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news.FDA has determined that US healthcare practitioners can resume the use of GlaxoSmithKline's (GSK) Rotarix (Rotavirus Vaccine, Live, Oral), a two-dose, orally-administered vaccine that offers protection against rotavirus to infants and children, effective immediately.
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GSK said that this action supersedes the FDA’s recommendation from March 22, 2010 and reflects the agency’s assessment that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.
The FDA stated that the benefits of rotavirus vaccination are substantial, and include prevention of death in some parts of the world and hospitalisation for severe rotavirus disease in the US. The FDA further concluded that these benefits outweigh the risk, which is theoretical.
Barbara Howe, vice president, director of North American vaccine development at GSK said: “We appreciate the swift and thorough review conducted by both the FDA and an expert advisory committee into the recent findings related to PCV-1 and the benefit/risk profile of Rotarix.
“We will continue to work with the FDA and other regulatory authorities on next steps as we maintain our commitment to helping protect infants from rotavirus disease in the US and around the world.”