FEAT DAILY NEWSLETTER Sacramento, California
"Healing Autism: No Finer a Cause on the Planet"
September 13, 2000
'Minimal Risk' FDA Conclusions On Chicken Pox Vaccine Challenged
Also: * Child MMR Vaccine Warning
* Late Events Calendar Additions
[From Barbara Loe Fisher of the National Vaccine Information Center.]
Calling the FDA report on adverse events associated with varicella
zoster (chicken pox) vaccine published in today's Journal of the American
Medical Association a "breakthrough" in the follow-up and public disclosure
of reports made by doctors and parents to the Vaccine Adverse Event
Reporting System (VAERS), the National Vaccine Information Center (NVIC)
applauded public release of the VAERS data but challenged the authors'
conclusions that the vaccine's risks are minimal.
"We have been getting reports from parents that their children are
suffering high fevers, chicken pox lesions, shingles (herpes zoster), brain
damage and dying after chicken pox vaccination, especially when the vaccine
is given at the same time with MMR and other vaccines. This FDA report
confirms our concern that the chicken pox vaccine may be more reactive than
anticipated in individuals with both known and unknown biological high risk
factors," Barbara Loe Fisher, president of NVIC.
In the VAERS data made public today, it was reported that VAERS had
received 67.5 adverse event reports per 100,000 doses of chicken pox vaccine
sold between March 1995 and July 1998 for a total of 6,574 reports. 82
percent of the adverse event cases occurred in individuals who received
chicken pox vaccine only. Admitting that underreporting made the figures
"highly variable fractions of actual event numbers," the authors revealed
that approximately 4 percent of cases (about 1 in 33,000 doses) were
serious, including shock, convulsions, encephalitis, thrombocytopenia and 14
deaths. The VAERS data has lead to the addition of 17 adverse events to the
manufacturer's product label since the vaccine was licensed for use in 1995,
including secondary bacterial infections (cellulitis), secondary
transmission (infection of close contacts), transverse myelitis, Guillain
Barre syndrome and herpes zoster (shingles).
"We have been waiting for the FDA to follow-up on VAERS reports and
then disclose and utilize the VAERS data to increase our knowledge about
vaccine reactions and possible high risk factors. This is how parents and
Congress expected the vaccine adverse event reporting system to be utilized
when it was centralized under the National Childhood Vaccine Injury Act of
1986. However, the conclusions drawn by the authors do not match the
substance of the data presented," said Fisher.
Based on today's published report on chicken pox vaccine, the National
Vaccine Information Center is calling for a halt to simultaneous
administration of chicken pox vaccine in combination with other vaccines,
particularly MMR, until the vaccine can be further evaluated for short and
long term reactivity, particularly in immune compromised individuals such as
asthmatics and those sick at the time of vaccination.
"This vaccine should not be mandated," said Fisher. "There are too many
questions about the true adverse event and efficacy profile of this
relatively new live virus vaccine and it is up to the manufacturer marketing
the vaccine and the federal agencies regulating the vaccine to conduct
further follow-up of this important VAERS report," said Fisher.
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