WASHINGTON, D.C. – The Obama Administration has failed to provide clear answers to national preparedness questions raised by Senator Susan Collins, R-ME, the Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, regarding the fast-moving H1N1 flu epidemic and the delays in vaccine production and delivery that have caused widespread shortages.
“It is disappointing that the Administration continues to recite the same promises and the same pledges, in spite of overwhelming evidence across the country that many Americans, including some of our most vulnerable children, do not have access to the H1N1 vaccine,” said Senator Collins. “Today, worried parents are left wondering when the vaccine will arrive. The Administration has no answers. It is not hyperbole to say that lives are at stake.”
In an Oct. 26 letter to Kathleen Sebelius, Secretary for the Department of Health and Human Services (HHS), Senator Collins asked for responses to several questions, including two key issues:
  • What is HHS’s revised schedule for distributing the full 250 million doses of H1N1 vaccine?
  • When does HHS expect that there will be enough vaccine to meet the needs of all those who are in the priority groups?
In her letter, Senator Collins also asked other questions about the Administration’s overall vaccine strategy, from production to delivery. The Secretary responded Oct. 30, but that letter failed to answer the two most critical questions and failed to address when supply would catch up with demand.
Instead, the Secretary stated, “Despite the delay, our goal is to ensure that everyone who wants to get vaccinated will ultimately be able to do so.”
 “This is a disturbingly inadequate response from the Secretary,” said Senator Collins.
“I am troubled that HHS has assured the public repeatedly since August that the government would have enough vaccine to meet demand.  It now appears that some of the vaccine will arrive only after many people have already been infected with H1N1.”
“The Administration needs a new plan for working with state and local public health officials that sets attainable goals to ensure that the vaccine is distributed to the most vulnerable groups,” Senator Collins continued.  “The Administration needs to convey realistic, achievable information on when vaccine quantities will be sufficient to immunize all high-risk individuals who wish to be vaccinated.”
Of concern is the lack of sufficient vaccine supply even for those at high risk for serious complications, including children, young adults, and pregnant women.  The HHS originally projected that it would have at least 40 million doses available by the end of October.  Those did not materialize.
Instead, the HHS downgraded that figure.  As of Oct. 30, there were less than 26.7 million doses, according to the latest data available from the Centers for Disease Control and Prevention.
Senator Collins also noted that “vaccine manufacturers warned about this very scenario months ago. They told the HHS back in July about the dangers of being overly optimistic regarding vaccine production predictions and about leading American families to believe that there would be ample supply of vaccine nationwide.”
           According to public health officials, 48 states are reporting widespread influenza activity, many doctors’ offices are being swamped with flu patients.  Also, a recent report by Purdue University found that the H1N1 flu epidemic may have already peaked in some states.
Note: Attached as addenda are the full texts of Senator Collins’ letter to Secretary Sebelius and the Secretary’s reply.
 Oct. 26, 2009
The Honorable Kathleen Sebelius
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201
Dear Secretary Sebelius:
As the President acknowledged just a few days ago, the nation is facing an emergency in responding to the H1N1 epidemic.  A primary concern for nearly every American at this time is the lack of sufficient vaccine supply even for those at high risk for serious complications, including children, young adults, and pregnant women.  The Department of Health and Human Services (HHS) originally projected that it would have at least 40 million doses available by the end of October.  More recently, however, HHS downgraded this amount to just 28 to 30 million doses by that time.  As I pointed out to you last week at the H1N1 hearing held by the Senate Homeland Security and Governmental Affairs Committee, the lack of sufficient supply is alarming.  
I am troubled that HHS has assured the public since August that the government would have enough vaccine to meet demand.  It now appears that much of the vaccine could arrive only after many people have already been infected with H1N1.  Indeed, an October 15, 2009 Purdue University study predicts that nearly 60 percent of the American population will be infected with H1N1, that a third of them will fall ill, and most disturbingly, that the peak week of infection was this past week.  It seems that HHS gave its assurance of sufficient supply in August without adequate information to make such a commitment.  In addition, HHS should have noted that an adequate supply also depended on whether one or two doses were needed for the vaccine to be effective – something that was not known until September.  
Before our Committee, you stated that delays in production were due to problems in the manufacturing process that have now been corrected.  To ensure that actions are taken to address fully the delays in providing the vaccine to the public, I ask that you respond to the following questions by October 30th:
  • What is HHS’s revised schedule for distributing the full 250 million doses of H1N1 vaccine?
  • When does HHS expect that there will be enough vaccine to meet the needs of all those who are in the priority groups?
