- ANVISA or the National Health Surveillance Agency announced on Monday that a clinical trial for the Covaxin vaccine made by India’s Bharat Biotech had been cancelled.
- Bharat had previously declared that it had terminated a memorandum of understanding with the Brazilian partner company that served as its intermediary.
Brazil has revoked Bharat Bioetch’s Covaxin’s Emergency Use Authorization request, which was suspended when the vaccine’s proposed clinical studies were halted.
The vaccine company alerted the South American country of the end of its deal with its partners in the country, prompting the Brazilian health regulator’s decision.
According to a statement released by Anvisa, Brazil’s National Health Surveillance Agency, the Collegiate Board unanimously decided on Saturday to “close the process that dealt with the temporary authorisation of emergency use, on an experimental basis, of the Covaxin vaccine.”
Anvisa has already halted clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin in Brazil due to the termination of the company’s contract with its Brazilian partners.
“The decision was made when Bharat Biotech International Limited, an Indian firm, informed Anvisa that Necessidade no longer has authority to represent Bharat Biotech, the maker of the Covaxin vaccine, in Brazil,” Anvisa said.
The decision by the National Health Surveillance Agency or ANVISA is in response to a request for emergency usage of Covaxin made by the Brazilian company Necessidade.
Bharat Biotech announced on July 23 that it has terminated its agreement with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for the Brazilian market of its COVID-19 vaccine Covaxin.
When a deal with the Brazilian government for the supply of 20 million doses of Covaxin stirred controversy and necessitated a Brazilian investigation, the MoU was discontinued.
The Brazilian government had temporarily suspended Covaxin’s order following the graft charges and ensuing investigation by authorities.
While announcing the termination of its deal with its Brazilian partners, Bharat Biotech stated that it will continue to work assiduously with Anvisa to complete the regulatory clearance process for Covaxin.