New vaccine fo r children re le as ed

Indian company takes on rotavirus, the most common cause of death from diarrhoea

Anew vaccine against a diarrhoeal disease that kills about 600 children a day worked well in a large trial in Africa and appears to be a practical way to protect millions of children, scientists said last week.

The new vaccine against rotavirus, the most common cause of death from diarrhoea in children under age five, is made by an Indian company and was tested in Niger by Medecins Sans Frontieres.

The vaccine is expected to be as cheap as or cheaper than current alternatives. More important, it can last for months without refrigeration, which makes it far easier to use in remote villages with no electricity.

It must be approved by the World Health Organization (WHO) before it can be widely distributed, a process that is under way.

Still, experts hailed the new vaccine as a leap forward.

“This is great news,” said Dr Paul Offit, an infectious disease specialist at the Children’s Hospital of Philadelphia and one of the inventors of another rotavirus vaccine, Rotateq, which was launched in 2006.

“I wish there were 10 companies making rotavirus vaccine, because thousands of children are dying of this,” Offit said.

About 215,000 children under five 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.

A major 2013 study sponsored by the Bill and Melinda Gates Foundation found that rotavirus was the leading cause of fatal diarrhoea in children under age two — and the only major one not caused by bacteria or parasites, which are treatable with antibiotic and anti-parasitic drugs.

One of that study’s conclusions was that more rotavirus vaccine should be available. Repeated bouts of diarrhoea can rob children of nutrients and leave them permanently stunted.

The new study, published in the New England Journal Of Medicine, found that the vaccine, made by the Serum Institute of India, was 67% effective in preventing severe episodes of rotavirus-related diarrhoea. There were only 31 cases among the 1,780 children who got three doses of the vaccine, while there were 87 among the 1,728 children who got a placebo.

There were no cases of intussusception, a rare but potentially lethal bowel obstruction. In 1999, the first American rotavirus vaccine, Rotashield, was withdrawn from the market because of fears that it triggered intussusception.

More than 300 medical personnel were involved in the trial in Niger, one of the world’s poorest countries. A trained health worker spent 24 hours a day in each of the 132 villages that the 3,500 children in the study live in.

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.

“Would we want a perfect vaccine? Definitely — and I also want a pony,” said Rebecca Grais, who directed the trial for Medecins Sans Frontieres. “But a vaccine that prevents two-thirds of the deaths and hospitalisation that rotavirus causes is definitely worth considering.”

“This provides hope in environments where there wasn’t any, so our level of enthusiasm is very high,” she added.

Even a moderately effective vaccine — combined with the herd protection that builds up once most children in an area are vaccinated and immune — “can have a huge public health impact”, said Dr Anita Zaidi, an expert in diarrhoeal diseases at the Bill and Melinda Gates Foundation, which helped underwrite the initial development and testing of the new vaccine.

Rotavirus vaccines are normally 80-90% effective in wealthy and middle-income countries. But among previously available vaccines, Rotarix was only 61% effective in a trial in Africa, while Rotateq was only 39% effective.

Infants in poor countries with open sewers and polluted water have more viruses and bacterial toxins in their intestines, blocking access to the gut cells where the vaccines would normally attach, Offit explained. And because mothers also get rotavirus, he added, they develop antibodies to it. Their babies get the antibodies in breast milk, and these may neutralise some of the vaccine.

Vaccines also may be less effective in poor countries because they may imperfectly match the circulating rotavirus strains, experts said, or because poor diets cause frequent diarrhoea, removing protective gut bacteria.

The new vaccine is known as BRV-PV, and will be called Rotasiil, said Rajeev Dhere, the executive director of the Serum Institute.

Forty-two poor or lower-middle-income countries are now using rotavirus vaccine, said Dr Seth Berkley, the chief executive of Gavi, the Vaccine Alliance, which buys billions of dollars of vaccines for poorer countries.

I wish there were 10 companies making rotavirus vaccine, because thousands of kids are dying of this