Reimagining Public Health
JAMA Network
Eli Y. Adashi, MD, MS1; I. Glenn Cohen, JD2
January 6, 2022
The Executive Summary below was edited by the author of this blog, as a voluntary service, with the purpose of reaching in particular de Brazilian audience. For the complete version of the original publication, please refer to the 2nd part of this post, with some visual editing only.
Health and Technology blog
Joaquim Cardoso MSc. (Chief Editor)
January 23, 2022
Executive Summary (of the proposal only)
On September 2, 2021, the White House released its long-awaited pandemic preparedness proposal titled American Pandemic Preparedness: Transforming Our Capabilities.1
The pandemic preparedness proposal is ambitious and all-encompassing and acknowledges that the transformation of “our medical defenses” will require “extensive scientific and technological efforts.”1
The leading objectives of the pandemic preparedness proposal are the following:
1.Vaccines
Addressing vaccines, the pandemic preparedness proposal seeks the “ability to rapidly make effective vaccines against any virus family.”1
- To realize this goal, the proposal calls for the design, testing, and authorization of vaccines “within 100 days after the recognition of a potential emerging pandemic threat” …
- and vaccine production for the “entire United States population within 130 days.”
- Commensurate advances in vaccine distribution (eg, eliminating the need for cold storage) is to follow suit.
- Simplified, rapid, large-scale vaccine administration is to be addressed as well.
- Replacing the need for sterile injection with skin patches or nasal sprays is to be explored.
- Efforts must also be directed at replacing “the need for multiple doses with time-released formulation.”
- The all-important capacity “to rapidly adapt, test, and review modified vaccines to keep pace with changes in the virus” is similarly emphasized.
2.Therapeutics
For therapeutics, the pandemic preparedness proposal aims to have at hand a “range of therapeutics suitable for any virus family, available before a pandemic or readily created during a pandemic.”1
- Hoped-for therapeutics are to include inhibitors of viral functions of the “small-molecule” and “programmable RNA” varieties.
- Yet other therapeutics are to comprise neutralizing monoclonal antibodies, the rapid and large-scale application of which to infected individuals is projected to be impactful.
- Additional consideration is being given to therapeutics that would “limit damage from infectious diseases caused by over- or under-active responses of the human body to infection.”1
3. Diagnostic tests
Seeking to maximize the utility of vaccines and of therapeutics, the pandemic preparedness proposal also argues for “simple, inexpensive, high-performance diagnostic tests [to become] available at large scale within weeks after the recognition of an emerging pandemic threat.”1
- Such diagnostics are to “be deployed in a range of settings and use cases, including home, point of care, and central labs.”
- Used in the context of a pandemic, these diagnostics are to “enable routine testing for circulating viruses, including in home settings.”
4.ContactTracing
- The combination of high-performance diagnostic tests and contact tracing is called for if the spread of a future pandemic is to be arrested.
5. Early Warning Systems (Ensure Situational Awareness)
Apart and distinct from shoring up the medical defenses against a pandemic, the pandemic preparedness proposal aims to ensure situational awareness (eg, early warning systems)
- … that would “detect viruses that pose a pandemic threat soon after they emerge in humans and produce and publicly share the full genome sequence.”1
- The capability to “monitor the spread and evolution of the virus” in real time is similarly emphasized.
6. Strengthening the Public Health System (and Supply Chain)
Above and beyond the preceding considerations, the proposal calls for
- strengthening the US public health system (eg, modernizing the extant infrastructure) and for
- building core capabilities (eg, personal protective equipment as well as stockpiles and supply chains).
7. Mission Management Model (Similar to the Apollo program)
Also, the proposal notes the imperative of managing the mission in a manner befitting an “Apollo program.”
8.Funding
As per the pandemic preparedness proposal, the total investment called for is $65.3 billion over 7 to 10 years.1
medpagetoday
ORIGINAL PUBLICATION
On September 2, 2021, the White House released its long-awaited pandemic preparedness proposal titled American Pandemic Preparedness: Transforming Our Capabilities.1
Called for by presidential executive order 13987 and National Security Memorandum 1, the proposal, 8 months in the making, comprises a whole-of-government review and update of US national biopreparedness policies.2,3
The pandemic preparedness proposal is ambitious and all-encompassing and acknowledges that the transformation of “our medical defenses” will require “extensive scientific and technological efforts.”1
In this Viewpoint,
we review the leading objectives of the pandemic preparedness proposal,
discuss the outcome of comparable past federal efforts, and
emphasize the imperative of intragovernmental coordination.
