The European Medicines Agency´s (EMEA) position as opposed to the U.S. Food and Drug Administration, announced that they saw no safety issues regarding GlaxoSmithKline Plc vaccine Rotarix. The vaccine is intended to prevent a diarrhoea-causing virus called rotavirus. (Rotavirus Vaccine, Live, Oral).

Due to the contamination with an apparently harmless pig virus, the FDA, Last March 22nd, requested the temporarily suspension of children inoculation with Rotarix vaccine, the specialty was originally approved by the regulators office on April 2008.

The drug maker had previously announced that the virus (known as PVC-1) “does not multiply and it is a non-disease cause in humans”. The British company emphasized that PCV-1 virus is found in daily meals such as meat, and it does not affect humans.

There are no evidence that PTCV-1 found in Glaxo vaccine can induce any kind of disease in humans or animals. “does not multiply and it is a non-disease cause in humans” said the company. On the other hand, Glaxo said they have distributed around 69 million doses (almost 2 million in the U.S alone) with no safety or security issues.

In the U.S., rotavirus affects around 80 percent of infants born each year, and around 55,000 infants will require hospitalization. It is estimated over $1billion are spent annually in medical and societal costs in the U.S.

Rotarix protects children against a diarrhoea-causing virus called, Rotavirus and is basically the name given to a family of germs that share similar characteristics when looked though an electronic microscope. The genetic material of the virus is made of two strains of RNA divided in 11 segments, their infection part is recovered by a protein of three sheath.

At the same time EMEA requested GSK Biologicals, which makes the vaccine, that they should identify and eradicate the cause of the contamination.

Rotavirus affects children up to the age of five years of age and is the most common cause of severe diarrhea and dehydration in infants across the world.

During 2009, Rotarix had global sales of 440 million dollars.