Bharat Biotech signs agreement with Precisa Medicamentos to supply Covaxin to Brazil

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Bharat  Biotech announced  that  it  has  signed  an agreement  with Precisa Medicamentos for the supplies of COVAXIN™ to Brazil.

A team from Precisa Medicamentos has visited the Bharat Biotech facility last week to discuss potential export possibilities of COVAXIN™, India’s 1stIndigenous vaccine for COVID-19. The team met Dr. Krishna Ella  at  Bharat  Biotech  on  the  7thand  8thof  January  at  the  Bharat  Biotech  facility  in  Genome  Valley, Hyderabad. During the discussion, his Excellency Ambassador of Brazil to India, André Aranha Corrêa do Lago joined on a virtual platform. He expressed his keen interest on behalf of the Govt. of Brazil, towards the procurement of COVAXIN™. In principle, it is understood between both parties that supplies of COVAXIN™ to be prioritized for the public market, through a direct procurement by the Govt. of Brazil.

Supplies  to the private market would be  based upon receipt of market authorization from ANVISA, the Brazilian regulatory authority.Pleased with the interest expressed by the Brazilian government, the Chairman and Managing Director of  Bharat  Biotech  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 an 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.

”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.”COVAXIN™ is a highly purified and inactivated 2 dose SARS-CoV-2 vaccine,  manufactured  in  a  Vero  cellmanufacturing platform with an excellent safety track record of more than 300 million doses.The Phase III human clinical trials of COVAXIN™ began mid-November  and  are  currently  ongoing  in ~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. 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.COVAXIN™, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) -National Instituteof 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  has  also  shown  to  generate  memory  T  cell responses,  for  its  multiple  epitopes,  indicating  longevity  and  a  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 has generated 5 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.

About Bharat Biotech
Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics with registrations in more than 123 countries and WHO Pre-qualifications of its products.Founded  in  1996in  Genome  Valley,  Hyderabad,  the  company  has  built  world-class  vaccines  &  bio-therapeutics, research & product development, including Bio-Safety Level 3 manufacturing facilities, for vaccine production, supply and distribution.Having  delivered  more  than  4  billion  doses  of  vaccines  worldwide,  Bharat  Biotech  continues  to  lead innovation  and  has  developed  vaccines  for  Hepatitis-B,  influenza  H1N1,  Polio,  Rotavirus,  Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid  conjugated  vaccine  for Typhoid.