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Additional Information for Healthcare Providers and Public Health Professionals Based on careful evaluation of a variety of scientific information, FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.
FDA has no evidence that either PCV1 or PCV2 poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans. In addition, both rotavirus vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients. (14/05/10) |
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FDA Revises Recommendations for Rotavirus Vaccines The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. (14/05/10) |
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Panel Tells FDA to Keep Rotavirus Vaccines Available Members of an FDA advisory panel agreed that the two approved rotavirus vaccines -- Merck's RotaTeq and GlaxoSmithKline's Rotarix -- should continue to be used, despite known contamination with a pig virus. (07/05/10) |
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FDA Says Viral Contamination Found in Second Rotavirus Vaccine DNA from a pig virus has been detected in Merck's RotaTeq rotavirus vaccine, an FDA official announced during the opening session of a hearing on rotavirus vaccines. (07/05/10) |
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European Medicines Agency sees no safety concerns with the Rotarix oral vaccine The European Medicines Agency has concluded that the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine Rotarix does not present a risk to public health. At an extraordinary meeting held on 25 March 2010, the Committee for Medicinal Products for Human Use (CHMP) endorsed the recommendations from its Vaccines Working Party and agreed that there was no need to restrict the use of Rotarix.
(26/03/10) |
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Rotavirus vaccination - WHO does not recommend any change to use of Rotarix vaccine Following announcements today by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding use of the rotavirus vaccine, Rotarix, the World Health Organization (WHO) encourages all countries using the vaccine to carefully consider the significant benefits of continued use of the vaccine in any decisions about further use.
(22/03/10) |
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European Medicines Agency statement on new information on Rotarix oral vaccine The European Medicines Agency is aware of new information reported by the manufacturer of Rotarix, GlaxoSmithKline Biologicals, relating to the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine. Through its own tests, the company has confirmed the finding of DNA originating from porcine circovirus type 1. This virus is commonly found in certain meat and other food products, and is not known to cause disease in either animals or humans.
(22/03/10) |
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Temporarily Suspend Use of
Rotarix® Us. FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.
(22/03/10) |
