March 2022 Spending Package

Department of Health and Human Services (HHS) – $18.25 billion 

Public Health and Social Services Emergency Fund. The request includes $15.7 billion to respond to the COVID-19 pandemic and prepare for future variants through the following activities: 

Medical Countermeasures ($12.2 billion). Funding would support near-term expenditures for procurement, and distribution of medical countermeasures to prevent and treat COVID-19 to ensure a sufficient and timely supply to protect and treat the American people. 

  • Procurement of oral antivirals that are highly effective at protecting people from severe disease. The requested amount would support procurement of millions of additional courses, with the exact amount depending on negotiated price as supply expands over time. While doses procured will be used over time, resources are needed promptly because available supply will decline as other countries place orders, creating a significant risk that the U.S. will be unable to secure the supply it needs.  
  • Procurement of monoclonal antibodies that are effective against current and future variants and pre-exposure prophylaxis to prevent infection in immunocompromised people. The requested amount would support immediate needs for procurement of monoclonal antibodies and pre-exposure prophylaxis; however, these needs are highly sensitive to case rates, vaccination rates, severity of disease, and potential future variants. The appropriate balance between monoclonal antibodies and oral antivirals will also need to be assessed on an ongoing basis.  
  • Resources to secure supply of additional vaccines to protect against variants (if authorized by the Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC)). Depending on the science, these vaccines could be prototype boosters or vaccines that provide broad cross-protection against one or more variants (“multivalent”). Because multivalent vaccines would need to be reserved several months prior to their distribution, it is critical to have sufficient resources on hand to quickly secure supply as the situation and the science evolve, although additional resources would be needed to procure supply for the full U.S. population.  
  • Procurement of pediatric vaccines to provide boosters to children ages 5 to 15 and third doses to children up to age five (if authorized by the FDA and recommended by the CDC). In combination with already-procured doses, the requested amount supports procurement for this population. Given the need to secure vaccine doses months in advance, funding is needed this spring to ensure sufficient supply taking into account the need to initially seed thousands of locations with smaller throughput and the expectation that wastage may be elevated due to vial size and an age-specific vaccine for under five year-olds. 

Testing and Supplies ($2.0 billion). Funding would support the Department’s efforts to provide no-cost community testing, manufacturing capacity, procurement of rapid at-home antigen tests, and accelerate the availability of rapid at-home antigen tests. The request supports: 

  • Short-term extension of the Increasing Community Access to Testing (ICATT) program. This program, which is managed by the Office of the Assistant Secretary for Preparedness and Response and the CDC, supports no[1]cost testing for communities that are otherwise underserved in testing access or are at greater risk of experiencing COVID-19 disease and poor health outcomes. In October 2021, ICATT reached its goal of establishing 10,000 free community testing sites. Without additional funding, this program would shut down in May. 

     
  • Continuation of the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative. This initiative develops innovations to reduce the cost-drivers of at-home tests: antibody production; manufacturing efficiency; packaging and labeling; and distribution costs.  
  • Continuation of the accelerated pathway for Emergency Use Authorization (EUA) of at-home tests. The Independent Test Assessment Program (ITAP) provides an accelerated pathway for test manufacturers that are currently marketing high-volume, high-quality at-home tests outside of the United States to receive an EUA and enter the U.S. market. In its first two months, ITAP resulted in accelerated EUAs for two high-volume manufacturers. In collaboration with FDA, ITAP conducts independent laboratory and clinical studies, shaving weeks to months off the EUA process.  
  • Support of the industrial base for test supplies and test manufacturing. The market for point-of-care and at-home rapid antigen tests is extremely volatile and heavily dependent upon inconsistent demand as cases rise and fall. As the Omicron surge wanes and testing demand declines, near-term investment is necessary to preserve manufacturing capacity. Without these investments, domestic manufacturing of tests could fall dramatically, as was experienced in the summer of 2021. It would then require as much as six months of ramp-up to restore capacity, severely limiting the ability to respond to a future surge. Funding would support investments in test supplies (including medical grade resins, reagents, and pipette tips), manufacturing capacity, and the procurement of tests.  
  • Support of commercial and public health laboratory capacity. Likewise, capacity for high-complexity nucleic acid amplification tests is at risk of declining when the Omicron surge wanes. In addition, commercial labs face surge demands that can cause delays in turnaround times due to the lack of available technicians. Funding would support near-term investments in manufacturing capacity, and the procurement of tests. Funding would also support technical support services to commercial and public health laboratories experiencing a shortage of personnel.  

Preparing for Future Variants ($1.5 billion). Funding would support initial steps to develop medical countermeasures to protect against future variants.  

Most immediately, $1.5 billion is needed for near-term research and development of a next-generation vaccine (“pan-SARS-CoV-2” or “pan-COVID”) that targets conserved viral antigens of the COVID-19 protein—areas that do not easily vary. Such a vaccine could offer broader neutralizing protection than current vaccines without requiring a new vaccine for each new variant. Development would be through the National Institutes of Health in partnership with academic consortia and in coordination with the Biomedical Advanced Research and Development Authority. Funding could also support rapid development of a vaccine that targets any new variant that emerges in the near term if needed, as well as sustainment and expansion of vaccine manufacturing capacity, including fill-finish capacity. 

Health Resources and Services Administration (HRSA). The request includes $1.5 billion to continue reimbursements to providers for testing, treatment, and vaccination of the uninsured and vaccination of the underinsured. This activity is currently financed through the Provider Relief Fund and the ARP testing appropriation, but available funding is projected to be exhausted in late April or early May of this year, and HRSA would need to stop accepting claims for the funds as soon as this month unless additional resources are provided. 

CDC. The request includes $1.05 billion to respond to the COVID-19 pandemic and prepare for future variants and other emerging needs through the following activities. 

Surveillance of Variants and Ongoing Domestic Response ($300 million). Funding would help strengthen core public health infrastructure for surveillance and laboratory capacity to detect emerging variants (as well as other infectious disease threats). Early detection and sequencing of variants can help accelerate the development of countermeasures. Program activities would include collecting and characterizing pathogens to monitor pathogen circulation and variance, expanding and enhancing laboratory capabilities to detect and monitor respiratory and other pathogens, targeting sequencing and other surveillance efforts in high-risk transmission zones, and strengthening multinational data systems to detect, characterize, and communicate rare events. Funding would also enable CDC to build upon existing scientific and programmatic efforts and support CDC’s epidemiologic studies, lab activities, and mitigation strategies to address the continuing threat posed by COVID-19 and nimbly respond to emerging and future new variants. 

Vaccinate the World: Vaccine Readiness and Technical Assistance ($750 million). Funding would expand and intensify global COVID-19 pandemic response activities. When this funding is combined with the Department of State’s and United States Agency for International Development’s (USAID) request, agencies would provide an estimated $2.55 billion to accelerate vaccine uptake through the U.S. Government’s recently announced Initiative for Global Vaccine Access (Global VAX). CDC would work in close coordination with USAID on this effort for a Government-wide approach to increase global COVID-19 vaccine readiness and technical assistance. Program activities would include vaccine policy development, vaccine confidence and demand creation, vaccine safety reporting, vaccine effectiveness evaluations, workforce development and training, data management, and program operations and planning support within countries.