Here it is 4 years later and they are STILL USING THESE VACCINES IN OUR CHILDREN. During the course of developing novel virus detection techniques, researchers at the San Francisco Blood Research Systems Institute and Lawrence Livermore National Laboratory (LLNL) unexpectedly identified nucleic acids from an adventitious virus in Rotarix [17]. The detected virus shared 98% homology with porcine circovirus-1 (PCV-1) and covered the complete circular genome [17]. PCV infection is common in pigs and the virus is often detected in human stool samples [18] but is not believed to cause illness among humans [19–21]. Contamination of Rotarix with PCV-1 was subsequently confirmed by the vaccine manufacturer. In March 2010, in light of these findings, the US Food and Drug Administration (FDA) recommended temporarily suspending the use of Rotarix [22]. On May 6, 2010, the FDA reported preliminary findings that the RotaTeq vaccine also contained detectable PCV material [23]. On May 7, 2010, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to review whether the contaminated rotavirus vaccines could pose risks to human health. The committee concluded that based on the available evidence, the hypothetical risk of PCV infection among humans does not outweigh the observed benefits of rotavirus vaccines in preventing severe acute gastroenteritis among infants. The committee expressed reassurance that the detection of DNA and DNA fragments from PCV in rotavirus vaccines was not likely to cause harm to humans and recommended that information on this topic be provided to parents prior to vaccination. The committee did, however, recommend that the vaccine manufacturers work to develop rotavirus vaccines free of PCV1 and PCV2 contaminants. On May 14, 2010, the FDA issued a recommendation for pediatricians to resume use of Rotarix and to continue use of RotaTeq [24]. Subsequent testing by the vaccine manufacturers identified that the PCV material was introduced into both rotavirus vaccines through porcine-derived trypsin, a reagent used in the cell-culture growth process of vaccine production, commencing very early in the development process [17, 25]. The use of cells or biological products from other species in the production of vaccines can lead to leakage of cellular DNA and the introduction of noninfectious proviral DNA [17]. ncbi.nlm.nih.gov/pmc/articles/PMC3980782/
Posted on: Mon, 14 Jul 2014 06:15:39 +0000
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