Bharat Biotech Covaxin trials suspended by Brazil
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.
Read also: Bharat Biotech dossier under review for Covaxin EUL, says WHO
Precisa Medicamentos was Bharat Biotechs partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others. Following the graft allegations, the Brazilian government has suspended Covaxin''s order temporarily.
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