WASHINGTON – Homeland Security and Governmental Affairs Committee Chairman Joe Lieberman, ID-Conn., and Ranking Member Susan Collins, R-Me., Monday pressed for answers to their questions about the Department of Health and Human Services’ H1N1 vaccine distribution plan. In a follow-up letter to HHS Secretary Kathleen Sebelius, the Senators expressed dissatisfaction with the Department’s response to letters the Senators sent last month questioning why some people designated as high risk had not been able to obtain a vaccine.

            The Committee will convene a hearing Tuesday at 2:30 p.m. with Department witnesses to further explore the vaccination shortages.  A copy of the letter follows:


November 16, 2009


The Honorable Kathleen Sebelius


U.S. Department of Health and Human Services

200 Independence Avenue, S.W.

Washington, DC  20201


Dear Secretary Sebelius:


            We appreciate your continuing leadership and efforts to confront the H1N1 influenza outbreak as well as your response to the letter that we wrote to you on October 27, 2009 and to Senator Collins’ letter on October 26, 2009.  With unprecedented speed your department has overseen the development of a safe and effective vaccine.  We strongly disagree, however, with your defense of the manner in which the vaccination campaign has been carried out.

            The glaring discrepancy between the demand for and supply of H1N1 vaccine in our country has resulted in pregnant women standing in line for hours, only to find no vaccine at the end.  This shortage of vaccine has left many parents of children in high risk groups scrambling, often in frustration, to find the vaccine the government has told them that they need.  However, your response does not acknowledge any missteps by the government, a sure sign that lessons have not been learned to ensure that this situation does not happen again.

            This problem was created in part by HHS’s decision to promote vaccination of an initial target group that represents almost half the U.S. population; 160 million people.  In explaining this decision, your letter states that “previous experience with seasonal influenza vaccine programs suggested that not all persons would want to be vaccinated, and that overly strict prioritization at the federal level might actually hinder vaccine uptake.”  The most often cited example of this effect by public health officials is the 2004 seasonal flu vaccine shortage in which contamination at a major vaccine manufacturer threatened half the U.S. seasonal flu vaccine supply.  When supplies increased later in the season, many people chose not to return and be vaccinated. 

            Yet, there are significant differences between the current vaccine campaign and previous vaccine shortages that should not be ignored.  We are not dealing with a shortage of just half the vaccine that is needed, but one in which only 7% of the doses required to cover the HHS initial target groups were available in mid-October.  Indeed, we have not faced a vaccine shortage this severe in recent years.  During the 2004 shortage, we could also rely on the fact that people who had the seasonal flu shot or who contracted the seasonal flu the previous winter still had some immunity against the strains circulating then.  With the H1N1 outbreak, we are not dealing with a typical seasonal flu outbreak, but an influenza outbreak in which many people have no immunity, that strikes a younger population not normally at risk, and which is putting a strain on our medical and public health infrastructure at a level not experienced during the peak of seasonal flu outbreaks. Regardless of the federal government’s intention not to be overly restrictive and turn people away, the simple reality is that people are being turned away because there is nowhere near the vaccine available to cover all those deemed eligible.

            HHS, through its advisory committee, had just such an extreme vaccine shortage eventuality planned for; it identified a subset priority group of 42 million people representing those at the greatest risk.  This scenario was to be implemented as a fall back, necessary if initial supplies did not meet expectations.  The current vaccination campaign has been characterized by unprecedented shortages, and while some states have chosen to implement aspects of this alternative prioritization category, HHS has continued to publicly encourage vaccination of the broader target group. 

            A federal message of broad eligibility and different states targeting different populations sends a confusing message to the public about who is able to get the vaccine in their community.  People rightly do not understand why in their area they are not eligible to get vaccinated, while individuals in a similar risk category across the state or city line are told they can get the vaccine.  The manner in which this vaccination campaign has been carried out bears some responsibility in contributing to the public frustration and apprehension evidenced in communities across the country. 

            Most important, your response to our letter misses the larger point–that the federal government cannot view as sufficient an approach in which the highest risk individuals wait in long lines that ultimately do not get them vaccinated.  We cannot have our state and local health departments making vaccination decisions based on faulty or no projections of supply.  The fact is the response failed to meet the public demand for vaccine — demand that the federal government accelerated by advising a larger group of the public to be vaccinated that it had the resources to meet.

            With at least 41.6 million H1N1 vaccine doses available last week, by now we should have covered well any of the people in the highest risk category who wanted to be vaccinated:  pregnant women, children with health conditions, and others.  Yet, we fear that many still struggle to find the vaccine and remain unprotected.

            The ideal solution is, of course, to have abundant vaccine supply, but lacking that ideal, it is incumbent on our government to use those constrained resources wisely in a manner that fosters public trust.  That half the population is currently not eligible to receive the vaccine and is waiting to allow individuals in the priority groups to be vaccinated first demonstrates that our citizens would accept a reasonable, if unfortunate, phased roll out that is applied equally across society.  Unfortunately, HHS insisted on promoting a plan for which the federal government did not have anywhere near sufficient resources to implement.

            This approach raises doubts about our capacity to respond effectively to the ongoing epidemic, but also to prepare effectively for what could be even more serious epidemics in the future.  We look forward to holding a frank conversation about these issues when representatives of your Department appear before our Committee at the hearing tomorrow.





Joseph I. Lieberman                                                    Susan Collins

Chairman                                                                                 Ranking Member