Vaccine Safety Advocates Warn of Risks of Proposed Mass Smallpox Vaccination Policy

WASHINGTON, Oct. 7 /PRNewswire/ -- Responding to the Bush administration's clear signal on Oct. 5 that they will release the smallpox vaccine for mass use because of fear terrorists will successfully use the smallpox virus as a weapon against Americans, the National Vaccine Information Center (NVIC) is warning that widespread use of the highly reactive live virus vaccine in the absence of real disease has the potential to compromise public trust in the integrity of government led mass vaccination programs. NVIC endorses the June recommendation of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) which recommended confining pre-attack smallpox vaccination to 20,000 or fewer emergency health care "first responders" investigating and responding to a suspected case of smallpox.

"We believe the administration should re-examine its strategy for dealing with fears that the smallpox virus may be used by terrorists in a widespread and successful attack on the U.S. population. Reintroduction of the live vaccinia virus into the human population in the absence of the eradicated smallpox disease is a very serious decision that has ramifications for not just the U.S. but for populations around the world," said Barbara Loe Fisher, NVIC co-founder and president.

NVIC points to the following risk factors associated with the government's mass release of the live vaccinia virus into the human population before there is a confirmed smallpox virus release by terrorists:

* The live vaccinia virus vaccine for smallpox is estimated to cause
very serious complications requiring the administration of vaccinia
immune globulin (VIG) in 1 in 4,000 persons who get vaccinated
according to the Working Group on Civilian Biodefense. If 280
million Americans were vaccinated pre-attack, there could be a
minimum of 70,000 persons risking injury or death with the vaccine
and requiring emergency VIG therapy;

* The live vaccinia virus vaccine for smallpox can be spread to a
family member or friend who comes into close contact with a recently
vaccinated person;

* Being exposed to the live vaccinia virus is especially dangerous for
children and adults who have a history of immune system problems
such as eczema, cancer, HIV and other health conditions. The number
of children and adults in America suffering from immune system
dysfunction is far larger than it was when the smallpox vaccine was
being used on a mass basis 40 years ago. Perhaps as many as 50
million Americans would be at risk for injury or death if they are
exposed to the live vaccinia virus either directly by getting
vaccinated or by coming into contact with someone who has been
recently vaccinated;

* Recently vaccinated Americans who travel to other countries can
transmit the live vaccinia virus in those countries;

* In addition to the more serious vaccinia virus vaccine complications
such as encephalitis (brain inflammation), progressive vaccinia
(also known as vaccinia gangrenosa) leading to death after the
internal organs, tissue and bones disintegrate; eczema vaccinatum
which resembles third degree burns; and generalized vaccinia which
can result in smallpox-like lesions that cover the body, almost all
who get vaccinated will suffer some kind of reaction including high
fever, fatigue, irritability, and swollen lymph glands.
Approximately half of all smallpox vaccine complications are for
"autoinoculation" where the recently vaccinated person touches or
scratches the lesion at the vaccination site and spreads the live
vaccinia virus to the eye, nose, mouth, and genitalia where more
lesions form. The CDC reports that autoinoculation occurs in 1 in
1,890 first time vaccinations.

* There have been case reports of progressive or generalized vaccinia
infection in persons with genital herpes and active acne. There are
many more millions of Americans suffering from genital herpes today
than three or four decades ago;

* Among those at highest risk for serious complications after exposure
to the live vaccinia virus are children under the age of one year.
The CDC reports that about 1 in 2,500 infant vaccinations result in
generalized vaccinia infection and about 1 in 24,000 result in brain
inflammation;

* Children today receive two to three times as many doses of multiple
vaccines in early childhood as did children who received smallpox
vaccine in past generations. The smallpox vaccine was never tested
for safety or efficacy in controlled human clinical trials prior to
mass use in the 19th and 20th centuries and there is no information
on how the vaccine will interact with the many other vaccines
routinely given to American children today or impact on their long
term health. Those genetically or otherwise biologically vulnerable
to vaccine-induced neuroimmune dysfunction will be at special risk;

* Vaccinia virus has been reported to cause fetal infection after
primary vaccination of the mother and usually results in stillbirth
or death of the infant soon after delivery;

* Vaccinia virus infection can be mistaken for smallpox disease. In
the past, doctors sometimes confused chicken pox with smallpox and
there are other diseases which can mimic smallpox infection such as
eczema vaccinatum or disseminated vaccinia virus infection (from the
vaccine); contact dermatitis, drug reactions and human monkeypox
infection;

* The 30-year old vaccinia virus vaccine stocks, which have been
diluted to prepare enough smallpox vaccine for all Americans, were
originally created using calf vesicle fluid containing "some
microbial contaminants," according to the Working Group on Civilian
Biodefense. The vaccine also contains the antibiotics polymyxcin B
sulfate; streptomycin sulfate; chlortetracycline hydrochloride and
neomycin sulfate; glycerin; and phenol (.25 percent), a compound
obtained by distillation of coal tar;

* If terrorists have the technology and means to culture, maintain,
transport and deliver the smallpox virus to large numbers of
Americans after evading American security and defense systems, there
is no guarantee they would not use a weaponized, genetically
engineered smallpox virus. In this case, the old smallpox vaccine
that will be used in pre-attack mass vaccination campaigns may not
work or may have limited effectiveness. In addition, there is no
guarantee that once the US population has been subjected to the side
effects of the smallpox vaccine, that terrorists will not use an
entirely different weaponized microorganism such as anthrax,
encephalitis virus or ebola.

"It is appropriate for the CDC to be calling for informed consent and a voluntary vaccination program, rather than forced vaccination, in the event the administration does release the smallpox vaccine for use by the general public before an actual bioterrorism attack occurs. But the fact remains that the child or adult who dies, is permanently disfigured or brain injured because he or she came into contact with a recently vaccinated person will not have had the opportunity to give their informed consent. This kind of pre-event mass vaccination policy has the potential side effect of causing fear and distrust of government-promoted vaccination programs in general. The terrorists will have caused the injuries and deaths of Americans and not even had to open fire," said Fisher.

The National Vaccine Information Center is a non-profit, educational organization founded in 1982 by parents of vaccine injured children and is dedicated to preventing vaccine injuries and deaths through public education. NVIC worked with Congress to create the National Childhood Vaccine Injury Act of 1986 and has been the leading national advocate of increased research into vaccination side effects and identification of genetic and other high risk factors for vaccine reactions.

A special, fully referenced report on smallpox and smallpox vaccine is available on NVIC's website at http://www.909shot.com along with information about The Third International Public Conference on Vaccination being sponsored by NVIC on Nov. 7-9, 2002 in Arlington, Virginia. The conference will feature presentations by physicians and bioethicists on smallpox as well as the threat to civil liberties posed by new state public health laws responding to fears of potential bioterrorism attacks on Americans.