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Center for Health Security Comments on Influenza Vaccine Executive Order

Amesh A. Adalja
Date posted:
February 17, 2020
Publication type:
Health Secur 2020;18(1)
Mary Ann Liebert, Inc.
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The Center for Health Security commends the issuance of the Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health, on September 19, 2019, which has the potential to significantly improve the nation's capacities against influenza. As noted in the executive order, influenza is the preeminent pandemic threat the world faces. Unlike many pandemic threats, however, seasonal occurrences of the infection provide a yearly stress test of our influenza pandemic mechanism. Recent years have seen severe seasonal strains of the virus inundate hospitals, spark spot shortages of antivirals, and expose stark deficiencies in vaccine technology. These events have unfortunately demonstrated that, were a severe pandemic to occur today, the United States is not sufficiently prepared to withstand such an event without major societal disruption.

Recognizing this, the executive order importantly identifies the most salient tasks required to ameliorate these shortcomings. The order crucially identifies this issue as a “national security priority” with disruptive capacities and creates a multidisciplinary interagency task force. Of the tasks enumerated in the executive order, there are 3 areas that the Center would like to emphasize and comment on.

1. Modernization of influenza vaccine manufacturing away from egg-based formulations. The Center applauds the efforts to encourage modernization of influenza manufacturing. Influenza vaccines have been manufactured using the same egg-based technology for decades upon decades, and the modernization of manufacturing is a dire need. Egg-based manufacturing has shown its shortcomings nearly every year in terms of egg-induced mutations and long manufacturing lead times, yet it still dominates the influenza market. In years past, despite the advent of recombinant and cell-based vaccines, government requests for proposals for influenza vaccines have still exclusively sought egg-based vaccines. Increasing capacity and market uptake of recombinant and cell-based vaccines should be an overarching priority, and, to the extent possible, government procurement through the Departments of Defense and Veterans Affairs, for example, should reflect this priority.

2. Increasing vaccination rates. The Center recognizes that fewer than half of the eligible population of Americans are vaccinated against influenza, posing a major public threat. Not only does this leave many Americans vulnerable, but it is also a barrier to return on investment for flu vaccine manufacturers. Part of the reason for vaccine hesitancy stems from the insufficient protection afforded by standard vaccines even in years in which the vaccine is well matched to circulating strains. However, new data exist showing the ability of cell-based, recombinant, adjuvanted, and high-dose vaccine formulations to significantly increase the protection conferred by these vaccines compared to the standard vaccine. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) does not offer preferential recommendations regarding the suitability of specific vaccines for specific populations—for example, high-dose vaccine for the elderly, recombinant vaccine for most adults, and the like. Innovative vaccines need sustainable markets, and guidance can provide an impetus for sales (as it does with many anti-infective products). As part of the endeavors prompted by this executive order, updated guidance to reflect the best clinical evidence supporting the newer flu vaccine formulations would encourage the furtherance of vaccine innovation.

3. Pull mechanisms for innovative vaccines. The Center enthusiastically supports the examination of the “current legal, regulatory, and policy framework surrounding payment for influenza vaccines.” Novel vaccines—recombinant, cell-based, adjuvanted, and high-dose—all have the potential to decrease the burden of influenza, including its economic toll. Rewarding this enhanced efficacy—as well as key pandemic variables, such as rapidity and scalability of manufacture—with additional payments to manufacturers (akin to a new technology add-on payment) could provide an important pull incentive for manufacturers to develop vaccines with improved efficacy. Acquisition costs should not simply be juxtaposed to cheaper, less efficacious, egg-based vaccine without incorporating enhanced efficacy and pandemic-relevant variables into the analysis.

This executive order is a welcome and long overdue step in recognizing the importance of infectious disease emergencies to national and health security. If it can achieve its vision, the country and the world will be much better poised to face the next pandemic when it appears.



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