Bharat Biotech of India announced that the World Health Organization (WHO) awarded the its rotavirus vaccine, Rotavac, prequalification status. The company introduced Rotavac into India’s national immunization program in 2016. However, the prequalification designation by the WHO is necessary for United Nations agencies and Gavi, the Vaccine Alliance that purchases vaccines in partnership with developing countries.1
Prequalification will allow the vaccine to be sold internationally in countries across Africa and South America.
Rotavac is intended for the prevention of rotavirus, a leading cause of severe diarrhea among children younger than five years of age. Bharat Biotech developed the vaccine through of a large public-private partnership that included collaboration from the United States National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).
NIH’s director of the Fogarty International Center, Roger Glass, MD, noted that the rotavirus is responsible for approximately 36 percent of diarrhea-related hospitalizations among children and approximately 200,000 deaths in low- and middle-income countries.1
“We are highly honored and delighted to become the first rotavirus vaccine from the developing world and India to be WHO-prequalified,” said Krishna Ella, PhD, founder of Bharat Biotech.1
According to The Hindu, this is the first vaccine designed internally using India’s scientific and regulatory process to receive prequalification. The drug was built on a strain of rotavirus isolated in India more than 30 years ago and had been in development since 2000. Nearly nine million children in nine Indian states have received the vaccination.2
Some medics cite concerns that the vaccine carries a risk of developing a bowel disorder known as intussusception—”a potentially life threatening complication where the intestine telescopes into itself and can become gangrenous.”2 3
A clinical trial for Rotavac conducted on 1,000 infants in the city of Vellore, India apparently did not show a significant increase in the number of intussusceptions. But the data from the trial have not been disclosed, even after being requested by the Prime Minister’s Office (PMO) of that country.3 4 Attorneys representing Bharat Biotech have expressed concern about the possible misinterpretation of the data which “would lead to disinformation about the product.”3
1 Bharat Biotech. World Health Organization Grants Prequalification to Bharat Biotech’s Rotavirus Vaccine, Rotavac. Business Wire (press release) Jan. 24, 2018.
2 Special Correspondent. First India-designed vaccine passes WHO test. The Hindu Jan. 24, 2018.
3 The Wire Staff. New Rotavirus Vaccine Criticised for Increasing, Not Reducing, Diarrhoea. The Wire July 20, 2017.
4 Our Correspondent. PMO plea ignored: Rotavirus vaccine trial results must be made public immediately. Sunday Guardian Live Feb. 22, 2016.