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1/16/2002

Anthrax Vaccine Offered, But Not Recommended, As Option to Treat Infection

Donna Young

The Department of Health and Human Services (HHS) announced December 18 that it would make the anthrax vaccine available to postal workers, Capitol Hill staffers, and any other people who were likely to have been exposed to Bacillus anthracis spores.

Five people have died of inhalational anthrax, and at least six others have been confirmed as having the pulmonary infection since the October 2001 discovery of anthrax-tainted letters in the mail.

In the weeks that followed the anthrax mailing, more than 10,000 Americans reportedly had been instructed to take a precautionary 60-day regimen of an antiinfective agent.

But, according to HHS, some of the studies conducted on animals indicated that live anthrax spores may persist in the lungs "up to 100 days following exposure."

Unusual caution. HHS has neither endorsed nor recommended the vaccine as a postexposure treatment. Rather, HHS has offered vaccination as a precautionary "option."

The department has also offered an additional 40 days of antiinfective therapy to people who had originally been offered the 60-day supply of ciprofloxacin, doxycycline, or amoxicillin.

Because FDA has not licensed the anthrax vaccine for postexposure use, said HHS Secretary Tommy G. Thompson, the public would be offered the product as an investigational treatment.

The decision to use the vaccine, HHS announced, would be left to the discretion of each individual "in recognition of the limited nature of the data now available concerning inhalation anthrax treatment and the factors underlying development of the disease, as well as uncertainty concerning the extent of exposure to spores that some persons may have received in the recent anthrax incidents."

According to the Department of Defense (DoD) Anthrax Vaccine Immunization Program (AVIP), the vaccine—administered to military personnel before possible exposure to anthrax bacteria or spores—is "not experimental, not investigational, and does not require special authorization, nor informed consent."

"It is a routine, common vaccination for people whose occupation places them at risk for exposure to anthrax," AVIP’s Web site says.

But any civilian who chooses to be vaccinated must sign a five-page informed-consent form, according to officials from the Centers for Disease Control and Prevention (CDC).

Investigational use. CDC contracted with Technical Resources International Inc. (TRI) of Bethesda, Maryland, to help develop the consent form, said Sandra S. Smith, a CDC spokeswoman.

TRI is also responsible, she said, for collecting a six-week "health diary" from civilians who have been inoculated with the anthrax vaccine.

CDC will conduct periodic telephone interviews over two years with people who have been vaccinated to gather information about any changes in health and the development of adverse events. The agency will analyze the data collected from the interviews and the diaries, Smith said.

A rocky history. DoD describes the anthrax vaccine as "safe and effective for people at high risk of exposure."

The vaccine is a cell-free filtrate produced from a strain of anthrax that does not cause the disease, according to DoD.

FDA approved the original biologics license for anthrax vaccine in 1970. Since that time, according to DoD, the vaccine has been "safely administered in the U.S. to at-risk veterinary and laboratory workers, livestock handlers, and service members."

BioPort Corp. of Lansing, Michigan, is the nation’s only manufacturer of the vaccine.

But FDA has cited BioPort for not adhering to quality standards in its manufacturing processes. BioPort has also had difficulty passing all of the safety inspections necessary for meeting FDA’s requirements for the company’s supplemental biologics license application.

Military use. The military adopted a mandatory anthrax vaccination program in 1998, exempting personnel who do not meet the criteria or are allergic to a component of the vaccine.

According to DoD, 522,529 people had been inoculated with 2,098,544 doses of anthrax vaccine through November 29, 2001. These numbers may include nonmilitary personnel.

As of December 18, the federal Vaccine Adverse Event Reporting System (VAERS) had received information about 1685 people who had untoward reactions after being inoculated with the anthrax vaccine. Of those reported, 885 adverse events were "certainly or probably caused by anthrax vaccine," according to DoD.

VAERS was created under the National Childhood Vaccine Injury Act of 1986. Health care providers are required by the act to report to HHS specific adverse events that occur after the administration of certain vaccines.

Reports received by VAERS about the anthrax vaccine have been evaluated by a panel of civilian medical experts sponsored by HHS, according to DoD. In addition, the U.S. Army is conducting "a long-term prospective study using a cohort of 600 soldiers" stationed at Tripler Army Medical Center in Honolulu.

Civilian use. The vaccine’s inoculation schedule for preexposure use requires a series of six doses to be administered over 18 months, a DoD spokeswoman said.

But HHS and CDC determined that civilians who had been exposed to anthrax spores and had an increased risk of acquiring inhalational anthrax should be administered three doses, according to officials.

The second dose is given two weeks after the initial inoculation, with the third dose given two weeks after the second dose, officials said.

