Summary

To protect against future infectious disease outbreaks, the Department of Health and Human Services (HHS) Coordination Operations and Response Element (H-CORE) should develop and maintain the capacity to regularly deliver N95 respirator masks to every home using a mail delivery system. H-CORE previously developed a mailing system to provide free, rapid antigen tests to homes across the U.S. in response to the COVID-19 pandemic. H-CORE can build upon this system to supply the American public with additional disease prevention equipment––notably face masks. H-CORE can helm this expanded mail-delivery system by (i) gathering technical expertise from partnering federal agencies, (ii) deciding which masks are appropriate for public use, (iii) pulling from a rotating face-mask inventory at the Strategic National Stockpile (SNS), and (iv) centralizing subsequent equipment shipping and delivery. In doing so, H-CORE will fortify the pandemic response infrastructure established during the COVID-19 pandemic, allowing the U.S. government to face future pathogens with preparedness and resilience.

Challenge and Opportunity

The infrastructure put in place to respond to COVID-19 should be maintained and improved to better prepare for and respond to the next pandemic. As the federal government thinks about the future of COVID-19 response programs, it should prioritize maintaining systems that can be flexibly used to address a variety of health threats. One critical capability to maintain is the ability to quickly deliver medical countermeasures across the US. This was already done to provide the American public with COVID-19 rapid tests, but additional medical countermeasures––such as N95 respirators––should also be included. 

N95s are an incredibly effective means of preventing deadly infectious disease spread. Wearing an N95 respirator reduces the odds of testing positive for COVID-19 by 83%, compared to 66% for surgical masks and 56% for cloth masks. The significant difference between N95 respirators and other face coverings means that N95 respirators can provide real public health benefits against a variety of biothreats, not just COVID-19. Adding N95 respirators to H-CORE’s mailing program would increase public access to a highly effective medical countermeasure that protects against a variety of harmful diseases. Providing equitable access to N95 masks can also protect the United States against other dangerous public health emergencies, not just pandemics. Additionally, N95s protect individuals from harmful, wildfire-smoke-derived airborne particles, providing another use-case beyond protection against viruses. 

Beyond the benefit of expanding access to masks in particular, it is important to have an active public health mailing system that can be quickly scaled up to respond to emergencies. In times of need, this established mailing system could distribute a wide array of medical countermeasures, medicines, information, and personal protective equipment––including N95s. Thankfully, the agencies needed to coordinate this effort are already primed to do so. These authorities already have the momentum, expertise, and experience to convert existing COVID-19 response programs and pandemic preparedness investments into permanent health response infrastructure.

Plan of Action

The newly-elevated Administration for Strategic Preparedness and Response (ASPR) should house the N95 respirator mailing system, granting H-CORE key management and distribution responsibilities. Evolving out of the operational capacities built from Operation Warp Speed, H-CORE has demonstrated strong logistical capabilities in distributing COVID-19 vaccines, therapeutics, and at-home tests across the United States. H-CORE should continue operating some of these preparedness programs to increase public access to key medical countermeasures. At the same time, it should also maintain the flexibility to pivot and scale up these response programs as soon as the next public health emergency arises. 

H-CORE should bolster its free COVID-19 test mailing program and include the option to order one box of 10 free N95 respirator masks every quarter. 

H-CORE partnered with the U.S. Postal Service (USPS) to develop an unprecedented initiative––creating an online ordering system for rapid COVID-19 testing to be sent via mail to American households. ASPR should maintain its relationships with USPS and other shipping companies to distribute other needed medical supplies––like N95s. To ensure public comfort, a simple N95 ordering website could be designed to mimic the COVID-19 test ordering site

An N95-distribution program has already been piloted and proven successful. Thanks to ASPR and the National Institute for Occupational Safety and Health (NIOSH), masks previously held at SNS were made available to the public at select retail pharmacies. This program should be made permanent and expanded to maximize the convenience of obtaining medical countermeasures, like masks. Doing so will likely increase the chance that the general population will acquire and use them. Additionally––if supplies are sourced primarily from domestic mask manufacturers––this program can stabilize demand and incentivize further manufacturing within the United States. Keeping this production at a steady base level will also make it easier to scale up quickly, should America face another pandemic or other public health crisis.

H-CORE and ASPR should coordinate with the SNS to provide N95 respirators through a rotating inventory system.  

As evidenced by the 2009 H1N1 influenza pandemic and the COVID-19 pandemic, static stockpiling large quantities of masks is not an effective way to prepare for the next bio-incident. 

