Rotavirus vaccine could save lives of almost 500,000 children a year

A vaccine capable of enduring scorching temperatures for months at a time could strike a decisive blow in the fight against rotavirus, preventing nearly half a million children around the world from dying of diarrhoea each year.

Médecins Sans Frontières (MSF) has hailed successful trials of the BRV-PV vaccine in Niger as a “game changer” in tackling rotavirus infection, which is the leading cause of severe diarrhoea globally and claims the lives of an estimated 1,300 children daily, most of them in sub-Saharan Africa.

According to results published in the New England Journal of Medicine, the vaccine has proven as effective as those currently used to treat severe gastroenteritis. Trials in Niger’s Maradi region successfully treated 4,000 children under the age of two.

Unlike existing vaccines, the BRV-PV vaccine does not require refrigeration and can remain stable for up to one year at 37C or six months at 40C. It is particularly effective against the strains of rotavirus found in sub-Saharan Africa, as well as affordable: at only $ 2.50 (£2), the vaccine could potentially be rolled out quickly in routine immunisation programmes.

“This is a game-changer,” said Dr Micaela Serafini, MSF’s medical director. “We believe that the new vaccine can bring protection against rotavirus to the children who need it most.”

Diarrhoea is the second largest cause of death in infants and children worldwide, primarily in low-income countries where access to clean water and sanitation is limited. Rotavirus is highly contagious, particularly among babies and young children, and can be spread by contaminated hands, objects such as toys and surfaces, and water and food.

Children in the world’s poorest countries account for 82% of rotavirus deaths, but vaccines make a significant difference. In Mexico, diarrhoeal deaths among children under five declined by as much as 50% after rotavirus vaccines were introduced.

The trials in Niger – the first of their kind to be approved in an African country – were conducted by MSF’s research and epidemiology branch Epicentre, in collaboration with Niger’s ministry of health, the Cincinnati children’s hospital and the makers of the vaccine, the Serum Institute of India. According to MSF, the results demonstrated no safety concerns and as a result the vaccine is hoped to fill the current supply gaps of the existing rotavirus vaccines, RotaTeq and Rotarix, both of which require refrigeration.

The World Health Organization recommends that rotavirus vaccines should be included in all national immunisation programmes, and considered a priority in south and south-east Asia and sub-Saharan Africa. The BRV-PV vaccine is awaiting pre-qualification from the WHO before it can be rolled out.

Licensing the product could take up to 18 months, said Anna-Lea Kahn, a WHO technical officer looking at innovations for facilitating vaccine supply and delivery. During that period, WHO scientists evaluate data supporting the vaccine’s quality and safety, drawing on independent specialist help when needed.

Most difficulties with vaccine delivery tend to arise during the “last mile” of the vaccine supply chain, said Kahn. “That’s where it goes wrong the most: where being able to maintain the cold chain is hardest; where constraints are most pronounced, be it due to lack of electricity or lack of resources, or inability to maintain a cold fridge. There may be geographical barriers, too, presenting a logistical challenge.

“In these scenarios, not having to depend on the cold chain … can make a valuable difference in getting vaccines to those who otherwise might not receive it.”

Serafini said: “The success of this trial shows that research and development into vaccines that are specifically adapted for use in low-income countries yields results.”

A spokesperson for Gavi, the international vaccine alliance, said BRV-PV’s results were encouraging.

“Adding more flexibility to the cold chain could allow more vaccines to reach the hardest-to-reach locations, boosting coverage and giving many more children access to lifesaving vaccines,” the spokesperson said. “However, it is anticipated that an important consideration for the countries will be the final recommendations on temperature control conditions of the vaccine, which could be different than the conditions used during the clinical trial.”

Rotavirus vaccine could save lives of almost 500,000 children a year