As pharmaceutical companies around the globe are hustling to produce efficient vaccines to fight covid-19, India-produced Covaxin hasn’t been finalized for emergency use by the WHO. The World Health Organization said it requires “more information” from manufacturer Bharat Biotech to approve their vaccine as the drugmaker seeks EUL (Emergency use listing).
As per the latest ‘Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process’ document released by WHO on May 18th, Bharat Biotech submitted its Expression of Interest (EOI) for approval on April 19th. The top health body mentioned that “more information is required” as the pre-submission meeting is likely “to be planned May-June 2021”.
Submissions for prequalification or to be listed under emergency use given to it are confidential, the WHO said.
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The body will publish results of an assessment test for a product submitted to it only if it ticks the criteria for listing. The emergency use listing date can differ for different products. The duration for approval is based on the quality of the data submitted by the vaccine maker and the data meeting WHO criteria.
Bharat Biotech International Limited (BBIL), the Hyderabad-based pharmaceutical company, said that it has given 90 per cent of the documents required for attaining the approval to the WHO, according to sources on Monday.
The drugmaker told the Centre that the rest of the documents are expected to be submitted in June. The update was given during a meeting pertaining to the EUL authorization from the WHO for Covaxin.
However, Bharat Biotech says that it is “confident” about receiving the EUL from WHO, the company said. Out of the 11 nations which approved Covaxin for emergency use, 7 have expressed interest to use BBIL’s technology for producing Covaxin as 11 companies have come forward, sources said.
They added that the drugmaker is in the final stages with the FDA of the US for negotiating and conducting small-phase-III clinical trials of Covaxin in the United States.
Bharat Biotech’s Managing Director V Krishna Mohan, his colleagues and senior officials of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs and Foreign Secretary Harsh Vardhan Shringla attended the meeting to discuss EUL.
The situation is intense as classes are slated to begin in August-September in foreign universities and if Covaxin doesn’t get approved till that time, Indian students will have to undergo the mandatory quarantine upon arriving in the country despite being vaccinated.
