The World Health Organisation has approved the manufacture of a new vaccine aimed at preventing a diarrhoeal disease spread by rotavirus among infants and young children.
The international health agency last week awarded prequalification to India’s pharmaceutical Bharat Biotech to manufacture the rotavirus vaccine, Rotavac.
Prequalification means that the United Nations agencies and the Vaccine Alliance (Gavi) can now procure the vaccine and make it available to the countries that need it.
The last rotavirus vaccine was given WHO prequalification in 2009. It is expected to be affordable, as it is meant for developing countries, where some of the world’s poorest people live.
In 2016, India introduced Rotavac into its national immunisation programme, with 35 million doses delivered to date.
Although more than 90 countries have introduced rotavirus vaccines into their national immunisation programmes, 67 per cent of all children (more than 90 million) still do not access it.
“The true impact of vaccines can be seen when vaccinations are carried out in affected populations,” said Dr Krishna Ella, chairman and managing director of Bharat Biotech.
“The Government of India has given a big boost by making Rotavac available to millions in India.”
“The vaccine has been supplied to low-income countries at $1 per dose, with the feasibility for further 30 per cent price reductions, based on the procurement of 100 million doses to these countries,” added Dr Ella.
Rotavirus is the leading cause of severe diarrhoea among children below five years, resulting in 215,000 deaths and two million hospitalisations globally.
It can cause severe watery diarrhoea, vomiting, fever and abdominal pain. Children who get rotavirus can become dehydrated.
While current manufacturers play an important role in meeting the global demand for the existing rotavirus vaccines, more options will ensure sustainable, affordable supply.
Rotavac was developed as a result of a multi country-multi partner collaborative model of team science for over two decades.
It has been under development since 2000, necessitating investment of around $200 million in product development and manufacturing infrastructure.
Most children (nine out of 10) who get the vaccine will be protected from severe illness.
Two oral, live, weakened rotavirus vaccines — Rotarix and RotaTeq — both considered highly effective in preventing severe gastrointestinal disease are available internationally.
The WHO recommends introduction of the vaccine in countries where diarrhoeal deaths account for more than 10 per cent of mortality among children under five years, with the first dose of either vaccines administered at 6–15 weeks.
The maximum age for administering the last dose of either vaccine should be 32 weeks.
In low-income countries, however, vaccine efficacy is usually lower than in industrialised settings.