Bharat Biotech files fresh application before Brazilian regulator for Covaxin
Anvisa recently approved the Covaxin clinical trial in Brazil, which will study the application of two doses, with 28 days of interval, involving 4,500 volunteers
Hyderabad: Bharat Biotech submitted a new application to the National Health Surveillance Agency of Brazil (Anvisa) for certification of Good Manufacturing Practices (GMP) for its Covid-19 vaccine Covaxin. The Brazilian regulator in March denied a certificate for GMP to the vaccine maker citing certain violations of GMP at its facility.
According to an announcement on Anvisa site, Bharat Biotech made the request on May 25 and filed a new application for authorisation to import 20 million doses of the Covaxin, furnishing new information on GMP. The application comes one day after Brazil’s Ministry of Health filed a new application for authorisation to import 20 million doses of the Covaxin manufactured in India, where the vaccine is authorised for emergency use.
On the fulfilment of GMP by Bharat Biotech, one of the main aspects that motivated the previous decision, the company filed a new certification request at Anvisa, referring to the production line of the finished product. The request is being analysed, the agency said.
Anvisa said, GMP certification of all stages of vaccine production is a prerequisite for the registration of the vaccine in Brazil. For the exceptional import order, only the minimum data of Good Production Practices are analysed, but without the need for the certificate in question.
It is pertinent to note that Anvisa on May 13 approved the Covaxin clinical trial in Brazil. The study foresees the application of two doses, with 28 days of interval. It is expected that 4,500 volunteers will be involved in the trial.
Bharat Biotech on February 26 said it has signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin, valued at around Rs 2,140 crore ($1.6 billion Brazilian real), with deliveries scheduled during the second and third quarters of 2021.
Following the denial of certificate for GMP by Anvisa, as per the March 29 Gazette, the vaccine maker stated, the requirements pointed out during inspection will be fulfilled, the timelines for fulfilment was under discussion with the Brazil National Regulatory Authority and will be resolved soon. Since then, the Ministry of Health and Bharat Biotech’s representative Precis Medicamentos had continued negotiations with Anvisa.
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