Fears Raised about Smallpox Vaccination Plan

A number of healthcare and worker organizations have questions about the administration's plan to limit the threat of a terrorist attack involving smallpox by vaccinating frontline workers.

The vaccinations, once given to children as a matter of course, have turned into a life-threatening menace, if you listen to some critics and even some cautious fans of the plan.

The plan, announced Saturday by President George W. Bush, involves the formation of smallpox response teams, who, as volunteers will receive the smallpox vaccination. The group will include healthcare workers and other first responders. The Department of Health and Human Services (HHS) will work with state and local governments to form these volunteer teams, who will be expected to provide critical services to the public in the event of a smallpox attack.

Also included in the plan are Department of Defense and State Department personnel. The Department of Defense (DOD) will vaccinate certain military and civilian personnel who are or may be deployed in high threat areas. Some United States personnel assigned to certain overseas embassies will also be offered vaccination.

"The nation needs a smallpox vaccination plan that doesn't make the threat worse. I'm sorry to say that the president's plan doesn't meet that standard," said William F. Henning Jr., chair of the Board of Directors of the New York Committee for Occupational Safety and Health (NYCOSH).

"Under the president's plan, half a million civilians are going to be in the first wave of people vaccinated," continued Henning. "Every one of them is a worker, and they must get at least as much protection from the vaccination process as they get from any other on-the-job hazard."

None of those essential protections is included in the president's plan, said Henning, adding that before the inoculations begin, the government needs to answer some tough questions about the vaccine's side-effects and their costs.

  • Critics of the plan note that by the government's estimates, one-third of the people vaccinated are likely to be made sick enough to miss a day or two of work. Employers, and in some cases, the workers themselves will be expected to shoulder the cost of the lost work time.
  • Also by the government's estimates, between seven and 26 of the healthcare workers vaccinated in the first wave are likely to develop life-threatening side effects. One of them is likely to die. Henning and other suggest the federal government should agree, in advance, to cover the cost of medical care for side effects and lost work-time.
  • The government acknowledges that the vaccine is so dangerous that people with compromised immune systems should not take it at all. That includes people with HIV/AIDS, because the vaccine could kill them. How is the federal government going to protect the estimated 500 healthcare workers in the first wave who are scheduled for the inoculation and who are HIV-positive, but don't know it?
  • People who are vaccinated will "shed" the live virus that is used for the vaccine for two weeks, exposing anyone they come into close contact with, such as a housemate or a co-worker, to a virus that could kill anyone with a compromised immune system. Critics question how they are going to be protected, and who will cover their medical expenses.
  • Critics question who is going to insure that the screening process that employers use to avoid vaccinating people who should not, or don't want to be vaccinated is confidential and does not result in employees suffering retaliation or discrimination?
  • Critics point out the federal government just purchased 50 million vaccination needles that lack any device to protect a healthcare worker from getting stuck with a used needle, even though safer needles are on the market. A federal law urging health care organization to use safer needles has been on the books for two years.

The federal government is not recommending vaccination for the general public at this time, but acknowledges there may be some members of the general public who insist on being vaccinated. In fact, anyone knowingly exposed to smallpox has two to three days to be vaccinated to prevent an outbreak and the Centers for Disease Control and Prevention has pledged to make vaccine available anywhere in the United States within 12 hours.

Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, participated in a press conference announcing the plan on Dec. 14. She said, in part, "By offering smallpox vaccine to the first people who have to step up to the plate and respond, we know that we can strengthen the ability of our states and our communities to protect the public in that kind of a situation."

As the government moves forward to implement the president's plan, it's important to note several things, said Gerberding. "First of all, we know how to fight smallpox…. Second, the smallpox vaccine is the best protection we have against smallpox, but it is not the only protection. Infection control measures, and especially isolation of infected people, also help prevent transmission. And these measures can help protect when people cannot or choose not to be vaccinated. Finally, but most importantly, as this program unfolds vaccine safety is a top priority. We intend to do everything that we can to minimize the risk and reduce the number of serious adverse reactions to the vaccine."

Soon after the Sept. 11 attacks, HHS began working to expand the national stockpile of smallpox vaccine. The United States currently has sufficient quantities of the vaccine to vaccinate every single person in the country in an emergency.

While voicing support for the president's plan, the American Medical Association (AMA), though trustee Timothy T. Flaherty, M.D., did say the association plans to "closely monitor the data on issues such as adverse reactions to the vaccine, inadvertent transmission to others, and the question of medical furlough. We are also working with the Department of Health and Human Services to ensure that vital federal liability protections are in place prior to the initiation of any smallpox vaccination program."

According to Flaherty, "The need for further voluntary vaccination beyond front-line health care workers and military personnel is a very complex issue. Any future plans for voluntary vaccination beyond the current ACIP recommendations will need to be reassessed using the information and scientific data available at that time."

The AMA voted Dec. 4 to take a cautious approach to any national smallpox vaccination program, urging the federal government to wait for good science before ordering vaccinations for all U.S. citizens. The group estimated vaccinating every American could result in as many as 300 deaths.

The American Nurses Association (ANA), which represents many of the frontline healthcare workers slated to be given the vaccine, has some concerns about the plan.

"We are well aware that there is a pressing need to be prepared against the possibility of a bio-terrorist attack," said ANA President Barbara A. Blakeney, MS, APRN,BC, ANP.

"Since 1998, the ANA has been involved in developing strategies for educating the nation's 2.7 million registered nurses to respond in the event of such an attack. ANA also is working closely with the U.S. Department of Health and Human Services (DHHS), to develop the National Nurse Response Teams for just such an event," she added.

"However, we want people to be able to make an informed decision about whether or not they should get vaccinated against smallpox, and I do not believe we have the answers we need to make that informed decision," she said.

The smallpox vaccine, which was routinely administered to Americans until 1972, is a highly effective protection against the disease when given before or shortly after exposure to the virus.

To read more on the disease, visit www.bt.cdc.gov/agent/smallpox.

To read more on the vaccine, visit www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.

To read more on medical conditions that make pre-vaccination unadvisable, visit www.bt.cdc.gov/agent/smallpox/vaccination/ contraindications-public.asp.

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