Next May 7th. An FDA independent advisory panel with review GlaxoSmithKline Plc. Rotarix (Rotavirus Vaccine, Live, Oral) and offer a guide regarding the vaccine´s contamination with DNA from porcine circovirus 1, apparently harmless for humans.

Last March 22nd. The FDA advise Glaxo to withdraw the product jointly with a warning for doctors and specialists on Merck & Co´s RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent). Back then GlaxoSmithKline sent a statement arguing that the virus (known as porcine circovirus 1, or PCV-1) “does not multiply and is harmless in humans”. The British company said that PCV-1 is found daily in meat products.

There is 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.

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.

Rotarix is a live-attenuated oral rotavirus vaccine. Glaxo uses monkeys renal line cells (vero cells). Merck & Co´s RotaTeq is manufactured under other process. 

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.