WASHINGTON – Homeland Security and Governmental Affairs Committee Chairman Joe Lieberman, ID-Conn., and Ranking Member Susan Collins, R-Me., Tuesday questioned the Department of Health and Human Services (HHS) about its initial promotion of an H1N1 vaccine distribution plan based on plentiful vaccine availability. HHS also developed a more conservative distribution plan based on less vaccine availability, which perhaps should have been more heavily promoted with state and local health departments.

               Following is text of the letter sent to HHS Secretary Kathleen Sebelius:


October 27, 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 are writing to express our strong concerns about the Department of Health and Human Service’s implementation of distribution plans for the H1N1 influenza vaccine.  After an impressive effort to research, test, and initiate production of an H1N1 influenza vaccine in record time, for which HHS deserves our nation’s appreciation, the schedule for H1N1 vaccine manufacturing and distribution originally communicated by the government has slipped. We have heard unsettling reports of growing vaccine shortages that are leading many people to ask if enough vaccine will be produced in time for those who will need it most as the H1N1 outbreak escalates.  Unfortunately, these missteps in estimating available doses of H1N1 vaccine have effects beyond just growing public frustration; they have the potential to critically undermine our vaccine distribution efforts, which depend on accurate estimates of vaccine availability. 


It was only three months ago that we were told, based on reports from vaccine manufacturers, that the Centers for Disease Control and Prevention (CDC) expected 120-160 million doses by the end of October.  Using those projections, the CDC’s Advisory Committee on Immunization Practices (ACIP) issued recommendations on July 29, 2009, intended to provide vaccination programs and providers with information to assist in planning for vaccinating high risk populations.  Those recommendations, as expanded upon in an August 28, 2009, report entitled “Use of Influenza A (H1N1) 2009 Monovalent Vaccine,” addressed two scenarios.  The first scenario, which presumed sufficient vaccine would be available, identified five groups comprising an estimated 160 million people in the United States who would receive priority for the vaccine.  The alternative prioritization plan—described as a “just in case scenario” at a July 29 CDC press briefing—was recommended to be implemented in the event that the supply of vaccine initially available was not adequate to meet demand among the broader five priority groups.  In this alternative, scenario, ACIP recommended giving priority to a subset of those groups, comprising approximately 42 million people. 


Two months ago, the estimate of vaccine availability dropped to 40 million by mid-October, with 20 million additional doses rolling out every week. Last week, the estimate dropped again.  Now, only about 28 million doses are expected to be available by the end of October.


Currently, the nation is witnessing stark variability in who is able to get vaccinated and where they are able to acquire vaccine.  The media has reported stories of pregnant women standing in long lines at mass clinics for hours only to be turned away as supplies run out, while others in the same community are able to obtain the vaccine by appointment from their obstetrician.  There is little explanation for why one pediatrician is able to vaccinate his patients, while another has not even received a shipment.


As vaccine shortages became more apparent, we question why the more conservative ‘just in case’ plan was not broadly implemented.  Directing the 28 million H1N1 vaccines at the 42 million highest risk individuals would presumably save the most lives and lead to a more orderly and consistent process. It would also help to prevent the long, often futile lines and growing public frustration.


             We are also concerned that HHS lacks the visibility into the production processes of vaccine manufactures, domestic and foreign, to provide more accurate and timely information of such a critical public health asset.


            Ensuring that our state and local communities can effectively distribute a scarce resource depends on accurate estimates of its availability.  In order to understand the ramifications that inaccurate estimates of vaccine availability have on our H1N1 preparedness and response, we ask that you respond to the following questions:


·         When did HHS make the initial decision to go forward with the broader, 160 million-person distribution plan?  What process, if any, was in place to revisit that decision if constrained supplies made a change in distribution plans necessary?  Who at HHS is responsible for making the determination about whether or when a more focused distribution plan should be implemented?

·         Have you or other HHS officials consulted with ACIP as to how its recommendations should be implemented based on the current constrained vaccine supplies?  If so, when did those consultations take place and what was ACIP’s recommendation?


·         When HHS reviewed state vaccine distribution plans, did the Department evaluate whether states were prepared to prioritize and distribute vaccinations based on both the broader and more targeted subsets of high risk populations?


·         When did HHS first learn that manufacturers would not be able to provide 40 million doses of vaccine by mid-October? How did HHS determine that this would be the case?


·         When it became apparent that manufacturing problems would result in inadequate vaccine doses to meet demand, did HHS officially notify states that they should implement the more targeted subset of vaccine recommendations?  If so, when did this notification take place?  If not, does HHS intend to alter its recommendation to states?  


·         What reporting, inspection, and review procedures does HHS employ to monitor H1N1 vaccine manufacturing and finishing processes?


·         What steps have and will HHS take ensure more accurate and timely reporting of vaccine availability in the future?



            We thank you in advance for your time and we look forward to your prompt response.






Joseph I. Lieberman                                                                Susan Collins

Chairman                                                                                 Ranking Member