Media Coverage World Health Organisation Grants Prequalification to Bharat Biotech s rotavirus vaccine, ROTAVAC(R)

Transcription

1 Media Coverage World Health Organisation Grants Prequalification to Bharat Biotech s rotavirus vaccine, ROTAVAC(R) 1) Business Wire World Health Organization Grants Prequalification to Bharat Biotech s Rotavirus Vaccine, ROTAVAC (L to R) Neeraj Jain, Director, PATH, Dr. TS Rao, Sr. Advisor, Department of Biotechnology, Mr. Duncan Steele, Deputy Director, The Bill and Melinda Gates Foundation, Dr. Krishna Ella, CMD, Bharat Biotech - announcing details about Bharat Biotech's ROTAVAC - India's 1st WHO Prequalified Rotavirus Vaccine in New Delhi, India (Photo: Business Wire) January 24, :33 AM Eastern Standard Time NEW DELHI--(BUSINESS WIRE)--Bharat Biotech today announced that the World Health Organization (WHO Geneva) has awarded prequalification to the developing world s first rotavirus vaccine, ROTAVAC.

2 WHO Prequalification is necessary for UN agencies and Gavi, the Vaccine Alliance to purchase the vaccine in partnership with developing countries and will help accelerate availability of the ROTAVAC to the developing countries with the highest burden of disease. India has introduced ROTAVAC into its national immunization program during 2016, with ~35 million doses delivered till date. Rotavirus is the leading cause of severe diarrhea among children less than five years of age around the world, resulting in ~215,000 deaths and 2 million hospitalizations. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP. We are highly honored and delighted to become the first rotavirus vaccine from the developing world and India to be WHO Prequalified. We feel proud to dedicate this innovated in India and Made in India vaccine to the world. The true impact of vaccines can be seen, when vaccinations are carried out in affected populations. The Government of India has given a big boost by making ROTAVAC available to millions in India already," said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech. Bharat Biotech s track record of lifesaving vaccines is a testimony to the company's longstanding commitment to make affordable vaccines for the developing world. ROTAVAC has been supplied to low income countries at $1.0 / dose, with the feasibility for further ~30% price reductions, based on the procurement of ~100 million doses to these countries, Dr. Krishna Ella added. ROTAVAC was developed as a result of a multi-country - multi-partner collaborative model of team science for over 2 decades. This large public private social innovation partnership included the Government of India s Department of Biotechnology (DBT), the Indian Council of Medical Research, the Indian Institute of Science (IISC), the All India Institute of Medical Sciences (AIIMS), the Translational Health Sciences and Technology Institute (THSTI), the Society for Applied Studies (SAS), Christian Medical College (CMC) Vellore, King Edwards Memorial Hospital (KEM) Pune, Stanford University School of Medicine, the U.S. National Institutes of Health (NIH), the U.S. Centers for Disease Control and Prevention (CDC), Johns Hopkins University and PATH. The ROTAVAC partnership has resulted in more than 15 international publications, including the pivotal phase III publication in Lancet in The novel team science partnership that developed this vaccine serves as a useful model for others to follow, said Dr. Roger I. Glass, Director of the Fogarty International Center at the U.S. National Institutes of Health, who helped shepherd the process. The result is an effective, yet economical, vaccine that has the potential to save thousands of children s lives in Africa and elsewhere. According to him, Rotavirus is responsible for an estimated 36% of hospitalizations for childhood diarrhea around the world and for an estimated 200,000 deaths in low and middle income countries. WHO prequalification for ROTAVAC is the result of a rigorous regulatory process. ROTAVAC has been under development since the year 2000 necessitating investments of around USD 200 million towards product development and dedicated manufacturing

3 infrastructure. The Genome Valley facility has an installed manufacturing capacity of up to 200 million doses / year, and is a scalable model ready to meet global demand. India s leadership in developing and introducing its own rotavirus vaccine is commendable and emphasizes a national commitment to improving the health of their children, said Duncan Steele, deputy director on the Enteric Diarrheal Diseases team at the Bill & Melinda Gates Foundation. The advent of a locally manufactured, WHO Prequalified rotavirus vaccine offers promise to protect children in India, Africa, the Americas and the rest of Asia from this debilitating disease. Bharat Biotech has successfully miniaturized the dose volume of ROTAVAC, to 0.5 ml / dose and is presented in a ready-to-use format, requiring no further reconstitution, similar to oral polio vaccines. The product profile of ROTAVAC has been optimally designed for the developing world by the developing world to aid ease of administration, reduced training requirements, and with the lowest cold chain footprint for an oral rotavirus vaccine in the world. The cold chain footprint has been reduced to ~3 cm 3 / dose, resulting in significant savings in cold chain storage and distribution costs. The 0.5 ml dose volume also reduces the amount of spit-ups by infants when the vaccine is administered. 2) The Economic Times WHO awards prequalification to Bharat Bio s Rotavirus vaccine ET Bureau Jan 26, 2018, PM IST India's vaccine maker Bharat Biotech has announced receiving prequalification from the World Health Organisation (WHO) for its rotavirus vaccine Rotavac, considered the developing world's first rotavirus vaccine. The vaccine to prevent infant deaths and hospitalisations due to rotavirus diarrhoea was launched by Prime Minister Narendra Modi in March In a statement, the Hyderabadd headquartered biopharmaceuticals firm said the WHO prequalification was necessary Read more at: //economictimes.indiatimes.com/articleshow/ cms?utm_source=contentofinterest& utm_medium=text&utm_campaign=cppst 3)

