US Coalition for Vaccine Safety calls on FDA to immediately suspend all contaminated rotavirus vaccines

Last Friday's recommendations by a US Food and Drug Administration panel of experts to support the continued use of rotavirus vaccines given to infants, notably Merck & Co's RotaTeq, which had been contaminated with DNA from pig viruses PCV1 and PCV2 and GlaxoSmithKline's Rotarix that had been found to contain PCV1 (The Pharma Letter May 10), has been strongly condemned by the US Coalition for Vaccine Safety (CVS).

Saying it was 'shocked at the advisory panel's recommendations,' the CVS yesterday called on FDA Commissioner Margaret Hamburg to 're-assess the panel's hastily-considered risk-benefit analysis and suspend the use of both rotavirus vaccines.' Steering Committee member Mary Holland said: "How can you say the benefits outweigh the risks when you don't know what the risks are?" A safety first agenda demands suspension of the vaccines immediately while the short and long term risks are studied, especially since rotavirus is a relatively benign and treatable gastrointestinal disease that is rarely fatal in the USA, she said.

The risks from PCV1 and PCV2 are real and potentially testable by analyzing lymphoid tissues, which is where the human immunodeficiency virus hides during its latency period. Immediate independent analysis should be done on children and primates who have received these vaccines before another child receives the rotavirus vaccine. According to CVS member Lyn Redwood, "It is impossible for parents to give free and informed consent to a vaccine containing pig virus DNA when their risks are unknown. To continue to administer these vaccines given the impossibility of informed consent is unethical."