NEW DELHI, July 24: Brazil has suspended the clinical studies of “Covaxin” developed by the Indian company Bharat Biotech, following termination of the company’s agreement with its partner there, the Brazilian health regulator said.
Bharat Biotech on Friday announced cancellation of the agreement it signed with the Precisa Medicamentos and Envixia Pharmaceuticals LLC for its Covaxin in 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. But following the graft allegations, the Brazilian government has temporarily suspended the Covaxin order.
(Manas Dasgupta)