Hyderabad-based Bharat Biotech has submitted an application to the World Health Organization for Emergency Use Listing (EUL). As per reports, the Indian company had submitted its Expression of Interest (EOI) on the 19th of April and is awaiting a pre-submission meeting to be held in May-June 2021, as per key WHO documents.
Following the pre-submission meeting, it will be required to go through 2 more stages, the acceptance of the dossier for review and the final status of assessment before its application is accepted.
As per data available, less than 10 nations have officially approved the Covaxin. Most countries only recognize Oxford-AstraZeneca’s Covishield as the required vaccine for passengers coming from India, reported Moneycontrol.
Speaking with Wion, Joint managing director of Bharat Biotech, Suchitra Ella said their vaccine, COVAXIN has been proved to be neutralizing all these variants including the double mutant, which has been observed in India & has an edge given it is inactivated virus produced in cell culture or Vero cell platform.
Attaining the emergency approval by WHO will bring with it many benefits, it will allow Covaxin to get global approval for the use which will in turn facilitate easy movement of Indians who have been vaccinated by it.
In the future, the company plans to produce one billion vaccines via its three different facilities in three states, 200-250 million from Hyderabad facility, around 500 million doses from Bangalore, and 200 million from Ankleshwar, Gujarat.
On the issue of WHO’s authorization for Emergency Use Listing (EUL), BBIL noted that they had submitted 90% of the documentation required for EUL to WHO. The remaining is expected to be submitted in June 2021. BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines pre-qualified by WHO.
Simultaneously, BBIL is in the final stages of submission of required documents for COVAXIN’s regulatory approvals in Brazil and Hungary. They have held extensive bilateral consultations with both the countries. Furthermore, BBIL is also in the final stages of negotiations with FDA of the USA for conducting small-scale Phase-III clinical trials in the US.
BBIL clarified that all regulatory approvals have both retrospective and prospective effect.
BBIL is in regular touch with regulatory authorities in the above-mentioned countries. They are confident about the robustness of their dossier, as they have data for much longer duration – for anti-body persistence after 6 months as well as 8 months. It is one of the few companies that have published papers on all four Covid virus variants.
It is important to note that no country has instituted a vaccine passport. Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
The EUL assesses the quality, safety, and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.