Jun 26, 2012 (CIDRAP News) – During the 2009 influenza pandemic, clinicians were frustrated by the lack of useful diagnostic tests, the government had no national system for monitoring stress on healthcare facilities, and there was some duplication in federal media campaigns.
Those are a few of the many challenges cited in a pair of reports released last week by the Department of Health and Human Services (HHS) concerning the response to the H1N1 pandemic and lessons for future preparedness.
One report, titled "HHS Retrospective on the 2009 H1N1 Influenza Pandemic to Advance all Hazards Preparedness," catalogs successes and problems in the response. The other, called the "2009 H1N1 Improvement Plan," is a more specific blueprint for revising previous pandemic preparedness plans.
'Opportunities for improvement'
The retrospective report says the pandemic preparations of preceding years paid off and pronounces the overall response to the pandemic a success, though it acknowledges that most of the vaccine supply arrived after the pandemic's peak. It lists numerous "opportunities for improvement" in the various categories of response, including surveillance, mitigation measures, vaccination, and communication.
The report covers much familiar ground, including the rapid characterization of the virus, the erroneous early projections about vaccine deliveries and the late arrival of much of the supply, the expanded use of antivirals, and the increased vaccination coverage of children and pregnant women.
But it makes some points that have received less attention.
On the surveillance front, the report says that national surveillance information often was not detailed enough to meet the needs and demands of local responders and citizens.
Diagnostic tests for confirming 2009 H1N1 cases were not accessible, leading to "frustration within the clinical community," and the low sensitivity of available rapid tests "led to misdiagnosis and under-treatment of people with 2009 H1N1 influenza."
"The absence of readily available, rapid, simple, and highly sensitive diagnostic tests which could detect the 2009 H1N1 virus made infection control more difficult," HHS says. The development of better point-of-care tests is listed as one of the priorities in the accompanying improvement plan.
The report notes that highly sensitive and specific reference tests were available at public health labs and used for surveillance. The Centers for Disease Control and Prevention (CDC) quickly produced and distributed real-time polymerase chain reaction test kits to states and international labs, it recounts. The Food and Drug Administration authorized 18 tests through the Emergency Use Authorization (EUA) mechanism.
In other observations, the retrospective cites a need for "more timely, data-driven clinical guidance regarding the best methods of treatment for seriously ill, hospitalized patients in an evolving public health emergency."
Many emergency research proposals submitted to institutional review boards (IRBs) during the pandemic were incomplete, the report says. One option for addressing the need for rapid IRB approval in future emergencies might be a single national IRB.
The report also cites the lack of a national, real-time system for assessing healthcare facility stress and monitoring resources. Efforts that were made to use a national bed-tacking system called HAvBED to assess facility stress need further study, it adds.
There was no system in place for tracking workplace and school absenteeism during the pandemic, and such a system would be critical for determining the full impact of a more severe pandemic, according to HHS. The report also notes that the Pandemic Severity Index developed before 2009 proved inadequate "to provide meaningful public health triggers" for nonpharmaceutical interventions in the initial response.
The retrospective lists several successes on the antiviral front, including their wide use, rapid distribution, and support by timely, appropriate guidance. But one problem was a shortage of mechanisms for studying the safety and efficacy of antivirals made available under EUAs.
For example, 2,100 doses of the intravenous antiviral peramivir were distributed, but there is insufficient information on its effectiveness in severe H1N1 cases to support approval, according to the report. Contributors to the problem included a lack of clinical consortia prepared to do the research and contractual restrictions involving the drug.
The HHS authors also note that states used different methods for distributing antivirals, resulting in greater availability and timeliness in some states than others.
Vaccine response pluses, minuses
Concerning the vaccine response, the report says HHS's investment in pandemic preparedness "enabled manufacturers to develop and establish the safety and immunogenicity of the 2009 H1N1 pandemic vaccine in fewer than six months, and in quantities sufficient for the U.S. population—the stated goal of pandemic planning."
But on the next page the report states, "Even though the six-month goals for initial vaccine delivery were met, most of the vaccine arrived too late to vaccinate much of the public before the pandemic peaked." It adds that more modern vaccine design, potency testing, and production technologies, such as cell-based and recombinant vaccines, are needed to speed vaccine production and improve yield.
The H1N1 Improvement Plan likewise calls for improving technologies to speed vaccine production, and also for developing recommendations for using adjuvanted vaccines. But neither report emphasizes the goal—often cited by experts—of developing new flu vaccine antigens that increase vaccine effectiveness and provide protection against a broader range of flu strains.
As for vaccine allocation and distribution, HHS says in the retrospective that the decision to use the Vaccines for Children Program's distribution network worked well, with 126 million doses delivered to close to 70,000 locations and 95% of orders received within 48 hours.
One wrinkle was that no plan for the recovery, donation, or disposal of unused doses was developed before the pandemic. Also, the pandemic plan did not address needles and syringes as critical components of the vaccination drive.
On the public communication front, the report calls communications "regular, balanced, transparent, and unified, which built confidence and trust with much of the public."
In particular, messages about hand washing were "enormously effective"—but public acceptance of them may have limited recognition and compliance with vaccine messages that followed. Also, there was some public skepticism about the seriousness of the pandemic and the need for vaccination, the report acknowledges.
It also says that different components of HHS awarded contracts for media campaigns to promote vaccination, adding, "The campaigns had different themes but in some cases resulted in duplicated efforts." In the future HHS should consider using one clear lead agency for media campaigns, the report says.
In other observations, the retrospective says:
- HHS provided nearly 17 million doses of H1N1 vaccine to the World Health Organization, though there were "few established policies and principles to guide international deployment" before the pandemic.
- Federal and state mechanisms for distributing public health emergency funds to state and local governments were burdensome, and the time required for federal approval of state applications affected states' response capacity.
The H1N1 Improvement Plan lists many objectives and timelines for improving various aspects of pandemic preparedness. The aim of the plan is to present HHS's key priorities for modifying and updating pandemic plans and to inform planning by state, local, tribal, and territorial agencies.
The plan designates a lead agency or agencies for each goal or objective. For example, it lists the CDC, the Biomedical Advanced Research and Development Authority, and the FDA as lead agencies for the goal of developing more accurate point-of-care diagnostic tests, with a target date of December 2012.
The plan sets a target date of the end of 2013 for updating recommendations on the use nonpharmaceutical interventions during a pandemic, with the CDC as the lead agency.
The document sets a December 2014 goal for completing at least phase 2 development of one existing and one new class of antiviral drug, combination therapy, or pediatric formulation of an antiviral for emergency use, with the CDC leading the effort.
HHS Retrospective on the 2009 H1N1 Influenza Pandemic (full text)
H1N1 Improvement Plan (full text)
Jun 28, 2011, CIDRAP News story on Government Accountability Office report on pandemic response
Oct 29, 2010, CIDRAP News story on IOM workshop summary on pandemic vaccinationprogram