1.Reviewing the leading objectives of the pandemic preparedness proposal !
Addressing vaccines, the pandemic preparedness proposal seeks the “ability to rapidly make effective vaccines against any virus family.”1
To realize this goal, the proposal calls for the design, testing, and authorization of vaccines “within 100 days after the recognition of a potential emerging pandemic threat” …
and vaccine production for the “entire United States population within 130 days.”
Commensurate advances in vaccine distribution (eg, eliminating the need for cold storage) is to follow suit.
Simplified, rapid, large-scale vaccine administration is to be addressed as well.
Replacing the need for sterile injection with skin patches or nasal sprays is to be explored.
Efforts must also be directed at replacing “the need for multiple doses with time-released formulation.”
The all-important capacity “to rapidly adapt, test, and review modified vaccines to keep pace with changes in the virus” is similarly emphasized.
For therapeutics, the pandemic preparedness proposal aims to have at hand a “range of therapeutics suitable for any virus family, available before a pandemic or readily created during a pandemic.”1
Hoped-for therapeutics are to include inhibitors of viral functions of the “small-molecule” and “programmable RNA” varieties.
Yet other therapeutics are to comprise neutralizing monoclonal antibodies, the rapid and large-scale application of which to infected individuals is projected to be impactful.
Additional consideration is being given to therapeutics that would “limit damage from infectious diseases caused by over- or under-active responses of the human body to infection.”1
Diagnostic tests — Seeking to maximize the utility of vaccines and of therapeutics, the pandemic preparedness proposal also argues for “simple, inexpensive, high-performance diagnostic tests [to become] available at large scale within weeks after the recognition of an emerging pandemic threat.”1
Such diagnostics are to “be deployed in a range of settings and use cases, including home, point of care, and central labs.”
Used in the context of a pandemic, these diagnostics are to “enable routine testing for circulating viruses, including in home settings.”
The combination of high-performance diagnostic tests and contact tracing is called for if the spread of a future pandemic is to be arrested.
Early Warning Systems — Apart and distinct from shoring up the medical defenses against a pandemic, the pandemic preparedness proposal aims to ensure situational awareness (eg, early warning systems) …
… that would “detect viruses that pose a pandemic threat soon after they emerge in humans and produce and publicly share the full genome sequence.”1
The capability to “monitor the spread and evolution of the virus” in real time is similarly emphasized.
Strengthening the Public Health System — Above and beyond the preceding considerations, the proposal calls for strengthening the US public health system (eg, modernizing the extant infrastructure) and for building core capabilities (eg, personal protective equipment as well as stockpiles and supply chains).
Also, the proposal notes the imperative of managing the mission in a manner befitting an “Apollo program.”
2.Discussing the outcome of comparable past federal efforts !
The success of the pandemic preparedness proposal is contingent upon its ability to break with a troubling historic record of well-meaning if ineffectual national preparation for public health emergencies.4
Decades of federal planning for a future pandemic such as the COVID-19 pandemic failed to live up to expectations.4
Legislative inaction was not at fault. Indeed, 4 US presidents, faced with outbreaks of influenza A (H1N1), Ebola, Zika, and SARS, signed into law a total of 9 significant bills over the last 20 years with the next pandemic in mind.4
Moreover
- authorized funds made their way to states and to hospitals,
- the position of Assistant Secretary for Preparedness and Response was created, and
- key organizations such as BARDA (Biomedical Advanced Research and Development Authority) and
- the US Department of Health and Human Services’ Centers for Innovation in Advanced Development and Manufacturing were established.4
What may have been missing was continuous leadership across administrations and a sense of urgency.
Without these key elements, the death toll, the societal disruption, and the economic dislocation caused by the COVID-19 pandemic were all but predictable.4
What may have been missing was continuous leadership across administrations and a sense of urgency.
3.Emphasizing the imperative of intragovernmental coordination !
In another nod to the “Apollo program,” the pandemic preparedness proposal calls for the establishment of “a strong, unified Mission Control to manage, integrate, and ensure accountability for all aspects of the U.S. pandemic preparedness program.”1
It would appear, however, that the pandemic preparedness proposal fails to note several key governmental constructs of central consequence to pandemic readiness.
