'Followed Step-by-step Approach for Approval': Covaxin Makers After Brazil Suspends Deal

India’s Bharat Biotech said on Wednesday it followed a “step-by-step” approach for the regulatory approval and supply contract of its COVID-19 vaccine in Brazil, and that it has not received advance payments from the Brazilian health ministry.

Brazil’s health minister said on Tuesday the country will suspend its $324 million contract for 20 million doses of Bharat Biotech’s vaccine after whistleblowers went public with alleged irregularities in the deal.

“In the specific case of procurement of Covaxin by the Ministry of Health, Brazil, since the first meetings during Nov 2020 until June 29, a step-by-step approach has been followed towards contracts, and regulatory approvals, during this eight-month-long process,” Bharat Biotech said in a statement.

“EUA received on June 4. As of June 29, Bharat Biotech has not received any advance payments nor supplied any vaccines to MOH Brazil. Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully,” said the Hyderabad-based vaccine maker.

Bharat Biotech says reports in the media over the past few weeks had “misrepresented” the procurement process of Covaxin in Brazil and other countries. “The procurement process for COVID-19 vaccines and several vaccines for routine immunization follow a common process which is widely accepted, and established in Industry,” said Bharat Biotech.

Brazilian federal prosecutors have opened an investigation into the deal citing comparatively high prices, quick talks and pending regulatory approvals as red flags for the contract signed in February.

Accusations that Brazilian President Jair Bolsonaro turned a blind eye to possible corruption in a deal to purchase coronavirus vaccines have heightened threats to his presidency, including a move to recommend slapping him with a criminal charge.

The claims have added impetus to the opposition’s impeachment drive and left the Brazilian leader’s allies in Congress evaluating the costs of their support.

The case has galvanized Bolsonaro’s opponents and prompted protest organizers to move up their next nationwide demonstration to Saturday. The percentage of people rating Bolsonaro’s government bad or terrible has reached an all-time high, according to pollster Datafolha.

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