Bharat Biotech on Wednesday issued a clarification over the procurement process of Covaxin in Brazil and other countries. This comes hours after the Brazilian government, which agreed to purchase 20 million doses of Bharat Biotech's COVID-19 vaccine Covaxin announced the suspension of the contract following allegations of irregularities in the deal.
The Covaxin contract to Brazil had landed in controversy after the South American country's Attorney General reportedly launched a probe into the deal.
Read | Brazil to suspend Covaxin deal with Bharat Biotech over allegations of irregularities by President
Bharat Biotech, in its clarification, has said the following
- The procurement process for COVID-19 vaccines and several vaccines for routine immunization follow a common process which is widely accepted, and established in Industry
- 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. In several countries, MOHs have placed orders for procurement prior to the approval of vaccines such as USA, EU, India, etc. 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
- 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 long month-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
- 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, 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 which are exported to more than 123 countries and has thus far delivered more than 4 billion doses of vaccines across the world
On Tuesday, Brazil's Health Minister Marcelo Queiroga, the head of the Federal Comptroller General (CGU) Wagner Rosario, said that the agency will investigate the process of purchasing the vaccine.
"We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week," said Rosario.
"We have put in a reinforced team for the verification. We hope to be very quick in this process, and we hope that in no more than 10 days we will already have an answer for this analysis," he said.