HHS Secretary Azar: How Operation Warp Speed delivered a COVID vaccine in record time

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As we enter this winter, we face alarming trends in the spread of COVID-19 around the country, but even in this challenging time, we have so much reason for hope.

On Friday, the Food and Drug Administration authorized the first COVID-19 vaccine in the United States, and Operation Warp Speed (OWS) and its private sector partners immediately began shipping vaccines to sites designated by states and other public health jurisdictions.

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With about 3 million doses on the way, this means that health care workers and residents of long-term care facilities across America will begin receiving vaccines in the coming days.

Americans who may fall into these categories—the exact allocations are done by states and public health jurisdictions—can find out more about where they will receive a vaccine from their state or local governments, such as through the state’s COVID-19 webpage.

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This spring, experts predicted that a vaccine was at least a year or year and a half away. Yet, within a year, we have one vaccine authorized, millions of doses being shipped, and another vaccine under review by the FDA.

We’ll easily beat the experts’ expectations not by luck, but because of deliberate planning by President Trump’s administration through Operation Warp Speed (OWS).

American researchers and partners around the world began research and development on COVID-19 vaccines back in January.

Work on the Moderna vaccine began the morning after the viral sequence was shared by Chinese researchers. While this work progressed, the Trump administration identified the potential challenges that could slow access to vaccines.

First, vaccines are complex and scaling up manufacturing takes time.

Second, rapidly distributing and administering vaccines to every American is an unprecedented logistical project.

Back in April, with the president’s support, I started working with the Department of Health and Human Services’ scientific leaders and our colleagues across the administration to tackle these problems, recruiting world-class leaders to execute on OWS’s bold goals.

First, beginning production as soon as possible would accelerate the process without compromising safety or efficacy. Vaccines are one of the most complex products made by modern industry, some are grown in chicken eggs or with other specialized living media. Drug makers almost never invest in large-scale manufacturing upfront, lest the investment go to waste if a drug isn’t approved.

To solve these challenges, we enlisted Moncef Slaoui, a scientist who has led the development of numerous major vaccines.

Together, we built a portfolio of promising candidates, investing more than $10 billion to give companies confidence, and worked closely with them to ensure they had what they needed to begin manufacturing.

HHS has deep experience working with researchers and innovators, but supporting a manufacturing endeavor of this scale required enlisting expert drug makers and another government partner: the Department of Defense.

Every day, the Pentagon ensures that manufacturing supplies go where they need to go, including between private-sector companies, so that the guns, bullets, food and everything else the military needs are produced and shipped where they need to go.

DOD uniformed and civilian experts have now done the same thing for vaccine manufacturing, through the Defense Production Act and other informal actions to prioritize supplies. When one manufacturer needed particular parts to bring a new bioreactor online, for instance, OWS staff ensured that the parts maker prioritized the order.

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Second, safe and effective vaccines are only as good as the plan we have for distributing and administering them. Coordinating with public health authorities and private sector partners would require the finest logistics experts in the world.

When I met with the Secretary of Defense and the Chairman of the Joint Chiefs back in April, they immediately had a name for just such an expert: Gen. Gustave Perna, who runs the U.S. Army’s logistics command.

Working with the private sector, on the same evening of the authorization, we began shipping vaccines to administration sites in all 50 states and other public-health jurisdictions. Through a military-style battle rhythm, OWS has been working to mitigate potential problems and setbacks, planning with a precision that marks the U.S. military.

Americans can have confidence that these vaccines are safe and effective because they’ve gone through an incredibly rigorous process.

OWS vaccines are proceeding through the typical three phases of clinical trials. Then, trial data is reviewed by an independent data safety and monitoring board, which makes its own statistical assessments, and then by the drug maker.

The data is then submitted to the FDA, which publicly consults with its outside panel of vaccine experts. Then, FDA’s career scientists review the data and the experts’ recommendations, and make a final decision—as they now have with Pfizer’s vaccine. It’s the same process Americans know and trust for any other drug authorized or approved by FDA.

We all owe a debt of gratitude to the public servants who have made this progress possible, and to every American who’s sacrificed to get us to this point.

Soon enough, it will be time for each of us to do our part and encourage our family and friends to go out and get a safe and effective vaccine—as I plan to do the first day I can.

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Operation Warp Speed will go down as one of the great scientific achievements in our country’s history, and it offers all the more encouragement to double down on the sacrifices we’re making now to slow the spread of the virus. As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing, and wearing face masks to protect ourselves, our loved ones, and our communities.

Hope is here and the end of this pandemic is in sight.