Brazil has suspended the clinical studies of Bharat Biotech’s Covid-19 vaccine Covaxin after termination of the company’s agreement with its partner, as per reports.
“The suspension was carried out as a result of a statement from the Indian company Bharat Biotech Limited International, sent to Anvisa on Friday (July 23),” the Brazilian health regulator said on Friday.
The news comes only a day after Bharat Biotech announced the termination of a memorandum of agreement to sell Covaxin to Precisa Medicamentos in Brazil. Bharat Biotech, on the other hand, did not say why.
“The Company has terminated the said MOU with immediate effect. Notwithstanding such termination, Bharat Biotech will continue to work diligently with ANVISA, the Brazilian drug regulatory body to complete the regulatory approval process for Covaxin,” the company 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 3 clinical trials.
The termination of the MoU came after the deal with the Brazilian government for the supply of 20 million doses of the vaccine landed in controversy. There have been allegations in Brazil of irregularities in the government’s efforts to buy 20 million doses of the vaccine using Precisa as an intermediary.
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