Contact: Leslie Phillips
(202) 224-2627
December 17, 2003

Lieberman Seeks Vulnerability Assessment, Remedies To Current Influenza Outbreak

WASHINGTON - Governmental Affairs Committee Ranking Member Joe Lieberman, D-Conn., asked the nation’s top health official Thursday to assess our vulnerabilities to and find remedies for a severe flu outbreak spreading across the country this season.

In a letter to Health and Human Services Secretary Tommy Thompson, Lieberman sought clarification on how HHS was coordinating the government’s efforts to address the current crisis, warning that the response to the flu outbreak reminds us of our vulnerabilities in the event of an intentional or unintentional infectious disease outbreak.

The extent and severity of the current (influenza) outbreak sends a clear signal that we do not have the federal, state and local coordination, organization, or overall public health preparedness to face a major health threat, Lieberman wrote. “We need to determine the extent of our vulnerability and find remedies as soon as possible.”

HHS has not issued a national strategic plan to combat a flu pandemic, and only four of 24 states now battling the epidemic have such action plans in place. Furthermore, a variety of circumstances surrounding the current outbreak could heighten the danger for the general population, Lieberman said. For example, this year’s flu outbreak appears more virulent than expected. The vaccine now being administered provides limited protection against the main strain of influenza currently infecting people. And only 83 million doses of the vaccine were produced, although 185 million people were identified as high risk.

In a series of questions to HHS, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health, Lieberman pressed the Administration on how it is dealing with vaccination shortages, prioritizing distribution of the vaccine, improvement of vaccine production, and federal-state coordination in dealing with pandemics.

Below is a copy of Lieberman's letter:

December 17, 2003


The Honorable Tommy G. Thompson
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201


Dear Secretary Thompson:

As characterized by the Director of the Centers for Disease Control and Prevention (CDC), Dr. Julie Gerberding, during your joint December 11, 2003, press conference, the United States is experiencing an influenza epidemic with severe outbreaks of the disease now confirmed in 24 states. Especially troubling are the growing number of deaths, especially among infants and children. While it is far too early to determine the full effect that this epidemic will have on the country, it is not too early to prepare for the potential of much more widespread transmission of this disease. I am writing to urge you to take additional steps.


I am extremely concerned that the federal response to this current health crisis highlights our vulnerabilities to the intentional or unintentional introduction of infectious diseases. Only 4 of the 24 states currently battling widespread outbreaks of the flu have plans in place to deal with a severe influenza epidemic or pandemic. The extent and severity of the current outbreak sends a clear signal that we do not have the federal, state, and local coordination, organization, or overall public health preparedness to face a major health threat. I ask you, as our nation’s health care leader, to promptly and thoroughly respond to these issues, as detailed below. We need to determine the extent of our vulnerability and find remedies as soon as possible.


While it is important not to overreact to the current crisis, the potential danger is heightened by several factors. Although it is believed by CDC that the current vaccine will provide some protection, it does not directly confer immunity against the predominant strain of influenza that is the source of the current epidemic. Although some 83.4 million doses of this vaccine were produced for the U.S. market, those supplies are being exhausted. I commend you for your efforts to obtain 625,000 additional doses of vaccine, but as described by Dr. Gerberding, there may be as many as 185 million people at risk for influenza. Consequently, the ability to further blunt the effects of the epidemic through additional vaccinations appears limited.


My concern is further heightened by a report released on December 11th by the Trust for America’s Health and the Robert Wood Johnson Foundation, entitled “Ready or Not? Protecting the Public’s Health in the Age of Bioterrorism,” which reported that very few states have developed plans for responding to an outbreak of “a severe, novel strain of influenza.” In fact, the report found that only 13 states had either a draft or final plan for dealing with such a threat and noted “CDC does not require each state to submit its influenza plan to the agency for analysis and approval. Thus, there is no guarantee that states are equally prepared, or that a response would be coordinated and sufficiently responsive across state lines.” Similarly, the report points out that there is no national plan for a federal response to pandemic flu. While it does not appear that the current outbreak will reach pandemic proportions, the lack of preparation and planning for a severe influenza outbreak is cause for real concern, especially given the shortcomings we are now experiencing in the annual development, production, and delivery of influenza vaccines.


Typically, the United States loses over 36,000 people to the flu each year. Even in the absence of a pandemic, flu accounts for 1.5% of all deaths. The flu is a serious cause of morbidity and mortality each year. Although we have made great strides in reducing the impact of the flu through the efforts of the National Immunization Program of the Centers for Disease Control and Prevention, as evidenced by the growing toll from the current outbreak, we still have yet to conquer this annual killer.


