AVIP AVA RECOMMENDATIONS

[Guest guest]

The Dec 15 MMWR contains the recommendations of the Advisory

Committee on Immunization Practices concerning Use of Anthrax Vaccine

in the United States. Below are edited portions of that

recommendation.

IT DOES NOT STATE THAT THE VACCINE " SHOULD " BE GIVEN TO THE MILITARY -

ONLY " For the military and other select populations or for groups for

which a calculable risk can be assessed, preexposure vaccination may

be indicated. "

Here is a link; you can download as a pdf or see the text below....

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm

December 15, 2000 / 49(RR15);1-20

Use of Anthrax Vaccine in the United States

Recommendations of the Advisory Committee on Immunization Practices

Advisory Committee on Immunization Practices Membership List, October

2000

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RECOMMENDATIONS FOR USE OF AVA

Preexposure Vaccination

Occupational and Laboratory Exposures

Routine vaccination with AVA is indicated for persons engaged a) in

work involving production quantities or concentrations of B.

anthracis cultures and in activities with a high potential for

aerosol production (81). Laboratorians using standard Biosafety

Level 2 practices in the routine processing of clinical samples are

not at increased risk for exposure to B. anthracis spores.

The risk for persons who come in contact in the workplace with

imported animal hides, furs, bone meal, wool, animal hair, or

bristles has been reduced by changes in industry standards and

import restrictions (82). Routine preexposure vaccination is

recommended only for persons in this group for whom these standards

and restrictions are insufficient to prevent exposure to anthrax

spores.

Routine vaccination of veterinarians in the United States is not

recommended because of the low incidence of animal cases. However,

vaccination might be indicated for veterinarians and other high-risk

persons handling potentially infected animals in areas with a high

incidence of anthrax cases.

Bioterrorism Preparedness

Although groups initially considered for preexposure vaccination for

bioterrorism preparedness included emergency first responders,

federal responders, medical practitioners, and private citizens,

vaccination of these groups is not recommended. Recommendations

regarding preexposure vaccination should be based on a calculable

risk assessment. At present, the target population for a

bioterrorist release of B. anthracis cannot be predetermined, and

the risk of exposure cannot be calculated. In addition, studies

suggest an extremely low risk for exposure related to secondary

aerosolization of previously settled B. anthracis spores (28,83).

Because of these factors, preexposure vaccination for the above

groups is not recommended. For the military and other select

populations or for groups for which a calculable risk can be

assessed, preexposure vaccination may be indicated.

Options other than preexposure vaccination are available to protect

personnel working in an area of a known previous release of B.

anthracis. If concern exists that persons entering an area of a

previous release might be at risk for exposure from a re-release of

a primary aerosol of the organism or exposure from a high

concentration of settled spores in a specific area, initiation of

prophylaxis should be considered with antibiotics alone or in

combination with vaccine as is outlined in the section on

postexposure prophylaxis.

Postexposure Prophylaxis --- Chemoprophylaxis and Vaccination

<snip>

RESEARCH AGENDA

The following research priorities should be considered regarding

anthrax vaccine: immunogenicity, evaluation of changes in use of the

current vaccine, human safety studies, postexposure prophylaxis,

antibiotic susceptibility and treatment studies, and safety of

anthrax vaccine in clinical toxicology studies among pregnant

animals.

Immunogenicity

Regarding the immunogenicity of AVA, priority research topics

include a) identifying a quantitative immune correlate(s) of

protection in relevant animal species (especially rabbits and

nonhuman primates) and b)defining the quantitative relation between

the vaccine-elicited immune response in these animal species and

humans. Specifically, such information could help to provide

scientific justification for changing the schedule and route of

administration of the existing vaccine.

Evaluating Changes in the Current Vaccine Schedule and Route

studies evaluating the effects of variations in use of the current

anthrax vaccine should include a definitive clinical evaluation

comparing the intramuscular and subcutaneous routes of

administration and an assessment of the effects of reducing the

number of inoculations required for protection. Both immunogenicity

and safety of these changes should be evaluated. Information about

the efficacy and safety of AVA use in children and elderly persons

is needed. Information about safety of the vaccine during pregnancy

is also needed. In addition, research to develop the next generation

of anthrax vaccines should continue.

Human Safety Studies

To assess the safe use of anthrax vaccine in humans, the Advisory

Committee on Immunization Practices (ACIP) recommends several areas

of research. Adverse event surveillance through VAERS should be

enhanced, which could include development of electronic reporting

capability and implementation of strategies to facilitate reporting.

In addition, the influence of lot-to-lot variations in the vaccine

on rates of adverse events should be evaluated. Other safety issues

related to use of anthrax vaccine that should be addressed include

development and evaluation of pretreatment strategies to decrease

short-term adverse events; assessment of risk factors for adverse

events, including sex and preexisting antibody levels; and analysis

of differences in rates of occurrence of adverse events by route of

anthrax transmission and method of vaccine administration

(intramuscular, subcutaneous, or jet injector). Because the role of

repeated inoculations in local and systemic reactions remains

unclear, further research is needed regarding this subject. In

addition, the feasibility of studies to evaluate longer term and

systemic adverse events should be determined.

Postexposure Prophylaxis

Although a substantial benefit of postexposure antibiotics in

preventing development of inhalation anthrax has been demonstrated

in macaques, further research is needed to determine the optimal

number of days of administration of those antibiotics and any

additional benefit of receiving the anthrax vaccine in combination

with antibiotics. This is a high priority for the current federal

initiative regarding bioterrorism preparedness. Determining

alternative antibiotics for children and pregnant women should be an

important part of this research.