Panel Urges Massive Smallpox Vaccination

By Michael L. Betsch | July 7, 2008 | 8:20 PM EDT

Washington, D.C. ( - The majority of state health officials across the nation do not advocate vaccinating the public against a bio-terrorist threat of smallpox, but there is increasing support for inoculating an estimated 500,000 emergency and medical personnel.

While government officials are saying they favor a plan from the Centers for Disease Control (CDC) to inoculate the nation's health care professionals, they warn that serious risks including disability and death still persist in the smallpox vaccine.

Addressing a forum Thursday hosted by the Alliance for Health Reform, Sen. Bill Frist (R-Tenn.), Dr. Anthony Fauci of the National Institutes of Health (NIH), D.A. Anderson of the Office of Public Health Preparedness and Edward Thompson of the Mississippi Health Department each voiced their concerns regarding bio-terrorism in the form of smallpox.

Contrary to popular opinion, Fauci said, smallpox vaccination policy decisions have neither been made, nor finalized in any government agency.

"They are right now, currently, under advisory with [Health and Human Services] Secretary [Tommy] Thompson," he said.

Fauci said it is "clearly, extraordinarily advantageous" for the U.S. to develop a safe and effective smallpox vaccine in the near future in the event of a bio-terror attack.

"If indeed smallpox were released, it could be very serious because it does have the capacity to spread and it has a 30 percent fatality rate," Anderson said. "It could be, potentially, a global catastrophe."

Although the current smallpox vaccine stockpile was successfully administered in past decades to Americans, it is currently not licensed by the Food and Drug Administration (FDA).

Currently, if a smallpox vaccine was administered to the public, Fauci said, it must be given under an "investigational drug mechanism."

"We'll soon have significant quantities of vaccine so that a decision as to the type of vaccination that you might want to do -- be it health workers, be it the general population - will not be constrained by numbers of doses of vaccine," he said.

But the panel noted that serious risks, including permanent disability and death, persist in the current smallpox vaccine. In addition, they warned that a newly vaccinated person could transmit the virus through casual contact for a brief period.

In light of apparent risks caused by the vaccine, the CDC's Advisory Committee on Immunizations Practices (ACIP) recently recommended that as many as 500,000 first responders be vaccinated against smallpox in the event of a bio-terror attack.

Thursday's Alliance for Health Reform panel agreed that the smallpox vaccine's benefit to the public outweighs the risk to emergency personnel.

In fact, researchers estimate that about one person in a million would die from the vaccine. And the remote possibility of death or disability would be 'red meat' for trial lawyers, the panel noted.

"The number of lawsuits have been estimated to skyrocket in the overall public arena with a lot of money to be made there," Frist said. "To me, this is going to be a great place for a trial lawyer in today's legal climate ... to make a lot of money."

Thompson said trial lawyers are increasingly suing drug manufacturers the moment a given drug's safety is publicly questioned.

He cited a recent article in the Scientific Journal that questioned the usefulness of hormone replacement therapy for the prevention of a number of chronic diseases. Two days later, Thompson said, newspapers across the country were running ads taken out by trial lawyers looking for patients crippled by the hormone therapy.

"There will be adverse effects and there will be lawsuits," he said. "I think the only possible solution is to come up with some sort of legislative protection against this."

But the smallpox vaccine is not your run-of-the-mill drug, the panel said. Preventing smallpox is both a public health and national defense issue, they said.

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