There are three critical reasons we face a severe flu outbreak and a shortage of effective flu vaccine at the same time:


I. Although vaccines give protection for extended periods of time they usually only work against one specific virus. Each year, the flu virus evolves into new strains that are not recognized by the immunity produced from old vaccinations. Each year, the World Health Organization (WHO) predicts how the flu virus will evolve that year in order to start production of the new flu vaccine with the three most likely influenza virus strains in time. It takes 6 to 8 months to make new vaccine so production must be initiated in advance. This year, the WHO predictions appear to have been wrong. The strain of flu that appears to be responsible for up to 75% of the confirmed influenza A cases in the United States, a drift variant off the A/Fujian/411/2002 strain, was not represented in this year’s vaccine. This strain was detected earlier this year, but too late for inclusion into vaccine production.


II. When the flu only changes a little in a year, everyone has some protection against the new strain from antibodies produced from prior flu infections or vaccinations. For this reason, a small change in the virus usually produces an epidemic. If larger changes in the flu genome occur, a pandemic can result. This year’s flu evolution is more dramatic than
most and the result has been what appears to be an earlier and more severe flu season


III. According to the CDC, last year, 95 million flu vaccine doses were manufactured and 12 million went unused (leading to a loss of $120 million in revenue to vaccine manufacturers). Based on last year's usage and the predicted change in the virus, the industry decided (with CDC's input) to produce only 83 million doses for this year. Unfortunately, given current flu vaccine production capability and techniques, there is no way to reverse this decision since the vaccine takes so long to manufacture.


The current flu season illustrates that combating annual flu epidemics is a multifaceted problem requiring good coordination and communication between agencies and governments. Today, I am calling on you to explain the roles played by the Department of Health and Human Services, the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the World Health Organization in this current health crisis. I ask that you respond to the questions below and clarify how these agencies will work to address the current crisis and prevent a recurrence of this severe influenza season in the future.


A. The Department of Health and Human Services (HHS)


As the recent report from the Trust for America’s Health pointed out only 13 of the 50 states have plans for a flu pandemic. As this current flu season has demonstrated, even a flu season moderately more severe than the norm can cause great concern and, possibly, great loss of life. Unfortunately, many of the states are hampered in their efforts to establish procedures for responding to a severe flu outbreak by the lack of a national flu pandemic plan.


1. When will HHS release the revised flu pandemic plan to the states?


2. What efforts will be taken to assist the 13 states that currently have pandemic flu plans to update their procedures to interface with the new national plan?


3. What has been done to ensure states without plans will receive the assistance they need during a pandemic?


B. The Centers for Disease Control and Prevention (CDC)


On May 30, 2001, the General Accounting Office (GAO) made several recommendations following their investigation of the 2000-2001 flu vaccine shortage. Its investigation found that there had been inadequate production of that year’s flu vaccine. Although it noted the total amount of flu vaccine is determined by the private sector, it made several recommendations for steps that CDC and HHS could take to improve the reliability of the vaccine. Please outline how the CDC has responded to each of the following areas of concern.



1. GAO noted that in 2000-2001 there was inadequate targeting of the vaccine to insure that in times of shortage individuals at highest risk received the vaccine. Since that time, CDC has revamped its procedures for distribution the vaccine in times of shortage. However, as of December 9, 2003, Dr. Julie Gerberding reported that more than 185 million people fell into the high-risk categories and yet only 83 million doses of the vaccine had been produced.


a. Please explain the procedure for determining the high-risk categories.


b. What, if any, steps are generally taken to revise these categories during a severe flu season and/or a shortage of vaccine?


c. What, if any, steps were taken during the current flu season to revise these categories?


d. Please describe what steps are taken to prioritize flu vaccinations.


e. What changes to these procedures would be required during an epidemic or pandemic flu season or a severe vaccine shortage?


f. This year a determination was made in August, prior to the outbreak, that sufficient vaccine supplies were available and there was no need to prioritize distribution of the vaccine. Even though the U.S. experienced earlier than normal flu outbreaks beginning in October, this decision was apparently never reexamined until December when vaccine supplies were exhausted. How was the August decision reached? What are the procedures for revisiting the determination when a late-stage vaccine shortage occurs? Why was the issue of vaccination prioritization not revisited sooner?


2. The GAO also noted that pneumococcal vaccination could decrease the morbidity and mortality associated with influenza infection. It recommended increasing vaccination of flu prone individuals with this relatively new vaccine. Since the pneumococcal virus is more stable over time, these patients could be vaccinated in advance to reduce the impact of the cyclical flu outbreaks.


a. How many additional individuals at risk for contracting influenza have been vaccinated with the pneumococcal vaccine since 2001?


b. What efforts have been taken to educate the public on the need for both vaccines?


c. Has CDC studied the effect of price on compliance with pneumococcal vaccine recommendations?


3. According to CDC’s December 12, 2003 Morbidity and Mortality Weekly Report (MMWR) flu report, as of December 3, 2004, 34 states had influenza vaccine supplies that had not been distributed. Even though state health departments usually account for less than 10% of the flu vaccine supply, in times of shortage it seems particularly important that state health departments move rapidly and efficiently to distribute their supplies and reduce the spread of the illness within their communities.


a. What steps have been taken to assist states in the distribution of their flu vaccine stores?


b. How will CDC ensure efficient utilization of state stores in the
future?