Congress has long recognized the need to shift the stockpiling status quo within HSS, including within the SNS. Recent draft legislation––including the Protecting Providers Everywhere (PPE) in America Act and PREVENT Pandemics Act, as well as being mentioned in the National Strategy for a Resilient Public Health Supply Chain––have advocated for a rotating stock system. While the concept is mentioned in these documents, there are few details on what the system would look like in practice or a timeline for its implementation.

Ultimately, the SNS should use a rotating inventory system where its stored masks get rotated out to other uses in the supply chain using a “first in, first out” approach. This will  prevent N95s from being stored beyond their recommended shelf-life and encourage continual replenishment of the SNS’ mask stockpile.

To make this new rotating inventory system possible, ASPR should pilot rotating inventory through this H-CORE mask mailing program while they decide if and how rotating inventory could be implemented in larger quantities (e.g. rotating out to Veterans Affairs, the Department of Defense, and other purchasers). To pilot a rotating inventory system, the Secretary of HHS may enter into contracts and cooperative agreements with vendors, through the SNS contracting mechanisms, and structure the contracts to include maintaining a constant supply and re-stock capacity of the stated product in such quantities as required by the contract. As a guide, the SNS can model these agreements after select pharmaceutical contracts, especially those that have stipulated similar rotating inventory systems (i.e., the radiological countermeasure Neupogen).

The N95 mail-delivery system will allow ASPR, H-CORE, and the SNS to test the rotating stock model in a way that avoids serious risk or negative consequences. The small quantity of N95s needed for the pilot program should not tax the SNS’ supply-at-large. After all, the afore-mentioned H-CORE/NIOSH mask-distribution programs are similarly designed to this pilot, and they do not disrupt the SNS supply for healthcare workers.

Conclusion

To be fully prepared for the next public health emergency, the United States must learn from its previous experience with COVID-19 and continue building the public health infrastructures that proved efficient during this pandemic. Widespread distribution of COVID-19 rapid diagnostic tests is one such success story. The logistics and protocols that made this resource dispersal possible should be continued for other flexible medical countermeasures, like N95 respirators. After all, while the need for COVID-19 tests may wane over time, the relevance of N95 respirators will not.

HHS should therefore distribute N95 respirators to the general public through H-CORE to (i) maintain the existing mailing infrastructure and (ii) increase access to a medical countermeasure that efficiently impedes transmission for many diseases. The masks for this effort should be sourced from the Strategic National Stockpile. This will not only prevent stock expiration, but also pilot rotating inventory as a strategy for larger-scale integration into the SNS. These actions will together equip the public with medical countermeasures relevant to a variety of diseases and strengthen a critical distribution program that should be maintained for future pandemic response.

Frequently Asked Questions

Medical countermeasures (MCMs) can include both pharmaceutical interventions (such as vaccines, antimicrobials, antivirals, etc.) and non-pharmaceutical interventions (such as ventilators, diagnostics, personal protective equipment, etc.) that are used to prevent, mitigate, or treat the adverse health effects or a public health emergency. Examples of MCM deployment during the COVID-19 pandemic include the COVID-19 vaccines, therapeutics for COVID-19-hospitalized patients (e.g., antivirals and monoclonal antibodies), and personal protective equipment (e.g., respirators and gloves) deployed to healthcare providers and the public.

This proposal would build off of capabilities already being executed under the Department of Health and Human Services, Administration for Strategic Preparedness and Response (HHS ASPR). ASPR oversees both H-CORE and the Strategic National Stockpile (SNS) and was recently reclassified from a staff division to an operating division. This change allowed ASPR to better mobilize and respond to health-related emergencies. ASPR established H-CORE at the beginning of 2022 to create a permanent team responsible for coordinating medical countermeasures and strengthening preparedness for future pandemics. While H-CORE is currently focused on providing COVID-19 countermeasures––including vaccines, therapeutics, masks, and test kits––their longer-term mission is to augment capabilities within HHS to solve emerging health threats. As such, their ingrained mission and expertise match those required to successfully launch an N95 mail-delivery system.

Presently, 270 million masks have been made available to the U.S. population. It’s estimated that this same number of masks would be enough for American households to receive 10 masks per quarter, assuming a 50% participation rate in the program.

The total annual cost of this program is an estimated $280 million to purchase 270 million masks and facilitate shipping across the United States.

There are several ways this initiative could be funded. Initial funding to purchase and mail COVID-19 tests to homes came from the American Rescue Plan. By passing the COVID Supplemental Appropriations Act, Congress could provide supplemental funds to maintain standing COVID-19 programs and help pivot them to address evolving and future health threats.

