Indian drugmaker Bharat Biotech on June 30 said it had not received an advance payment nor supplied coronavirus vaccines to the Brazilian government, which suspended the $324-million deal following a firestorm of allegations of graft.
The company followed the procedure laid down globally for procurement of vaccines by governments, the Hyderabad-based vaccine-maker said in response to reports of “serious accusations” of irregularities.
"During the past few weeks, there have been reports in the media at large misrepresenting the procurement process of Covaxin in Brazil and other countries," the company said.
The deal has become the latest problem for Brazilian President Jair Bolsonaro who faces elections next years and is under fire for mishandling the coronavirus outbreak in the country, where 500,000 people have died of COVID.
Bolsonaro and his health minister Marcelo Queiroga have denied allegations of wrongdoing. An investigation is underway.
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A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
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Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Read: Brazil probes Health Ministry deal to buy Covaxin vaccine
The company said that in the case of procurement of Covaxin by the ministry of health (MOH) Brazil, since the first meetings with MOH Brazil during Nov 2020, until June 29 2021, a step by step approach was followed towards contracts and regulatory approvals.
"The emergency use authorisation (EUA) received on June 4, 2021. As of 29th June 2021, Bharat Biotech has not received any advance payments nor supplied any vaccines to MOH Brazil," the company said.
“Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully.”
Also read: Explained: Brazil's $324 million controversial Covaxin deal and its implications for President Jair Bolsonaro
The company said that the procurement process for Covid jab and other vaccines for routine immunisation followed a common process that is widely accepted and established.
"Based on a country’s requirement, the company receives a letter of intent (or MoU) for procurement. The company then proceeds to apply for emergency use authorization (EUA) in the respective country
Once EUA is received, the Ministry of Health (MoH) would proceed to place a firm order by releasing a purchase order, with the required initial quantities," the company said.
The Bolsonaro government has been accused of agreeing to buy the vaccine at an inflated price and that too without regulatory approval.
In several countries such as the USA, EU, India, health ministries placed orders prior to the approval of vaccines. “However, procurement happens only post EUA. In order to secure a firm purchase order from the country, the company proceeds to raise a Pro Forma Invoice to the MOH, towards the supply of the vaccine. Based on the invoice, the MOH pays the amount in advance. Once the payment is received, the company proceeds to supply the agreed quantities and within the agreed timelines," the vaccine maker added.
Bharat Biotech said the pricing of Covaxin was clearly established between $15 and 20 a dose for supplies to governments outside India.
The pricing for Brazil, too, was been indicated at $ 15 a dose, it said. Covaxin is a double-dose jab.
Bharat Biotech received advance payments from several other countries at the same price point, with supplies in process, pending approvals, it said.
Brazilian drug maker Precisa Medicamentos is Bharat Biotech’s partner in that country, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance, conduct of phase III clinical trials, etc.
Bharat Biotech said it followed a similar partnership model in all countries, as it does not have its offices in these countries
Bharat Biotech and Precisa Medicamentos are conducting a 5,000-subject phase III clinical trial in Brazil, which was recently approved by ANVISA, the country’s drug regulator. The trial would be conducted by the Albert Einstein Institute