Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza

摘要

Between April 2009 and February 2010, the United States experienced its most recent outbreak of pandemic influenza, this one resulting from the appearance of a novel strain of Type A, H1N1 virus. From the earliest recognition of the pandemic, public health officials in the United States moved rapidly to respond, but their efforts were impeded by unanticipated delays that arose in manufacturing what was supposed to be the most powerful tool for preventing widespread morbidity and mortality: a vaccine designed to protect against the 2009 H1N1 virus. Fortunately, the pathogenic potential of the 2009 H1N1 virus remained relatively mild, limiting morbidity and mortality, although a disproportionate number of deaths occurred among children and young adults. This less-than-optimal experience--one that developed despite the appropriate and energetic response of vaccine manufacturers and public health officials--raised new awareness of the limitations of the system by which influenza vaccines are produced today.