On December 23, the bipartisan leadership of the House Energy and Commerce Committee—Reps. Fred Upton (R-MI), Frank Pallone (D-NJ), Tim Murphy (R-PA) and Diana DeGette (D-CO)—sent a letter
to Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response at the Department of Health and Human Services, expressing concern about the age and effectiveness of the nation's stockpile of pre-pandemic vaccines.
"The national vaccine goals for pandemic influenza preparedness call for pre-pandemic vaccine stockpiles to protect 20 million people as well as for manufacturing infrastructure to support rapid production of 600 million doses," the letter states. "At a recent National Academy of Sciences workshop, one industry official noted the dynamic nature of the influenza threat and questioned the match of vaccine stockpiles that were purchases 10 years ago against today's circulating strains."
As an example, the lawmakers pointed to strain of H5N1, or avian flu, emerging in Egypt this year, which is "not necessarily the H5N1 strain that emerged in Vietnam in 2004."
The lawmakers requested that Lurie provide them with the results of vaccine testing carried out by the Biomedical Advanced Research and Development Authority (BARDA), part of the Health Department's preparedness and response office.
"We would be interested in the test results to determine whether the vaccines would provide protection against the circulating avian flu viruses which devastated US poultry this year," the lawmakers wrote, referring to the recent outbreak in which tens of millions of birds died. Farms hit hard by bird flu are still recovering, and both farmers and government officials are on alert
for the next outbreak. "At a June 2015 meeting of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), a CDC official said tests showed that neither H5N8 nor H5N2 viruses cross-reacted with an H5N1 vaccine, suggesting that the vaccine would not be protective," the lawmakers added in their letter.
The four legislators also raised alarm over an apparent budgeting shortfall for life-saving vaccines.
“While vaccines for seasonal influenza change year-to-year, BARDA maintains a stockpile of roughly $1.75 billion worth of pandemic influenza vaccine," they wrote. "This year, however, BARDA has only budgeted about $20 million—or 1 percent of the stockpile value—for replenishment and maintenance of this asset.”
The lawmakers also reminded Lurie that the National Strategy for Pandemic Influenza
, the government's detection, preparedness and response plan, states that the nation should have "sufficient vaccine to vaccinate the entire US population within six months of the emergence of a virus with pandemic potential."
"There is a need to ensure that the pre-pandemic vaccine stockpile is protective," the lawmakers asserted. "Earlier this year, the World Health Organization (WHO) stated the unprecedented number of currently circulating and new avian and swine flu strains is 'ominous.' Two new highly pathogenic strains of avian flu (H5N8, H5N2) are circulating in the US, and they have already caused the death of nearly 50 million birds at a cost of $1 billion to our economy. A health alert
issued by CDC on June 2, 2015 notified public health workers and clinicians of the potential for human infection with these viruses."
"If these strains were to make the jump to humans, pandemic risk would increase," the lawmakers warned. "These developments heighten our interest in assuring that the United States is sufficiently prepared for pandemic influenza."
The committee members asked Lurie to answer a series of questions by January 16. These include data on the results of BARDA vaccine testing, information on the status of the development of new H5N2 and H5N8 vaccines, data on the effects of long-term storage on vaccine efficacy and an inquiry about how much funding will be sufficient to "maintain and replenish" vaccine stockpiles going forward.
At a November House hearing on influenza preparedness, Rep. Murphy, chairman of the House Energy and Commerce Committee Oversight and Investigations subcommittee, voiced concern
that "we are still developing flu vaccines with 1940s technology."
“We need better testing to quickly learn of mutations," Murphy stressed.
At the same hearing, Rep. DeGette, the ranking Democrat on the committee and a longtime advocate of a robust vaccine regimen, expressed frustration at the slow pace of change.
“I’ve been pushing for 10 years to fix the system," she said.