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More than a month after US regulatory body — Food and Drug Administration (FDA) — recommended that the use of Rotarix, a vaccine used to prevent rotavirus disease that causes severe diarrhoea and dehydration in children, be suspended, it recently declared that the vaccine could be resumed."Based on the careful evaluation of a variety of scientific information, FDA has determined that it is appropriate for clinicians to resume the use of Rotarix and to continue the use of Rota Teq," says the FDAAccording to the FDA, it has got no evidence that Rotarix poses a safety risk in humans. Noting that "both rotavirus vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients, it said benefits of this vaccine were "substantial and include prevention of hospitalisation for severe rotavirus disease in the US and of death in other parts of the world," it said.In March this year, the FDA had warned healthcare professionals and parents to suspend the use of vaccine based on a research by an independent US academic team which said the vaccine might be contaminated with a pig virus called porcine circovirus or PCV1."FDA has carefully reviewed the available data on the presence of DNA from PCV1 in Rotarix. The agency, through its own laboratory studies, has confirmed its presence in the vaccine," it had said.A month later, the FDA has recommended in favour of the vaccine based on extensive studies, including placebo-controlled, randomised clinical studies which support the safety and effectiveness of the vaccine. The FDA, therefore, has opined the parents that there is no need for "medical follow-up" for children who have been vaccinated with Rotarix and RotaTeq vaccines.Given to children below the age of six months until eight months, Rotavirus disease causes over 500,000 infant deaths across the world each year. An estimated one lakh children die in India every year of the virus.
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