- Tuesday, March 04, 2025
By: Pramod Kumar
THE health regulator of Brazil Anvisa has canceled a clinical study for the Covaxin vaccine for Covid-19 developed by India’s Bharat Biotech, amid allegations of irregularities in the government’s efforts to buy millions of doses of the shot.
Last week, Bharat said it had terminated a memorandum of understanding with the local partner company acting as its intermediary in Brazil.
Anvisa on Monday (26) said that the trials could not go forward as a result and would be canceled. It had previously suspended the trials temporarily.
Brazil has now scrapped the emergency use authorisation request made by the Indian company for the jab.
According to a statement issued by Anvisa, its Collegiate Board on Saturday (24) unanimously decided “to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Covaxin vaccine”.
“The decision was taken after Anvisa was informed by the Indian company Bharat Biotech International Limited that the company Necessidade no longer has the authorization to represent Bharat Biotech, manufacturer of the Covaxin vaccine, in Brazil,” Anvisa said.
Bharat Biotech on July 23 said it terminated the MoU it entered with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its Covid-19 vaccine Covaxin for Brazilian market.
The termination of the MoU came after the deal with the Brazilian Government for the supply of 20 million doses of the Covaxin landed in controversy and attracted investigation by authorities there.
Following graft allegations and subsequent inquiry by the authorities, the Brazilian government had earlier suspended Covaxin’s order temporarily.
Bharat Biotech has said that it will continue to work diligently with Anvisa, to complete the regulatory approval process for Covaxin.
