ACIP Provisional Recommendations for Use of Anthrax Vaccine Adsorbed

ACIP Provisional Recommendations for Use of Anthrax Vaccine Adsorbed

Date of ACIP Vote: October 2008/February 2009 Date of posting of provisional recommendations: October 5, 2009

Anthrax vaccine adsorbed (AVA) is recommended for use in one of two ways: (1) prior to exposure to Bacillus anthracis (pre-event vaccination) via the FDA licensed regimen to prevent infection by priming the immune system, and (2) following exposure to aerosolized B. anthracis spores (post-exposure prophylaxis, PEP) under an Investigational New Drug IND or potentially under an emergency use authorization (EUA).
Recommendations for use of AVA differ for pre-event versus post-exposure situations.
Pre-event vaccination is recommended for certain personnel, as described in Table 1, who may be occupationally at risk for exposure to aerosolized B. anthracis spores. For persons who receive pre-event vaccine, ACIP recommends 5 intramuscular (IM) doses administered at day 0; week 4; and months 6, 12, and 18, followed by annual boosters.
Post-exposure prophylaxis (PEP) should be utilized for previously unvaccinated persons following exposure to aerosolized B. anthracis spores, whether exposure is naturally occurring, occupationally related, or intentional. Since the highest and most rapid immune response possible is desired in a post-exposure setting, ACIP recommends a 3-dose subcutaneous (SC) series administered at day 0, week 2 and week 4, along with a 60 day course of appropriate antimicrobial agents (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5041a1.htm and http://www.cdc.gov/eid/content/14/4/e1.htm). Vaccine will be administered under an IND or potentially under an emergency use authorization (EUA).
Occupational exposures constitute a subgroup of those for whom PEP was considered and include the following groups: fully vaccinated personnel (completed the 5-dose series and maintain annual boosters); previously unvaccinated personnel; and personnel who have begun, but not completed, the primary vaccination series. Fully vaccinated personnel do not require antimicrobial PEP if wearing appropriate personal protective equipment (PPE) unless PPE is disrupted. Previously unvaccinated workers should begin receiving vaccine under PEP schedule along with a 60 day course of antimicrobial PEP, then switch to the licensed regimen at 6 month dose. Persons who have begun and not completed the primary series should receive a 30 day course of antimicrobial PEP and continue with their primary vaccination schedule.

Table 1 – Recommendations for pre-event and post-exposure use of Anthrax Vaccine Adsorbed (please, see the pdf full-text)

*When exposed to aerosolized Bacillus anthracis spores in the absence of completing the pre-event vaccination schedule
†Recommended only if handling potentially infected animals in research settings or in areas with a high incidence of enzootic anthrax or if standards and restrictions are insufficient to prevent exposure to B. anthracis spores
**Laboratorians working: with high concentrations or pure cultures of B anthracis spores, with environmental samples associated with anthrax investigations, in spore-contaminated areas or other settings with aerosol exposure; laboratorians not working in these settings are not recommended for pre-event vaccine
††Persons involved in emergency response activities include, but are not limited to, police departments, fire departments, hazardous material units, government responders, and the National Guard. Such persons may perform site investigations, respond to suspicious substances (colloquially known as “white powder incidents”) and perform related activities such as evacuation procedures or other activities critical to the maintenance of infrastructure.
This document available at: www.cdc.gov/vaccines/recs/provisional/default.htm

ABRIR AQUÍ:
http://www.cdc.gov/vaccines/recs/provisional/downloads/anthrax-vax-oct2009-508.pdf