Glaxo’s Infant Rotavirus Vaccine Tainted with Pig Virus, FDA Says

Doctors have been told to temporarily stop using the <"">Rotarix vaccine. The vaccine, which is made by GlaxoSmithKline, contains a pig virus. However, federal health regulators maintain that the tainted vaccine does not pose a health threat.

Rotarix protects infants against rotavirus, which causes severe dehydration and diarrhea. It is estimated that more than 500,000 deaths in infants worldwide each year are the result of rotavirus. Before the first rotavirus vaccine, Merck’s RotaTeq, was introduced in 2006, the disease caused an estimated 50,000 hospitalizations and several dozen deaths in the U.S. every year.

According to the Food & Drug Administration, (FDA) the vast majority of U.S. children receive the RotaTeq vaccine, but about 1 million have received Rotarix. Many pediatricians have switched to Rotarix because it only requires two doses, while RotaTeq requires three. Both vaccines are administered to infants by mouth.

The Rotarix vaccine has been found to contain a pig virus called porcine circovirus 1, or PCV1. The discovery of this virus was made by an independent U.S. academic research team, using a novel technique that revealed DNA from PCV1 in Rotarix. Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies.

The agency is now attempting to determine whether the vaccine contains intact PCV1 or simply viral fragments, as well as how it got into the vaccine. The FDA said it would convene an expert advisory panel in four to six weeks to make further recommendations on the use of rotavirus vaccines.

According to the FDA, PCV1 is not known to cause illness in humans, and no adverse effects have been observed in children vaccinated with Rotarix. However, as a precaution, the agency is recommending that clinicians temporarily suspend using Rotarix as the agency learns more.

Preliminary testing by both the academic researchers and FDA scientists of RotaTeq has not detected components of PCV1, the FDA said. For the time being, the agency is recommending that healthcare providers use RotaTeq.

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