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A step-by-step approach has been followed in signing the Covaxin supply contract with Brazil and the process. A similar procedure is being followed in other countries where Covaxin is being supplied `sucessfully' Bharat Biotech has said on Wednesday.
The Hyderabad-based vaccine maker responded to the suspension of a $324 million contract to supply 20 million doses of Covaxin by Brazil following complaints' it received on alleged irregularities and `high pricing'.
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Bharat Biotech said the company will issue a statement on the matter in due course``In the specific case of procurement of Covaxin by the Ministry of Health, Brazil, since the first meetings from November 2020 until June 29, 2021, a step by step approach has been followed towards contracts and regulatory approvals,'' the company said in a statement issued.
While the Emergency Use Authorisation (EUA) was received on June 4, 2021, Bharat Biotech has not received any advance payments nor supplied any vaccines to the Ministry of Health, Brazil, the statement said.
“Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin being supplied successfully,'' it added.
On pricing
The company said 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,'' it added.
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Bharat Biotech has denied any allegation of wrongdoing with respect to Covaxin supplyPrecisa 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 and Precisa Medicamentos are conducting a 5000 subject phase III clinical trial in Brazil, which was recently approved by Brazilian regulator, Anivsa. The trial will be conducted by the Albert Einstein Institute, the company said.
Additional trials
Bharat Biotech is conducting additional clinical trials to establish safety and efficacy in children between 2-18 years of age in India. “Further, a clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study Variants of Concern and assess their suitability for follow-up booster doses,'' it said.
Covaxin has so far received EUAs in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc., with EUA’s in process in 50 countries worldwide. Bharat Biotech is in discussions with WHO to obtain Emergency Use Listing fo Covaxin.
The company has taken up manufacturing of Covaxin at four facilities within India. Further expansion is underway to reach an annualised capacity of one billion doses by the end of 2021. Technology transfer activities are in progress to companies in the United States and other countries, it added.
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