Brazil has suspended the clinical studies of Bharat Biotech's Covid 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 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 a statement from the company Bharat Biotech, via e-mail, informing that Precise Comercializao de Medicamentos Ltda is no longer authorised 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.
(To receive our E-paper on whatsapp daily, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)