THE RotaTeq vaccine, created to protect children against the rota virus, could soon be added to the list of approved vaccines for children in Jamaica.

According to the Valerie Germaine, acting director of the Pharmaceutical and Regulatory Affairs Branch of the Standards and Regulation Division in the Ministry of Health, a report regarding the vaccine trial that was conducted in Jamaica over three years was recently reviewed by the Product Registration Committee.

“The product was referred to two clinicians for comment. Positive comments have been received from one and we are awaiting the other comment,” said Germaine.

The use of the vaccine, she added, is scheduled to be discussed at this week’s meeting of the Product Registration Committee.

In the meantime, Celia Christie-Samuels, professor of pediatrics and infectious diseases at the University of the West Indies, told the Observer that the trial revealed that the vaccine, created by Merck & Company Incorporated, is 100 per cent protective.

The study was designed to demonstrate the safety of vaccine with respect to intussusception, which is a problem with the intestine in which one portion of the bowel slides into the next.

Professor Christie Samuels, who led the trial, also pointed out that the vaccine trial for RotaTeq was selected as the best piece of medical research that was published in the year 2006 by the New England Journal of Medicine. The journal said that in the United States, RotaTeq reduced the number of lost workdays from rotavirus by nearly 87 per cent, a welcome benefit with clear economic implications for families.

“The product is being accepted as part of the immunisation regime in other countries in the Caribbean and Central and South America,” she added.

The trial was conducted using approximately 70,000 children in 11 countries – United States, Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Sweden and Taiwan.

In Jamaica, 1,805 children participated in the study, which began in May 2004. They were actively monitored through telephone calls, passive surveillance, through parent education and intensive surveillance for the first six weeks after each dose.

Meanwhile, the vaccine, licensed by the FDA in February 2006, is used for the routine vaccination of US infants to protect against rotavirus, which causes severe diarrhoea, vomiting, fever and dehydration in children. The Centres for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend that all infants, starting at six to 12 weeks of age, be vaccinated with RotaTeq to prevent rotavirus gastroenteritis. The ACIP recommended that the oral, ready-to-use, three-dose vaccine be given during routine visits at two, four, and six months of age.

Currently, RotaTeq is the only vaccine approved in the US for prevention of rotavirus disease, with study indication that it can prevent about 74 per cent of all rotavirus cases.

In February, the Food and Drug Agency warned health care providers and consumers that it had received reports of intussusception following RotaTeq vaccination. But the FDA, ACIP (The Advisory Committee on Immunization Practices) and CDC later concluded that the number of intussusception reports after administration of RotaTeq has not exceeded the number expected to occur without vaccination.

However, Professor Christie said there was no reason to panic because intussusception occurred whether or not children were given the vaccine.

“What has happened is that Merk has distributed 3.5 million doses of the vaccine in the United States, and among those they have found 28 cases of intussusception in children who have gotten the vaccine,” she said. She added that there were four cases of intussusception during the Jamaican vaccine trial.

“There is no evidence to date to say that that (intussusception) is higher than what is expected if no vaccine was being given,” said Christie.

Rotavirus disease kills approximately more than a million children annually in developing countries and accounts for one third of hospitalisations for diarrhoea worldwide.