Prosecutors cite the high price of the drug, quick talks and pending regulatory approvals as red signs of the contract.
Brazilian federal prosecutors have opened an investigation into a contract worth 1.6 billion reais ($ 320 million) for 20 million doses of a COVID-19 vaccine manufactured by India’s Bharat Biotech, according to a document seen by Reuters.
The Attorney General’s Office (PGR) cited comparatively high prices, quick talks and pending regulatory approvals as red flags for Bharat’s contract signed in February, before similar deals with Pfizer Inc and Johnson & Johnson.
Bharat did not respond to a request for comment outside of business hours in India.
Bharat’s contract has also been investigated by an investigation by the Brazilian Senate, which requested a statement Wednesday from the head of Precisa Medicamentos, Bharat’s intermediary in Brasilia.
Justifying the preliminary evidence, prosecutors noted in a June 16 document that Precisa’s partners include Global Saude, a company accused of selling but not delivering drugs to the Ministry of Health in a case investigated by police.
Precisa said he was unaware of the prosecutors’ investigation and was open to cooperating with Senate investigators. In a statement, the company said its talks with the health ministry were transparent and the price of Bharat vaccine in Brazil was the same as that charged in more than a dozen countries.
The Ministry of Health said on Tuesday in a statement that no payment of any kind had been made to Precisa and that its legal department was analyzing the case.
Global Saude did not immediately respond to requests for comment.
Prosecutors wondered why the Ministry of Health had agreed to buy the Bharat vaccine, which had not removed regulatory barriers, for about $ 15 per dose – significantly more than it paid for the Pfizer vaccine, which had regulatory approval.
“The history of irregularities related to Precisa partners and the high price paid for the doses contracted … require in-depth investigation into both civil and criminal matters,” prosecutors wrote.
In a separate document seen by Reuters, Senate investigators cited the testimony of an unnamed public official who described “abnormal pressure” from senior health ministry officials to reach an agreement for the brand’s Bharat vaccine. Covaxin.
In March, Brazilian health regulator Anvisa rejected a government request to import doses of Covaxin, alleging concerns about Bharat’s manufacturing standards, as well as a lack of safety data and other documentation.
This month, the board of Anvisa agreed to allow the import of only four million doses of Covaxin to further study its safety and effectiveness, but the Ministry of Health must first sign an agreement with the regulator on key conditions.