New Delhi: The Jair Bolsonaro-led Brazil government Saturday cancelled Indian drugmaker Bharat Biotech’s Emergency Use Authorisation (EUA) request for its Covaxin vaccine.
Last Friday, the Hyderabad-based pharma company terminated its Memorandum of Understanding with Brazilian intermediaries, Precisa Medicamentos and Envixia Pharmaceuticals, which was signed in November 2020.
At the time, Bharat Biotech said in a statement that it will continue to work with Brazilian healthcare regulator Anvisa to obtain all required approvals for the use of Covaxin in the country.
According to local Brazilian reports, the “rupture” of the MoU left Covaxin without a formal representative in Brazil and thereby complicated matters regarding the EUA.
The decision to cancel the EUA request comes weeks after Brazil and Bharat Biotech’s $324 million contract — currently suspended — began facing allegations of corruption and irregularities.
ThePrint draws up the timeline of events that led up to the cancellation of Covaxin’s EUA request in Brazil.
How ball rolled from what whistleblowers told parliament
25 June: Whistleblowers — Luis Ricardo Miranda, head of imports at the Health Ministry, and his brother, Congressman Luis Miranda —tell a parliamentary inquiry committee that they received “atypical pressure” for the purchase of Covaxin from superiors. They further claim they raised these concerns with President Bolsonaro in March but nothing was done to investigate the deal. 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.
25 June: Bolsonaro claims there are no irregularities or overpricing in the Covaxin contract. Questions are also 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.
29 June: Brazil suspends its contract with Bharat Biotech, worth $321 million (1.6 billion reais), to procure 20 million Covaxin doses.
29 June: Anvisa suspends Covaxin’s emergency use application, citing incomplete paperwork provided by the intermediary. Bolsonaro fires health ministry logistics chief Roberto Ferreira Dias, who reportedly asked for a bribe in a coronavirus vaccine deal on the same day. This comes amid fresh calls for the president’s impeachment.
30 June: Bharat Biotech denies any wrongdoing in the Brazil-Covaxin deal and said it neither received any advance payments nor supplied any vaccines to Brazil’s health ministry. It also reiterates that Covaxin was offered to Brazil at US$ 15 per dose.
5 July: Bharat Biotech revises its 29 June statement in which it claimed “EUA received on 04 June 2021”. It clarifies this section by stating: “On 4th June 2021, ANVISA authorised exceptional import of Covaxin vaccine by Ministry of Health for distribution and Use Under Controlled Conditions”.
23 July: Bharat Biotech terminates MoU with Precisa Medicamentos and Envixia Pharmaceuticals. That same day, Anvisa suspends clinical trials of Covaxin in a precautionary manner.
24 July: Brazil cancels Bharat Biotech’s EUA request. According to a statement issued by the National Health Surveillance Agency of Brazil, it decided “to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Covaxin vaccine”.
26 July: Anvisa cancels clinical trials of Covaxin, requested by Precisa. This involves cancellations of the opening document of the study, the Dossier for Clinical Development of Medication (DDCM), and the clinical protocol of the research, the Specific Clinical Trial Dossier (DEEC).
(Edited by Paramita Ghosh)