With the World Health Organisation (WHO) deferring emergency use authorisation (EUA) for Bharat Biotech’s covaxin, till October 5, many wanting to travel abroad from India might have to wait longer.
According to a report by the ANI news agency, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to decide on granting the EUA to Covaxin.
The SAGE session of the specialised agency of the United Nations will recommend EUA based on the clinical on Covaxin from Phase 1, 2, and 3 trials, according to the report.
When it comes to the approval of countries and regulatory bodies, people vaccinated with some of the Covid-19 vaccines are finding it difficult to be treated as vaccinated and be 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 listing. On June 10, the US Food and Drug Administration (US FDA) also rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin .
The FDA has cited insufficient information on Covaxin to grant approval to its emergency use authorisation request for this vaccine.
The process for approval of a vaccine by WHO consists of four steps: an 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 on status of assessment, and the final decision on approval.
In case of Bharat Biotech’s Covaxin, the first step itself i.e. it’s EOI has not been accepted yet and in its status report, WHO remarks that ‘more information is required’.
The Hyderabad-based biotech company had submitted its EOI on April 19.
So far, only Brazil, Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin.
Due to its pending approval from WHO, the European Union and the US are not willing to allow Indians who have been vaccinated by Covaxin to enter their countries.
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