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Rotarix Vaccine Temporarily Suspended

by Sue Hubbard, M.D.

I received the CDC Health Alert yesterday afternoon notifying physicians to “temporarily suspend the usage of GlaxoSmithKline (GSK) Rotarix (rotavirus) vaccine. Rotarix was licensed for use in 2008 to prevent rotavirus disease, which typically causes fever, vomiting and diarrhea in infants and young children.

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Prior to this Merck’s vaccine RotaTeq had been licensed for us in 2006. Both of these vaccines are given orally. Both RotaTeq and Rotarix were found to prevent serious rotavirus illness and hospitalizations for dehydration.

The GSK product, Rotarix, which is a “live attenuated” vaccine, has been found to contain DNA from porcine circovirus type 1 (PCV 1). PCV 1 virus is not known to multiply in human cells or to cause illness.  According to the FDA, “all available evidence indicates that there had been no increased risk to patients who have received this vaccine”.  The GSK vaccine, Rotarix, is made in a different manner than the Merck vaccine RotaTeq.  Preliminary studies by the FDA on RotaTeq vaccine have not shown the presence of PCV 1 DNA.

Preliminary data reported to the FDA  by GSK related to PCV 1 being in the vaccine seems to suggest that it has been present since the early stages of the vaccine’s development.  Studies on Rotarix, both before and after the approval of the vaccine, have shown it to be extremely safe and no unusual adverse events have been reported.  At the same time, the vaccines that have been given are presumed to be effective.

In the interim, while futher studies are being completed, it is recommended that children continue to receive RotaTeq vaccine.  The FDA plans to convene an advisory committee to look into how the DNA components came to be present in this vaccine. They are also going to look into the use of new techniques for identifying viruses in vaccines.  After this meeting, the FDA will make further recommendations about the use of rotavirus vaccines in the United States.

This recall was limited to the United States, and children in other areas or the world are continuing to receive Rotarix, as the available evidence suggests that the benefits of the vaccine outweigh the risks, especially in areas where rotavirus disease causes severe disease and even deaths.

I would not be alarmed if my baby had received this vaccine as it does not cause disease in animals or humans.  I would also complete my child’s vaccine series with the Merck product which is available.  We will all have to stay tuned for further details,  but this should also make parents aware that the safety of vaccines continues to be monitored, even after they have been approved.

That’s your daily dose for today.  We’ll chat again tomorrow!

Send Dr. Sue your question now!

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