Announcing the decision of the Brazilian government, its Ministry of Health said in a statement that, ‘On the recommendation of the Office of the Comptroller of the Union (CGU), the Ministry of Health is to purchase the Kovid-19 vaccine from Covaccine from this Tuesday (June 29) Temporarily suspends the agreement entered into. “This move will not affect the pace of the vaccination campaign against Kovid 19 in Brazil and follows compliance practices in public administration,” the ministry said.
This agreement will be evaluated by the Integrity Directorate of the Ministry of Health, which will also conduct an administrative inquiry. It said the entity would work with the ‘controller’ in determining the terms of the agreement. Reacting to this, Bharat Biotech said that the company has not received any advance payment nor has it supplied any vaccines to Brazil.
“As of June 29, 2021, Bharat Biotech has not received any advance payments nor has it supplied vaccines to the Brazilian Ministry of Health,” the company said in a statement. It said, ‘Bharat Biotech has followed the same approach in terms of agreements, regulatory approvals and supplies as it did in countries of the world where there have been successful supplies of Covaccine.’
Precisa Medicamentos is a partner of Bharat Biotech in Brazil providing support and guidance in conducting regulatory presentations, licensing, distribution, insurance, Phase III clinical trials, etc.
The covaccine deal with Brazil was embroiled in controversy when the South American country’s attorney general opened an investigation into the deal. The CGU minister, Wagner Rosario, said the suspension was a precautionary measure. “We started a preliminary inquiry last week, which is a special audit in relation to the agreement,” he said. The period of suspension will be till the assessment is done. We have deployed a strong team to expedite the process.
The CGU said it had launched an investigation on June 24 into possible irregularities in the covaccine agreement. Brazil’s Health Minister Marcelo Quiroga tweeted, ‘On the recommendation of CGUOnline, we have decided to temporarily suspend the Covaccine Agreement. “As per the preliminary analysis of CGU, there are no irregularities in the agreement but due to non-compliance, the ministry has decided to withhold the agreement for further analysis,” he said.
Bharat Biotech Limited said on 26 February that it has entered into an agreement with the Brazilian government for the supply of 20 million doses of Covaccine during the second and third quarters of 2021. Earlier, Brazil’s national health monitoring agency-Anvisa had refused permission to import the vaccine under the Emergency Use Tribunal after officials found that the Indian plant, where the vaccine is being made, was in a Goods Manufacturing Process (GMP). does not meet the requirements of.
On June 5, Anvisa had approved the proposal to import Covaccine into the South American country with certain conditions. Brazil approved the emergency use of the vaccine on June 4. The cost of Covaccine was fixed at $15 to $20 per dose for supply to governments outside India.
The price for Brazil is also shown at $15 per dose. Bharat Biotech said it has received advance payments from several other countries over and above the fixed prices, while the approvals remain in line and the supplies are in process. The company has adopted a similar partnership model in all the countries where its vaccines have been supplied as it does not have offices there.