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1/22/2003

Limited Smallpox Vaccination to Resume in United States

Kate Traynor

President Bush, on December 13, 2002, made his long-awaited announcement on the resumption of smallpox vaccinations in the United States.

The first part of the inoculation program begins with the vaccination of approximately 500,000 military personnel and State Department employees deemed most likely to be exposed to an intentional release of the variola virus, which causes smallpox.

Some Hospitals Opt Not to Vaccinate Workers

According to the Washington Post, two hospitals—Virginia Commonwealth University (VCU) in Richmond and Grady Memorial Hospital in Atlanta—are refusing to vaccinate their health care workers against smallpox. At least two other hospitals are said to be weighing whether to decline to participate in the voluntary vaccine program.

In a December 2002 National Public Radio interview, Richard P. Wenzel, president of MCV Physicians, VCU's faculty physician group, expressed reservations about exposing vulnerable patients to the vaccinia virus used in the smallpox vaccine.

"If this live virus in the vaccine were to infect them, either by inadvertent vaccination or by transmission of the virus from a vaccinated person," Wenzel said, "they could have a horrible, overwhelming infection."

Wenzel noted that VCU would evaluate its decision not to vaccinate should circumstances change.

"We would change our policy in a minute if there was a single case [of smallpox] anywhere remotely in the world, or if we had any kind of assurance from the state or federal government that we had an imminent danger of smallpox transmission," he said.

Julie Gerberding, director of the Centers for Disease Control and Prevention (CDC), said during a December 19, 2002, media briefing that national smallpox vaccination plans had budgeted for some refusals.

"This is a voluntary program," Gerberding said. "We know, from our long experience in working with the public health system, that implementation varies from jurisdiction to jurisdiction. So, it's really not surprising that some hospitals would have chosen not to vaccinate."

She noted that most of the 3600 hospitals identified by states in plans submitted to CDC have already agreed to participate in the vaccination program.

Shortly afterward, nearly 500,000 health care workers identified in states' smallpox-response plans will be asked to volunteer to receive the vaccine.

The final part of the plan calls for the vaccination of as many as 10 million other Americans designated as first responders. Tommy G. Thompson, secretary of the Department of Health and Human Services, described these vaccinees as police officers, firefighters, emergency medical technicians, and hospital and health care workers who did not participate in the first round of vaccinations.

Wyeth's vintage but recently licensed Dryvax vaccine, which contains live vaccinia virus, will be used for the nation's vaccination programs.

Thompson estimated that, once vaccination of civilians begins, each state would need about 30 days to complete the initial round and up to three months to vaccinate first responders. He said the state programs are likely to begin no earlier than January 24, 2003, when the Homeland Security Act of 2002 will provide liability protection to those involved in vaccination programs.

Military vaccination program. According to the Army News Service, the Department of Defense launched its smallpox vaccination education and screening program on December 13, 2002, and began vaccinating members of epidemic-response teams three days later. About 500 soldiers and civilian contractors at Walter Reed Army Medical Center in Washington, D.C., the National Naval Medical Center in Bethesda, Maryland, and Aberdeen Proving Ground in Aberdeen, Maryland, were the first to be vaccinated.

Lieutenant Colonel John D. Grabenstein, a pharmacist and deputy director for military vaccines at the Army Surgeon General's Office, is responsible for implementing and monitoring the Department of Defense's biodefense vaccination programs.

Grabenstein said that, although military pharmacists have not been involved in administering smallpox vaccine, distribution of the vaccine and maintaining the so-called cold chain during transport is overseen by a pharmacist and his staff. That duty has included personally escorting vaccine shipments to their destination.

Grabenstein emphasized that ample room exists for pharmacists' involvement in the smallpox vaccination program. Roles for pharmacists include supply logistics, drug information, patient screening and counseling, and completion of the required documentation.

As with most vaccines, dilution of the vaccine used by the military is performed not in the pharmacy but by the person who administers the vaccine, Grabenstein said.

Because the live smallpox vaccine can transmit vaccinia virus to the people who handle it, prior vaccination of those who administer the vaccine is necessary. "Everyone who administers the vaccine should get vaccinated," Grabenstein emphasized.

State vaccination programs. State and local plans to vaccinate members of smallpox-response teams were submitted to the Centers for Disease Control and Prevention (CDC) for review late last year. CDC Director Julie Gerberding said during a December 19, 2002, media briefing that vaccine would be shipped to the states as soon as they are ready to launch their vaccination programs.

Is Bifurcated Best?

