The following alert has been released by the FDA’s MedWatch program.
Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Audience: Pediatric and family practice healthcare professionals, public health professionals
FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA’s recommendation is a precaution taken while the agency learns more about the situation.
FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.
There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.
Additional information, including information for healthcare professionals and parents, is provided in the document below.
Read the complete MedWatch 2010 Safety summary, including a link to the Update statement from FDA, at:
http://www.fda.gov/…/SafetyAlertsforHumanMedicalProducts/ucm205640.htm
Notice that the FDA does not in this instance choose to alert consumers. The problem with that is that many who prescribe this vaccine will fail to see the alert. Too often consumers are kept in the dark about things that affect them by the FDA.
Remember too that stating “PCV1 is not known to cause disease in humans” is not the same as saying it does not cause adverse effects or disease in humans. In a separate notification of this issue the FDA used the phrase “there is no known safety risk” which sounds reassuring but should be viewed as the reverse. Why is it that the FDA, when it comes to regulating drug company products, can get away with testing anything and everything they choose to approve on a trusting population of consumers? Yes, I know they have laws to empower them, but why do people simply accept this scandalous situation? I guess the saying about needing enough ignorant people to form a democracy has some truth in it.
Tags: MedWatch, Rotarix vaccine, vaccine error