Bharat Biotech today emphatically denied any wrongdoing amid a huge controversy in Brazil over a $324 million contract for Covaxin shots, now suspended over allegations of irregularities.
In a statement, Bharat Biotech said it had followed a “step-by-step” approach towards contracts and regulatory approvals with Brazil.
“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.
Brazil President Jair Bolsonaro is engulfed in allegations linked to the deal for 20 million Covaxin doses. 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.
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.
Bharat Biotech said the price of Covaxin had been “clearly established” between $15-20 per dose for countries other than 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,” said the statement.
The company said it had partnered with Precisa Medicamentos for regulatory submissions, distribution, insurance and to carry out Phase 3 clinical trials.
It highlighted its credentials and those of its founder Krishna Ella, pointing at a “large portfolio of 20 products” exported to more than 123 countries and more than 4 billion doses of vaccines delivered across the world.
It said it wished to “dispel any notion or implication of any wrongdoing whatsoever”.
Madison Biotech, said the company, was founded by Dr Ella last year for the purpose of external research and development and sales and marketing of vaccines.
Among the allegations roiling Brazil is that the invoice for advance payments was raised in the name of Madison Biotech, a third party.