The Service Employees International Union (SEIU) is asking health care workers to carefully weigh the risks and benefits of smallpox vaccination before volunteering to receive the vaccine. Among SEIU's recommendations is that the vaccine be administered using relatively safe vaccination needles, as required by the Needlestick Prevention and Safety Act of 2000.

For now, however, the federal government requires that smallpox vaccination be done using the bifurcated needles supplied with the licensed vaccine-the same type of needle the Centers for Disease Control and Prevention (CDC) says was used during the global smallpox eradication program.

"It's the tried and true needle," said CDC Director Julie Gerberding during a December 19, 2002, media briefing. "We know how to use this needle, and we know that it can be an extremely effective way of administering the vaccine."

Gerberding said CDC had tested one bifurcated safety needle for possible use with the smallpox vaccine but discovered that the device was unsuitable.

Gerberding said that the safety needle was too short to reach the bottom of the vaccine vial. "If we used [the safety needle]," she said, "we would end up either potentially wasting vaccine because we couldn't get it out of the vial, or, if we tipped the vial, then we would run the risk of spilling the vaccine."

Transferring the vaccine into a container that would allow the use of a safety needle is not a viable alternative to using the bifurcated needle. According to CDC, transferring the vaccine would violate FDA regulations on the repackaging of pharmaceutical supplies.

Distribution of smallpox vaccine to the states will be coordinated by staff at the National Pharmaceutical Stockpile with the aim of making the process as efficient as possible. Because the vaccine comes in 100-dose vials, efforts should be made to vaccinate people in groups of about 100 to minimize waste of the vaccine.

"We're working with our expert logisticians from the National Pharmaceutical Stockpile, who are really the world's experts in deploying these kinds of assets," Gerberding said. "They have an enormously comprehensive strategy for ensuring [that] not only are we avoiding waste of the vaccine as it gets distributed locally, but also that its potency is maintained."

In December, CDC hosted a training program for about 200 public health workers that demonstrated how to administer the vaccine. Gerberding said that these health workers will return to their states and train others who will administer the vaccine.

Monitoring adverse events. The Dryvax vaccine was developed decades ago and is not considered as safe as vaccines produced using modern technology. Adverse events, including serious harm and death, have historically been associated with use of the vaccine. According to CDC, vaccinia immune globulin (VIG) will be available from the National Pharmaceutical Stockpile to treat some vaccine-related complications.

Gerberding said CDC and the military will share data on adverse events among vaccinees and CDC will organize and generate reports on the data.

According to CDC, adverse events associated with use of the smallpox vaccine include

  • Mild rash, lasting two to four days,   
  • Swelling and tenderness of lymph nodes, lasting two to four weeks after the blister heals,   
  • Fever,   
  • Transfer of vaccinia virus to the eye, potentially causing blindness,   
  • Rash that covers the entire body, occurring in up to 1 in 4000 vaccinees,   
  • Encephalitis, occurring in up to 1 in 83,000 vaccinees, and   
  • Death, occurring in 1 or 2 of 1,000,000 vaccinees.

Adverse events are expected to be particularly common among people with immunodeficiencies or a history of skin conditions such as eczema or atopic dermatitis-people for whom the vaccine is contraindicated. Other contraindications include

  • Pregnancy,   
  • Dermatological conditions, such as chickenpox, impetigo, or severe burns, that cause breaks in the skin,   
  • Corticosteroid or other immunosuppressive therapy for two weeks or more,   
  • Most cancers, and   
  • Household contact with anyone for whom vaccination is contraindicated.

CDC has emphasized that, if a smallpox attack occurs, anyone directly exposed to the virus should be vaccinated. For those who may have been exposed to the virus, the vaccine's contraindications should be weighed against the risk of contracting smallpox, and a decision would be made about whether to vaccinate.

Homeland Security Act protections. The prospect of serious adverse events occurring among smallpox vaccine recipients raises the possibility that those harmed by the vaccine will file lawsuits against people and entities involved in the vaccination process. Provisions in the Homeland Security Act were created to address this concern.

Section 304 of the act prevents liability claims for injury or death against the vaccine manufacturer and hospitals and health care workers who administer the vaccine while acting as agents of the federal government. The protection extends to liability arising from the use of VIG or other so-called smallpox countermeas-ures used to treat or prevent smallpox. Claims for injury or death may be filed against the federal government but are restricted to harm that arises from a negligent or wrongful act or omission.

In most cases, institutions that are not designated by the state as an official component of the state's smallpox plan are not covered under the act if vaccinated employees transmit the vaccinia virus and cause harm to fellow employees or patients.

Additional information about the act is available from CDC at www.bt.cdc.gov/agent/smallpox/vaccination/section-304-qa.asp.