Rotarix | FDA advises doctors to stop using rotavirus vaccine

A pediatrician examining a smiling baby.

If your child has had the Rotarix vaccine, there is no danger to their health. Image from Picasa.

Yesterday afternoon, FDA drug regulators sent a notice to pediatricians, recommending that they stop using the Rotarix rotavirus vaccine from GlaxoSmithKline. The European Medicines Agency and Swissmedic have also issued this advisory to doctors in Switzerland and most of Europe. There does not appear to be any danger to humans, and the vaccine is not being recalled – yet. British drug maker GlaxoSmithKline manufactures the drug, and spent several million dollars – some of it from a loan company – on Roatrix’s development.

Rotarix is intended to vaccinate against diarrhea

Originally approved by the FDA for use in 2008, Rotarix is a vaccine intended for children. It vaccinates against the rotavirus, an intestinal infection that can cause severe dehydration. The virus is responsible for more than 600,000 children’s deaths each year worldwide. Rotarix is not the only vaccine on the market intended for this use – Merck’s RotaTeq was approved in 2006. Rotarix is a two-dose vaccine, while RotaTeq is a three-dose vaccine. The FDA estimates that Rotarix has been used to vaccinate approximately 1 million children.

PCV1 found in GSK’s Rotarix

The recommendation that doctors pause the use of Rotarix came after independent researchers found porcine circovirus 1 (PCV1) in the Rotarix vaccine. The PCV1 virus is not known to cause illness in humans or animals, and every health agency has stressed that there is no risk to anyone who has had the Rotarix vaccine. The reason they have asked doctors to stop the use of Rotarix is based, instead, on the fact that vaccines are supposed to be sterile and the virus is unexpected in the Rotarix drug.

What will happen to Rotarix

The FDA has announced that it intends to convene an expert advisory committee within the next few weeks to make recommendations on the use of rotavirus vaccines. GlaxoSmithKline has also issued a statement on the contamination of Rotarix, stating that they will continue producing the vaccine with the extraneous virus that originated in pigs until they could find an “acceptable substitute.” It is without question, though, that GSK will most likely have to do more toward its reputation credit repair in the future.

What to do if your child has taken the Rotarix vaccine

If your children have been given the Rotarix vaccine, there is no risk to to their health. PCV1 is regularly found in both the food supply and the environment, and is not considered dangerous. Both Rotarix and RotaTeq are multiple-dose vaccinations. If your children have had one dose of Rotarix, they will be fully protected if they are given two additional doses of RotaTeq. As with all vaccines and medications, keep a close eye on your children and talk to their pediatrician if you have any concerns.


Reuters News Service
U.S. News and World Report
The New York Times

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