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Bharat Biotech Successfully Ships out COVAXIN™ to 11 cities, donates 16.5 Lakh doses to the Government

Hyderabad, India, January 13, 2021: Bharat Biotech has announced the successful air-shipment of COVAXIN™, to 11 cities in India in the early hours of Wednesday. Bharat Biotech has also donated 16.5 Lakh doses to the Government of India.

The company also expressed deepest gratitude to the nation, all the clinical trial volunteers, and its partners for making this a successful and milestone public-private partnership for the development of India's first COVID19- vaccine.

After having received the government purchase order for 55 lakh doses, Bharat Biotech shipped the first batch of vaccines (each vial containing 20 doses) to Ganavaram, Guwahati, Patna, Delhi, Kurukshetra, Bangalore, Pune, Bhubaneswar, Jaipur, Chennai and Lucknow. While some shipments have arrived in the respective cities, others will be delivered later this evening.

COVAXIN™ is a highly purified and inactivated 2 dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

This vaccine by Bharat Biotech is India's totally indigenous COVID-19 vaccine 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) biocontainment 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.

This vaccine 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.

Bharat Biotech COVAXIN™ Publications

Preclinical Product Development
https://www.biorxiv.org/content/10.1101/2020.09.09.285445v2
 
Animal Challenge Studies – Hamsters
https://www.researchsquare.com/article/rs-76768/v1
 
Animal Challenge Studies - Rhesus Macaques
https://vaccine.icmr.org.in/images/pdf/934dd262-405d-43c6-af12-e59901253050.pdf
 
Human Clinical Trials – Phase I
https://www.medrxiv.org/content/10.1101/2020.12.11.20210419v1
 
Human Clinical Trials – Phase II
https://www.medrxiv.org/content/10.1101/2020.12.21.20248643v1


About Bharat Biotech: 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 with registrations in more than 123 countries and WHO Pre-qualifications of its products.

Founded in 1996 in 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.

The company has proven proficiency in conducting extensive multi-center clinical trials, having completed more than 75 trials enrolling more than ~ 700,000 participants across continents. Our commitment to global social innovation programs and public-private partnerships resulted in the introduction of path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combating Polio, Rotavirus and Typhoid infections respectively. Bharat Biotech has successfully partnered with NIV-ICMR having developed JENVAC®, a licensed Japanese Encephalitis vaccine.

The 2019 acquisition of Chiron Behring (CHIRORAB®), has positioned Bharat Biotech as the largest Rabies vaccine manufacturer in the world.

To learn more about Bharat Biotech visit www.bharatbiotech.com

Media contact for Bharat Biotech: Sheela Panicker | +91 984 980 9594 | enright@enrightpr.com

Hyderabad, India, January 13, 2021: Bharat Biotech has announced the successful air-shipment of COVAXIN™, to 11 cities in India in the early hours of Wednesday. Bharat Biotech has also donated 16.5 Lakh doses to the Government of India.

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