According to the results of a recent Doctors Without Borders (MSF) rotavirus vaccine trial in Nigeria, Africa, a new heat-stable vaccine has proven effective against the disease, as published in the New England Journal of Medicine on Thursday.
The new vaccine, BRV-PV, is considerably cheaper than existing vaccines in the market and is specifically conformed to match the rotavirus strains found in sub-Saharan Africa. Additionally, it does not need to be refrigerated, making it easier to reach communities in remote areas with limited access to healthcare. The vaccine could prove valuable in preventing the deaths of large numbers of children due to diarrhea in Sub-saharan Africa.
MSF medical director, Dr Micaela Serafini, believes the vaccine to be game-changer, with the potential to safeguard those children who need maximum protection against rotavirus.
The vaccine was manufactured by an Indian company
The trial in Nigeria was conducted by MSF’s research and epidemiology branch, Epicentre, in alliance with the Nigerian Ministry of Health, the Cincinnati Children’s Hospital, Serum Institute of India Pvt Ltd – the manufacturer of the drug, and other partners.
More than 4000 children, younger than 2 years old, participated in the trial which revealed that the vaccine was 67% effective in preventing severe episodes of rotavirus-related diarrhea.
While 67% protection is imperfect, it is greater than that provided by Merck’s Rotateq or Rotarix, a vaccine made by GSK, when tested in Africa, reported The New York Times.
Rotavirus vaccines are normally 80-90% effective, but are costlier than BRV-PV, hence available only in wealthy and middle-income countries. Furthermore, they need to be refrigerated at all times. Rotasiil is much easier to store as it does not require refrigeration which might be a problem in rural areas due lack of electricity.
But BRV-PV must be reconstituted with liquid, which might be a hindrance as the extra step could lead to mistakes.
BRV-PV also had no side effects of intussusception (a rare but potentially lethal bowel obstruction) as in the case of Rotashield, an American rotavirus vaccine which was withdrawn from the market in 1999 because of fears that it triggered intussusception.
The vaccine will be sold at a lesser price than existing vaccines for poor countries
To enable BRV-PV (to be called Rotasiil) accessible to poor and low-income countries, it will be available at a price less than $2.50. Rotarix costs $5 for two doses, while Rotateq is $10.50 for three.
The low cost of Rotasiil helps ensure speedy incorporation of the vaccine into new immunisation programs of such countries. It is also expected to fill the current supply gap for the existing vaccines.
Dr. Anita Zaidi, an expert in diarrheal diseases at the Bill and Melinda Gates Foundation, said that the vaccine can have a huge public health impact. The Serum Institute is ready to make about 60 million doses a year and the initial price of Rotasiil will be about $6 for three doses, but will be lowered for large orders.
The idea behind keeping the initial price low is to first give the low-income countries a chance to procure the vaccine and as they gradually become more economically stable, they can pay private-market prices.
The goal is to get vaccine companies to expect enough profit that they enter the field, but to foster enough competition to keep prices reasonable, said Dr Berkley, the chief executive of Gavi – the Vaccine Alliance which buys billions of dollars of vaccines for poorer countries.
Rotavirus kills about 600 children a day globally: WHO, and India is one of the countries most affected by the disease
About 215,000 children under 5 die each year of rotavirus, almost half of them in just four countries: India, Pakistan, Nigeria and the Democratic Republic of Congo, according to the WHO.
Rotavirus is the most common cause of diarrhea among children, leading to hospitalisation and death. In india alone about 1 lakh children die annually due to diarrhea by Rotavirus, while nearly 9 lakh are hospitalised with severe diarrhea.
The virus attacks the villus tip cells of the small intestine and sticks to glycolipids on the cells, causing atrophy, loss of digestive enzymes, and a fall in absorption. Once the villi becomes insensitive, it results in malabsorption of carbohydrates causing diarrhea.
Ten countries account for two-thirds of all deaths by rotavirus. Twenty-two percent of all rotavirus deaths under five years of age occurred in India in 2013.
The Logical Indian appreciates the efforts taken by Doctors Without Borders to prevent the deaths of children by rotavirus. We also laud the accomplishment of Serum Institute of India Pvt Ltd to manufacture a virus specially adapted to meet the requirements of low-income countries.