  • What is the estimate of the number of doses of H1N1 vaccine required to vaccinate those in the high-risk groups?
  • How will HHS ensure that the currently limited supply reaches those groups in an expedited manner?
  • What actions is HHS taking to recover ground lost due to the prior production delays?
There are longer-term issues as well that affect our response capability.  Most experts agree that a significant limiting factor in the production of any type of flu vaccine is our dependence on egg-based production rather than cell-based technology to produce the vaccine more quickly.  How soon does HHS anticipate that the United States government can shift to cell-based technology for the production of flu vaccine?  What effort is HHS making to ensure that this shift in production occurs rapidly and safely?
Of the five manufacturers of the H1N1 vaccine, only one is based in the United States while the other four are foreign.  In the case of a pandemic, a foreign vaccine producer will likely be compelled to prioritize the bulk of their production for their own country’s consumption.  What investment or policy changes should the United States undertake to ensure that the U.S. can manufacture a sufficient percentage of flu vaccine domestically?
Should you have any questions about this letter, please contact me directly or have your staff contact Asha Mathew on my Committee staff at (202) 224-8432.  I look forward to your prompt response.
                                                                                                Susan M. Collins
                                                                                                Ranking Member
October 30, 2009
The Honorable Susan Collins
United States Senate
Washington, DC 20510-0001
Dear Senator Collins:
Thank you for your letter of October 26, 2009 regarding H1N1 influenza preparedness. As I discussed in my testimony before the Senate Committee on Homeland Security and Governmental Affairs on October 21, my Department and this Administration remain fully
engaged in the 2009 H1N1influenza response effort, working in conjunction with governors, mayors, tribal leaders, state and local health departments, the medical community, and our private sector partners.
In response to your specific questions concerning H1N1 influenza vaccine and vaccination, I would like to emphasize that, with unprecedented speed, we have completed key steps in the vaccine development and manufacturing process: HHS scientists have characterized the virus, identified candidate strains, expedited manufacturing, and performed clinical trials and licensed four 2009 H1N1 influenza vaccines.  The speed of this vaccine development was made possible due to investments made through the office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) over the past four years in advanced research and development and infrastructure building and in collaboration with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA).  The rapid responses of HHS agencies, in terms of surveillance, viral characterization, pre-clinical and clinical testing, and assay development, were greatly aided by pandemic preparedness efforts for influenza pandemics set in motion by the H5N1 outbreaks in 2004, and the resources Congress provided for those efforts.
Since September 30, when the 2009 H1N1 vaccine was first made available to states to distribute, the number of doses produced, distributed, and administered has grown steadily, and states are executing their plans for providing vaccine to high-priority populations. While modest amounts of vaccine have been made available ahead of schedule, poor production yields with the initial vaccine strains, late completion of seasonal influenza vaccine manufacturing, and equipment failures on new production lines have caused significant reductions in the manufacturers’ timelines. These delays are affecting both the U.S. and global H1N1 vaccine supplies. Manufacturers assure us they are taking active steps to overcome the remaining challenges, and we are doing all in our power to help them. Updated production estimates are provided weekly to the states from HHSICDC. Despite the delay, our goal is to ensure that everyone who wants to get vaccinated will ultimately be able to do so. HHS, through CDC, is working closely with states to ensure that vaccine gets to the public as soon as it is received. HHS/CDC has worked with the vaccine distributor to ensure same-day shipping for next-day delivery for the vast majority of orders transmitted from CDC. Additionally, the distributor is now receiving vaccine from the manufacturer seven days a week. HHS continues to offer technical assistance to, and meets regularly with, states and other partners to improve the effectiveness of the vaccination program.
Moreover, BARDA conducts regular site visits to the vaccine manufacturers – completing two earlier this week – and constantly monitors the progress of every lot produced and works to make up ground wherever possible. Also, FDA visited a third manufacturer this week. Finally, on October 29, I personally spoke with the CEOs of each of the five manufacturers to emphasize the importance of accelerating production in the coming weeks.
States will continue to receive a pro rata allotment of H1N1 vaccine amounts for ordering as more vaccine becomes available. State and local health departments are distributing the first shipments of vaccine to providers serving people in the Advisory Committee for Immunization Practices’ (ACIP’s) recommended priority groups (pregnant women, children 6 months of age through adults 24 years, health care workers and emergency medical services personnel, caretakers for infants less than 6 months of age, and those with high-risk conditions 25-64 years), and many are holding vaccination clinics in schools, hospitals, or other public venues for persons in these priority groups.
