The National Health Surveillance Agency of Brazil, Anvisa, on Tuesday, suspended the temporary authorisation to import and distribute Covaxin. The country had earlier suspended the proposed clinical trials of Covaxin and the request for Emergency Use Authorisation. With the decision, the decision to import four million doses of Bharat Biotech manufactured Covaxin also stands suspended.
"The Collegiate Board of Anvisaunanimously decided, on Tuesday (27/7), to provisionally suspend the exceptional and temporary authorisation for import and distribution of the vaccine against Covid-19-Covaxin, requested by the Ministry of Health," Anvisa said.
The decision comes after Bharat Biotech informed the South American government on July 23 about the termination of its pact with its Brazilian partners Precisa Medicamentos and Envixia Pharmaceuticals LLC. The India-based vaccine manufacturer terminated the MoU with the companies after the deal with the Brazilian government to supply 20 million Covaxin doses landed in controversy and attracted investigation by the country authorities.
"The measure prevails until there is new information that allows us to conclude that the legal and technical security of maintaining the decision that authorised the importation is maintained," Anvisa added.
Brazil authorised the exceptional and temporary importation of Covaxin on June 4 at the ninth Extraordinary Meeting of the Collegiate Board of Anvisa. However, they never imported the vaccine.
Even while terminating the pact with its Brazilian partners, Bharat Biotech had informed that it would continue to work diligently with Anvisa to complete the regulatory approval process for Covaxin.