President Donald Trump launched Operation Warp Speed to accomplish something the world has never done before: harnessing the full power of the federal government, the private sector, the military and the scientific community to deliver substantial quantities of a safe and effective vaccine within a year after the discovery of a new virus. The strategy we devised for OWS will allow us to accomplish this goal while following all the same procedures for safety and efficacy, applied by the same apolitical FDA experts, that Americans expect with all vaccines.
So far, the OWS strategy is working. We originally established our objective — substantial quantities of a safe and effective vaccine no later than January — as an optimistic target. While one can never guarantee success in any scientific endeavor, it is now becoming increasingly likely we will deliver this historic victory for the American people and the world.
The strategy of OWS meant to accelerate the timeline
The strategy behind OWS was recently described in a perspective published in The New England Journal of Medicine. In brief, the strategy aims to accelerate the timeline and maximize the probability of delivering a safe and effective vaccine by carefully selecting scientifically sound and promising candidates, building a diverse portfolio of vaccine candidates to mitigate risk of technical failure, providing unprecedented levels of support for clinical trials, and engaging simultaneously in industrial-scale manufacturing “at risk” — i.e., manufacturing the vaccine candidates while still conducting the clinical trials.
Each of these elements of the strategy makes OWS a unique public-private partnership and an unprecedented alliance of FDA scientific and industrial expertise. This partnership will substantially shorten the timeline needed to bring a vaccine to the American people and, through transparent sharing of all safety and efficacy data with the scientific community, ensure that the FDA's assessment meets the same standards as those applied for any other vaccine, without undue pressure or influence.
Potential COVID-19 vaccines on March 20, 2020, in Gaithersburg, Maryland.
To select the candidates, four criteria were developed in consultation with experts across the federal government — from the National Institutes of Health, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the Department of Defense’s scientific components, and elsewhere.
Candidate vaccines needed robust scientific data supporting them. They needed the potential to enter large-scale Phase 3 trials for efficacy by this summer or fall. They had to be based on vaccine technologies that permit rapid and effective manufacturing. Finally, they had to use one of four vaccine-platform technologies we believed most likely to yield a safe and effective vaccine against COVID-19.
These four platforms — the messenger RNA platform, the replication-defective live-vector platform, the recombinant subunit adjuvanted protein platform and the attenuated replicating live-vector platform — represent a continuum, from unproven but highly promising technologies to technologies used to deliver vaccines for decades. By aiming to select eight candidates for support, two from each platform, we have built a portfolio that will maximize our chances at success.
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Each of the candidates selected has received support for some combination of research and development, clinical trials and industrial manufacturing. These financial investments, thus far totaling more than $10 billion, combined with significant technical and logistical support, allow each company to undertake several steps of the vaccine development process in parallel, mitigating its financial risk without compromising the safety and efficacy of its vaccine.
For instance, companies have used these investments to conduct clinical site preparation for Phase 3 trials as soon as they began Phase 1 studies. With the active support of federal partners, companies are recruiting 30,000 to 50,000 volunteers in each of the Phase 3 trials, which is a larger scale than typical vaccine trials, to allow fast answers on efficacy and a broader set of data for determining safety. More patients are enrolling in trials at a faster pace than we have ever seen, and work continues with trusted partners to ensure we have diverse populations represented in these trials.
Apolitical experts will assess vaccine
OWS is supporting the selected companies in building or adapting manufacturing facilities needed for the vaccines, while also supporting manufacturing of ancillary products such as needles, syringes, stoppers and vials. The messenger RNA vaccines are already being manufactured at scale, while manufacturing sites for other candidates are in the process of being refurbished and will soon begin manufacturing.
Results from all these efforts are promising: Three OWS-supported candidates are in Phase 3 trials in the United States, and more are expected to enter U.S. Phase 3 trials by the end of this month.
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While there are no guarantees in science, we can assure Americans that OWS is structured, resourced and led to maximize the probability of success.
Thanks to OWS, the entire process for delivering a safe and effective vaccine — to be assessed by FDA’s apolitical scientific experts just as any other vaccine would be — is underway and on track. We are immensely encouraged by the progress so far, and hope to celebrate the successful delivery of a safe and effective vaccine in large quantities in the months to come.
Alex M. Azar II (@SecAzar) is U.S. secretary of Health and Human Services. Moncef Slaoui is chief scientific adviser to Operation Warp Speed.
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This article originally appeared on USA TODAY: COVID-19: developing a vaccine with Operation Warp Speed