CVS calls on FDA to suspend use of contaminated rotavirus vaccines

FDA Expert Advisory Panel Fails to Follow Safety First Agenda for Childhood Vaccines Containing DNA from Pig Viruses

On Friday, the Food and Drug Administration (FDA) convened a panel of experts to review recent findings that rotavirus vaccines given to infants in the U.S., Rotateq, produced by Merck Pharmaceuticals and Rotarix produced by GlaxoSmithKline, are contaminated with DNA from pig viruses PCV1 and PCV2.  On March 22nd  the FDA Commissioner asked doctors to suspend use of the Rotarix vaccine due to the contamination.  Upon additional testing, Rotateq was also found to be contaminated.

At the meeting, the experts acknowledged that the PCV2 virus is known to cause a wasting disease in pigs, similar in type to the AIDS virus in humans. While acknowledging that the entire short and long term risks from the porcine circoviruses PCV1 and PCV2 are as yet unknown, the advisory panel decided that 'the benefits of the vaccine trump its risks.' By contrast, health authorities in Hong Kong ordered an immediate recall of Merck Rotateq despite the U.S. panel's recommendation to keep the vaccine on the market.

Shocked at the advisory panel's recommendations for the health and safety of American children, the Coalition for Vaccine Safety (CVS) calls on FDA Commissioner 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 United States.  

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, RN, "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."

The FDA expert panel's failure to urge suspension of contaminated vaccines underscores the need for immediate Congressional hearings on vaccine safety.  The apparent conflicts of interest in the U.S. vaccine program are illustrated by the fact that the Director of the Centers for Disease Control and Prevention (CDC) until January 2009, Dr. Julie Gerberding, is now the President of Merck Vaccines. In 2007, under her stewardship, 97% of CDC outside experts failed to complete their conflict of interest disclosure forms as required by law. The lack of direct corporate accountability for vaccine products, codified by the 1986 Childhood Vaccine Injury Compensation Act, further complicates conflicts of interests in the national vaccine program.

CVS is an alliance of organizations dedicated to vaccine safety representing over 75,000 families.  In recent letters to the Chairmen and Ranking Members of House and Senate Committees charged with oversight of the Department of Health and Human Services (HHS), the Coalition called for hearings to investigate HHS, CDC and other government agencies.  These federal agencies have failed to comply with the terms of the 1986 Vaccine Injury Compensation Act (VICA) by not providing critical vaccine safety science.

SOURCE Coalition for Vaccine Safety