The Biden Administration has laid out a $65.3-billion, multi-year post-pandemic plan for US preparedness against future pandemics and biological threats, which includes $36 billion for vaccine and therapeutic development and manufacturing and $2.1 billion to rebuild national stockpiles and resilient supply chains, including for active pharmaceutical ingredients (APIs).

This plan, laid out in American Pandemic Preparedness: Transforming our Capabilitiess, outlines goals and funding targets over seven to 10 years in five key areas: (1) medical defense, which includes improving and expanding vaccines, therapeutics, and diagnostics; (2) ensuring situational awareness about infectious-disease threats for both early warning and real-time monitoring; (3) strengthening public health systems for emergency response, with a particular focus on reducing inequities and protecting vulnerable communities; (4) building core capabilities, including personal protective equipment, stockpiles and supply chains, biosafety and biosecurity, and regulatory improvement; and (5) the establishment of single, unified “mission control” office at the US Department of Health Human Services, responsible for overseeing the funds to ensure overall program management, execution, and accountability.

The release of the plan follows an executive order issued in January 2020 under which the President directed a whole-of-government review of US national biopreparedness policies and re-established the National Security Council Directorate on Global Health Security and Biodefense.

Funding and details of medical defense plan

The plan sets forth key goals in strengthening US medical defense through $36 billion in funding for vaccine ($24.2 billion) and therapeutic ($11.8 billion) development manufacturing as well as an additional $5.0 billion for diagnostics.

The plan sets specific goals with an overall goal to rapidly make effective vaccines against any human virus family by meeting the following development and manufacturing targets:

• Design, test, and review by 100 days after pandemic threat appears (for COVID-19 = May 2020);
• Produce enough vaccine for the US by 130 days and the entire world by 200 days;
• Simplify vaccine distribution (e.g., eliminate need for cold storage); and
• Simplify vaccine administration (e.g., replace sterile injection, with skin patches and nasal sprays).

With respect to therapeutics, the plan calls for an overall goal of developing therapeutics for any virus family through the following:

• Develop medicines to block key virus functions (as done for HIV);
• Enable rapid production of neutralizing antibodies (currently too slow); and
• Develop medicines to prevent severe immune over-reactions (useful in public health).

The plan also calls for $8.8 billion in funding to build core capabilities by: (1) increasing effectiveness, comfort, affordability, and manufacturability of personal protective equipment, $3.1 billion targeted; (2) refilling stockpiles and building resilient supply chains for APIs, $2.1 billion; (3) accelerating biosafety, biosecurity, and deterrence measures, $2.0 billion: and (4) making regulatory Improvement to ensure regulatory capacity for vaccines, therapeutics, and diagnostics, $1.6 billion.

Separately, in a September 2, 2021 press briefing, on an immediate basis, the White House says it has allocated $2.7 billion to expand US manufacturing of critical vaccine inputs. This funding, which will start going out in the coming weeks (as reported on September 2, 2021), will enable companies that manufacture and produce vaccine inputs to add new production lines and facilities and to also expand fill-finish capacity.

Source: the White House (preparedness plan) and the White House (vaccine manufacturing)