When SARS-CoV-2 spread out of Wuhan, China, to the rest of the world, it became only the fifth pandemic to be documented since the 1918 flu pandemic. As the entire world went into lockdown, waiting in anticipation for a miracle treatment, the scientific community accomplished what had never been accomplished before, developing first-of-their-kind vaccines against the virus in record time, subsequently saving millions of lives.
Although the rapid COVID-19 vaccine rollout was primarily a success – with nearly 70% of people in the U.S. alone having received their primary vaccination series – and the number of deaths and hospitalizations from COVID-19 has dropped, the fight against the virus is not over. It is still evolving rapidly – with a new variant called Pirola having only recently been discovered in Denmark, on July 24 – and continues to cause a substantial number of infections. Furthermore, the evolution of the virus is difficult to predict, and new variants are constantly a threat – what if a variant emerges that manages to entirely evade the protection provided by COVID-19 vaccines?
This is what the Biden administration in the U.S. is attempting to remind everyone with its new $5 billion initiative, called Project NextGen, which is designed to accelerate and streamline the rapid development of the next generation of COVID-19 vaccines and treatments, through public-private collaborations.
The project is based at the U.S. Department of Health and Human Services (HHS), and led by the Administration for Strategic Preparedness and Response (ASPR’s) Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH’s) National Institute of Allergy and Infectious Diseases (NIAID).
Project NextGen: what exactly does it entail?
Project NextGen, which was originally announced on April 10, 2023, is a successor to the Operation Warp Speed initiative that helped bring the first COVID-19 vaccines and drugs to market in record time.
The new project will coordinate across the U.S. government and the private sector to advance a pipeline of new, innovative COVID-19 vaccines and therapeutics into clinical trials before safely delivering them to the American people with a U.S. Food and Drug Administration (FDA) stamp of approval. The aim is to bring this to fruition by investing in research and development, expanding manufacturing capability and innovation, and providing updated and streamlined regulatory guidance.
The initiative will focus on several key areas: mucosal vaccines – such as those delivered intranasally – which could dramatically reduce infection and transmission; vaccines that provide broader protection against concerning COVID-19 variants and protect people from the virus for longer; pan-coronavirus vaccines to protect against several different types of coronavirus; new and more durable monoclonal antibodies that are resilient against new variants; and, finally, advancing new technologies to improve access and enable faster, cheaper, and more flexible vaccine and therapeutic production.
There are multiple reasons why government investment is required in these areas. According to a perspective in the New England Journal of Medicine from Xavier Becerra, U.S. Secretary of Health and Human Services, and Ashish Jha, Dean of the Brown University School of Public Health and the former White House COVID-19 response coordinator, although there is consensus that the tools the initiative will provide are critical for our fight against COVID-19 moving forward, current market forces have made development slow.
They said: “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.”
Project NextGen awards more than $1.4 billion to develop new COVID-19 drugs and vaccines
In the first major announcement from Project NextGen in August, the U.S. government said it will be awarding $1.4 billion across a series of contracts to develop new drugs and vaccines for COVID-19. The funding includes $1 billion for vaccine clinical trials, as well as an extra $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies that will help to streamline the manufacturing process.
To be more specific, the $1 billion will go to four BARDA clinical trial partners to support vaccine phase 2b studies, which should speed up the development of new vaccine candidates, and provide a network of at-the-ready trials with the flexibility to pivot towards the most promising candidates as they progress.
The four partners for the phase 2b clinical trials are ICON Government and Public Health Solutions, which will conduct a trial involving 10,000 subjects expected to be enrolled over a six-month period, and CRO firms Pharm-Olam, Technical Resources International, and Rho Federal Systems.
Meanwhile, HSS’ partnership with Regeneron will see $326 million go towards supporting the development of a next-generation monoclonal antibody that will protect people who do not respond to or cannot take existing vaccines. Although Regeneron was originally one of a few companies to successfully develop an antibody drug for COVID-19, the success was short-lived, as new coronavirus variants evaded the protection of the company’s drug and others like it. Therefore, this is seen as a critical gap within COVID-19 therapeutics.
The remaining awards of $100 million and $10 million will go to the non-profit organization Global Health Investment Corp. (GHIC), which is managing the BARDA Ventures investment portfolio to expand investments in new technologies that will accelerate responses in the future, and to BLUE KNIGHT, which is a joint initiative between BARDA and Johnson & Johnson Innovation – JLABS, to distribute to the awardees of the BLUE KNIGHT™ Resident QuickFire Challenge: Accelerating Project NextGen.
HSS has said that it also expects to announce more awards before the end of this fiscal year.
Potential funding issues with Project NextGen
Despite the $5 billion investment, Project NextGen has raised concerns in some corners regarding the fact that the funding for the initiative is far less than that of Operation Warp Speed, and therefore, will not have the ability to make the bulk purchases that fueled the vaccine rollout effort during COVID-19.
In fact, during POLITICO’s Health Care Summit in June, Becerra downplayed expectations that the administration would be able to repeat the success of Operation Warp Speed, and lamented the fact that Congress isn’t funding Project NextGen in the same way. “We’ve got some really innovative approaches and therapies in the works,” Becerra said. “Here’s the difference…they really did have trillions of dollars.”
Although this was perhaps an overstatement from Becerra, it is certainly true that Operation Warp Speed was better funded, having received an estimated $18 billion.
Having said that, Project NextGen is still in its infancy, and, if given the time to succeed, it could ultimately save the day as it advances the science the world needs to better prepare ourselves for future pandemics.