Bharat Biotech confident of obtaining WHO's emergency use listing for Covaxin

Covaxin, developed by Bharat Biotech in collaboration with ICMR, has already received regulatory approval from 11 countries.

Created On: May 25, 2021 17:56 ISTModified On: May 25, 2021 17:57 IST
Bharat Biotech confident of obtaining WHO's emergency use listing for Covaxin

Indian drug manufacturer Bharat Biotech is confident about getting World Health Organization's (WHO) Emergency Use Listing for its COVID-19 vaccine, Covaxin. The drugmaker has already submitted 90 percent of the documentation required for WHO emergency use listing.

Bharat Biotech has previously got many of its other vaccines pre-qualified and hence, it is confident that Covaxin will also soon get emergency use approval from the global health body. 

Key Highlights 

•The Hyderabad-based drug maker had held a meeting recently to discuss the status of its application for WHO's EUL for Covaxin.

•The meeting was attended by Bharat Biotech International Ltd. MD Dr. V Krishna Mohan and senior officials from the Union Ministry of Health, Department of Biotechnology and External Affairs Ministry.

•Covaxin, developed by Bharat Biotech in collaboration with ICMR, has already received regulatory approval from 11 countries.

•Eleven other companies in seven countries have also shown interest for technology transfer and its production.

•The drugmaker has submitted 90 percent of the required documents WHO's emergency use approval and the remaining documents are expected to be submitted by June 2021. 

•The company is currently in the final stages of submission of required documents for Covaxin's regulatory approvals in Brazil and Hungary.

•It is also in the final stages of negotiations with the US Food and Drug Administration (FDA) for conducting small-scale Phase-III clinical trials in the United States.

•As per sources, the company is in regular touch with the regulatory authorities of the countries it is applying for regulatory approvals in and is confident about the robustness of its dossier.

•As per company data, its vaccine has shown a longer duration of anti-body persistence after six months as well as eight months.

Significance

Bharat Biotech is one of the few companies that have published papers on all four COVID virus variants.

WHO Emergency use listing

•The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure that involves assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics. 

•The procedure aims to expedite the availability of these products to the people affected by a public health emergency.

•It helps the member states in determining the acceptability of using specific products, based on the available quality, safety, efficacy and performance data.

What is the eligibility criteria?

•WHO will consider a product for EUL assessment if the disease for which the product is intended is serious or immediately life-threatening and has the potential of causing an outbreak, epidemic or pandemic.

•There are, however, no licensed products for a critical subpopulation such as children. The WHO’s Emergency Use Listing (EUL) is considered as a prerequisite for COVAX Facility vaccine supply. Hence, it is important for vaccine manufaturers to get their vaccine listed.

Which vaccines have received WHO's EUL?

WHO has so far listed Sinopharm COVID-19 vaccine, Pfizer/BioNTech vaccine, two AstraZeneca/Oxford COVID-19 vaccines produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India, Moderna and Johnson & Johnson COVID-19 vaccine for emergency use. 

 

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