Public Health Emergency - Leading a Nation Prepared
The primary challenge faced by the PHEMCE is the sustainability of the MCM response capabilities and capacities of the SNS built through PBS. Successful procurement of an MCM obligates SNS to expend additional funding for sustainment. First, SNS faces replenishment requirements upon expiration for products added to the SNS by BARDA through PBS contracts. PBS funding used for initial MCM procurement rarely supports ongoing maintenance and replacement of the products after it is approved by FDA. In the past, the PHEMCE SNS Annual Review recommended tradeoffs when available SNS funds were insufficient to both maintain current capabilities and absorb additional products. These tradeoffs translated to increasing levels of risk across the threat portfolios potentially jeopardizing the nation’s ability to realize the full benefits of prior research and development investments. For example, prior SNS Annual Reviews proposed reducing anthrax vaccine holdings and in 2015 proposed reducing both anthrax vaccine and antibiotics to meet budget constraints. The 2016 SNS Annual Review reported that the SNS inventory was below the established stockpiling goals for several types of MCMs.
Preparing the nation against the threat of pandemic influenza remains a prominent challenge. The
2017 Pandemic Influenza Plan Update establishes as one of the key actions that HHS will “support innovation in influenza vaccine production for improved efficiencies to enable the production and distribution of final presentation vaccines for pandemic response within 12 weeks from the declaration of an influenza pandemic.”
6 To achieve this, BARDA supports the advanced development of cell- and egg-based vaccine domestic manufacturing and infrastructure capacity. Infrastructure capacity is critical to maintaining domestic vaccine manufacturing capability, and includes ongoing vaccine and adjuvant stockpiling programs, including storage, stability, and testing. The estimated funding projected in the out-years (FY 2021 and FY 2022) will also provide continued support for advanced development of therapeutics and novel antiviral drugs for severely ill and hospitalized patients, universal influenza vaccines, home-use diagnostics, as well as reusable respirators, and universal portable ventilators.
Beyond these immediate challenges, the PHEMCE must address the entire range of capabilities required to effectively use stockpiled MCMs in response to a public health emergency or natural disaster. These include: the ability to rapidly and accurately detect an incident has occurred that requires MCM assets; the capability to rapidly generate the data necessary to support the emergency use of MCMs using appropriate frameworks including clinical trials as well as expanded access and other emergency use authorization when necessary; the availability of evidence-based guidance on the appropriate use of these MCMs in all populations; the ability to monitor efficacy and safety of MCMs in all populations during and after an emergency to inform future actions; and the ability of state and local partners to receive, distribute, and dispense MCMs. These capabilities, the costs for which are only partially reflected in this report, are as important as establishing and maintaining a complete inventory of the appropriate pharmaceuticals and medical supplies.
4 Pandemic Influenza Plan: 2017 Update
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