People who work on Capitol Hill, where an anthrax-tainted letter was opened in a Senate office building, were the first group to be offered the vaccine on December 20.

According to CDC officials, 58 Capitol Hill staffers chose to be vaccinated after receiving counseling by health officials about the vaccine.

Lt. Col. John Grabenstein, the Army pharmacist who oversees the military’s anthrax vaccine program, had "provided information about the vaccine to a group of people on Capitol Hill," earlier in the week, according to his spokeswoman.

Capitol Attending Physician John Eisold reportedly had "strongly urged" about 70 people on Capitol Hill to receive the vaccine. But the Washington Post also reported in December that District of Columbia (D.C.) Health Director Ivan C.A. Walks had advised against the vaccine because of the lack of available data about its safety.

CDC officials announced that the vaccine would be available from late December 2001 until January 7, 2002, to people in Washington, New Jersey, New York, and Florida who had been exposed to anthrax spores.

However, the deadline was extended for employees of American Media Inc. of Boca Raton, Florida—the company that employed 63-year-old editor Bob Stevens, who died of inhalational anthrax on October 5.

Joe Posid, public health adviser for CDC’s Emergency Operations Center, said that, when CDC first deployed its vaccination team to Florida on December 23, most of American Media’s employees "had left town for the holidays." CDC officials left "well over 500" telephone messages for the employees to contact the agency about the vaccine and antiinfectives, he said.

As of December 30, said CDC spokesman Curtis Allen, a little over 60 Florida residents had been counseled about the vaccine. Of those, 36 received the 40-day extension of antiinfective therapy and 4 had been vaccinated and also given a 40-day supply of medication.

Education and acceptance. On December 21, the U.S. Postal Service and CDC began an educational program to provide postal workers with information about the precautionary treatments available to them.

CDC held a one-hour live information session about the vaccine, which was made available to postal employees by satellite broadcast at facilities in Washington, New York, and New Jersey. (The broadcast was archived as a webcast.

On December 27—the first day the vaccine was offered to D.C.-area postal workers—about 130 postal employees received counseling about the vaccine from CDC officials at four local postal facilities, said Smith. Of those employees, 9 were inoculated with the vaccine and accepted the additional 40-day supply of antiinfectives.

By 4 p.m. on January 7, a total of 2115 D.C.-area postal workers, Capitol Hill staffers, State Department employees, and others had been counseled about the vaccine and antiinfective therapy, Allen said. Of those people, 746 decided to continue antiinfective therapy for another 40 days. Fifteen State Department employees and 37 D.C. postal workers were vaccinated.

The federal government contracted with Baltimore-based Passport Health to administer the vaccine and dispense the antiinfectives in the D.C. area. Pharmacist and epidemiologist Jim Hayslett, an officer with CDC’s Epidemic Intelligence Service (EIS), and EIS physician Bruce Tierney oversaw the operation.

Hayslett, who generally works out of his office in Austin, Texas, said he arrived in Washington last October 18, a few days after an anthrax-tainted letter had been opened in the office of Senate Majority Leader Thomas A. Daschle.

Hayslett has been involved in the anthrax investigation on Capitol Hill as an epidemiologist and acted as the adverse-events coordinator and oversaw postexposure prophylaxis in the D.C. area.

He said his involvement in the anthrax investigation has been an "amazing opportunity" for pharmacy and epidemiology.

"This is the real deal . . . real-life, pure public health," Hayslett said. "Any data we can gain is great. But our real goal is to make sure no one else gets sick."

CDC’s Smith said the agency deployed at least one physician and one nurse, in addition to four or five other team members to each vaccination operation site. Some of these team members are employees of the federal Public Health Service and its Commissioned Corp Readiness Force.

CDC contracted with Wisconsin-based Logistics Health Inc. to administer the vaccine and dispense antiinfectives in New York and New Jersey, Allen said.

Postal workers in New York were offered the vaccine on December 27, and New Jersey postal workers began receiving the vaccine at midnight the next day.

In New York, 2296 postal workers had attended information sessions about the vaccine as of January 7, Allen said. Of those, 158 had accepted the 40-day additional supply of antiinfective therapy, and 7 had been vaccinated and given medication.

In New Jersey, 652 postal workers had been counseled about the vaccine by late afternoon on December 30, Allen said. Of those workers, 305 had received the additional supply of antiinfectives and 41 had been vaccinated and given the 40-day supply of medication.

CDC officials said they would offer the vaccine to Connecticut postal workers who had completed their initial 60-day regimen of antiinfective therapy.

A 94-year-old Oxford, Connecticut, woman died of inhalational anthrax on November 21.