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Concerns over Rotavirus Vaccine (RV)

Posted Mar 22 2010 7:50am

Rotavirus is a leading cause of severe winter diarrhoea in young children, it is often called ‘stomach flu’, although the virus is no relation to influenza. RV each year causes an estimated 500,000 doctor visits and 50,000 hospital admissions in the United States. Nearly everyone catches RV before school age but, with rehydration (and good nutrition), nearly everyone fully recovers. However, with each infection, immunity develops, subsequent infections are less severe, and adults are rarely affected. There are seven species of this virus, referred to as A, B, C, D, E, F and G. Rotavirus A, the most common, causes more than 90% of infections in humans.

Regulators in the USA have advised doctors to temporarily suspend use of GlaxoSmithKline’s rotavirus vaccine Rotarix after impurities in the product were discovered. This is not the first time that there have been concerns about contaminants in GSK vaccines. The discovery that GSK used a mercury based preservative in their MMR vaccine for babies is well documented.

The US Food and Drug Administration has been informed by the company that components of an extraneous virus, PCV1, are present in Rotarix. The agency says that “there is no evidence at this time that this finding poses a safety risk” but is still recommending suspension. The agency said that it will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present. In four to six weeks, it will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

The European Medicine’s Agency’s Committee for Medicinal Products for Human Use has now requested that GSK provide further information “as a matter of urgency” and called a meeting on March 23-24, with the participation of experts from the World Health Organisation, and international regulators including from Canada and the USA.

Rotarix is a big-seller for GSK and sales last year reached $440 million, and $118 million of that came from the USA, where most children receive Merck & Co’s rival product RotaTeq. In an investor note, analysts at JP Morgan said the US suspension was “insignificant” for the healthcare giant.

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