# Presentation: 378694

## Anthrax Vaccine Protocol

**Jairam Lingappa, MD**
**Meningitis & Special Pathogens Branch, **
**Division of Bacterial and Mycotic Diseases, NCID, CDC**
**Speaker 2 of 4 for program “CDC Responds: Update on Options for Preventive Treatment for Persons at Risk for Inhalational Anthrax,” broadcast December 21, 2001**

## Anthrax Vaccine and Antibiotics Availability Program

**Anthrax Vaccine, Adsorbed (AVA)**
- Objective:
**	**To make vaccine and antibiotics 	available to people who have had a 	high dose exposure to *B. anthracis* 	spores
** **

## Anthrax Vaccine and Antibiotics Availability Program

**Eligibility**
**Persons who have been exposed to high doses of anthrax spores and were directed to take 60 days of antibiotic prophylaxis**

## Anthrax Vaccine and Antibiotics Availability Program

**Exclusion Criteria**
- No specific exclusion criteria

## Additional Options for Those Exposed to B. anthracis spores

- Earlier Recommendations – 60 days of antibiotics + medical monitoring
- Additional Option 1 – 40 additional days of antibiotic treatment + medical monitoring
- Additional Option 2 – 40 additional days of antibiotic treatment + 3 doses of anthrax vaccine over 4 weeks + medical monitoring

## Anthrax Vaccine in this Program 

- Schedule:
- Day 0, 2-weeks, 4-weeks
- Route:
- Subcutaneous
- Intramuscular (<18 years age)

## Risks: Antibiotics

- Side effects include:
- Hypersensitivity reactions
- Photosensitivity (cipro and doxy)
- Tendonitis (cipro)
- Dental staining (doxy - prenatal to < 7 years of age)
- Fetal affects (unproven association between cipro and bone-joint formation)

## Risks: Vaccine

**18 safety studies**
**Local reactions:** soreness, redness, itching, swelling
- 30% of men, 60% of women
- Lump at site occurs commonly and lasts a few weeks
**Systemic reactions:**
- Rashes (16%), headaches (14% to 25%), malaise (6% to 17%), muscle aches (3% to 34%), fever (1% to 5%).
- Typically resolve in a few days
**Rare reactions:**** **
- Severe allergic reactions < 1 per 100,000 doses

## Benefits

- We do not know if there is a risk of disease among people who have been exposed to anthrax spores and have taken 60 days of antibiotics.
- However, if there is such a risk, then either 40 days of additional antibiotics or 40 days of additional antibiotics and the vaccine may be of benefit in reducing the risk of disease.

## Anthrax Vaccine and Antibiotics Availability Program

**The anthrax vaccine used in this program is considered investigational because:**
- The vaccine is not approved for post-exposure prophylaxis;
- The vaccine is not approved for a 3-dose regimen; and
- The lot of vaccine to be used in this program is not approved for commercial use.

## Antibiotics used in this program are investigational because:

No antibiotic is approved for use beyond 60 days for prophylaxis for inhalational anthrax;

2. 	Amoxicillin is not approved for use for any prophylaxis against inhalational anthrax

- No antibiotic is approved for use beyond 60 days for prophylaxis for inhalational anthrax;
- 2. 	Amoxicillin is not approved for use for any prophylaxis against inhalational anthrax

## Anthrax Vaccine and Antibiotics Availability Program

**Consent Issues**
- There is no data to predict if vaccination will be a benefit after exposure
- The vaccine is not approved for this use
- Lots of vaccine to be used are not licensed by the FDA