Hyderabad (Telangana) [India], January 12 (ANI): Bharat Biotech has announced that it has signed an agreement with Precisa Medicamentos for the supply of COVAXIN to Brazil.
A team from Precisa Medicamentos visited the Bharat Biotech facility last week to discuss potential export possibilities of COVAXIN, India's first indigenous vaccine for COVID-19.
The team met Chairman and Managing Director of Bharat Biotech, Dr Krishna Ella at Bharat Biotech on January 7 and 8 at the Bharat Biotech facility in Genome Valley, Hyderabad.
During the discussions, the Ambassador of Brazil to India, Andre Aranha Correa do Lago joined on a virtual platform.
He expressed his keen interest on behalf of the Government of Brazil, towards the procurement of COVAXIN.
In principle, it is understood between both parties that supplies of COVAXIN will be prioritised for the public market, through a direct procurement by the Government of Brazil, Bharat Biotech said in a release.
Supplies to the private market would be based upon receipt of market authorization from ANVISA, the Brazilian regulatory authority, it added.
Dr Krishna Ella said, "The COVID-19 pandemic has affected humanity at large. As a company determined to protect global public health, it has always been important for us to develop vaccines for a global cause. COVAXIN is innovation and a perfect example of novel product development from India."
"Our goal for all vaccines developed at Bharat Biotech is to provide global access to populations that need it the most. COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist. We are happy to note that vaccines innovated in India are able to address the public health needs of Brazil," he added.
After the technical visit to Bharat Biotech's Genome Valley facility in Hyderabad, the pharmaceutical director of Precisa Medicamentos, Emanuela Medrades said, "We identified highly technological, scientific and sanitary control levels. There were also excellent outcomes in clinical trials, which will be published soon. Bharat Biotech has exceeded our expectations, demonstrating quality and safety at the level of the largest vaccine suppliers in the world."
Bharat Biotech said, "COVAXIN is a highly purified and inactivated two-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses."
"The Phase-III human clinical trials of COVAXIN began in mid-November and are currently ongoing on around 26,000 volunteers across India. This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India," it added.
It further said: "COVAXIN has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals."
Bharat Biotech further informed: "COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world."
"The evaluation of COVAXIN has resulted in several unique product characteristics including long term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad-spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants," it added.
Further, the pharmaceutical manufacturer elaborated: "It has also shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data. COVAXIN is presented in multi-dose vials, can be stored at 2-8oC."
"The product development and clinical trial data thus far have generated five publications, which have been submitted to international peer-reviewed journals, 4 of which have been accepted and will be published soon. The publication of phase II trial data is undergoing the peer review process," it added. (ANI)