Bharat Biotech on Friday said it has suspended the clinical studies of its vaccine with two Brazilian companies
Drugmaker Bharat Biotech on Friday said it has suspended the clinical studies of its vaccine with two Brazilian companies, which came after the Jair Bolsonaro-led Brazil ended its $324 million-contract for procuring 20 million Covaxin doses. The deal had landed in controversy, attracting investigation by Brazilian authorities.
The indigenous drugmaker announced the cancellation of the MoU it had signed with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for the Brazilian market, reported PTI.
Bharat Biotech said, “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.”
“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.
Amid the growing controversy, Bharat Biotech had last month denied any wrongdoing and said it had followed a “step-by-step” approach.
However, Brazilian authorities, denying Bharat Biotech’s claim, said the drugmaker replaced “EUA received on June 4″ in its statement with ‘On 4th June, ANVISA authorized exceptional import of Covaxin vaccine by Ministry of Health for distribution and Use Under Controlled Conditions”.
Precisa Medicamentos was Bharat Biotech’s partner in Brazil and provided assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.