The controversy for the import of 20 million doses of the 'made-in-India' COVID-19 COVAXIN vaccine over a $324 million deal between Brazil and Bharat Biotech continues to grow. As per the reports from the South American country, "its national health regulatory authority ANVISA - had never actually granted the Hyderabad-based manufacturer an EUA (emergency use application)".
Last week Bharat Biotech emphatically denied any wrongdoing on its part, the Hyderabad-based company said it had followed a "step-by-step" approach, and "EUA received on June 4".
The company, however, has now replaced "EUA received on June 4" in its statement with 'On 4th June, ANVISA authorized exceptional import of Covaxin vaccine by Ministry of Health for distribution and Use Under Controlled Conditions".
Although, hours after the company issued that statement, 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.
ANIVSA stressed the difference between the EUA application which said it received on June 29 - and a June 4 notice authorising import of Covaxin under "controlled conditions".
The June 4 notice was for the import of four million doses "which can be used only under specific conditions (as determined by the Brazilian government)", ANVISA said, adding that its decision on the EUA had been held up over "... information gaps in the analysis of Covaxin's data...".
Bharat Biotech has not yet responded to ANVISA suspending its EUA application deadline, or its differentiating between that and the June 4 notice.
The final approval of Covaxin for use in Brazil will likely depend on ANVISA satisfying itself with the safety and efficacy of the vaccine, which is 77.8 percent effective based on Phase III trial results.