By John Rees ~
In April 2008, vaccine research and production company Replikins released a news announcement predicting a novel flu virus outbreak was on the near horizon. While preparing vaccine for the upcoming seasonal flu season, their evolutionary research into the H1N1 genomic sequencing data showed a convergence of scenarios where H1N1 might become the leading candidate for the next expected—and overdue—pandemic with a virulence not seen since the 1918 Spanish Flu. A year later, on Saturday, April 25, 2009, under the rules of the International Health Regulations, the Director-General of the World Health Organization (WHO) declared the 2009 H1N1 outbreak a Public Health Emergency of International Concern.
The National Library of Medicine (NLM) holds two archival and oral history collections, newly described by archival staff, that document a portion of the U.S. national response to the 2009 H1N1 flu pandemic. These collections provide a behind-the-scenes view of the Dept. of Health and Human Service’s (HHS) Office of the Assistant Secretary of Preparedness and Response’s (ASPR) central role in coordinating the public health, political, and social response to the pandemic within a newly emergent global pandemic response infrastructure developed by the WHO and its partner nations to strengthen global health security.
Since the 2001 anthrax attacks, the 2003 SARS epidemic, and the 2005 H5N1 avian flu outbreak, the U.S. federal government, during the George W. Bush administration, had been aggressively bolstering its emergency preparedness and coordination infrastructure. The World Health Organization was similarly funding research, creating policy, and scenario planning for global responses to biological attacks and the emergence of devastating new viruses.
In the spring of 2009, as the newly-elected President Barack Obama was in the midst of selecting cabinet secretaries and establishing his administration, news of a strange respiratory illness sweeping Mexico, Texas, and California reached senior staff of the Centers for Disease Control (CDC) and HHS. Kathleen Sebelius had been nominated as HHS Secretary, but was not yet confirmed. The agency was under the direction of Acting Secretary Charles Johnson, and the CDC was also led by an acting head. Within days of the first reports in the 2nd week of April, it was clear a novel non-seasonal flu virus was disproportionately infecting adolescents and adults under 60, and that a national and international response was needed. However, the nation’s planning scenarios never accounted for an outbreak that started in the U.S., putting to test all the assumptions leaders had made about a response.
On Wednesday, April 22, 2009, The CDC activated its Emergency Operations Center (EOC) to coordinate the response to this emerging public health threat. Response activities were organized into a team structure according to the National Incident Management System (NIMS). On Saturday, April 25, the Director-General of WHO declared the 2009 H1N1 outbreak a Public Health Emergency of International Concern. On Sunday, April 26, acting HHS Secretary Charles Johnson declared the outbreak a National Health Emergency. Initially the CDC estimated between 60-100 million citizens would become infected. Without any senior appointees to lead, much of the early work fell to the HHS Chief of Staff Laura Petrou and CDC’s acting director Richard Besser.
Dr. Nicole Lurie, director of ASPR during the pandemic, started a documentation plan with the hope that what was learned during this outbreak would serve as lessons for preparing for the next pandemic. Through cooperation between ASPR and NLM leadership, NLM contract historian Dr. Sheena Morrison was embedded with the ASPR team, attending the daily response coordination meetings, working with Lurie on a documentation strategy, and interviewing senior HHS staff about their roles, in some cases on a monthly basis, during the course of the pandemic.
Morrison conducted 36 interviews with 21 individuals between October 2009 and June 2010. The Interviewees include senior officials from HHS, CDC, FDA, and NIH such as Nicole Lurie, Rich Besser, and Anthony Fauci. The interviews provide first-hand accounts of the challenges, failures, and successes of the federal response and ultimately the successful nation-wide vaccination program that helped quell the disease. Readers will learn about the hectic first days of the outbreak, a history of national preparedness since the 9/11 attacks, the complexity of organizing and bringing to bear the vast resources needed to fight such a pandemic, the personal sacrifices and long hours devoted to the response by health authorities across the nation, and after-action opinions about what worked and where gaps in our national infrastructure remained.
The archival collection now held at NLM largely consists of born-digital electronic records that document ASPR’s coordination activities with the White House; sister agencies such as the State Department, Homeland Security, Transportation, and Education; and the CDC, FDA, and NIH through a framework of 4 main pillars: disease surveillance; mitigation (medical surge, community, medical counter measures); immunization; and communications. These records consist of a wide-range of daily policy documents such as daily Chief of Staff meeting agendas and minutes, policy formulation and decisions such as leveraging the national stockpile of antigen drugs and N95 respirator masks, developing vaccination strategies and vaccine production; and emergency response planning with first responders and hospitals.
In addition, there is a large cache of public health service announcements, posters, websites, and videos geared to inform the public and mitigate the disease. The CDC, state, and local health authorities produced hundreds of public health prevention posters on topics such as frequent hand-washing, containing coughs and sneezes, wearing face masks and gloves, social distancing and home self-isolation, immunization, and anticipating school and business closures. Leveraging the White House’s relationships with the private sector and Hollywood, many celebrities of the day such as Amy Ryan, Marc Anthony, and Jackie Joyner-Kersey joined the cause with Senators, Congressmen, and health officials to create PSA videos for television that are preserved in this collection.
The virus was designated as influenza A (H1N1)pdm09 virus and is commonly called “swine flu.” The (H1N1)pdm09 virus was very different from H1N1 viruses that were circulating at the time of the pandemic. Studies of the genome showed it originated from a mixture of avian, pig, and human influenza strains and had likely existed in various forms for decades before jumping from pigs to humans.
Few young people had any existing immunity (as detected by antibody response) to the virus, but nearly one-third of people over 60 years old had antibodies against this virus, likely from exposure to an older H1N1 virus earlier in their lives. Since the (H1N1)pdm09 virus was very different from circulating H1N1 viruses, vaccination with seasonal flu vaccines offered little cross-protection against (H1N1)pdm09 virus infection. While a monovalent (H1N1)pdm09 vaccine was discovered, the virus did not grow well which hampered vaccine production in large quantities until late November after the peak of illness during the second wave had come and gone in the United States.
From April 12, 2009 to April 10, 2010, CDC estimated there were 60.8 million cases, 274,304 hospitalizations, and 12,469 deaths in the United States due to the H1N1 virus. Globally, 80 percent of the virus-related deaths were estimated to have occurred in people younger than 65 years of age which differs greatly from typical seasonal influenza epidemics. Though the 2009 flu pandemic primarily affected children and young and middle-aged adults, the impact of the (H1N1)pdm09 virus on the global population during the first year was less severe than that of previous pandemics.
The United States mounted a complex, multi-faceted, and long-term response to the pandemic that challenged what was thought to be a robust federal emergency response policy infrastructure. Despite years of planning and simulation exercises the daily realities of responding to a new disease exposed the natural state of competing political and public health priorities, but ultimately demonstrated the effectiveness of the scientific process, the vital collaboration between the federal, state, and local health infrastructure, the private sector, and the resolve of national citizenries. Ultimately H1N1 proved to be highly infectious, but posed limited significant health consequences. On August 10, 2010, WHO declared an end to the global 2009 H1N1 influenza pandemic. (H1N1)pdm09 virus continues to circulate as a seasonal flu virus, and causes illness, hospitalization, and deaths worldwide every year.
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