New Delhi: Hyderabad-based 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 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 shape and we will be aggressive in the sector," said Dr M.K. Bhan, former secretary, Department of Biotechnology.

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 disorganized 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."

Dr. Roger I. Glass, director of the Fogarty International Center at the US National Institutes of Health, who helped shepherd the process, said, “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 diarrhoea around the world and for an estimated 200,000 deaths in low and middle income countries.

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