Bharat Biotech awaits emergency use approval from WHO for COVID-19 vaccine

Bharat Biotech International Limited (BBIL) has applied to the World Health Organisation (WHO) to get an emergency use listing (EUL) for its COVID-19 vaccine. It hopes to get the nod by the third or fourth quarter of this year. BBIL has submitted 90 percent of required documents to WHO to get approval, and the remaining documents will be submitted by June, the Hyderabad-based pharma company told the Central government during a discussion. The meeting was attended by the company’s managing director V Krishna Mohan and his colleagues, along with senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs and Foreign Secretary Harsh Vardhan Shringla. Speaking to PTI, a source said, “BBIL is confident about obtaining WHO’s emergency use listing.” “We’ve started this process with WHO. It’s not an immediate approval that you get. It takes a couple of months. We are quite hopeful that by Q3 or Q4 we will receive our WHO approval," said Raches Ella, head of business development and advocacy at BBIL to  TOI. “Bharat Biotech, in the past, has been approved by WHO for several other vaccines, so we’re not new to this process. we are aware of it", he added. According to a report by TOI, WHO documents show BBIL had submitted its expression of interest on 19 April, 2021, and WHO has asked for more information from the company. A pre-submission meeting is supposed to be held some time between May-June 2021. The WHO has given approvals to the Pfizer/BioNTech vaccine for emergency use on 31 December, 2020. The AstraZeneca/Oxford COVID-19 vaccine got its approvals on 15 February, and the COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) was approved on 12 March. Moderna’s COVID-19 vaccine and China’s Sinopharm COVID-19 vaccine have also both been approved in its EUL. According to a report by  Hindustan Times, people who have been vaccinated with Bharat Biotech’s COVAXIN might not be allowed to travel overseas, as it not officially recognised by the WHO or by many countries. The vaccine is indigenously co-produced by BBIL, India’s apex health agency ICMR and the NIV-Pune. With countries slowly opening back to allow foreign travellers, they are most likely to introduce new rules that allow only fully vaccinated people into their countries, in order to stop the spread of the disease. And while not many countries have instituted a ‘vaccine passport’, they will create these rules based on the recommendations of their respective health agencies or basis the vaccines approved by the WHO. This might be one reason why BBIL is rushing to get this process started. The European Union (EU), United Kingdom (UK) and Canada have not included COVAXIN in their approved list of vaccines. COVAXIN has already received regulatory approval from 11 countries, and sources say there is also interest from 11 companies in seven nations for technology transfer and production of the vaccine. While countries such as Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe and Nepal have approved the vaccine, sources told PTI the company is trying to get regulatory approvals in Brazil and Hungary and is in the final stages of submitting the required documents. The company is also negotiating with the US Food and Drug Administration to conduct a small-scale phase-III clinical trial of COVAXIN in the US.