US Food and Drug Administration (FDA) has determined that US healthcare practitioners can resume use of GlaxoSmithKline's Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the US 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 US FDA stated that the benefits of rotavirus vaccination are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. The US FDA further concluded that these benefits outweigh the risk, which is theoretical.
Barbara Howe, vice president, director, North American Vaccine Development, GlaxoSmithKline stated, “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 US 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.”
Porcine circovirus 1 (PCV-1) is a small circular virus composed of a single strand of DNA. According to scientific literature, PCV-1 is a common virus that has been found in pork products.
Rotarix is a two-dose, orally-administered vaccine that offers protection against rotavirus to infants and children.