Due to the cancellation of Bharat Biotech’s agreement with its partner in Brazil, the South American country has suspended clinical trials of Bharat Biotech’s COVID-19 vaccine, Covaxin said Brazil’s health regulator in a statement on Friday.
The termination of the pact comes after the deal for the supply of 20 million doses of the vaccine landed in controversy and attracted investigation by Brazilian authorities.
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Bharat Biotech also announced the termination of the MoU it signed with Brazil’s Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine for the Brazilian market.
“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.
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Precisa Medicamentos was Bharat Biotech’s partner in Brazil, that provided 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.