C. The Food and Drug Administration (FDA)


Currently, the FDA is responsible for ensuring the adequacy of the drug supply, although private manufacturers determine the number of flu vaccine doses to produce. Given the fluctuation in vaccine production and the negative consequences of vaccine shortages, the HHS should immediately investigate alternatives to ensure production and distribution is adequate to protect public. For example, FDA should immediately investigate the possibility of guaranteeing purchase from vaccine manufacturers of a limited number or percentage of flu vaccinations that remain unused at the end of the flu season thereby reducing the financial risk of higher production levels. Consideration should also be given to increasing the authority of the FDA in determining the number of doses to be produced and stabilize the supply, and to HHS’s role in stockpiling flu vaccine to respond to the types of shortages that are now occurring. Greater involvement by HHS in managing the supply of influenza vaccine would also give HHS an additional incentive to conduct public education campaigns to increase compliance with vaccine recommendations.


1. What has the FDA done to address the shortage of flu vaccine that occurred in 2000-2001 and again in 2003-2004?


2. Has the FDA taken steps to stabilize the predicted demand so drug manufacturers can more accurately determine the doses needed?


3. What industry incentives have been put in place to maintain adequate flu vaccine production?


4. On December 9, 2003, Dr. Julie Gerberding announced that the United States would look for foreign sources of flu vaccine. In the past, only one foreign flu manufacturer (in the United Kingdom) has been licensed to sell flu vaccines to the United States.


a. Please outline the steps the FDA has taken to establish and maintain a list of foreign flu vaccine manufacturers that could supply flu vaccine in times of shortage.


b. What steps are being taken to expedite review and approval of such vaccines during this epidemic?


c. What steps are being taken to expedite review and approvals of
vaccines for use in future epidemics or a pandemic?


d. How is the price determined for these foreign vaccine
manufacturers?


D. The National Institutes of Health (NIH)


Each year, the production of adequate supplies of flu vaccine is limited by our scientific expertise. Currently, scientists must make large quantities of vaccine in an avian culture system. As the May 30, 2001, GAO report pointed out, we could vastly improve flu vaccine supply if we knew the smallest effective dose in order to stretch current supplies and production capacity, as well as development of a reliable mammalian cell culture system to improve influenza vaccine production technology.


1. How much funding does the NIH devote to research on improving flu vaccine production?


2. What progress has been made in developing a reliable mammalian culture system for vaccine production?


3. Has NIH concluded studies to determine the lowest effective dose of flu vaccine?


4. What are the latest developments in anti-viral research to fight influenza?


E. Coordination with the United States Department of Agriculture (USDA)


Each year influenza evolves and new strains are transmitted from avian and swine sources to the human population. Often the avian forms of flu are passed to humans under conditions in which birds have close contact with people. This includes small farms, personal pets, and outdoor live bird or poultry markets.


1. Given that many of these conditions exist in the North Eastern United States where live bird markets are common and in the West and Southwest where small family bird farms are found, what steps have been taken to: (1) regulate the sanitation in these facilities; (2) produce rgulations to ensure adequate handling of these birds; and (3) conduct inspections of these types of facilities?


2. New flu strains originate as zoonotic diseases and we need an adequate plan for measuring the transmission of new diseases and strains from animals (in this country and abroad) to humans. What steps have been taken to coordinate flu surveillance efforts with the efforts of USDA?


3. Given this year’s outbreak of Epizootic Newcastle Disease (END), it is not unreasonable to improve the oversight of bird handling in these circumstances and prevent the illegal handling of birds, such as cock fighting. What has been done to address this concern?


F. Coordination with the World Health Organization and the Department of State New flu strains often arise in Asia. Last year’s SARS (severe acute respiratory syndrome) outbreak demonstrated the danger of relying on the Chinese public health system for early and accurate reporting of new illnesses.


1. Since the SARS outbreak, what steps have been taken to ensure Chinese authorities accurately and promptly report new infectious disease outbreaks?


2. Since early intervention can reduce the spread of new strains of flu, what assistance is provided to China and other Asian nations to respond to the annual flu season?


3. The World Health Organization (WHO) is responsible for predicting the new strains of influenza likely to arise in a given year. This year the predicted strains may not be the strain that is most deadly for U.S. patients.


a. What role did the U.S. Government play in the prediction for the 2003-2004 flu season?


b. What steps does the U.S. Government take to ensure that WHO accurately predicts emerging flu strains?


While we have been able to avoid a recurrence of the tragedy of the 1918 pandemic that killed 500,000 Americans, it appears that we have become too complacent about the risk of influenza. We all hope that the current epidemic will be short-lived and the loss of life minimal, but we must learn from this event. And while we pray for the best, we must prepare for the worst.


If you have any questions regarding this matter, please have your staff contact David Berick on my Governmental Affairs Committee staff at (202) 224-2627.


Sincerely,

Joseph I. Lieberman
Ranking Member
Committee on Governmental Affairs


cc: The Honorable Susan Collins
Chair, Committee on Governmental Affairs