The decision on emergency approval for Covaxin India’s indigenous vaccine manufactured by Bharat Biotech will be made next month, World Health Organisation’s (WHO) Chief Scientist Dr Soumya Swaminathan told today. Developed by India’s Bharat Biotech and the Indian Council of Medical Research (ICMR), Covaxin was approved by the Indian Drug Controller in January and has been in use since. Covaxin has been awaiting approval from WHO for emergency use authorisation fro WHO.
The decision on Covaxin approval will be made by the second week of August, 2021
Yesterday, Bharat Biotech’s joint managing director Suchitra Ella said the vaccine is moving towards emergency use listing. “Approval from WHO is not expected to be a long drawn process as cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” Ms Ella said in a tweet.
Dr Swaminathan’s remark today came on the heels of a row over approval for Covaxin and Covishield by the European Union.
India had said that unless the European Union accepts Covishield and Covaxin certificates, their covid-19 vaccine certificates will not be accepted in the country and people from EU will face mandatory quarantine upon arrival in India.
The coronavirus vaccine manufactured by the Serum Institute has already received emergency approval from WHO and there were questions on why it did not get approval of the European Medicines Agency, which has already approved the vaccine’s European version, manufactured by AstraZeneca.
Covax – the worldwide initiative aimed at equitable access to COVID-19 vaccines – has pushed for universal approval of vaccines okayed by WHO.
In a strong statement, Covax urged “all regional, national and local government authorities to recognise as fully vaccinated all people who have received COVID-19 vaccines that have been deemed safe and effective by the World Health Organization and/or the 11 Stringent Regulatory Authorities (SRAs) approved for COVID-19 vaccines,