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pharmalicensing
Tuesday, 10 September 2002

 

 

news: PR Newswire

New Paper From Journal of Allergy and Clinical Immunology: Groups at Risk For Severe Reactions From Smallpox Vaccine

    MILWAUKEE, Sept. 6 /PRNewswire/ -- Smallpox vaccines could do more harm
than good for people with AIDS or allergic skin diseases, according to
research presented in the September 2002 issue of the Journal of Allergy and
Clinical Immunology (JACI).  The JACI is the peer-reviewed, scientific journal
of the American Academy of Allergy, Asthma and Immunology (AAAAI).
    Smallpox vaccines were discontinued in the United States in 1972, and the
disease was considered eradicated by 1980.  However, the threat of
bioterrorism has brought renewed concern about an outbreak of the disease and
consideration by government officials for possible mass vaccination efforts.
    Of all vaccines being used routinely today, the live virus smallpox
vaccine (called vaccinia) has one of the highest rates of adverse reactions.
With this in mind, the possibility of mass public smallpox vaccination must be
carefully considered, according to lead review author Renata J.M. Engler, MD,
FAAAAI, Chief of Allergy/Immunology at the Walter Reed Army Medical Center in
Washington, DC.
    "The current CDC guidelines in the setting of a smallpox outbreak include
a recommendation to immunize anyone with contact regardless of risk factor for
an adverse event," Engler said.  "Many expert groups are reviewing these
questions and considering the fine points of risk-benefit and what other
options exist to protect those patients who are at very high risk for serious
or even life-threatening smallpox vaccine complications."
    Because more people have immune deficiencies or skin diseases now than
30 years ago when the smallpox vaccine was regularly administered, researchers
anticipate there could be a greater risk for adverse reactions among these
groups.
    People expected to be vulnerable to the vaccinia side effects include:
    -- Patients with congenital or acquired immune deficiency diseases such as
       AIDS;
    -- People on immunosuppressive drugs, such as those undergoing organ
       transplantation; and
    -- People with active or inactive atopic dermatitis, and potentially other
       skin conditions that affect the skin's outer layer.

    Atopic dermatitis, sometimes called "eczema," is an itchy skin condition,
characterized by thickened red and scaly patches. It commonly affects the face
in infants, and the inner elbows and knees, neck and eyelids in children and
adults.  While the precise cause of atopic dermatitis is unknown, the immune
system of the skin is altered, and the disease can often be seen in
individuals with a personal or family history of asthma or allergic rhinitis
("hay fever").
    Eczema vaccinatum (EV) is a risk for people who have atopic dermatitis or
have had it in the past.  The risk exists if they are exposed to vaccinia
directly through vaccination, or indirectly by contacting someone who has
recently been vaccinated.  In this reaction, the vaccinia virus spreads
unchecked throughout the skin, and, at its worst, could cause scarring,
blindness, and even death.  Vaccinia immune globulin (VIG) has been used
successfully to treat or moderate this complication, if given soon after the
reaction starts.
    Current CDC smallpox vaccine guidelines recommend not vaccinating people
with a current or past history of atopic dermatitis.  Because rates of atopic
dermatitis in developed countries have increased two- to three-fold (up to 15%
in the U.S. population) since the days of routine smallpox vaccination, it is
possible that up to half of the population may not be eligible to receive the
smallpox vaccine under routine preventive circumstances, said paper co-author
Julie Kenner, MD, PhD, Adjunct Clinical Professor of Dermatology at the
University of Hawaii John A. Burnes School of Medicine in Honolulu, HI.
    With these groups at risk for severe reactions from the vaccine, it may
prove difficult to include the majority of the population in a routine mass
smallpox vaccination campaign.  However, if the risk of smallpox infection is
high, such as after a bioterrorism attack, the benefit of vaccination in some
patients with atopic dermatitis may outweigh the risks of the vaccine, Kenner
said.
    "The very real dangers associated with the live vaccinia virus vaccine may
take on a greater urgency today than decades ago given the current numbers of
people with pre-existing medical conditions that put them at risk for serious
side effects," Kenner said.  "It is incumbent upon the medical community to
protect our population to the best of our ability against these potentially
lethal vaccine side effects, while at the same time, protect them from a very
deadly disease."
    The paper's authors recommend that additional research be conducted to
explore how the immune system responds to vaccinia to better understand why
people with atopic dermatitis are susceptible to EV, and how the reaction can
be prevented.
    The AAAAI is the largest professional medical specialty organization in
the United States representing allergists, asthma specialists, clinical
immunologists, allied health professionals and others with a special interest
in the research and treatment of allergic disease.  Allergy/immunology
specialists are pediatric or internal medicine physicians who have elected an
additional two years of training to become specialized in the treatment of
asthma, allergy and immunologic disease.  Established in 1943, the Academy has
more than 6,000 members in the United States, Canada and 60 other countries.
The Academy serves as an advocate to the public by providing educational
information through its Web site, http://www.aaaai.org , or the toll-free physician
referral information line at (800) 822-2762.

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