Project Nextgen: Brandon Doubling Down On Unsafe and Inneffective Vaccine-Only Strategy...,

NEJM  | 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 longer-lasting 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 NextGen, 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 beta-coronaviruses.

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.