Project NextGen - Defeating SARS-CoV-2 and Preparing for the Next Pandemic

The development of safe and effective Covid-19 vaccines and treatments within a year after SARS-CoV-2 was first identified represents one of the great successes of modern science.¹

Thanks to the ingenuity of scientists, along with cooperation between the U.S. government and the private sector, these medical countermeasures changed the trajectory of the pandemic, saving millions of lives in the United States and tens of millions globally. Today, nearly 70% of Americans have received their primary vaccination series, including nearly 95% of those over 65 years of age.²

Although the numbers of deaths and hospitalizations due to Covid-19 have dropped by more than 90% since President Joe Biden took office, our fight against SARS-CoV-2 is not over. The virus continues to evolve rapidly³ and still causes substantial numbers of infections, hospitalizations, and deaths each day. The emergence of new variants is hard to predict and continues to threaten the ability of countermeasures such as monoclonal antibodies to protect vulnerable patients. Immunity from both vaccines and infection wanes over time. The only way to stay ahead of the virus is to continue to update the composition of our vaccines and administer them in a regular cadence. Although this strategy is critical, with our current generation of vaccines, it also requires immense resources for mounting frequent vaccination campaigns — at a time when antivaccination sentiment continues to grow and the public’s appetite for regular vaccinations has waned.

Next-generation vaccines and treatments are needed if we are to break the cycle of responding to new variants as they appear: we need tools that can improve our bodies’ ability to stop infections, reduce transmission, build longerlasting immunity, and target parts of the virus that are less likely to evolve.⁴ Ideally, such vaccines and treatments would provide better protection, enabling us to avoid disruptions of our lives and continue to enjoy the activities we value.

Since it’s safe to assume that SARS-CoV-2 will continue to evolve, the goal for the next generation of vaccines and treatments is to be effective irrespective of that evolution — to protect against infection, transmission, and severe illness. This new approach is important for everyone, but particularly for the most vulnerable people — older adults and people who are immunocompromised, for whom infections can have more severe consequences.

The Biden administration has therefore announced Project Next Gen, which will coordinate a whole-of-government effort to advance innovations from labs through clinical trials and safely deliver them to the public. It aims to bring new vaccines and treatments to market by investing in research and development, expanding manufacturing capability and innovation, and providing updated and streamlined regulatory guidance. This $5 billion investment will focus on three main areas: vaccines that provide broader immunity both against new SARS-CoV-2 variants and across the family of epidemic-prone sarbecoviruses, vaccines that generate effective mucosal immunity to block infection and transmission, and monoclonal antibodies that can weather viral evolution and serve as a basis for our arsenal against new threats from betacoronaviruses.

“Next-generation vaccines and treatments are needed if we are to break the cycle of responding to new variants as they appear.”

Why is government investment needed at this time and for this effort? Although there is consensus that these tools are critical for our fight moving forward, current market forces have made development slow. Reduced interest in traditional vaccines has limited investments in this area. In addition, the science underpinning these efforts is difficult and requires work that is not guaranteed to pay off on the timelines that many private investors seek. There are also important scientific and regulatory challenges, such as determining how to best measure a new vaccine’s efficacy. Although companies may eventually bring the needed products to market, the current anticipated timelines could leave the public vulnerable, without additional tools, for many years. This prospect reflects a classic market failure: the costs of development have been left to private market forces that may not place adequate value on products’ broad benefits for the people of the United States and the rest of the world.

The U.S. government has committed to accelerating the science by streamlining development processes, using such strategies as standardizing assays, standardizing protocols, and providing timely regulatory guidance. This approach will build on years of success of the Biomedical Advanced Research and Development Authority (an agency within the Department of Health and Human Services), and it is designed to help ensure that new tools reach the American people in the shortest time possible.

Over the past 2 years, many experts have underscored the importance of such a new generation of tools.⁵ And though this U.S. government investment is one of the largest to date, other organizations, including the Coalition for Epidemic Preparedness Innovation, Japan’s Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response, and the European Union’s Health Emergency Preparedness and Response Authority, have either already invested in similar initiatives or signaled their interest in doing so. This moment offers an important opportunity for us to coordinate with our international partners, create strong channels of communication so that the failure or success of one strategy can inform the path forward for another, and plan out strategies to provide rapid and wide access to products when they are successful.

Although our public health emergency (PHE) has ended, SARS-CoV-2 continues to evolve and pose challenges to human health. The important work of keeping Americans safe continues throughout the Biden–Harris administration. As the investment in Project NextGen makes clear, the end of the PHE did not end the government response, for the reality is that Covid-19 is unlikely to be the last pandemic we face. Technological innovations leading to new vaccines and treatments will have direct benefit in future pandemics caused by respiratory pathogens, enabling more rapid development of better vaccines against other high-priority pathogens, whether they are other coronaviruses or pandemic influenza. These innovations may also help us improve our approaches to current threats that still resultin a significant burden of disease, such as seasonal influenza and respiratory syncytial virus.

By bringing together government agencies, scientists, and the private sector, the administration aims to catalyze a new approach to building vaccines and treatments that finally tames SARS-CoV-2 and prevents it from continuing to cause a high burden of disease. Equally important, we expect this effort to advance the science needed to better prepare our country to prevent the next pandemic.

 

1. Slaoui M, Hepburn M. Developing safe and effective Covid vaccines — Operation Warp Speed’s strategy and approach. N Engl J Med 2020;383:1701-3.

2. Centers for Disease Control and Prevention. COVID-19 vaccinations in the United States. May 11, 2023 (https://covid.cdc.gov/ covid-data-tracker/#vaccinations_vacc -people-booster-percent-pop5)

3. Rubin EJ, Baden LR, Abraham J, Morrissey S. Audio interview: viral evolution and the future of monocolonal antibodies. N Engl J Med 2022;386(24):e75.

4. Marks PW, Gruppuso PA, Adashi EY. Urgent need for next-generation COVID-19 vaccines. JAMA 2023;329:19-20.

5. Moore KA, Leighton T, Ostrowsky JT, et al. A research and development (R&D) roadmap for broadly protective coronavirus vaccines: a pandemic preparedness strategy. Vaccine 2023;41:2101-12.