Senator Collins demands urgent explanation of H1N1 vaccine shortages, delays

In a letter Monday to Kathleen Sebelius, Secretary for the U.S. Department of Health and Human Services, Senator Susan Collins, Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, asked for urgent explanations on the availability of the H1N1 flu vaccine. Her letter follows the committee’s recent hearing, “H1N1 Flu: Monitoring the Nation’s Response,” held Oct. 21 to examine safety, supply and delivery issues.
In her letter Monday, Senator Collins, R-Maine, expressed additional concerns and questioned why some of the vaccines won’t arrive until after people have been infected with the virus. Senator Collins requested answers to her inquires by Friday. The full text of the letter follows:

The Honorable Kathleen Sebelius
Secretary
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.

Sincerely,



Susan M. Collins
Ranking Member