Hyderabad: After calling off the proposed clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, Brazil has now decided to scrap the Emergency Use Authorisation request made by the Indian company for the jab.
The Brazilian health regulator’s verdict comes after the COVID-19 vaccine maker conveyed the South American nation about the termination of its pact with its partners in that country.
As per a statement released by the National Health Surveillance Agency of Brazil, Anvisa, its Collegiate Board on July 24 unanimously decided “to close the process that dealt with the temporary authorisation of emergency use, on an experimental basis, of the Covaxin vaccine”.
Previously, Anvisahad suspended the clinical studies of Bharat Biotechs vaccine Covaxin for Coronavirus in Brazil following the end of the company’s deal with its partners there.
“The decision was taken after Anvisa was informed by the Indian company Bharat Biotech International Limited that the company Necessidade no longer has authorization to represent Bharat Biotech,manufacturer of the Covaxin vaccine, in Brazil,” Anvisa said.
Anvisa’s move also refers to the request for emergency use of Covaxin COVID-19 vaccine that had been pushed by the Brazilian company Necessidade with Anvisa.
On July 23, Bharat Biotech had stated that it terminated the MoU it entered with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for Brazilian market.
The above-mentioned termination of the MoU came after the deal with the Government of Brazil for the supply of 20 million doses of the Covaxin landed in controversy and attracted investigation by authorities in that country.
Right after the graft allegations and subsequent inquiry by the authorities, the government had previously suspended Covaxin’s order temporarily.
Bharat Biotech will continue to work diligently with Anvisa, to complete the regulatory approval process for Covaxin, Bharat Biotech had said while announcing the termination of its pact with its Brazilian partners.