Innovative vaccine could prevent thousands of child deaths from diarrhoea

Innovative vaccine could prevent thousands of child deaths from diarrhoea

Thursday, March 23, 2017 — An innovative new vaccine which could prevent large numbers of children from dying of diarrhoea in sub-Saharan Africa has been successfully trialled in Niger, announced international medical organisation Médecins Sans Frontières (MSF)/Doctors Without Borders today.

Rotavirus infection is the leading cause of severe diarrhoea and kills an estimated 1,300 children each day, primarily in sub-Saharan Africa. A new and innovative  vaccine  – known as BRV-PV – has been shown to be both safe and effective against rotavirus, according to the results of a recent trial in Niger, published in the New England Journal of Medicine on 23 March. Moreover, the new vaccine is particularly adapted to the strains found in sub-Saharan Africa.

Diarrhoea is the second biggest cause of death in infants and children. Most of these deaths occur in low-income countries, in places where access to water and sanitation is limited, and where people are unable to get the medical care that could save their child’s life. In such situations, preventive measures such as vaccinations have an enormous impact.

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

Currently two vaccines exist against rotavirus, but they must be kept refrigerated at all times. The most innovative aspect of the new vaccine is that it is heat stable, so it does not require refrigeration. This will make it much easier to reach communities in remote areas who have limited access to health services and who are most in need of the vaccine.

The new vaccine is also adapted to the type of rotavirus most commonly found in sub-Saharan countries. It is affordable, with a price of under US$2.50, which is much cheaper than the lowest price of rotavirus vaccines currently available. This should allow it to be rolled out quickly as part of routine immunisation programmes. The new vaccine, manufactured by Serum Institute of India Pvt Ltd, will also fill the current supply gaps for the existing vaccines.

An efficacy trial of the BRV-PV vaccine – conducted by MSF’s research and epidemiology branch, Epicentre, in collaboration with the Nigerien Ministry of Health, the Serum Institute of India Pvt Ltd, the Cincinnati Children’s Hospital and other partners – was recently conducted in Niger’s Maradi region, involving more than 4,000 children under two years old. Results showed that the vaccine has no safety concerns and has been proven efficacious against severe gastroenteritis.

The BRV-PV vaccine is currently under review by the World Health Organization (WHO) for prequalification. Once approved, low-income countries will be able to procure the vaccine at an affordable price and roll it out in their countries.

“The success of this trial shows that research and development into vaccines that are specifically adapted for use in low-income countries yields results,” says Dr Serafini. “The quicker this vaccine is prequalified by the WHO, the sooner it can be used to prevent the deaths of thousands of children in the countries where it is needed most.”

Credits: Séverine Bonnet / MSF

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We are available to organize interviews with Dr. Micaela Serafini, Medical Director of MSF Switzerland, Dr. Monica Rull, Operations Health Advisor of MSF Switzerland,  Dr. Rebecca Grais, Trial Director and Maya Shah, Innovation Manager of MSF Switzerland.

If there are inconsistencies in the data, the monitoring team can send somebody out to the communities or to one of the five health centres, where teams of archivists also check that the information in the files is consistent.
In parallel with the study into a new rotavirus vaccine, over 1,000 pregnant women are being monitored as part of a substudy that aims to evaluate the impact of the nutritional condition of pregnant women on the health of their babies.
Every weekend, the five health centres report on their stock levels and requirements so that all of the necessary vaccines can be delivered to them in simple insulated boxes.
In the laboratory of Maradi, a team of a dozen people receive about 1,200 specimens (blood, urine/stool, mothers' breast milk...) every week, to be analyzed for the trial.
In order to guarantee the effectiveness of the existing vaccines against Rotavirus (as many other vaccine, ie.: polio, whooping cough, hepatitis B, diphtheria and tetanus...), these vaccines must be stored and transported in strict conformity with cold-chain rules.
Eight-week-old Mohamed Zakari receives his first dose of the oral rotavirus vaccine (or the placebo). Eight weeks is the cut-off age.
At her 10-week appointment, Nana Hanissa is also vaccinated against eight antigens: polio / Pentavalent 2 / whooping cough / hepatitis B / diphtheria and tetanus.