Brazil suspends Clinical Trials of Bharat Biotech’s Covaxin

Bharat informs that the company Necessidade is no longer authorized to represent Bharat in Brazil

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Laboratory
Picture: Pixabay

Brazil has suspended the clinical trials of Bharat Biotech‘s C-19 vaccine, Covaxin after the Hyderabad based company terminated agreement with its partner late on Friday.

“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,”Anvisa, the Brazilian health regulator said.

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), it added.

Medicine Injection Vaccine
Picture: Pixabay

Bharat informs that the company Necessidade is no longer authorized to represent Bharat in Brazil, which in Anvisa’s assessment makes it impossible to carry out the study. Bharat is the manufacturer of the Covaxin vaccine’” it further said.

Late on Friday, Bharat Biotech terminated the Memorandum of Understanding (MoU) with Precisa Medicamentos and Envixia Pharmaceuticals LL.C, Bharat Biotech’s partners in Brazil for introducing Covaxin in Brazil. Precisa Medicamentos was Bharat Biotech’s partner in Brazil, which was providing assistance and support with regulatory submissions, licensure, distribution, insurance and conduct of Phase 3 clinical trials in Brazil.

“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 had said on Friday.

The termination of the MoU came after the deal with the Brazilian government for the supply of 20 million doses of the vaccine landed into a controversy. Last month, the Brazilian government which earlier agreed to purchase 20 million doses of Covaxin suspended the contract following allegations of irregularities in the deal.

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