HYDERABAD: Issuing clarification on COVAXIN pricing controversy in Brazil, Bharat Biotech on Tuesday said it followed a step-by-step regulatory approval process during the eight-month period, but the company has neither received any advance payments nor supplied any vaccines to Brazil's Ministry of Health (MOH) as of now.
"In the specific case of procurement of COVAXIN by MOH Brazil, since the first meetings with MOH Brazil during Nov 2020, until June 29, 2021, a step by step approach has been followed towards contracts, and regulatory approvals, during this eight-month-long process. Emergency Use Authorization (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," the company statement said.
The Hyderabad-based company clarified that the pricing of COVAXIN has been clearly established between USD 15 to USD 20 per dose for supplies to governments outside India. "The pricing for Brazil has also been indicated at USD 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 adds.
As per Bharat biotech, Precisa Medicamentos is a partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance, the conduct of phase III clinical trials, among other things and the Hyderabad-based vaccine maker follows a similar partnership model in all countries, where its vaccines are supplied, as it does not have its own offices in these countries.
The company also revealed that they 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. "Bharat Biotech and Precisa Medicamentos are conducting a 5000 subject phase III clinical trial in Brazil, which was recently approved by ANVISA. The trial will be conducted by the Albert Einstein Institute," the statement reads.
However, as per the company, COVAXIN has now received Emergency Use Authorizations in 16 countries including, Brazil, India, the Philippines, Iran, Mexico, among others and the company is in process of getting EUAs in 50 other countries worldwide.
"Bharat Biotech is in discussions with WHO to obtain Emergency Use Listing for COVAXIN. The product has been exported to several countries, with additional requests for supplies being received," the company said.
Amid a probe into accusations of irregularities against President Jair Bolsonaro, Brazil's health minister has announced that the country will suspend a USD 324 million contract to buy 20 million doses of Bharat Biotech's Covaxin.
Addressing a press conference on Tuesday with Health Minister Marcelo Queiroga, the head of the Federal Comptroller General (CGU) Wagner Rosario, said that the agency will investigate the process of purchasing the vaccine.
"We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week," said Rosario, as quoted by CNN Brasil. "We have put in a reinforced team for the verification. We hope to be very quick in this process, and we hope that in no more than 10 days we will already have an answer for this analysis,"; he added.
Brazil's Health minister Queiroga said his ministry is going to carry out an administrative investigation to verify all aspects of the issue that are being raised. "As soon as we have more concrete data, we will communicate," said Queiroga.
The contract for the acquisition of the Covaxin vaccine was signed by the two sides in February for the import of 20 million doses of vaccine by Bharat Biotech.