4 WHO grants prequalification to Bharat Biotech's Rotavirus Vaccine 'ROTAVAC' Bharat Biotech on Thursday announced that the World Health Organisationn (WHO Geneva) has awarded prequalification to the developing world's first rotavirus vaccine, ROTAVAC. WHO prequalification is necessary for UN agencies and Gavi, the Vaccine Alliance to purchase the vaccine in partnership with developing countries and will help accelerate availability of the ROTAVAC to the developing countries with the highest burden of disease. India has introduced ROTAVAC into its national immunisation program during 2016, with 35 million doses delivered till l date. 4) WHO grants prequalification to Bharat Biotech's Rotavirus Vaccine 'ROTAVAC' ANI Updated: Jan 25, :20 IST New Delhi [India], Jan 25 (ANI-BusinessWire India): Bharat Biotech on Thursday announced that the World Health Organisation (WHO Geneva) has awarded prequalification to the developing world's first rotavirus vaccine, ROTAVAC. WHO prequalification is necessary for UN agencies and Gavi, the Vaccine Alliance to purchase the vaccine in partnership with developing countries and will help accelerate availability of the ROTAVAC to the developing countries with the highest burden of disease. India has introduced ROTAVAC into its national immunisation program during 2016, with 35 million doses delivered till l date. Rotavirus is the leading cause of severe diarrhea among children less than five years of age around the world, resulting in 215,000 deaths and 2 million hospitalisations. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP. "We are highly honored and delighted to become the first rotavirus vaccine from the developing world and India to be WHO Prequalified. We feel proud to dedicate this innovated in India and Made in India vaccine to the world. The true impact of vaccines can be seen, when vaccinations are carried out in affected populations. The Government of India has given a big boost by making ROTAVAC available to millions in India already." said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.

5 "Bharat Biotech's track record of life saving vaccines is a testimony to the company's longstanding commitment to make affordable vaccines for the developing world. ROTAVAC has been supplied to low-income countries at $ 1.0/dose, with the feasibility for further 30 percent price reductions, based on the procurement of ~ 100 million doses to these countries", he added. ROTAVAC was developed as a result of a multi country - multi partner collaborative model of team science for over 2 decades. This large public private social innovation partnership included the Government of India's Department of Biotechnology (DBT), the Indian Council of Medical Research, the Indian Institute of Science (IISC), the All India Institute of Medical Sciences (AIIMS), Christian Medical College (CMC) Vellore, King Edwards Memorial Hospital (KEM) Pune, and others. The ROTAVAC partnership has resulted in more than 15 international publications, including the pivotal phase III publication in Lancet in "The novel team science partnership that developed this vaccine serves as a useful model for others to follow. The result is an effective, yet economical, vaccine that has the potential to save thousands of children's lives in Africa and elsewhere," said Dr. Roger I. Glass, Director of the Fogarty International Center at the U.S. National Institutes of Health. According to him, Rotavirus is responsible for an estimated 36 percent of hospitalisations for childhood diarrhea around the world and for an estimated 200,000 deaths in low and middleincome countries. WHO prequalification for ROTAVAC is the result of a rigorous regulatory process. ROTAVAC has been under development since the year 2000 necessitating investments of around USD 200 million towards product development and dedicated manufacturing infrastructure. The Genome Valley facility has an installed manufacturing capacity of up to 200 million doses/year, is a scalable model ready to meet global demand. "India's leadership in developing and introducing its own rotavirus vaccine is commendable and emphasizes a national commitment to improving the health of their children. The advent of a locally manufactured, WHO prequalified rotavirus vaccine offers promise to protect children in India, Africa, the Americas and the rest of Asia from this debilitating disease," said Duncan Steele, deputy director on the Enteric Diarrheal Diseases team at the Bill & Melinda Gates Foundation. Bharat Biotech has successfully miniaturized the dose volume of ROTAVAC, to 0.5 ml/dose and is presented in a ready to use format, requiring no further reconstitution, similar to oral polio vaccines. The product profile of ROTAVAC has been optimally designed for the developing world by the developing world to aid ease of administration, reduced training requirements, and with the lowest cold chain footprint for an oral rotavirus vaccine in the world. The cold chain footprint has been reduced to 3 cm3/dose, resulting in significant savings in cold chain storage and distribution costs. The 0.5 ml dose volume also reduces the amount of spit ups by infants when the vaccine is administered. (ANI-BusinessWire India)

