WHO’s Rotavac vaccine pre-qualification to step up diarrhoea fight

By MASEMBE TAMBW

IMMUNISATION against diarrhoea for children under five years in Tanzania and globally has received yet another boost, thanks to prequalification by the World Health Organisation (WHO), of an additional rotavirus vaccine dubbed ‘Rotavac’, which is produced by India’s Bharat Biotech.

Rotavirus is a virus that spreads easily among infants and young children; it causes severe watery diarrhoea, vomiting, fever and abdominal pain. Children who get rotavirus disease can become dehydrated and may need to be hospitalised.
According to a statement issued to the ‘Daily News’ by the Indian manufacturer, Bharat Biotech, the new vaccine will prevent infant deaths and hospitalisations brought about by rotavirus diarrhoea.
The pre-qualification by WHO 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 ‘Rotavac’ to countries with the highest burden of the disease.
In a response to queries by this newspaper yesterday, Deputy Minister in the Ministry of Health, Community Development, Gender, Elderly and Children, Dr Faustine Ndugulile, explained that Tanzania has been using other brands of rotavirus vaccines since 2013. “Since we started immunisation in 2013, we have been able to cover 95 per cent of all children under one-year old with the rotavirus vaccine. We do not directly deal with manufacturers of the vaccine, Gavi and UNICEF are responsible for the procurement process,” Dr Ndugulile explained.
He did not indicate the brand of vaccine being used in Tanzania, but literature review indicates that there are various types on the market which have been approved by the WHO for use in both developing and developed countries. These include RotaTeq, Rotarix, Rotavin-M1 and Lanzhou lamb.
According to the Deputy Minister, a dosage of the vaccine costs between five and six US dollars, which is highly subsidised by GAVI, with the government contributing 20 US cents. “The dosage is administered twice, at first when the infant is six weeks old and the second one at the tenth week. GAVI purchases the vaccines and UNICEF facilitates distribution as per demand and schedule of respective countries,” he explained.
The Indian government introduced ‘Rotavac’ into its national immunisation programme in the year 2016 where 35 million doses have been delivered to date. “We are honoured and delighted to become the first producer of rotavirus vaccine from the developing world and to be prequalified by WHO. We feel proud to dedicate this innovation.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,” the Chairman and Managing Director of Bharat Biotech, Dr Krishna Ella, stated. Dr Ella boasted that Bharat Biotech’s track record of life saving vaccines is a testimony to the company’s long-standing commitment to make affordable vaccines for the developing world.
“The novel team science partnership that developed this vaccine serves as a useful model for others to follow”, said Dr Roger Glass, Director of the Fogarty International Centre at the United States 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 per cent of hospitalisation for childhood diarrhoea around the world and for an estimated 200,000 deaths in low and middle income countries.
The WHO prequalification for Rotavac is the result of a rigorous regulatory process which started in 2016. The vaccine has been under development since the year 2000, necessitating investments of around 200 million US dollars towards product development and dedicated manufacturing infrastructure.