Friday, May 27, 2022

Bharath Biotech refutes charges of irregularities in Covaxin supply to Brazil

By Telangana Today

Published: Published Date - 03:06 PM, Wed - 30 June 21

Hyderabad: Bharath Biotech has refuted the reports that it resorted to irregularities in supply of its Covid-19 vaccine – Covaxin, to Brazil and asserted that the company had not digressed from any rules and regulations.

This assertion came from Bharath Biotech, after Brazil indicated suspension of its contract with the Hyderabad-based vaccine maker after allegations of irregularities in the deal surfaced.

Brazil’s President Jair Bolsonaro and Health Minister Marcelo Queiroga have also denied allegations of wrongdoing.

Bharath Biotech reiterated that it had followed a step-by-step approach towards contracts and regulatory approvals during the eight-month long process of finalising the deal with Brazil. The EUA was received on June 4.

The company also maintained that it had neither received any advance payments nor did it suuply vaccine to Brazil. The company had followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin was being supplied successfully.

The pricing of Covaxin was between $15 and $20 per dose for supplies to other countries. The pricing for Brazil was also fixed at $15 per dose. Precisa Medicamentos was Bharat Biotech’s partner in Brazil. The partner is expected to assist, guide and support with regulatory submissions, licensure, distribution, insurance, conduct of phase III clinical trials, etc. Bharat Biotech followed 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 5,000 subject phase III clinical trial in Brazil, which was recently approved by ANVISA. The trial will be conducted by the Albert Einstein Institute.

Standard procurement process

Explaining the typical vaccine procurement process, the company stated that the procurement for Covid-19 vaccines and several vaccines for routine immunisation follow a common process which is widely accepted and established in the 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 the 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 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.