Half of second target group for smallpox shots may refuse them, officials estimate

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Dec 16, 2002 (CIDRAP News) – Federal health officials project that about half of the estimated 10 million health and emergency response workers targeted for the second round of smallpox vaccinations will refuse the shots.

Jerry Hauer, assistant secretary for public health preparedness at the Department of Health and Human Services (HHS), said in a telephone press conference Dec 14, "Our projection at this point . . . is that probably about half of those people will wind up getting vaccinated. So we'll probably use between 5 and 6 million doses of the vaccine."

The estimate was one of several specifics provided by HHS officials in the Saturday briefing, a day after President Bush officially announced the administration's smallpox vaccination plan. Under the plan, the Department of Defense (DoD) has already begun vaccinating about half a million military personnel, and the vaccine will be offered to about the same number of frontline healthcare workers, starting in late January. In the second round of the program, the vaccine will be offered to the rest of the nation's healthcare workers and emergency responders, a group estimated at about 10 million. The shots are not recommended for the public now, but the government will try to accommodate those who want them.

In other comments during the news conference, a transcript of which is available on a government Web site, officials said:

  • The government already has 65 million to 70 million doses of the new cell culture–grown smallpox vaccine being produced by Acambis and Baxter.
  • Healthcare workers who are injured or miss work because of side effects of the vaccine are likely to get help from state worker compensation programs.
  • The public's apparent desire to get smallpox shots probably is partly a reflection of people's ignorance of its risks.
  • The vaccine won't be distributed to physicians nationwide any time soon.

Commenting on the vaccine supply situation, HHS Secretary Tommy Thompson said, "At the present time we have taken control of about 65 to 70 million doses of Acambis-Baxter 2000," the cell culture–produced vaccine. He predicted that the two partner companies will fulfill their full 209 million–dose contract next spring, probably by May.

The vaccine for the first two rounds of vaccinations is from the government's 15 million–dose stockpile of Dryvax, the decades-old vaccine produced from calf lymph. The Food and Drug Administration is currently inspecting and licensing individual lots of undiluted Dryvax. Although clinical trials have shown that Dryvax remains effective when diluted by 5 or 10 parts to 1, the diluted form is not currently licensed and is not likely to be licensed until March or April at the soonest, Hauer said.

Thompson also noted that HHS has 85 million doses of frozen smallpox vaccine that was made by Aventis Pasteur in 1958 or 1959. That vaccine can't be licensed because the manufacturing records are missing, but clinical tests have shown it is "very potent good stuff," he said. He also revealed that when HHS negotiated to buy the Aventis supply for $12 million, it was thought to amount to 35 million to 40 million doses. Only later, when the deal had been made, did an inventory show the supply was more than twice that size. In an emergency, the vaccine could be diluted five or even tenfold and used, Thompson said.

In response to questions, Thompson outlined the current provisions for covering people who suffer harm or have to miss work because of smallpox vaccine side effects. He said Section 304 of the legislation establishing the Homeland Security Department will protect vaccine manufacturers and those who administer the vaccine from lawsuits by injured vaccinees. People hurt by the vaccine could sue the government under the Federal Tort Claims Act, but they would have to prove negligence, which could be difficult, he said.

However, injured people should get coverage from their own health insurance, Thompson said. "Secondly," he said, "they will also be covered by the state workers compensation laws of the particular state, which would pay them compensation. And heaven forbid, if somebody dies, they would be able to receive the wrongful death portions of the worker compensation law put out by the particular state."

Later, in response to a question about the concerns of a healthcare workers union, Michael T. Osterholm, PhD, MPH, said it appears that most if not all state worker compensation programs would assist workers who have problems because of the vaccine. "In the past 2 weeks, we have not yet identified a single state which has refused to cover this program under the workman's compensation program," said Osterholm, an adviser to Thompson and director of the University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP), publisher of this Web site.

Regarding public interest in smallpox vaccine, Thompson said focus groups have indicated that up to 59% of people want to get the shot. Other officials involved in the briefing suggested many people don't understand its potential side effects. "We're finding a disconnect between people's desire to get vaccinated and their knowledge of the toxicities," said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

At a lecture, about 60% of the audience raised their hand when Fauci asked how many were interested in getting vaccinated, he said. But after he showed slides of the adverse events and then asked the question again, the proportion dropped to about 20%, he said.

Julie Gerberding, MD, MPH, director of the Centers for Disease Control and Prevention (CDC), said her agency wants to give people the most accurate information possible, so they will "really understand what the decision is all about."

Fauci said the Acambis vaccine should be licensed sometime in 2004 and should then be made available to the public. People who are not in one of the target groups but want a smallpox shot before then have the option of trying to enroll in a clinical trial, either through HHS or Acambis, or seeking vaccination under an investigational new drug program, he said. "We will do as best we can . . . to make a program under an investigational new drug, IND, approach, to have those people vaccinated," he said.

Gerberding predicted that most states will be able to accomplish the vaccinations of frontline healthcare workers in a 30-day period, "though some may take longer and that's fine. We want people to do it as safely as they need to to gear up and get the job done right." She added, "We haven't issued guidance for the expansion into the second round of healthcare personnel and first responders."

Thompson said that smallpox vaccine will not be distributed to physicians' offices nationwide, even in 2004. "We will not be giving up the vaccine out of our custody until we have a plan in place and determine how the vaccine will be distributed. But it will not be willy-nilly handed out to doctors throughout America."

See also:

Transcript of press conference
http://www.cdc.gov/media/transcripts/t021214.htm

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