Hyderabad: Upon terminating the proposed clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin and a request for Emergency Use Authorisation (EUA), Brazil has now suspended its decision to import four million doses of the vaccine into that country.
As per a statement issued by the National Health Surveillance Agency of Brazil, Anvisa its Collegiate Board on Tuesday made the call to suspend the exceptional and temporary authorisation for distribution and import of Covaxin COVID-19 vaccine after Bharat Biotech informed the South America government about the cancellation of its pact with its Brazilian partners.
“The Collegiate Board of Anvisaunanimously decided, on Tuesday (July 27), 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 in statement posted on its website.
On July 23, Bharat Biotech said it terminated the MoU it entered with Envixia Pharmaceuticals LLC and Precisa Medicamentos for its Coronavirus vaccine Covaxin for Brazilian market.
The move to terminate of the MoU came right after the deal with the Brazilian government for supply of 20 million doses of Covaxin turned into a controversy and attracted investigation by authorities in that country.
“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 further said in a roughly translated version of Portuguese of the statement.
Though the exceptional and temporary importation of the vaccine had been authorized on June 4, at the ninth Extraordinary Meeting of the Collegiate Board of Anvisa, Brazil never imported the jab.
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.