Brazil scraps Covaxin's EUA application after Bharat Biotech terminates pact with partners newindianexpress.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newindianexpress.com Daily Mail and Mail on Sunday newspapers.
After suspending Covaxin clinical trials, Brazil closes EUA request | India News indiatimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from indiatimes.com Daily Mail and Mail on Sunday newspapers.
Synopsis
The move comes after Anvisa was informed by Bharat Biotech that it’s Brazilian partner-Necessidade no longer has authorization to represent them in Brazil.
AFP
Brazil’s health regulator, ANVISA has scrapped Bharat Biotech’s application seeking emergency use authorisation (EUA) of Covaxin.
“The Collegiate Board of the National Health Surveillance Agency unanimously decided to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Covaxin vaccine,” it said in a statement.
It said that the process will be closed without evaluating the merits of the request for temporary authorization for emergency use, on an experimental basis, filed by the company Necessidade Comercialização de Medicamentos Ltda. on June 29 this year.
Hyderabad: Less than a week after Brazil’s health regulator gave its nod for “exceptional import” of four million doses of Bharat Biotech’s Covaxin, i.
Less than a week after Brazil’s health regulator green-lighted the “exceptional import” of 4 million doses of Bharat Biotech’s Covid-19 jab Covaxin, it has now granted certification of Good Manufacturing Practices (GMP) to the company’s vaccine-manufacturing facility as well as its biological input, paving the way for full-fledged exports of Covaxin to Brazil.