Vaccine maker Bharat Biotech (BB) on Wednesday denied any wrongdoing in the procurement process of Covaxin in its deal with the Brazilian government.
“Bharat Biotech has not received any advance payments, nor supplied any vaccines to ministry of health, Brazil. Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully,” the company said in a statement.
The Brazil health ministry has suspended its contract with Bharat Biotech for a month, after a whistleblower alleged that there were irregularities in the deal. The country’s federal prosecutors have opened an investigation into the allegations.
The vaccine maker had signed a $324-million deal with the government of Brazil to supply 20 million doses of the Covaxin at $15 per vaccine.
Precisa Medicamentos, Bharat Biotech’s partner in Brazil, is providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance, conduct of phase III clinical trials. Bharat Biotech said it has followed similar partnership model in all countries where its vaccines are being supplied, as it does not have its own offices there. “The procurement process for Covid-19 vaccines and several vaccines for routine immunisation follows a common process, which is widely accepted, and established in industry,” the company said.
Bharat Biotech and Precisa Medicamentos are conducting a 5,000-subject phase III clinical trial in Brazil, which was recently approved by ANVISA, the regulatory authority in the South American country. The trial is being conducted by the Albert Einstein Institute.
According to the management of Bharat Biotech, they had a meeting with the Brazilian health ministry in November 2020 and followed a step-by-step approach towards contracts and regulatory approval until June 29. Bharat Biotech received emergency use approval on June 4.
The pricing of Covaxin was established between $15-20 per dose for supplies to governments outside India. The pricing for Brazil has also been indicated at $15 per dose.
The company said Covaxin has received emergency use authorisation in 16 countries, including Brazil, and is in the process of doing so in 50 countries. Bharat Biotech is also in discussions with the World Health Organization to obtain emergency use listing for Covaxin.
The company is manufacturing Covaxin at four facilities in India and is expanding capacity to reach an annualised capacity of one billion doses by 2021-end. Technology transfer activities are in progress to companies in the United States and other countries, it said.