6 5) Bharat Biotech s diarrhoea vaccine ROTAVAC gets WHO pre-qualification The WHO pre-qualification paves the way for health and humanitarian organizations such as UNICEF to procure ROTAVAC for public health vaccination programmes Last Published: Thu, Jan AM IST New Delhi: Hyderabad-basedd Bharat Biotech Ltd on Wednesday announced that it had earned the World Health Organization (WHO) pre-qualification tag for its rotavirus vaccine, ROTAVAC. The WHO pre-qualification paves the way for health and humanitarian organizations such as Unicef, GAVI and Pan-American Health Organization to procure it for public health vaccination programmes across the world. The move indicates that the WHO has given the vaccine its stamp of approval in safety and efficacy and United Nations procuring agencies may source it. We are honoured and delighted to become the first rotavirus vaccine from the developing world and India to be WHO Prequalified. We feel proud to dedicate this innovated in India and Made in India vaccine to the world. This is the first success story where the virus was isolated in 1986 at AIIMS and how Indo-US vaccine action programme involved in this programme with the involvement of both bilateral governments, said Dr Krishna Ella, chairman and managing director of Bharat Biotech. ROTAVAC will be supplied to low income countries at $1.0/dose and the company is in talks with other countries like Nigeria, Congo and other African nations which would receive the low cost vaccine. The diarrhoeal disease, which h is both preventable and treatable, is the second leading cause of death among children under 5 years of age. Globally, diarrhoea kills more than 2,000 children every day more than AIDS, malaria and measles combined. Rotavirus is the most common cause of severe diarrhoea and kills more than 200,000 children every year. While child deaths from rotavirus have more than halved since 2000, almost half of the deaths each year occur in just four countries: India, Pakistan, Nigeria and the Democratic Republic of Congo, according to the WHO. India had introduced ROTAVAC into its national immunization programme during 2016, with 35 million doses delivered till date. It is a great success to Make in India. Rota vaccine is a tremendous boost. We are laying out the foundation for TB, Chikungunya and Dengue vaccine. We are in good shapee and we will be aggressive in the sector, said Dr M.K. Bhan, former secretary, Department of Biotechnology.

7 With the evidence growing that stunting is not caused because of nutritional issues only, Dr Bhan said, what we are learning is that it looks like that nutrition stunting particularly we always thought it was food but there must be much more than food to it. It may be infection. Every time a micro organism enters a gut it creates a havoc inside. The diarrhoea disappears but leaves the gut disorganizedd immunologically.when you prevent gut infection you prevent systematic inflammation and it helps in growth. Earlier we thought food was the only reason for causing stunting but there is a lot to it, he added. The development of ROTAVAC is also an evidence of a growing drug development sector in India, a country previously known for remaking existing drugs in generic form. We have never done a community based-efficacy trial. What we do is generic, for the first time we did efficacy trial on 10,000 babies. It was not easy. Unless we Indians do not do trials we will not have innovation, added Dr Ella. The parliamentarians and the judiciary system need to be activated. I think they should look at it rationally. If something is done unethically than that company should be put on the blacklist. The regulatory agencies should take a much more proactive role. But how can we make in India we don t do innovation here. 6) Bharat Biotech's rotavirus vaccine gets WHO pre-qualification World Health Organisation (WHO) prequalification is necessary for the UN agencies and Gavi, the Vaccine Alliance to purchase vaccines in partnership with developing countries. Vaccine maker Bharat Biotech today said WHO has granted prequalification to its rotavirus vaccine ROTAVAC, used for prevention of infant deaths and hospitalisations due to rotavirus diarrhoea. World Health Organisation (WHO) prequalification is necessary for the UN agencies and Gavi, the Vaccine Alliance to purchase vaccines in partnership with developing countries. "The WHO prequalification will ensure access of the vaccine to almost 1000 countries," Bharat Biotech Chairman and MD Krishna Ella told reporters. This vaccine is innovated and made in India. The true impact of vaccines can be seen when vaccinations are carried out in affected populations, he added.