NEW YORK (Reuters Health) – An experimental oral rotavirus vaccine, when given at birth and in two subsequent doses, can reduce the rate of severe and potentially deadly diarrhea by 75%, according to new study conducted among Indonesian babies.
Researchers found that while the rate of illness up to age 18 months was 5.6% among babies who received placebo, administering the vaccine within the first five days of birth, followed by booster doses at 8 and 14 weeks, cut that rate to 1.4%.
When the vaccine was given a bit later – at eight, 14 and 18 weeks – the rate was 2.7%, meaning it was effective 51% of the time.
The study, published online February 21 in The New England Journal of Medicine, comes at a time when more than 90 million infants worldwide lack access to conventional rotavirus vaccines and doctors are trying to improve the effectiveness of existing products in low-income countries.
The World Health Organization has estimated that about 215,000 children under age 5 die each year from a preventable rotavirus infection.
The new vaccine, known as RV3-BB, is novel because it comes from a strain of rotavirus that commonly infects babies but doesn’t cause symptoms, chief author Dr. Julie Bines of the University of Melbourne told Reuters Health in a telephone interview. “With this vaccine, because it doesn’t cause disease in its natural form, we can be very confident it will be safe in newborns.”
“And it’s a novel strategy to give the vaccine at birth,” she said. Other rotavirus vaccines aren’t given until age six weeks, making babies vulnerable at the beginning of life.
The vaccine was developed at Murdoch Children’s Research Institute in Melbourne, Australia, where Bines is a researcher.
The phase 2b study done in Indonesia because the rotavirus childhood death rate is high – about 10,000 per year among children under 5. The virus also results in more than 200,000 hospitalizations annually, according to the institute. In addition, rotavirus vaccination is not part of the country’s immunization program, making it ethical to give some babies placebo.
The results were based on 1,588 babies followed for 18 months. Combining the neonatal and infant groups, the efficacy of the vaccine against severe rotavirus gastroenteritis was 63% compared to placebo.
The effectiveness against rotavirus gastroenteritis of any severity when given to newborns was also 63%. On the infant schedule it was 45%.
And among babies who did get sick from a rotavirus infection, the illness arrived much later in the vaccinated children – perhaps three or four months later.
Side effects were comparable in the three groups.
Other rotavirus vaccines are made by GlaxoSmithKline (Rotarix), Merck (RotaTeq) and Bharat Biotech (Rotavac).
“The rotavirus vaccines that are currently available work very well in places like Australia, the U.S. and Europe, but they don’t seem to work as well in low-income settings in Africa and Asia where severe gastroenteritis is common and many children die,” Dr. Bines said in a news release.
SOURCE: http://bit.ly/2CtLbwL
N Engl J Med 2018.
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