Vaccination of Risk Groups
In evaluating scientific data from the few animal studies that have been done, government policymakers have decided to offer the anthrax vaccine to at-risk persons. Earlier this group had been advised to take antibiotics for 60 days, which may not be long enough. Officials feel that three groups of people should seriously consider more aggressive therapy (i.e., vaccination and/or 40-day antibiotic course following 60-day course). They are:
anyone who had significant contact with anthrax spores or a contaminated envelope
those who worked in an area where someone developed inhalation anthrax
those who were in an environment heavily contaminated with anthrax spores.
The three preventive options for persons with risks for inhalational anthrax are:
60 days of antimicrobial prophylaxis, accompanied by monitoring for illness;
40 additional days of antimicrobial prophylaxis (intended to provide protection against the theoretical possibility that anthrax spores might cause illness up to 100 days after exposure) accompanied by monitoring for illness or adverse reactions;
40 additional days of anti-microbial prophylaxis plus 3 doses of anthrax vaccine administered over a 4-week period.
Although not a use approved by the Food and Drug Administration, the vaccine might provide additional protection by inducing an immune response to Bacillus anthracis. As an investigational new drug, the vaccine should be administered with informed consent, and vaccinated persons may participate in a follow-up evaluation measuring the effect of the vaccine when administered after exposure.
While the vaccine has known risks, the anthrax risk and vaccine benefits are both unknown. Those who are extremely worried about the risk for anthrax could decide to accept the vaccine risk. Persons less worried could decide to continue only with antibiotics (i.e., an extra 40 days), or take no new medicines. The final decision is being left by the government to the individual and his or her doctor. Because the vaccine has not been approved for post-exposure treatment, those wanting the vaccine must sign a consent form which accepts the potential risks.
Four prominent American newspapers describe the government's decision and the dilemma over inadequate information faced by exposed persons.
New York Times
Wall Street Journal
Washington Post
Washington Post editorial
Los Angeles Times
The initial reaction to the availability of the vaccine was described the following day, as people voice their frustrations over epidemiologic uncertainty.
Washington Post-1
Washington Post-2
New York Times
New York Times editorial
Wall Street Journal
The Centers for Disease Control attempted to address the fears and concerns of exposed persons, yet worries remain.
Click for news account of CDC efforts
Click for news account of postal worker reactions
Click for news account of worries in Connecticut
Click for news account of low acceptance of vaccine
Click for news account of vaccine rejection by NY postal workers
Click for news account of vaccine rejection by civilians
Click for news account of
CDC's view of diminishing risk
Click for news account of
CDC's vaccination disappointment
Click for news account of
consequences of non-adherence
What follows is CDC's earlier recommendation for people potentially exposed to Bacillus anthracis aerosols in Florida, New Jersey, New York City, Virginia or Washington DC. These recommendations were for persons at risk for inhalational anthrax. Such risk occurs first when there has been an inhalational case at work or other facility where people have contact. An example is the media company in Florida where cases 5 and 7 occurred. Second, risk occurs when environmental specimens positive for B. anthracis in facilities along the path of a contaminated letter in which aerosolization might have occurred. An example is the postal facilities in New York City or New Jersey as typlified by cases 11 through 13 (case 10 earlier was in this group but later removed from the outbreak). Third, people are at risk where there is exposure to an air space known to be contaminated with aerosolized B. anthracis from an opened letter. Typical of this category was the Senate office building in Washington DC and case 20. CDC recommended that person in these three risk groups receive a full 60-day course of antimicrobial prophylaxis.
The organization went on to provide specific recommendations by site. These include:
Boca Raton, FL -- prophylaxis is recommended for employees and visitors who spent >1 hour during August 1 to October 6 in the American Media, Inc., building.
New York City, NY -- prophylaxis is recommended for all employees who worked during October 9 to 26 on the second and third floors of the south section of the Morgan Central Postal Facility in Manhattan.
Hamilton Township, NJ -- prophylaxis is recommended for all employees and business visitors (i.e., temporary postal workers, vendors, contractors, and anyone in nonpublic work sites) who were in the U.S. Postal Service Route 130 Processing and Distribution Center during September 18 - October 18.
Washington, DC (Capitol Hill) -- prophylaxis is recommended for persons who were on the fifth and sixth floors of the southeast wing of the Senate Hart Building on October 15, from 9 a.m. to 7 p.m.
Washington, DC -- prophylaxis is recommended for all employees and business visitors to the nonpublic mail room of the U.S. Postal Service Processing and Distribution Center at 900 Brentwood Road during October 12 to 21.
Sterling, VA -- prophylaxis is recommended for all mail room employees and business visitors who were at the Department of State Annex 32 mail room facility during October 12 to 22.
In addition, CDC recommended a 60-day course of antimicrobial prophylaxis for other workers with specified risks for inhalational anthrax. In some areas, local health authorities facilitated access to a 60-day course of antimicrobial prophylaxis for persons who handled mail in facilities from which B. anthracis was isolated but did not have exposures for which antimicrobial prophylaxis is recommended. These persons may choose or may be directed by local health authorities to discontinue antimicrobial prophylaxis before completing a 60-day course.
Evaluation
CDC is evaluating the program to distribute antimicrobial agents and assessing adverse events and adherence. The objectives of this evaluation are to assess the provision of antimicrobial agents and educational materials to affected persons, to determine adverse events associated with the antimicrobial agents, and to characterize adherence to the recommended regimen. Starting in late January 2002, a brief telephone interview will be conducted by RTI International (contracted by CDC) of all persons for whom postexposure antibiotic prophylaxis was recommended. The survey will take about 8 weeks. The information from this evaluation will be critical to CDC's effort to improve the technical assistance and supplies needed with future anthrax postexposure prophylaxis campaigns and to comply with Food and Drug Administration regulations for monitoring for adverse events.
Click for program announcement in MMWR
Follow-up
Scholars will be reviewing what took place in the American Anthrax Outbreak of 2001, and provide thoughts on correct and incorrect actions. As these views become available, material will be added to this section.
Click for news of Science article on value of early antibiotic treatment