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  • Writer's pictureP.K. Peterson

Can “Project NextGen” Defeat SARS-CoV-2 and Prepare Us for the Next Pandemic?

“As the [SARS-CoV-2] virus continues to evolve, we need new tools that keep pace with those changes.”

- Dawn O’Connell, Assistant Secretary for Preparedness and Response, Department of Health and Human Services

“We’ve lost a lot of the trust and the support of the public over the last several years because they [the public] felt like we were not being truthful when we should have said we don’t know. And so I think we have a lot of work yet to do for the next pandemic. And if I had to give you my best professional judgment, I would say we’re less prepared for a pandemic today than we were in 2019.”

- Michael T. Osterholm, PhD, MPH, Regents Professor and Director, Center for Infectious Diseases Research and Policy, University of Minnesota

Recently, the Department of Health and Human Services (HHS) announced its first round of funding through “Project NextGen”—a program designed to speed and streamline the development of new vaccines and treatments for COVID-19. As some readers may not have heard of Project NextGen, in this week’s Germ Gems post, I provide a brief overview of the program and explain what defeating SARS-CoV-2 may mean. In addition, I stress the importance of restoring public trust in both the Centers for Disease and Control and Prevention (CDC) and the National Institutes of Health (NIH) in preparing for the next pandemic.

What is Project Next Gen? In their August 21, 2023 New England Journal of Medicine article, “Project NextGen—Defeating SARS-CoV-2 and Preparing for the Next Pandemic,” U.S. Secretary of Health and Human Service, Xavier Becerra, and Dr. Ashish Jha, Dean, Brown University School of Public Health and former White House COVID-19 Response Coordinator, state that it’s safe to assume that SARS-CoV-2 will continue to evolve and that new generation vaccines and treatments are going to be needed to address this very tenacious virus.

In April 2023, the HHS announced the creation of the federal program “Project NextGen”—a $5 billion initiative to create the development of better vaccines and monoclonal antibodies against COVID-19 through public-private collaborations. (Project NextGen is reminiscent of “Operation Warp Speed”[OWS]—a public-private partnership that led to the astonishing development in less than a year’s time of two mRNA COVID-19 vaccines that have saved many millions of lives globally. Project Next Gen’s funding seems somewhat anemic when compared with the $10 billion support of OWS.)

The $5 billion Project is concentrated in the main on bolstering the immune system with vaccines and monoclonal antibodies. It focuses on three areas: (1) vaccines that provide broader immunity against new SARS-CoV-2 variants as well as other related coronaviruses; (2) vaccines that generate mucosal immunity; and (3) monoclonal antibodies that can weather viral evolution and provide more effective treatment of beta-coronavirus infections. In August, the HHS awarded $1.4 billion in grants to a collection of pharmaceutical companies, nonprofits, and nongovernmental organizations to foster involvement of public-private partnerships in vaccine development.

Will we “defeat” SARS-CoV-2? It depends on what you mean by “defeat.” According to the Merriam-Webster Dictionary, the transitive verb “defeat” means to completely overcome or subdue a competitor in a battle, conflict, or contest. By this definition, smallpox is the only human infection to be completely defeated, or in public health parlance eradicated—“permanently reduced to zero worldwide.” Early in this pandemic, the consensus of experts was that this lofty goal would not be achievable with COVID-19.

A more modest but potentially achievable goal in the battle against SARS-CoV-2 is elimination—“a reduction to zero incidence of infection in defined geographic areas.” Measles and malaria, are examples of this kind of “defeat.” The current status of COVID-19 suggests, however, that we have a long way to go before we reach even this goal.

A more realistic goal is having SARS-CoV-2 attain the status of influenza virus. We certainly haven’t defeated the flu virus. (Seasonal influenza kills 30,000 to 70,000 Americans per year, and “bird flu” is in the wings threatening to blossom into the next pandemic). Nonetheless, from a public health point of view, influenza virus infection is considered an endemic, that is, it is more like a stalemate than a defeat (no clearcut victor, at least not yet).

Current status of COVID-19: what we know. In March 2023, Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, CA, and editor-in-chief of Medscape, declared that it was time to consider COVID-19 an endemic. It’s not clear that other experts think we’re quite there—yet.

On September 7, 2023, the World Health Organization (WHO) announced its concern about the increased number of COVID-19 cases in the Northern Hemisphere. On that same day the New York Times posted this article, “Covid Continues to Rise, but Experts Remain Optimistic.”

Despite a recent uptick in COVID-19 hospitalizations and deaths, the evidence to date suggests new SARS-CoV-2 subvariants like BA.2.86 may be less contagious and less immune-evasive than originally feared. The good news is that the updated mRNA boosters from both Pfizer and Moderna generate a strong immune response to this subvariant. And the really good news is that by the time this Germ Gems is posted these new mRNA SARS-CoV-2 boosters will be available.

Restoring trust. One thing that all public health experts agree upon is the inevitability of new pandemics. It’s not a matter of if, it’s a matter of what and when? Just because we’re weary of fighting SARS-CoV-2, doesn’t mean we should stop working on ways to prevent the emergence of new pathogens.

Along with state departments of health, U.S. citizens and health professionals alike depend on the CDC to provide guidance on all matters impacting the health of Americans. For health-related research and development, the NIH is our most trusted resource. Americans should be enormously proud of these institutions. Not surprisingly, however, both made mistakes in confronting COVID-19 and transmitting information to the general public, and, as a result, public trust was eroded. We need to restore the public’s trust in these organizations.

Currently, both organizations are under new leadership. It’s reassuring to read articles like this in the September 7, 2023 MedPage Today, “CDC’s New Chief Plans to Rebuild Trust in the Agency,” in which she (Mandy Cohen, MD, MPH) is quoted as saying, “Trust is absolutely foundational to our ability to help Americans.”

Dr. Monica Bertagnolli, a world-renowned surgical cancer specialist and former director of the NIH’s National Cancer Institute, is the new director of the NIH. Dr. Bertagnolli has been cited for her “career of pioneering discovery and pushing the boundaries of what is possible to improve prevention and treatment for patients.” I am optimistic that she will prove herself to be the right leader in the right place at the right time.

So, in addition to developing new vaccines and monoclonal antibodies with a broader scope of antiviral activity through Project Next Gen, new leadership at the CDC and NIH should help foster the defeat of SARS-CoV-2 and prepare us for pandemics that are yet to come.

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Main Page images courtesy of Shuxian Hu, MD. Dr. Hu is a scientist in the Neuroimmunology Research Laboratory at the University of Minnesota.

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