Source: USA Today

By Alex M. Azar II and Moncef Slaoui; Opinion contributors

We are encouraged by the progress so far, and hope to celebrate the successful delivery of a safe and effective vaccine soon.

President Trump launched Operation Warp Speed (OWS) 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 2021 — 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 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 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 FDA’s assessment meets the same standards as those applied for any other vaccine, without undue pressure or influence.

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 the summer or fall of 2020. 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.

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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.

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