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"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.
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