HHS, along with many infectious disease and public health experts, was concerned about the possibility of an increase in cases during the early fall. Thus, an overarching goal of the ACIP’s recommendations for use of pandemic vaccine was to reduce the number of ill persons, the severity of illness, and the impact on the health care system by vaccinating as many persons as possible as quickly as possible. ACIP also wanted to target vaccination during the initial phases of the program to protect those who were at higher risk for acquiring influenza (children, young adults, healthcare personnel, and emergency medical service workers) or developing influenza complications (persons with chronic medical conditions, pregnant women, and young infants). This target group totaled an estimated 159 million persons.
These initial target groups were broad, and there was no attempt to precisely match any estimate of the projected number of doses with target group size. 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. During the development of the ACIP recommendations in late July, one recurring theme was that vaccine demand and availability might vary widely in the early phases of vaccine distribution, because each program was likely to have access to a different mix of persons who wanted to be vaccinated in the initial target groups. In addition, some formulations of vaccine are only approved for certain groups. To provide maximal flexibility, within ACIP’s recommended priority groups, a smaller priority group of persons at highest risk for infection or severe illness was identified (pregnant women, people in regular contact with infants less than 6 months, health care personnel or emergency medical services workers with direct contact with patients or infectious materials, children age 6 months to 4 years, and children age 5 to 18 with chronic medical conditions, totaling approximately 42 million people), to provide some guidance for vaccine use if overall vaccine supplies, or supplies of certain formulations, were less than expected. As demand and availability allowed, programs were encouraged to expand programs to include as many persons as possible. ACIP considered local health officials and vaccination providers as being better positioned to make decisions about vaccine administration and distribution in accordance with state and local conditions, using the evidence-based framework developed by ACIP to guide their decisions. During the annual meeting of the Association of State Health Officers a couple weeks ago, HHS and CDC staff sought input on whether further recommendations to restrict priority groups would help states target vaccine. A resounding message was that states were already targeting the highest-risk populations, and that such a move would be highly disruptive to vaccination programs.
The distribution and prioritization systems going forward will remain the same as at the beginning of the vaccination campaign. As expected, immunization programs planned their efforts according to local capacity and needs, and developed strategies to get vaccines to clinics and programs that could provide services to those persons at highest risk for infection or severe illness. During the past few weeks, as the initial vaccine allocations have come out, states have had to adapt to the low initial allocation and the fact that much of the initial allocation was live attenuated (FluMist) vaccine, which cannot be given to some people in the ACIP highest-risk groups, such as pregnant women, people with underlying health conditions, and children under two years old. In those cases, the live attenuated vaccine has been targeted – appropriately – to healthy health care workers under 50 and children two and older. In some instances, immunization programs have focused on some or all of the highest-risk priority groups, while in other areas, programs have found it to-be more efficient to continue programs for the initial target groups. In most instances, states and local health officials are enabling rapid and appropriate use of their vaccine allocations. In addition, the disappointing news about vaccine supply is partly balanced by the scientific evidence indicating that only one dose will be necessary for older children and adults, which means that more persons can be fully protected more quickly than had been expected.
Going forward, HHS planning efforts will continue to support the advanced development of seasonal and pandemic influenza vaccines. In 2005 and 2006, the first six contracts for advanced development of cell-based influenza vaccines were initiated. Several of these contractors have made significant advances toward U.S. licensure of their cell-based influenza vaccines. One of these contractors started in 2008 to build a new state-of the-art cell-based influenza vaccine manufacturing facility with a surge production capacity of 150 million doses of pandemic vaccine in six months using HHS/ASPR support. Additionally, HHS is supporting the advanced development of one recombinant influenza vaccine, which promises to have a shorter timeframe for production of pandemic vaccines and expects to h d development of more recombinant vaccines soon. HHS also provided cost-sharing support to expand the domestic influenza vaccine manufacturing infrastructure by retrofitting existing domestic vaccine manufacturing facilities, provided support for a secure year-round supply of eggs and other supplies for existing U.S.-based egg-based facilities, and supported the construction of new U.S.-based cell-based influenza vaccine manufacturing facilities. These investments will advance U.S. pandemic preparedness goals and decrease dependence on foreign manufacture of influenza vaccines.
If you have additional questions regarding federal pandemic preparedness, please do not hesitate to contact my Office of the Assistant Secretary for Preparedness and Response, led by Dr. Nicole Lurie.
I appreciate your strong commitment to public health preparedness and look forward to continuing to work with you on these important issues.
Kathleen Sebelius