Controversy over a $324 million deal between Brazil and Bharat Biotech – for the import of 20 million doses of the ‘made-in-India’ COVID-19 vaccine Covaxin – continues to grow, with reports from the South American country saying 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 that: “EUA (was) received on June 4”.
However, 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 it 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 per cent effective based on Phase III trial results.
The controversy – being called ‘CovaxinGate’ by some media outlets – erupted after Ricardo Miranda, a Brazilian health ministry official red-flagged potential illegalities.
Brazilian federal prosecutors and a Senate panel are investigating the deal, citing high prices, quick talks and pending regulatory approvals as points of concern in the February contract.
The $324 million deal has been suspended while investigations are ongoing.
President Bolsonaro has denied any wrongdoing on his part.
One of the focal points of the investigation is the invoice for $45 million sent by Madison Biotech – a Singapore-based company that Bharat Biotech has said was set up last year by its founder, Dr Krishna Ella, for research and development, sales and marketing of vaccines.
A detailed report by news website The Wire, which has been tracking this story with inputs from Brazil reporters, said three such invoices were raised by the same company.
Allegations they were forged were dismissed in a report by Brazilian newspaper O Globo, which said all three were recorded by the Brazilian health ministry.
The raising of these invoices appear to contradict what Bharat Biotech said last week; the company stressed: “Bharat Biotech has not received any advance payments…”.
Legal experts say an entity not mentioned in a contract cannot raise an invoice for advance payment.
Brazil President Jair Bolsonaro is already under fire for his handling of the Covid pandemic; a Senate panel is presently investigating this. He is also facing massive protests over ‘CovaxinGate’, with thousands taking to the streets this week to demand his resignation.
On Friday, Brazil’s Supreme Court authorized an investigation of President Bolsonaro by the federal prosecutor, or PGR, for dereliction of duty in the process of procuring a COVID-19 vaccine.
Dereliction of duty is a criminal offense in Brazil and, in Mr Bolsonaro’s case, an impeachable one.
With input from AFP, Reuters