Not received any advance payment nor supplied any jab: Bharat Biotech
Soon after Brazil announced it was suspending a USD 324 million Covaxin contract that has mired President Jair Bolsonaro in accusations of irregularities, Hyderabad-based Covid vaccine maker Bharat Biotech has said it has not received any advance payment nor supplied any vaccines.
The deal is now suspended over allegations of irregularities that have singed Brazil’s top leadership, including President Jair Bolsanaro, according to reports.
Brazilian federal prosecutors have opened an investigation into the Covaxin deal, citing comparatively high prices, quick talks and pending regulatory approvals as red flags for the contract signed in February.
“During the past few weeks, there have been reports in the media at large misrepresenting the procurement process of Covaxin, in Brazil and other countries,” Bharat Biotech said in a statement here even as it shared details of procedure in acquiring the deal.
It said in the specific case of procurement of Covaxin by the Ministry of Health, Brazil, since the first meetings with MOH Brazil during November 2020, until June 29, 2021, a step by step approach has been followed towards contracts, and regulatory approvals, during this eight-month long process.
Bharat Biotech said, “EUA was received on June 4, 2021. As of June 29, 2021, Bharat Biotech has not received any advance payments nor supplied any vaccines to MOH Brazil”.
The vaccine maker said it has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully.
“The pricing of Covaxin has been clearly established between $15-20 per dose for supplies to Governments outside India. The pricing for Brazil has also been indicated at $ 15 per dose. Bharat Biotech has received advance payments from several other countries at the above price points, with supplies in process, pending approvals,” it added.
Precisa Medicamentos is Bharat BiotechRs s partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance, conduct of phase III clinical trials, etc.
Bharat Biotech follows a similar partnership model in all countries, where its vaccines are supplied, as it does not have its own offices in these countries. Bharat Biotech said the price of Covaxin had been “clearly established” for countries other than India.
Bharat Biotech and Precisa Medicamentos are conducting a 5,000 subject phase III clinical trial in Brazil, which was recently approved by ANVISA. The trial will be conducted by the Albert Einstein Institute.
“According to the preliminary analysis of the CGU, there are no irregularities in the contract but, for compliance, the Health Ministry chose to suspend the contract for a more in-depth analysis,” the Brazil Ministry said in a statement.
Among the allegations being investigated is that the contract was assigned when Covaxin had not been approved by Brazil’s National Health Surveillance Agency. Despite this status, however, Covaxin’s price was agreed at USD15 a dose, the highest paid by this country for any of the six vaccines contracted so far. Covaxin was rejected by the Brazil health body on March 31 and then approved for limited imports with strict conditions on June 4.
Last week, a Health Ministry official, Ricardo Miranda, testified at the Senate that he and his brother, federal deputy Luis Miranda, had informed the President about serious problems in an invoice of $45 million sent by Madison Biotech, an offshore company from Singapore.
Bharat Biotech has said Madison Biotech was set up by its founder Krishna Ella last year for research and development, sales and marketing of vaccines.