New Delhi: Brazil Tuesday suspended a $324 million contract with Bharat Biotech for 20 million doses of the Covid-19 vaccine, Covaxin, following recommendations by the country’s comptroller general.
A day later, the country’s health regulator also suspended the vaccine’s emergency use application, citing incomplete paperwork provided by the intermediary.
Brazil’s Health Minister Marcelo Queiroga tweeted the announcement and noted that the decision had not been made due to irregularities in the contract “but, due to compliance”.
“It is noteworthy that Brazil govt did not pay a CENT for the Covaxin vaccine,” said Queiroga, the fourth health minister to be appointed by President Jair Bolsonaro since the pandemic began.
The controversy surrounding the Brazil-Bharat Biotech vaccine deal has been going on for several months now. ThePrint explains the various contours of the matter.
Brazil’s decision to suspend the contract with Bharat Biotech, the Indian pharmaceutical company that developed and manufactures Covaxin, comes amid an ongoing investigation into the contract by Brazilian federal prosecutors and lawmakers.
Following allegations of bribery and corruption by a whistleblower in the health ministry, the Covaxin contract became the main focus of the parliamentary commission of inquiry (CPI), which is investigating the handling of the pandemic by the Bolsonaro-led government. Among other things, the price of vaccine doses has been a point of contention.
Questions have also been raised on why the government struck a speedy agreement with Bharat Biotech while offers from the US firm Pfizer at a lower price were ignored.
Bolsonaro, under growing pressure to explain the deal with the Indian company, said that there were no irregularities in the contract last Friday. “I am incorruptible,” he had said.
According to a Reuters report, the allegations threaten Bolsonaro’s pledge of zero tolerance for corruption in his government.
Meanwhile, Bharat Biotech Tuesday denied any wrongdoing, saying it had followed a “step-by-step” procedure with Brazilian authorities and Precisa Medicamentos, the intermediary between Brazil and Bharat Biotech.
Claims made by Brazilian whistleblower about contract
Luis Ricardo Miranda, head of import of the Department of Health Logistics, and his brother, Congressman Luis Miranda, are key witnesses in the ongoing probe into the Covaxin contract.
In a statement to the Federal Prosecutor’s Office last week, Miranda said he received “atypical pressure” for the purchase of Covaxin from superiors, including Lieutenant Colonel Alex Lial Marinho. A former general coordinator of Acquisitions of Strategic Health Insumos in the health ministry, Marinho is also an aide to one of Bolsonaro’s closest allies, former health minister Eduardo Pazuello.
Miranda and his brother have also alleged that they met Bolsonaro in March and raised concerns about the contract but nothing was done to investigate the deal. During a Senate hearing last week, the Congressman wore a bullet-proof vest for safety.
According to the brothers, Bolsonaro recognised that the situation was serious and told them that another Congressman, Ricardo Barros, was involved in the Bharat Biotech deal.
Barros is also connected to a deal for the AstraZeneca vaccine, organised by intermediary company Davati Medical Supply, which is currently being probed for alleged bribery.
Timeline of Brazil-Bharat Biotech deal
This is not the first time Bharat Biotech has encountered challenges in exporting Covaxin to Brazil.
In late March this year, the Brazilian health regulatory agency, known as Anvisa, denied permission to import Covaxin after its authorities found that the Hyderabad-based plant in which the vaccine is being made did not meet Good Manufacturing Practice (GMP) requirements. The GMP is a prerequisite for drug manufacturers to receive authorisation for the emergency use of the vaccine.
At the time, Anvisa published a report that stated Bharat Biotech had skipped key steps in ensuring that the SARS-CoV-2 virus in the vaccine was fully killed, or was incapable of multiplying in the human body. Covaxin is an inactivated vaccine which means that it is made up of killed coronaviruses.
When Bharat Biotech signed an agreement with Precisa Medicamentos in January, Emanuela Medrades, pharmaceutical director of the company, had said: “We identified highly technological, scientific and sanitary control levels. There were also excellent outcomes in clinical trials, which will be published soon. Bharat Biotech has exceeded our expectations, demonstrating quality and safety at the level of the largest vaccine suppliers in the world.”
In April, when asked about Anvisa’s report about GMPs, Bharat Biotech MD Krishna Ella said it was a product of Brazilian “nationalism”, and a desire to keep an Indian vaccine out of the country.
“Each country wants to defame the other countries and their vaccine strategies. It’s a global phenomenon. We don’t have to worry about it,” he said in an interview with NDTV in April.
On 25 May, Bharat Biotech filed a new request to the Brazilian authorities for certification.
It got Emergency Use Approval from Anvisa on 4 June, privy to certain conditions. First, that Brazil would receive four million doses of Covaxin after which Anvisa would analyse the data and assess the next quantities to be imported.
So far, Brazil has registered a total of 1,86,22,304 cases and 5,20,189 deaths.
Bharat Biotech has also faced scrutiny within India. In December 2020, it applied for regulatory approval for Covaxin even though it had no efficacy data.
There was also criticism when the Drugs Controller General of India (DCGI) — the apex drug authority in India — gave Covaxin an accelerated approval on 3 January 2021. The phase 3 human clinical trials had begun in mid-November 2020 and results for the final phase were only announced in March 2021.
(Edited by Rachel John)