Here’s what went wrong with Bharat Biotech’s Covaxin deal in Brazil
In November 2020, Bharat Biotech entered into an agreement with Precisa Medicamentos and Envixia Pharmaceuticals LL.C. Precisa, the Bharat biotech partner that provides assistance, advice and support for regulatory submissions, licensing, distribution, assurance, and conduct of Phase III clinical trials, among others.
Since Precisa has until now represented Bharat Biotech in Brazil and will not do so from now on, the clinical trial must naturally be suspended.
Allegation of transplant or partnership problem?
The Bolsonaro government has faced corruption allegations over its deal with Bharat Biotech, which is still under investigation. Whistleblowers from Brazil’s health ministry said there was pressure from higher authorities over the deal with Bharat Biotech. It was also alleged that Pfizer was distributing vaccines in Brazil at a lower price. As a result, the deal was canceled and the Brazilian government said there had been no corruption as no money was given to Bharat Biotech. Bharat Biotech also confirmed that it had not received any advance payment from the Brazilian government or provided any vaccine.
Precisa is a company based in Brazil while Envixia is registered in Dubai.
As Bharat Biotech has now distanced him from these two companies, he has also made allegations without pointing fingers at any particular company. “We were recently informed that some letters believed to have been executed by company executives are being posted online. We would like to emphatically point out that these documents were not issued by the company or its executives and therefore vehemently deny the same, ”Bharat Biotech said in the statement, released on Friday.
And now? Is Covaxin approved in Brazil?
When the deal was made, it was claimed that Bharat Biotech’s Covaxin had received approval from Brazilian health regulator Anvisa on June 4. controller conditions.
Now that the deal is canceled, Bharat Biotech has said it will work diligently with Anvisa to complete the regulatory approval process.
“There are two company processes related to the regularization of Covaxin in Brazil – an emergency use authorization application and a protocol to conduct clinical research in that country. On the basis of the communication made by Bharat Biotech, Anvisa will reassess the processes underway at the Agency and adopt the appropriate measures, ”said the Brazilian health regulator, quoted by the PTI news agency.