Examples include but are not limited to
- the Antiviral Program for Pandemics (APP),
- the Accelerating COVID-19 Therapeutics and Vaccines (ACTIV), and
- the Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.5–7
Ensuring the success of the pandemic preparedness proposal will require impeccable inclusivity such that no meaningful governmental program is left behind.
An effective program to ensure that the US is prepared for future pandemics and other major biological threats will require significant annual investments over a sustained period.1
The annualized costs are nevertheless likely to be far less in comparison with those associated with missile defense ($20 billion per year) or with terrorism prevention ($170 billion per year).1
The attendant opportunity cost is likely to be substantial as well.
The Global Preparedness Monitoring Board, an expert group convened by the World Bank and the World Health Organization, estimates that a “pandemic akin to the scale and virulence of the 1918 influenza pandemic could cost the global economy $3 trillion in Gross Domestic Product and cause 50–80 million deaths.”8
… a “pandemic akin to the scale and virulence of the 1918 influenza pandemic could cost the global economy $3 trillion in Gross Domestic Product and cause 50–80 million deaths.”8
As per the pandemic preparedness proposal, the total investment called for is $65.3 billion over 7 to 10 years.1
A recent proposal of the White House called for the authorization of $15 billion for the pandemic preparedness program in fiscal year 2022.
As of December 13, 2021, however, the fiscal year 2022 outlay for the pandemic preparedness program in the Build Back Better Act (HR 5376) is capped at $10 billion.
Passed by the House on November 19, 2021, the Build Back Better Act has yet to be voted on by the Senate.
Limiting important funding in efforts involving preparation for the next pandemic would be unwise and shortsighted.
Zoonotic outbreaks on a pandemic scale are here to stay, and ignoring this reality is not an option.
Viewed in this light, the American Pandemic Preparedness proposal is a critically important initiative for responding effectively to pandemics and other biological threats in the future.
About the authors & affiliations
Eli Y. Adashi, MD, MS1; I. Glenn Cohen, JD2
- 1 Department of Medical Science, Brown University, Providence, Rhode Island
- 2 Harvard Law, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts
References
References
1.
The White House. American pandemic preparedness: transforming our capabilities. Published September 2, 2021. Accessed October 9, 2021. https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
2.
The White House. Executive order on organizing and mobilizing the united states government to provide a unified and effective response to combat COVID-19 and to provide United States leadership on global health and security. Published January 20, 2021. Accessed October 9, 2021. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-organizing-and-mobilizing-united-states-government-to-provide-unified-and-effective-response-to-combat-covid-19-and-to-provide-united-states-leadership-on-global-health-and-security/
3.
The White House. National security memorandum on united states global leadership to strengthen the international COVID-19 response and to advance global health security and biological preparedness. Published January 20, 2021. Accessed October 9, 2021. https://www.whitehouse.gov/briefing-room/statements-releases/2021/01/21/national-security-directive-united-states-global-leadership-to-strengthen-the-international-covid-19-response-and-to-advance-global-health-security-and-biological-preparedness/
4.
Alexander L. Preparing for the next pandemic: a white paper. Published June 9, 2020. Accessed October 9, 2021. https://www.help.senate.gov/imo/media/doc/Preparing%20for%20the%20Next%20Pandemic.pdf
5.
National Institute of Allergy and Infectious Disease. Antiviral program for pandemics. Published July 8, 2021. Accessed October 9, 2021. https://www.niaid.nih.gov/research/antivirals
6.
National Institutes of Health. Accelerating COVID-19 therapeutic interventions and vaccines (ACTIV). Accessed October 9, 2021. https://www.nih.gov/research-training/medical-research-initiatives/activ
7.
National Institute of Allergy and Infectious Diseases. Antiviral drug discovery (AViDD) centers for pathogens of pandemic concern. Accessed October 9, 2021. https://www.niaid.nih.gov/research/antiviral-discovery
8.
Congressional Research Service. US global health assistance: FY2017-FY2021 funding. Published February 5, 2021. Accessed October 9, 2021. https://crsreports.congress.gov/product/pdf/IF/IF11758/2
Originally published at https://jamanetwork.com
