the World Health Organization for emergency use list. On June 10, the US Food and Drug Administration (US FDA) also rejected Bharat Biotech’s emergency use authorization (EUA) proposal for Covaxin.
The FDA cited insufficient information on Covaxin to approve its emergency use authorization request for this vaccine.
The vaccine approval process by WHO consists of four stages: acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for review by WHO, decision evaluation on the status, and Final decision on approval.
In the case of Bharat Biotech’s Covaxin, the first step i.e. its EOI has not yet been accepted and in its status report, WHO comments that ‘more information is needed’.
The Hyderabad-based biotech company had submitted its EOI on April 19.
So far only Brazil, Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved Covaxin.
Due to its pending approval from WHO, the European Union and the US are unwilling to allow Indians who have been vaccinated by Covaxin to enter their countries.
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