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    India’s COVAXIN, Long Awaited in the US to be Evaluated by FDA

    COVAXIN maker Bharat Biotech announced today that U.S. Food and Drug Administration (FDA) has lifted its clinical hold to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN® outside the United States.

    COVAXIN® has already been granted Emergency Use Listing (EUL) in several countries as on January 31 according to the WHO. COVAXIN was granted EUL by the national regulator, Drugs Controller General of India (DCGI), in the age group 12 to 18 years on December 24, 2021.

    COVAXIN® is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

    Bharat Biotech Partner in the United States Ocugen, Inc. in their announcement made today stated U.S. FDA Lifts Clinical Hold on the Submission of Its Investigational New Drug Application for Its COVID-19 Vaccine Candidate COVAXIN™ (BBV152)

    “We are pleased to be able to move our clinical program for COVAXIN forward, which we hope will bring us closer to offering an alternative COVID-19 vaccine,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate.”

    Dr. Krishna Ella, Chairman and Managing Director had stated earlier “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. Our goal for all vaccines developed at Bharat Biotech is to provide global access. COVAXIN™ has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”

    COVAXIN has Emergency Use Listing (EUL) authorisation in 20 countries

    COVAXIN™ (BBVI52) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

    With more than 200 million doses having been administered to adults outside the U.S., COVAXIN is currently authorized under emergency use in 20 countries, and applications for emergency use authorization are pending in more than 60 other countries.

    The World Health Organization (WHO) recently added COVAXIN to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN. The trade name COVAXIN has not been evaluated by the FDA.

    Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industr,

    Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

    Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

    Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

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