Bharat Biotech reveals details of procurement process as Brazil suspends Covaxin deal

The Brazilian government had agreed to purchase over 20 million doses of Bharat Biotech's Covaxin has now decided to suspend the deal citing irregularities. The Indian pharma major has therefore given out the details of the procurement process of their COVID-19 vaccines. Bharat Biotech also informed that it has not received any advance payments nor supplied any vaccines to the Ministry of Health of Brazil. 

Bharat Biotech gives out details of the procurement process

Bharat Biotech in its statement responded to the media reports and explained the procurement process of Covaxin which was sought by Brazil and other countries. Issuing a clarification, it stated that the company follows a common process that is widely accepted and established in the industry. It further added that based on a country’s requirement, the company receives a letter of intent (or MOU) for procurement. Further, the company proceeds to apply for emergency use authorization (EUA) in the respective country, the statement added. 

According to the statement, Bharat Biotech further stated that 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. In several countries, MOHs have placed orders for procurement prior to the approval of vaccines such as USA, EU, India, etc, the statement added. However, it also mentions that the procurement happens only post EUA. It further says that 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. Later, the MOH pays the amount in advance based on the invoice. Once the payment is received, the company proceeds to supply the agreed quantities and within the agreed timelines

'Not received any advance payments from MOH Brazil' 

Bharat Biotech has said that it did not receive any advance payments nor supplied any vaccines to MOH Brazil. Here's the complete statement:

"In the specific case of procurement of COVAXIN®️ by MOH Brazil, since the first meetings with MOH Brazil during Nov 2020, until 29th of June 2021, a step-by-step approach has been followed towards contracts, and regulatory approvals, during this 8-months-long process. EUA received on 04th June 2021. As of 29th June 2021, Bharat Biotech has not received any advance payments nor supplied any vaccines to MOH Brazil. Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where COVAXIN®️ is being supplied successfully," 

Here are some other points from the statement: 

• The pricing of COVAXIN®️ has been clearly established between $15-20 per dose for supplies to Governments outside India. The pricing for Brazil has also been indicated at $ 15 per dose. Bharat Biotech has received advance payments from several other countries at the above price points, with supplies in process, pending approvals
• Precisa Medicamentos is Bharat Biotech’s partner in Brazil, providing assistance, guidance, and support with regulatory submissions, licensure, distribution, insurance, the conduct of phase III clinical trials, etc. Bharat Biotech follows a similar partnership model in all countries, where its vaccines are supplied, as it does not have its own offices in these countries
• Bharat Biotech and Precisa Medicamentos are conducting a 5000 subject phase III clinical trial in Brazil, which was recently approved by ANVISA. The trial will be conducted by the Albert Einstein Institute
• Bharat Biotech has a large portfolio of 20 products that are exported to more than 123 countries and has thus far delivered more than 4 billion doses of vaccines across the world