The FY2023 President’s Budget for HHS also provides ample funding for H-CORE, the SNS, and ASPR, meaning it could also provide alternative funding for an N95 mail-delivery system. Presently, the budget asks for: $133 million for H-CORE and mentions their role in making masks available nationwide. Additionally, $975 million has been allotted to the SNS, which includes coordination with HHS and maintaining the stockpile. Furthermore, is petitions for ASPR to receive $12 billion to generally prepare for pandemics and other future biological threats (and here it also specifically recommends strong coordination with HHS agency efforts).

N95 respirators have a number of benefits that make them a critical defense strategy in a public health emergency. First, they are pathogen-agnostic, shelf-stable countermeasures that filter airborne particles very efficiently, meaning they can impede transmission for a variety of diseases––especially airborne and aerosolized ones. This is important, since these two latter disease categories are the most likely naturally occurring and intentional biothreats. Second, N95 respirators are useful beyond pandemic responses and also protect against wildfire smoke. Additionally, N95 masks have a long shelf-life. Therefore, the ability to quickly and widely distribute N95s is a critical public health preparedness measure.

Domestic mask manufacturers have also frequently experienced boom and bust cycles as public demand for masks can change rapidly and without warning. This inconsistent market makes it difficult for manufacturers to invest in increased manufacturing capacity in the long-term. One example is the company Prestige Ameritech, which invested over $1 million in new equipment and hired 150 new workers to produce masks in response to the 2009 swine flu outbreak. However, by the time production was ready, demand for masks had dropped and the company almost went bankrupt. Given overwhelmingly positive benefits of having mask manufacturing capacity available when needed, it is worthwhile for the government to provide some ongoing demand certainty.

Furthermore, making masks free and easily available to the general public could increase the public’s mask usage during the annual flu season and other periods of sickness. While personal protective equipment has decreased in cost since the peak of the pandemic, making them as accessible as possible will disproportionately increase access for low-income citizens and help ensure equitable access to protective medical countermeasures.

It is true that N95s are not regulated outside of healthcare settings, but that shouldn’t dissuade public use. Presently, there is no federal agency currently tasked with regulating respiratory protection for the public. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) currently have a Memorandum of Understanding (MOU) coordinating regulatory authority over N95 respirators for medical use. Neither the FDA nor NIOSH, though, have jurisdiction of mask use in a non-medical, non-occupational setting. Using an N95 respirator outside of a medical setting does not satisfy all of the regulatory requirements, like undergoing a fit-test to ensure proper seal. However, using N95 respirators for every-day respiratory protection (i) provides better protection than no mask, a cloth mask, or a surgical mask, and (ii) realistically should not need to meet the same regulatory standards as medical use as people are not regularly exposed to the same level of risk as medical professionals.

Presently, there is no central regulator for public respiratory protection in general. In fact, the National Academies of Science Engineering and Medicine recently issued a recommendation for Congress to “expeditiously establish a coordinating entity within the Department of Health and Human Services (HHS) with the necessary responsibility, authority, and resources (financial, personnel, and infrastructure) to provide a unified and authoritative source of information and effective oversight in the development, approval, and use of respiratory protective devices that can meet the needs of the public and protect the public health.”

Moving forward, NIOSH alone should regulate N95 use for the public just as they do in occupational settings. The approval process used by other regulators––like the FDA––is more restrictive than necessary for public use. The FDA’s standards for medical protection understandably need to be high in order to protect doctors, nurses, and other medical professionals against a wide variety of dangerous exposure situations. NIOSH can provide alternative regulation and guidance for the general public, who realistically are unlikely to be in similar circumstances.

Aside from federal agencies, professional scientific societies have also provided their input in regulating N95s. The American Society for Testing and Materials (ASTM), for example, recently published standards for barrier face coverings not intended for medical use or currently regulated under NIOSH standards. While ASTM does not have any regulatory or enforcement authority, HHS could use these standards for protection, comfort, and usability as a starting point for developing guidelines for respirators suitable for public distribution and use.

After the 2009 H1N1 influenza pandemic and the COVID-19 pandemic, it became evident that SNS must change its stockpile management practices. The stockpile’s reserves of N95 respirators were not sufficiently replenished after the 2009 H1N1 pandemic, in large part due to the significant up-front supply restocking cost. During the early days of COVID-19 response, many states received expired respirators and broken ventilators from the SNS. These incidents revealed a number of issues with the current stockpiling paradigm. Shifting to a rotating inventory system would prevent issues with expiration, smooth out the costs of large periodic restocks, and help maintain a capable and responsive manufacturing base.