09 April 2021 | News
With its commercial launch in December 2019, ROTAVAC 5D is the world’s first and only liquid formulation with the lowest dosage form and can be stored at 2 to 8°C for up to 24 months
A new variant of rotavirus vaccine, ROTAVAC 5D which is safe and effective in the prevention of rotavirus diarrhoea, developed by Hyderabad based Bharat Biotech has been awarded BioSpectrum Product of the Year Award 2020. Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, Hyderabad received the award at a virtual ceremony held in March 2021. The ceremony witnessed the participation of over 200 industry leaders from across the country.
With its commercial launch in December 2019, ROTAVAC 5D is the world’s first and only liquid formulation with the lowest dosage form and can be stored at 2 to 8°C for up to 24 months. ROTAVAC 5D is a monovalent vaccine containing a suspension of live, naturally attenuated rotavirus neonatal 116E strain prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 mL ROTAVAC 5D contains not less than [NLT] 105.0 FFU [Focus forming unit] of live rotavirus 116E and is administered in five drops as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. It is a unique rotavirus vaccine formulation that can be administered without a buffer. Low dose facilitates easy vaccine logistics and cold chain management, aside from low biomedical waste disposal post-vaccination.
ROTAVAC 5D confers similar clinical safety and immunogenicity profiles when compared to the WHO Prequalified ROTAVAC. It is available in three different presentations, single-dose vial/pre-filled syringe and multi-dose vial. The available presentations and lowest dosage form make it convenient and easy to adapt under Universal Immunization Programs (UIP) by countries. ROTAVAC 5D presented in multi-dose vials results in saving approximately $0.30/dose in supply chain and delivery costs. Over 25 countries have granted patents for ROTAVAC 5D.
In his acceptance speech Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said “Dr Maharaj Kishan Bhan was the one who isolated the strain way back in 1983 in AIIMS New Delhi. The product has finally arrived with almost 17-18 years of journey. It came into the market in 2015 and it was launched by Prime Minister Narendra Modi. Many markets said -20°C wasn’t good, we need to develop a 5D refrigerated temperature and one multi-dose vaccine. We once again took up the R&D project. We brought it as a five degrees (5D) stable formulation and we got almost eight patents around that. This product was launched by M Venkaiah Naidu, Vice President of India in December, 2019. There have been many firsts for this product. This is a true public-private partnership for the country. More than 65 scientists globally were involved in this project. This vaccine can be administered to a baby as soon as it is born. We conducted clinical trials in eight different countries. The Gates Foundation supported us with $200 million in funding for this clinical programme. ROTAVAC 5D is the first multi-dose vaccine, which reduces the cold chain space and also reduces logistics cost, therefore making this an affordable vaccine. That speaks to what we can deliver to the world. India can innovate, India can deliver to the world! ”
Besides the Product of the Year award, a panel of jury chaired by Dr Renu Swarup Secretary, Department of Biotechnology (DBT), Government of India, has selected other awards namely – Life Time Achievement Award, Entrepreneur of the year award, Woman Entrepreneur of the Year award and Business Person of the Year Award at a meeting held at her office in February 2020.
The jury panel includes Utkarsh Palnitkar, Founder & Managing Partner, Aarna Corporate Advisors, US; Dr Gagandeep Kang, the then Executive Director, Translational Health Science & Technology Institute (THSTI), New Delhi (she is now Professor of Microbiology, at the Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences at the Christian Medical College (CMC) in Vellore) ; Deepanwita Chattopadhyay, Chairperson and CEO, IKP Knowledge Park, Hyderabad; and Dr Bhagirath Choudhary, Board member of APEDA, Ministry of Commerce & Industry and Founder Director, South Asia Biotechnology Centre (SABC), New Delhi.
Talking about the BioSpectrum Excellence Awards 2020, Ravi Boratkar, Managing Editor and Publisher, BioSpectrum India, MM Activ Sci-Tech Communications, New Delhi said “BioSpectrum awards as we know were constituted in 2003. Unfortunately, the awards ceremony was discontinued in between. However, we used to receive queries and calls. Finally, in 2019, we decided to keep up this good work and acknowledging, appreciating and awarding the exemplary work of individuals and companies in the respective fields with these awards. The actual BioSpectrum Awards Ceremony was organised at The LaLiT Ashok Bangalore, on March 27, 2020. But due to the COVID-19 pandemic, we were forced to cancel the ceremony. We hoped to do it at a later date. However now we realised that it will be a time for next year’s award. So we decided to go virtually. Hence we thought let’s come together and do this programme virtually.”