Alec Stapp is a co-founder of the Institute for Progress, a think tank focused on innovation. Arielle D’Souza is a biosecurity fellow at the Institute for Progress.
Before covid-19, the record for fastest vaccine creation had been four years. Yet Operation Warp Speed delivered multiple safe and effective vaccines against the coronavirus in less than one year. By accelerating the development and rollout of the vaccines, Warp Speed saved an estimated 140,000 American lives during the first five months the shots were available and provided a $1.8 trillion boost to the U.S. economy in the first six months. The operation succeeded because it focused exclusively on speeding up the production of vaccines, spending billions of dollars and streamlining regulations across dozens of government offices to make it happen.
Government rarely works so single-mindedly. Consider, for instance, the Chips Act, an example of “everything-bagel liberalism,” by which the government tries to do so much that it ends up failing to do anything at all. The Chips Act is meant to bring advanced semiconductor manufacturing back to the United States. But the project has been so larded with ancillary goals — domestic sourcing, free child care, environmental responsibility, union labor — it’s unclear whether America’s advanced semiconductor industry will ever be rebuilt.
One of Next Gen’s primary projects — to develop universal coronavirus vaccines — has already run into red tape. Animal studies have been slowed by customs-related delays in importing monkeys, and researchers have had trouble getting access to existing mRNA vaccines and adjuvants. These bottlenecks jeopardize the viability of the mission.
To ensure Next Gen’s success, the Biden administration will need to streamline regulatory processes and unblock the development pipeline, even if it means slaughtering a few sacred cows. Pharmaceutical companies will probably make a profit, and some well-meaning regulations will need to be curtailed, but this is what it will take to prioritize accelerated production of vaccines and treatments.
Although Project Next Gen’s budget is only about half what was originally set out for Operation Warp Speed, $5 billion should be sufficient to attract investment from the pharmaceutical industry. The drug companies’ primary risk lies in making big investments in developing and manufacturing vaccines and treatments without knowing how many doses will be needed.
Operation Warp Speed used advance purchase agreements to guarantee demand for coronavirus vaccines, enabling drugmakers to charge ahead on development. Project Next Gen should similarly guarantee demand while also providing funding and expertise to smaller pharma companies for clinical trials, in the same way that Warp Speed supported Moderna.
Next Gen could improve on Warp Speed’s strategy by giving the Department of Health and Human Services expanded contracting authorities to procure products without relying on the Defense Department. This would enable HHS to deal flexibly with the drug industry and work with more diverse partners than it has been able to attract in the past.
One of Operation Warp Speed’s most effective strategies was to speed up the regulatory process involved in developing, testing and distributing vaccines. The U.S. Food and Drug Administration, for example, allowed clinical trial phases to be conducted concurrently. In some cases, Phase 1 trials were allowed to start before certain animal safety and efficacy studies were finished. This was an extraordinary departure from normal procedure.
Following the standard rules, it can take six months to review data from Phase 2 trials before initiating a Phase 3 trial; for Warp Speed, this process was condensed to just three weeks. For the coronavirus vaccines, companies started Phase 3 clinical trials before completing Phase 1 trials. The FDA also expedited the trials and increased their statistical power by requiring about 30,000 participants instead of the more typical population size of 20,000. Next Gen project leaders should use these same strategies to safely unblock today’s development pipeline.
Project Next Gen should take the opportunity to build on the infrastructure that was developed during the covid pandemic and keep it warm for when the next crisis hits. The Operation Warp Speed model can keep the program from falling prey to everything-bagel liberalism. If Next Gen is to create the vaccines and treatments needed for the next pandemic, the Biden administration will need to focus exclusively on its mission.