The Ministry of Externals Affairs (MEA) on Thursday said a decision on emergency authorisation for the Covaxin Covid-19 vaccine made by Bharat Biotech is expected to be announced by September as the World Health Organisation (WHO) takes 6-8 weeks to grant the emergency use listing.
MEA spokesperson Arindam Bagchi said, “Covaxin submitted its application on July 9 so we are expecting a response by September as it takes 6-8 weeks for the WHO to grant the EUL.”
External Affairs Minister S Jaishankar had made a similar statement at the CII annual event on Wednesday.
World Health Organisation has said the agency expects to make a decision next month on an emergency authorisation for the Indian-made COVID-19 vaccine. Dr Mariangela Simao, a WHO assistant director-general for vaccines, told the Associated Press the UN health agency’s assessment of the Bharat Biotech vaccine was “quite advanced” and officials hoped for a decision by mid-September.
Last week, Bharat Biotech’s Covaxin has received Good Manufacturing Practices (GMP) compliance certificate from Hungary. The certificate of GMP is now listed on the EudraGMDP database which is the collection of records of the European Community of manufacturing authorisations and certificates of good manufacturing practice, Bharat Biotech said.
Bharat Biotech intends to submit documentation for emergency use authorisation to several additional countries worldwide, the company said. “With this approval Bharat Biotech has achieved another significant milestone in innovating and manufacturing vaccines at Global quality standards and moving forward in the ongoing fight against the COVID-19 pandemic,” it said in a press release.
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