Brazilian federal prosecutors have begun investigation into a contract by the country’s health ministry to buy 20 million (2 crore) doses of the coronavirus vaccine developed by India’s Bharat Biotech, AP reported on Wednesday.
The comparatively high prices for Covaxin, which had not cleared regulatory hurdles, drew prosecutors’ attention to the deal signed in February. According to a document sent to AP by the prosecutor general’s office, the health ministry has to pay $320 million (Rs 2,375 crore approximately) to Precisa Medicamentos, the intermediary for Bharat Biotech in Brazil. Each dose costs $15.
This was significantly higher than what the health ministry paid for American pharmaceutical giant Pfizer’s vaccine, which had obtained regulatory approval. Last year, Brazilian President Jair Bolsonaro had ignored Pfizer’s offer to supply vaccines and repeatedly raised doubts about its efficacy, reports said.
Health ministry officials also did not take into account Precisa’s history of alleged irregularities in previous contracts with the federal government. “The history of irregularities involving Precisa partners and the high price paid for the contracted doses require a thorough investigation in both civil and criminal matters,” federal prosecutor Luciana Loureiro Oliveira said on June 16.
The Indian government and Prime Minister Narendra Modi have taken pride in showcasing Covaxin as the country’s first indigenously developed vaccine against Covid-19. Bharat Biotech developed the vaccine in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
The contract has also drawn scrutiny from a Brazilian Senate commission, The Wire reported. “It has drawn our attention because it is an unusual acquisition in all aspects,” said Senator Renan Calheiros, the commission of inquiry rapporteur. “So, we will have a week to go deeper into everything that happened in the background.”
He added that the commission would investigate all the “scandalous things” in the purchase of Covaxin.
Francisco Maximiano, a Precisa shareholder, was supposed to appear before the commission on Tuesday to answer about the deal. However, he postponed his testimony saying he was in quarantine after travelling from India, AP reported.
The panel, which is also investigating into the government’s handling of the pandemic, has documents to show that Bolsonaro’s government aggressively pushed for a contract with Bharat Biotech, according to The Wire.
Meanwhile, logistics department official Luís Ricardo Miranda has informed prosecutors that he was under pressure by Alex Lial Marinho, an aide to one of Bolsonaro’s closest allies, to purchase the Bharat Biotech vaccine, Reuters reported. “It’s a visible attempt to extract public money without a documented purpose, with an inflated value and ulterior motives,” a Congressman said. The Senate panel had called Miranda for questioning on Wednesday.
In March, Brazilian health regulator Anvisa had rejected a request from the government to import Covaxin, citing concerns about Bharat Biotech’s manufacturing standards and lack of safety data. In June, Anvisa’s board agreed to import four million Covaxin doses for further study of its safety and effectiveness.
Covaxin was granted emergency use authorisation in India in January even though data of phase 3 trials were not available at that time. The company had then said it would submit efficacy results by March. On June 9, it said that the data will be made public in July.
Phase 1 of a clinical trial is usually small and is used to determine its safety profile. Phase 2, on the other hand, employs a bigger sample size, and looks at the immune responses triggered by the vaccine. However, a vaccine is deemed safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants.
Last weekend, the company submitted the phase 3 trial data. Reports said the vaccine was 77.8% effective against the coronavirus. The data has not yet been published in a peer-reviewed journal. However, Bharat Biotech can now approach the World Health Organization for emergency use listing of the vaccine, which would make it easier for Covaxin to receive approvals in other countries.