Ethics of Administering
Anthrax Vaccine to Children
Background of
the problem
- To prevent bioterrorism attack, Obama administration
suggested to test the existing anthrax vaccine on kids.
- It is found effective among adults and already been tested on
adults and administered to millions of members of the military,
especially those involved in bioterrorism defense.
- National Biodefense Safety Board, recommend that the studies
proceed if outside experts determined they could be done safely and
ethically.
Anthrax
- Anthrax is an infection caused by the bacterium Bacillus
anthracis. It can occur in four forms: skin, lungs, intestinal, and
injection.
- Human infection may occur by three routes of exposure to
anthrax spores: cutaneous (through the skin), gastrointestinal (by
ingestion), and pulmonary (inhalation). In North America, human
cases of anthrax are infrequent.
Anthrax
vaccination
- The only licensed anthrax vaccine, Anthrax Vaccine Adsorbed
(AVA) or BioThraxTM is indicated for active immunization for the
prevention of disease caused by Bacillus anthracis, in persons 18 –
65 years of age at high risk of exposure.
- The vaccine was developed from an attenuated strain of B.
anthracis.
- According to CDC those who recommeds to get anthrax vaccine
are
- People who are at an increased risk of coming into contact with
the bacteria that cause anthrax because of their job
- People who have been exposed to the bacteria that causes
anthrax
Ethics of drug
administration
- Ethical issues related to medical errors can be categorized
around four ethical principles: autonomy and right to
self-determination; beneficence and nonmaleficence; disclosure and
right to knowledge;and veracity
1.Autonomy and Right to Self
Determination
- Healthcare providers have an ethical obligation to inform
patients about their ongoing plan of care, including if a medical
error has occurred.
- Healthcare providers are also obligated to assist patients in
making decisions including medication error and potential adverse
effects and follow their instructions for treatment so that
minimize harm from the error.
2.Beneficence and Nonmaleficence
- This may create moral conflicts for healthcare providers in
terms of balancing projected benefits with possible risk for the
patient.
3.Disclosure and Right to
Knowledge
- Healthcare providers have an ethical obligation to disclose
information that patients need for informed decision making.
- The patient’s bill of rights calls for full disclosure of a
medical error
4.Veracity
- The principle of veracity requires healthcare personnel to
provide comprehensive, accurate, and objective information in a
manner that helps patients understand the information.
- Telling the truth about medical errors helps to establish
trust.
Anthrax
vaccination administration in children ethical
considerations
- A major ethical consideration in “pre-event” trials, in which
testing occurs before an actual or imminent attack, is that
children do not stand to benefit directly from participating in the
study, and so risk must be kept very limited and small.
- Bio ehtics commision recommends many significant
steps would have to be taken, including additional minimal-risk
research with adult volunteers, before pediatric anthrax vaccine
trials prior to an attack should be considered
- the individual is given enough information about the risks and
benefits of a trial to make a decision about participating in
vaccination
- Since the children are not in a possition to give informed
consent, or desicion making ethical consideration should be more
focused
- Ethical principles includes. Information necessary to make a
decision must be presented—that is, the risks and benefits, if any,
of participation., The information must be presented at a level
that can be understood by the patient or study
subject.,Participation must be voluntary, and be free of coercion
or pressure is questionable when it comes to children