107th Congress

Smallpox, Hearing Before the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, and Education, November 2, 2001

Members Present

Tom Harkin (D-IA), Chairman; Arlen Specter (R-PA), Ranking Member; Robert Byrd (D-WV) and Ted Stevens (R-AK), Chairman and Ranking Member, respectively, of the Senate Committee on Appropriations.

Witnesses

Anthony S. Fauci, Director, M.D., National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); James W. LeDuc, Ph.D., National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC); Michael Friedman, M.D., Chief Medical Officer for Biomedical Preparedness, Pharmaceutical Research and Manufacturers of America (PhRMA).

Summary

Purpose of Hearing: This hearing, the third in a series on bioterrorism preparedness, was held to receive information on efforts targeted to the detection, prevention, and treatment of possible smallpox exposures should they occur. Specifically, Members were interested in the status of the smallpox vaccine stockpile, efforts to increase the number of available doses, and availability of therapies to treat smallpox exposures. They also wanted to know what is needed to ensure national preparedness in the event of a smallpox emergency. All witnesses appeared on a single panel.

Opening Statements

Senator Harkin noted the recent anthrax events and the more dangerous threat of smallpox. He spoke of Senator Byrd's proposal for additional funds for additional smallpox vaccine and funding included in the emergency supplemental bill. He noted his specific interest in the status of the stockpile, the efficacy of the existing supply, how quickly vaccine could be distributed to the public, and asked what additional actions citizens could take to protect themselves. Senator Specter cited bipartisan support of the Subcommittee with respect to public health issues. He noted Secretary Thompson's appearance before the Subcommittee several weeks earlier and a followup letter to the Secretary requesting information on exactly what is needed to address preparedness issues. Senator Byrd noted the eradication of smallpox as a success story but said we now face the threat of smallpox as a weapon. He cited the vulnerability of the U.S. population to smallpox and the need to establish a plan for dealing with the spector of such a threat. Senator Stevens expressed his extreme interest in the subject of the hearing.

Statements of Witnesses

Dr. Fauci noted the threat of smallpox as a bioterrorist weapon as real. Smallpox is highly contagious and, unlike anthrax, is transmitted person-to-person. He said the current stockpile of smallpox vaccine was last produced some 20 years ago, and it has not been given to the public since 1972. Those persons vaccinated years ago have waning immunity, and it is not clear how effective the level of immunity will be. Dr. Fauci spoke of a three-pronged implementation plan: dilution studies to determine if diluting current vaccine will still provide protective immunity; development of a second generation vaccine as an intermediate solution, involving the original manufacturers and other large pharmaceutical companies; and development of a long-term third-generation vaccine that could be given to pregnant women and the immunocompromised. Dr. Fauci also discussed potential drugs that could be used to treat smallpox and said NIH is committed to basic and clinical research and to working with other Federal agencies and public health officials on these serious issues. Dr. Fauci responded to questions regarding Cydofovir and said the drug shows promise as a secondary back up for smallpox infection. He cautioned that the drug has not been tested in humans and offered that NIAID, CDC, and USAMRID are working aggressively on other new drugs in an effort to identify better products.

Dr. LeDuc discussed CDC responsibilities for detecting, responding and preventing exposure to bioterrorism agents. He spoke of a five-pronged approach including collaborations with NIH and the Department of Defense on a variety of relevant research activities, ensuring additional quantities of available smallpox vaccine, enhancing disease surveillance with particular emphasis on local communities, improving rapid diagnostic capabilities, and strengthening the nation's public health communications infrastructure. Dr. LeDuc addressed questions regarding whether the current smallpox vaccine is still viable and whether it provides protection against all 400 different stains. Dr. LeDuc replied in the affirmative to both questions. Regarding new smallpox vaccines, he said he was 99.9 percent certain the new and the old vaccine products will be the same.

Dr. Friedman said PhRMA companies are committed to the national effort and are focused on how best to coordinate with Federal, State, and local efforts aimed at bioterrorism threats. Following the September 11 terrorists attacks, participating companies have provided antibiotics, are making vaccines, and have made their scientists available to assist in the national effort. Several PhRMA companies also have made known their capabilities for vaccine development. He said new vaccines and therapies will be needed, and PhRMA companies are prepared to respond. Dr. Barry spoke of the demands that local communities face in responding to bioterrorism threats. She said proper infrastructure and vaccine distribution capabilities must be in place in order for widespread delivery to take place. While she felt local agencies and communities are capable of responding, she said they are woefully underserved. She called for additional funding for local first responders.

Questions

Senator Harkin:

People get chickenpox routinely. Are there enough doctors and nurses who know the difference between chickenpox and smallpox.

Senator Harkin addressed a point raised by Senator Stevens about spending money for non-existent threats. He noted the threat of naturally-occurring virus mutations and resistant organisms that plague our food supply. He said our public health systems need to address these as well. Our first priority should be to provide an adequate supply of smallpox vaccine then focus on other possible bio-threats.

Does the current smallpox vaccine protect against all 400 different strains of smallpox?

Will the new smallpox vaccine also protect against all strains?

Can you tell us more about the drug Cydofovir which has been found to be effective against smallpox?

Senator Specter:

What can be done to make adequate supplies of smallpox vaccine?

What can be done now to get enough for the entire U.S. population? If money is not an object, how fast could we have enough? Senator Specter asked Dr. LeDuc to provide information within a week on what can be done expeditiously to obtain sufficient quantities for 100 million, 200 million and 280 million people, respectively. What are the risks associated with vaccinations?

We have heard of a doctor/nurse shortage in the Boston area. Can you tell us what is being done to alleviate that problem?

Is a significant amount of the proposed increase for NIAID in FY 2002 going to bioterrorism activities?

Senator Byrd:

If you were the enemy, which would you think could cause the greatest damage to our country-anthrax, smallpox, influenza? How would you rate the one most dangerous, the one most dangerous to us as a nation, the one most easily spread by an enemy?

Of the amount that is in the budget proposal, how much did you ask for NIAID activities?

Prepared by Rosalind Gray/OD/OLPA, January 7, 2002