With its contract to supply 20 million Covaxin doses to Brazil suspended over charges of irregularities, vaccine maker Bharat Biotech implored that it has committed nothing wrong and was only following the "widely accepted vaccine procurement process."
The Hyderabad-based firm stated that it did not receive any advance payments nor has supplied any vaccines to Brazil yet.
Embroiled in accusations over Covaxin pricing and “hasty procurement”, the Jair Bolsonaro government has on Tuesday announced the temporary suspension of the contract worth over $300 million. The decision of the Ministry of Health (MoH) was following the recommendation of Brazil's Comptroller General and an investigation has been initiated to reevaluate the purchase terms.
“We wish to dispel any notion or implication of any wrongdoing whatsoever,” Bharat Biotech said in a statement on Wednesday following the shelving of its contract with Brazil.
The largest Latin American nation, one of the worst affected in the world, had approved Emergency Use Authorization for the Bharat Biotech manufactured Covid-19 vaccine on 4 June. Vaccine purchase talks between Brazil's MoH and Bharat Biotech were initiated in November last year, after Covaxin's Phase-3 trials were initiated in India.
Covaxin pricing for Brazil was pegged at $15 per dose, as per the company's $ 15-20 per dose pricing policy for supplies to the governments outside India.
“As of Tuesday, Bharat Biotech has not received any advance payments nor supplied any vaccines to Brazil,” the company said.
Citing the “widely accepted procurement process for Covid-19 and other vaccines,” Bharat Biotech said that after the EUA is given, “the vaccine company proceeds to raise a Pro Forma Invoice to the MoH, towards the vaccine supply.” And once the MOH pays the amount in advance, the company proceeds to supply the agreed quantities and within the agreed timelines.
“Since the first meetings with MOH Brazil during November 2020 until 29 June 2021, a step by step approach has been followed towards contracts, and regulatory approvals. We have followed a similar approach in several countries worldwide, where Covaxin is being supplied successfully,” the firm said.
Precisa Medicamentos is Bharat Biotech’s partner in Brazil, providing guidance and support with regulatory submissions, licensure, distribution, insurance, etc.
Bharat Biotech said it has adopted a similar partnership model in all countries where its vaccines are supplied, as it does not have its own offices in those places.
Bharat Biotech and Precisa Medicamentos are conducting Covaxin's phase III clinical trial on 5,000 people in Brazil. The trials approved recently by ANVISA, Brazil's health regulatory agency would be conducted by the Albert Einstein Institute.
Covaxin, developed in collaboration with ICMR, has so far received Emergency Use Authorizations in 16 countries including Brazil, India, Philippines, Iran, Mexico and the EUA process is on in 50 countries, Bharat Biotech said adding that it is in discussions with the WHO to obtain Emergency Use Listing for its Covid-19 vaccine.
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