SAO PAULO (Reuters) – The board of Brazilian health agency Anvisa has provisionally suspended its import authorization for Bharat Biotech’s COVID-19 vaccine while it seeks information, it said on Tuesday.
The move is the latest upset to the country’s vaccine rollout, which has been derailed by a Senate committee investigation into potential corruption in the process of procuring vaccines.
Brazil has the world’s second highest death toll related to the pandemic, with over 550,000 fatalities, trailing only the United States.
Anvisa said in a statement it decided to suspend “the exceptional and temporary authorization for import and distribution” after India’s Bharat Biotech last week terminated an agreement with its local partner Precisa to represent it in Brazil.
It said the import permit, which was issued on June 4, would be suspended until Anvisa receives additional information about the vaccine, including technical and legal documents related to the shot.
Bharat Biotech did not have any immediate comment.
“The decision also took into account that illegitimate documents may have been submitted … which could impact the agency’s conclusions regarding the quality, safety and efficacy aspects of the vaccine to be administered to the population,” Anvisa’s statement said.
Based on an indicative price per dose of $15, Bharat’s contract to supply 20 million shots to the Brazilian government would be valued at $300 million.
Bharat Biotech terminated a memorandum of understanding to sell its COVID-19 vaccine Covaxin via a parternship with Precisa in Brazil last week.
(Reporting by Ana Mano; editing by Barbara Lewis)