Using Passive Antibody Therapies in the Next Pandemic.

The twenty-first century has witnessed seven human viral pandemics. Approximately once every three to four years over the past quarter-century, the world has experienced a new viral epidemic that expanded well beyond its original national borders to become a pandemic. The probability that another pandemic caused by a previously unknown agent will occur in the near future is thus very high and public health agencies must prioritize mechanisms for detecting their first signals. At the onset of these recent pandemics, no specific therapeutic agent was available for any of the newly emergent pathogens. However, convalescent plasma therapy can be available as soon as there are survivors and is likely to be effective if used early and in sufficient strength. But for the three forms of passive antibody-convalescent plasma, monoclonal antibodies, and hyperimmune globulins-to be available and effective in a pandemic situation, careful strategic planning will be necessary. In the pre-pandemic period, we must reinforce the capacities of blood banks and plasma fractionating companies in the production and storage of their products; ensure that outpatient settings can provide intravenous products; educate providers in the proper use of plasma; and create a research infrastructure to examine the effectiveness of passive antibody products. Once a pandemic is underway, regulatory bodies should simplify the approval of research and emergency use protocols and develop treatment registries. Incentives for the rapid production of monoclonal antibodies and hyperimmune globulins will likely be required. A national resource to link providers with passive antibody products and national databases to monitor pandemic progress and pandemic treatment will permit the most effective allocation of pandemic-fighting resources. We cannot afford to wait until the next pandemic is upon us to respond. The time to strengthen clinical, research, and manufacturing infrastructure to permit us to be ready to confront the next new virulent pathogen is now.