Biotechnology company Bharat Biotech on Wednesday said that it has followed a “step-by-step” approach for supply contracts and regulatory approvals for its coronavirus vaccine, Covaxin, in Brazil, reported ANI.
This came amid a federal investigation in Brazil into the alleged irregularities in a $320 million (Rs 2,375 crore approximately) contract between the country’s health ministry and Bharat Biotech for 20 million (2 crore) doses of Covaxin. The Brazilian government had reportedly agreed to pay a higher price for Covaxin as part of the contract in February despite the vaccine not clearing regulatory checks at that time.
In a statement on Wednesday, Bharat Biotech said that Covaxin received emergency use authorisation on June 4, reported NDTV. “Covaxin has now received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUAs in process in 50 countries worldwide,” the company said.
Bharat Biotech also said that as of Tuesday, it has neither received any advance payments nor supplied any vaccine doses to the country.
Regarding the cost of the vaccine in Brazil, the company said the pricing of the shots has been established between $15 and $20 (Rs 1,100-1500 approximately) per dose for supplies to governments outside India. It said that the price of the vaccine for Brazil is also $15.
In March, Brazilian health regulator Anvisa had rejected a request from the government to import Covaxin, citing concerns about Bharat Biotech’s manufacturing standards and lack of safety data. In June, Anvisa’s board agreed to import four million Covaxin doses for further study of its safety and effectiveness.
Earlier on Tuesday, Brazil Health Minister Marcelo Queiroga had said that the country will suspend its Covid-19 vaccine contract with Bharat Biotech amid the allegations.
“According to the preliminary analysis of the CGU [comptroller general of the Union], 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 health ministry said in a statement.
To buy vaccines, the Brazilian health ministry will have to pay $320 million (Rs 2,375 crore approximately) to Precisa Medicamentos, Bharat Biotech’s intermediary in Brazil. So each dose of Covaxin will cost Brazil $15 (approximately Rs 1,100).
This is significantly higher than what the health ministry paid for American pharmaceutical giant Pfizer’s vaccine, which has already obtained regulatory approval in Brazil.
Officials from the Brazilian health ministry also reportedly did not consider that Precisa, Bharat Biotech’s intermediary, had a history of alleged irregularities in contracts with the federal government.
Luís Ricardo Miranda, an official from the logistics department, had told the federal prosecutors on Wednesday that he was pressured by one of Bolsonaro’s closest allies to buy Bharat Biotech’s vaccine.
Covaxin, a made-in-India vaccine, had been found to be 77.8% effective against the coronavirus disease in phase 3 trials. The data has not yet been published in a peer-reviewed journal. However, Bharat Biotech can now approach the World Health Organization for emergency use listing of the vaccine, which would make it easier for Covaxin to receive approvals in other countries.