Brazil suspends Covaxin clinical trials after Bharat Biotech cancels contracts with its partner

HYDERABAD: Brazil has suspended the clinical studies of Bharat Biotech’s COVID-19 vaccine, Covaxin following termination of the company’s agreement with its partner there, the South American Country’s health regulator said.

Bharat Biotech on Friday announced cancellation of the MoU it signed with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for the Brazilian market.

The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.

“In The Coordination of Clinical Research at Anvisa (Copec/GGMED) determined this Friday (23/7) the precautionary suspension of clinical studies of the Covaxin vaccine in Brazil The suspension was carried out as a result of a statement from the Indian company Bharat Biotech Limited International, sent to Anvisa on Friday (23/7),” Anvisa, the Brazilian health regulator said on Friday.

Precisa Medicamentos was Bharat Biotech’s partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.

“Anvisa received this Friday (23/7) a statement from the company Bharat Biotech, via e-mail, informing that Precise Comercializao de Medicamentos Ltda.”

“It is no longer authorized to represent Bharat in Brazil,” the Brazilian regulator said.

There are two processes of the company related to the regularisation of Covaxin in Brazil- an application for authorisation for emergency use and a protocol for conducting clinical research in that country.

Based on the communication made by Bharat Biotech, Anvisa will reassess the processes underway at the Agency and adopt the relevant measures, it said.

The clinical trials of Covaxin in Brazil did not commence.

On February 26, Bharat Biotech Ltd had said it signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of 2021.

Following the graft allegations and subsequent inquiry by the authorities, the Brazilian government had earlier suspended Covaxin’s order temporarily.

Bharat Biotech will continue to work diligently with Anvisa, the Brazilian drug regulatory body to complete the regulatory approval process for Covaxin, Bharat Biotech said on Friday while announcing the termination of its pact with its Brazilian partners.

The Health Ministry of India is aware of media reports about the Covaxin controversies, but this relates exclusively to an agreement between a commercial entity Bharat Biotech and another country, Lok Sabha was told on Friday.

Minister of State for Health Bharati Pravin Pawar stated this in a written reply to a question on whether the government has received reports about a “huge” controversy between Bharat Biotech and the Brazilian government over the supply of Rs 2 crore worth of anti-Covid vaccine Covaxin.

“The health ministry is aware of media reports of some controversy around contracts and regulatory approvals for supply of Covaxin to Brazil. This, however, relates exclusively to an agreement between a commercial entity i.e. M/s Bharat Biotech and a foreign country,” she said.