108th Congress

Examining the Challenges and Next Steps in Regard to Smallpox Vaccination—Senate Committee on Health, Education, Labor and Pensions

January 30, 2003

Members Present

Senators Judd Gregg (R-NH), Chairman; Bill Frist (R-TN), Majority Leader and member of the Committee; Edward Kennedy (D-MA), Ranking Member; Christopher Dodd (D-CT); Barbara Mikulski (D-MD); James Jeffords (I-VT); Jack Reed (D-RI); and Hillary Rodham Clinton (D-NY).

Witnesses

Panel One:

• Julie Gerberding, M.D., M.P.H., Director, Centers for Disease Control and Prevention (CDC)
• Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH).

Panel Two:

• William J. Bicknell, M.D., MPH, Boston University School of Public Health
• Jon Abramson, M.D., on behalf of the American Academy of Pediatrics (AAP)
• Martha Baker, R.N., Service Employees International Union Nursing Alliance
• Kim Bush, President, Vaccines Division, Baxter Healthcare Corporation.

Purpose of Hearing:This hearing, which was Senator Gregg's first as Committee chairman, was held to examine the Administration's smallpox vaccination plan, challenges to implementation of the plan and critical next steps.

Opening Statements:The Committee was particularly interested in addressing the appropriateness of vaccinations for the general population and for children, and the need for a compensation system should adverse reactions occur. Senators Gregg and Frist were supportive of the Administration's vaccination plan, although they expressed concerns about how liability and compensation issues would be addressed. In particular, Senators Dodd, Mikulski, and Reed raised concerns about the plan's costs to states and compensation issues for those injured by the vaccine. Senator Jeffords was interested in selection process for states and counties to participate in the initial round of vaccinations and plans for evaluating implementation of the smallpox program. Senator Clinton inquired about studies in children and vaccines for immunocompromised persons.

Statements of Witnesses:

Panel One:Dr. Gerberding provided an overview of the Administration's smallpox plan. She noted that the highest priority is protecting public health workers and clinicians who would be the first to respond and treat infected persons. Citing progress, she said in November 2002, no states had plans in place for mass vaccinations; however, by January 2003 all states had plans for immunization of smallpox response teams. To date, some 22 states and 2 counties have received smallpox vaccine sufficient to vaccinate their first responders. Although there is sufficient quantities available to vaccinate the general population, the President's plan does not recommend mass vaccination. Quantities of licensed vaccine is not yet available.

Referring to the 30 percent mortality rate for smallpox, Dr. Fauci said that Dryvax, the currently available vaccine, is highly effective and was used historically to eradicate smallpox worldwide. He cited cohort study data for every million individuals vaccinated, 14 to 52 will experience life-threatening adverse events and some 49 to 935 will experience non-life threatening adverse events, with one or two deaths. He pointed out that individuals who were previously vaccinated with smallpox vaccine are less likely to experience an adverse event should they be re-vaccinated. Dr. Fauci discussed the use of Vaccinia Immune Globulin (VIG), which may be given to persons experiencing vaccination-related events, and said sufficient quantities of VIG exist to take care of any such events that occur in this first wave of vaccinations. He indicated that by this summer, there will be enough to cover projected adverse events were we to vaccine 300 million people. However, there are no plans to vaccinate this number of individuals. Dr. Fauci also said Cidofovir, an antiviral agent, has been found to be effective should VIG fail and has been added to the arsenal. He cited ongoing research to develop vaccines with fewer toxicities and attenuated vaccines, as well as research on other pathogens that could be used as weapons. The ultimate goal is to develop universal antibiotics, antimicrobials, antivirals, and molecularly based immune modulators.

Panel Two:Participants were of differing views on the Administration's plan. Dr. Bicknell said the President's three-phase plan is sound, but its implementation is not. He said the country will not be protected until phase 2 of the plan, vaccination of other responders, is carried out. "We have to plan for a worse-case scenario." He said ring vaccination will not work, side effects in children need to be studied, and CDC needs to develop simple plans and guidelines. Dr. Abramson said the safety and efficacy of smallpox vaccines should be tested in children; thus, the AAP is not recommending vaccination for children. The AAP favors ring vaccination rather than voluntary or mass vaccination. Ms. Baker cited drawbacks in the Administration's plan and the need for compensation safeguards. She said further that CDC's surveillance plan is too soft, and workmen's compensation will only provide partial coverage for vaccinated workers. Mr. Bush cited the need for incentives for public/private partnerships, legislation for the biodefense initiatives mentioned by the President in his State of the Union address, enhancement of procurement systems, and intellectual property protections.

Questions to NIH Witness:

Senator Gregg:

• Isn't it a reasonable assumption that should a smallpox attack occur, there will be multiple outbreaks? Dr. Fauci responded that there could be minor, moderate or multi-focal events, and that we need to be prepared for all possibilities.
• Maybe you can identify the six category A organisms you mentioned and what the status is on each one relative to our capacity to protect society. Dr. Fauci identified the six as smallpox, anthrax, botulism toxin, tularemia, plague, and the hemorrhagic fevers, particularly Ebola. He then described research to address these threats.
• Are you doing anything in the chemical area–ricin gas and other such agents? Dr. Fauci explained that NIH does not directly research chemcial agents. Although NIH will do research on certain aspects of chemical and radiation exposures regarding their effects on the nervous system and the like.

Senator Frist:

• How do you see infrastructure, national security risk and liability play out? Dr. Fauci said infrastructure has diminished, lack of incentives for companies to enter or stay in the vaccine field are a problem, and liability issues are still a concern.
• Can you comment on the bioshield project that was mentioned by the President? Six billion seems like a significant amount. Dr. Fauci explained that it is a permanent and indefinite appropriation authority, where the authority exists, that could be drawn upon when the Secretaries of Health and Human Services and Homeland Security determined that a particular product is needed and must be purchased.

Senator Jeffords:

• Regarding genetic manipulation of some of these organisms that could be used in a terrorist attack, I'm concerned that there could be potentially unlimited variations of these bacteria or viruses. Could you elaborate on these issues and how we can be prepared? Dr. Fauci cited two broad categories of manipulation and the NIAID's strategic plan to address them.
• Do we need to concerned about prion diseases as a potential bioterrorism threat? Dr. Fauci responded that they are of lesser concern as an agent of bioterrorism; however, NIH does support such research.

Senator Reed:

• Regarding monitoring vaccinations and adverse events, Dr. Fauci, can you comment on that, because I assume you want to validate those statistics of two deaths in a million, et cetera? Dr. Fauci said such information will be very important, as data currently used was collected over three decades ago.

Senator Clinton:

• What effect will the large population of immunosuppressed persons have on the number of injuries, deaths and side effects resulting from smallpox vaccination? Dr. Fauci responded that a pre-event vaccination program will be important in this regard where you have the time to go through the multiple menus of contraindications in order to avert the vast majority of inadvertent vaccinations for someone who should not be vaccinated. Obviously, such individuals would have to be vaccinated in a massive attack, but adequate supplies of VIG would be needed for treatment.
• I recognize that there are studies of smallpox vaccine safety in children currently in progress in Cincinnati and Los Angeles; is that right? Dr. Fauci responded that the clinical trial in children with Dryvax has been called off; and, "we're not going to do a trial in children for this particular product."

Prepared by Rosalind Gray, OLPA
February 5, 2003