Bharat Biotech-Brazil row: Covaxin nod under controlled conditions

The agency said the suspension – which put the EUA application on ice – was due to missing data from the vaccine’s clinical trials

Covaxin, bharat biotech, covid, coronavirus, vaccine, drugs, medicine, pharma

As controversy over the $324-million deal for 20 million doses of Covaxin with Brazil brews, on Monday some reports pointed out that the Brazilian regulator had not granted Bharat Biotech — the makers of Covaxin — emergency-use authorisation (EUA). The Hyderabad-based company’s website noted that on June 4, ANVISA — the Brazilian regulator — had authorised the “exceptional import of Covaxin by the health ministry for distribution and use under controlled conditions”. This is a departure from the June 30 press statement wherein the company had clarified it had not received any money from Brazil’s health ministry.

On Monday, NDTV reported that ANVISA “suspended the deadline for evaluating the application for emergency use of Covaxin”. The agency said the suspension — which put the EUA application on ice — was due to missing data from the vaccine’s clinical trials. NDTV claimed that ANVISA had stressed the difference between the EUA application and authorising imports under ‘controlled conditions’. The news channel claimed that the June 4 notice was for import of 4 million doses “which could be used only under specific conditions (as determined by the Brazilian government)”. It added that ANVISA had claimed that its decision on the EUA was held up over information gaps in the analysis of Covaxin’s data.

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