NVIC Questions Licensing & Policymaking

"Protecting the health and informed consent rights
of children since 1982."

Contact: Barbara Loe Fisher
(703) 938-0342

For Immediate Release
July 16, 1999 

VACCINE SAFETY ORGANIZATION QUESTIONS LICENSING AND POLICYMAKING STANDARDS APPLIED TO ROTAVIRUS VACCINE 

Reacting to the announcement on 7/15/99 by the Centers for Disease Control (CDC) and the American Academy of Pediatrics (AAP) that all vaccination of infants with rotavirus vaccine is being suspended because of reports of bowel obstruction developing within weeks of vaccination, the National Vaccine Information Center is questioning the licensing and policymaking standards used to recommend universal use of rotavirus vaccine in all American infants under six months of age.

Infant diarrhea caused by rotavirus is highly treatable with rehydration therapy and, unlike in poor Third World countries, rotavirus does not cause widespread death among children in the US.. The CDC estimates that 20 to 40 deaths are associated with rotavirus infection in the US every year but has not indicated how many of these deaths could have been prevented with proper medical treatment.

Rotavirus vaccine, which was developed by NIH researchers and is produced and marketed as RotaShield by Wyeth-Ayerst Laboratories, was recommended for universal use in infants by the CDC’s Advisory Committee on Immunization Practices (ACIP) six months before the vaccine was licensed by the FDA on August 31, 1998. The oral rotavirus vaccine is the first rhesus-human reassortment vaccine and was created by co-cultivating rhesus monkey rotavirus with human rotavirus strains to create a genetic human-monkey hybrid strain of rotavirus. The vaccine’s efficacy rate ranges from 48 to 91 percent.

Barbara Loe Fisher, NVIC co-founder and president, said, "Yesterday’s announcement concerning rotavirus vaccine and bowel obstruction is a sobering reminder of the need to apply very high standards to licensing new vaccines and making policy for mass vaccination of our children. It also highlights the importance of paying close attention to data coming out of The Vaccine Adverse Events Reporting System (VAERS). The data from VAERS shows persistent reports of vomiting and diarrhea following receipt of rotavirus vaccine and there has been at least one death reported in a premature infant who received rotavirus in combination with other vaccines.

What is the biological mechanism at work to induce the bowel to fold in on itself? Could it be associated with the fact that this vaccine is introducing a newly created monkey-human hybrid live virus into young infants or that there is a negative effect when the vaccine is given in combination with other vaccines to infants with immature immune systems? And what is the justification for universal vaccination for a common infection which most children get and recover from in the US without permanent injury or death?"

Prior to yesterday’s suspension, the CDC had recommended that three doses of rotavirus vaccine be given to all infants before six months of age. The three-dose series can cost parents getting the shots in private pediatricians offices up to $80 per dose ($65 for the vaccine and a $15 administration charge) or $240 for a three dose series. When the vaccine was licensed in 1998, there were reports that in order to be able to finance delivery of Rotashield to Third World populations, where the infection is a serious health threat, the richer countries like the US would have to use it.

The National Vaccine Information Center in Vienna Virginia, is a non-profit, educational organization founded in 1982 by parents of vaccine injured children and advocates the institution of vaccine safety and informed consent protections in the mass vaccination system.

The National Vaccine Information Center is a non-profit educational organization founded by parents of vaccine-injured children in 1982.