Bharat Biotech has announced the termination of its memorandum of understanding (“MOU”) dated November 24, 2020, with Precisa Medicamentos and Envixia Pharmaceuticals LL.C, a huge set back to Brazil vaccination drive, to bring and introduce COVAXIN in Brazil.
The unjustified controversy in Brazil also slowed down the process – not because the vaccine lacks scientific backing or efficacy standards, but got dragged into of the tremor of national vaccine politics.
The coronavirus delta variant continue to impact people across the globe and is on a rampage, with the slowing down of COVAXIN import will further the pain for Brazil, where people have to wait longer to get vaccinated by India’s vaccination. Brazil has reported 500,000 plus covid deaths and the number is growing.
So, what’s the story? Why did the fall out happen between the partners. The said MOU was entered with Precisa and Envixia to introduce Bharat Biotech’s innovative COVID 19 vaccine COVAXIN® in the territory of Brazil. The Company has terminated the said MOU with immediate effect.
One of the reason for termination is as it may be could be the recent information that Bharat Biotech got to know, that certain letters, purported to have been executed by executives of Precisa, are being circulated online. In a statement issued to media Bharat Biotech said “We would like to emphatically state that these documents have not been issued by Bharat Biotech or its executives and therefore vehemently deny the same”
All Covaxin export orders are prepaid
As part of its global supply outreach, the Bharat Biotech has offered to supply COVAXIN ® to Brazil. The global pricing (save for India) of COVAXIN® has been set between USD 15-20.
COVAXIN® has been offered to the Government of Brazil at the rate of USD 15 per dose, similar to the set price for international markets, in fact the private market in India charges $19 for COVAXIN®. While the Government of India is administering for free of cost, the 1% of Indian population who wish to go to the private market will have to pay $19.
It is further stated that the company has not received any advance payments from Brazil, nor has it supplied any vaccines to the Ministry of Health in Brazil.
Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country.
Notwithstanding such termination, the company further stated that Bharat Biotech will continue to work diligently with ANVISA, the Brazilian drug regulatory body, to complete the regulatory approval process for COVAXIN®.
The Company also stresses that all its actions, including its global dealings, are done under local laws and that the Company employs and follows the highest standards of ethics, integrity
and compliance at all times.
COVAXIN® Product Development – Towards a global Covid-19 vaccine
Bharat Biotech’s vaccine research, development, and manufacturing practices are driven by science and validated by empirical evidence.
Bharat’s commitment to vaccine discovery data transparency has an
impeccable record and has been proven with 10 scientific publications even with its newest COVID-19Vaccine – COVAXIN®, covering all aspects of product development, within 12 months.
COVAXIN® has been formulated to enable shipping and long-term storage at 2-8oC, it does not need diluents or frozen storage conditions, thereby reducing infrastructure, distribution, and logistics costs.
Bharat Biotech’s commitment to continuous improvement of COVAXIN® is currently underway with 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.
COVAXIN® has received Emergency Use Authorizations in 16 countries including 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 for COVAXIN®. The product has been exported to several countries, with additional requests for supplies being received.
Bharat Biotech has established COVAXIN® manufacturing at four facilities within India, and further expansion is in the process to reach an annualized capacity of 1 billion doses by the end of 2021.
Technology transfer activities are in progress to companies in the United States and other countries.
It is further stated that the company has not received any advance payments from, nor has it supplied any vaccines to the Ministry of Health in Brazil.
We have very recently been informed that certain letters (as attached), purported to have been executed by executives of the company are being circulated online. We would like to emphatically state that these documents have not been issued by the Company or its executives and therefore vehemently deny the same.
Bharat Biotech Stated in its statementThe Company also stresses that all its actions, including its global dealings, are done under local laws and that the Company employs and follows the highest standards of ethics, integrity and compliance at all times.
Bharat Biotech earlier reaffirmed , saying it had followed a “step-by-step” procedure with Brazilian authorities and Precisa Medicamentos, the intermediary between Brazil and Bharat Biotech.
Precisa Medicamentos was Bharat Biotechs partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.
COVAXIN® Product Development – Towards a global Covid-19 vaccine
Bharat Biotech’s vaccine research, development, and manufacturing practices are driven by science and validated by empirical evidence.
Bharat commitment to vaccine discovery data transparency has an
impeccable record and has been proven with 10 scientific publications even with its newest COVID-19Vaccine – COVAXIN®, covering all aspects of product development, within 12 months.
COVAXIN® has been formulated to enable shipping and long-term storage at 2-8oC, it does not need diluents or frozen storage conditions, thereby reducing infrastructure, distribution, and logistics costs.
It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money for procurement agencies and governments alike.
Bharat Biotech’s commitment to continuous improvement of COVAXIN® is currently underway with 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.
COVAXIN® has now received Emergency Use Authorizations in 16 countries including 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 for COVAXIN®. The product has been exported to several countries, with additional requests for supplies being received.
Bharat Biotech has established COVAXIN® manufacturing at four facilities within India, and further expansion is in the process to reach an annualized capacity of 1 billion doses by the end of 2021.
Technology transfer activities are in progress to companies in the United States and other countries.
The reason for the termination of the contract could be because of differing business practices but what is important to note that the company continues to engage with the health authorities in Brazil and also are in talks with ANVISA for the export of COVAXIN.
