Labels Matter: Operation Warp Speed and Emergency Use Authorization

During the early stages of the COVID pandemic, both the CDC and FDA used certain words or phrases that inadvertently frightened or confused the American public.

On February 13, 2024, National Geographic Press will be publishing a book I wrote called, TELL ME WHEN IT’S OVER: AN INSIDER’S GUIDE TO DECIPHERING COVID MYTHS AND NAVIGATING A POST-PANDEMIC WORLD. Before publication, I will be writing about various issues discussed in that book.

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COVID vaccines were first available in December 2020. In retrospect, however, some of the phrases used to describe how these vaccines were made, tested, and approved were misleading.

May 2020

Operation Warp Speed

On May 15, 2020, President Donald Trump announced the creation of Operation Warp Speed. The federal government would provide $11 billion to pharmaceutical companies to speed up the development of a COVID vaccine. The term Warp Speed was inspired by the faster-than-light travel used in the popular television series Star Trek. The goal of the program was to produce and deliver hundreds of millions of doses of COVID vaccines by January 2021. Given that no vaccine against COVID had yet been created, much less tested, few thought this was possible.

Typically, vaccines take 15 to 20 years to create. Operation Warp Speed turned the timeline for vaccine development on its head. Proof-of-concept studies in mice and monkeys were done over a period of weeks, instead of years. Phase 1 and phase 2 studies to determine the right dose and the right number of doses were combined and involved as few as 20-50 participants—instead of the usual hundreds: again, taking months instead of years. Companies then went directly to placebo-controlled phase 3 trials involving tens of thousands of participants while at the same time mass producing the vaccine, assuming their studies would prove that the vaccines worked and were safe; and if not, millions of doses would be thrown away at no financial risk to the companies. In late 2020, when more than 3,000 Americans were dying from COVID every day, phase 3 studies were completed in three months instead of several years.

Operation Warp Speed was arguably one of the greatest medical and scientific achievements in the past 50 years. Unfortunately, the breakneck speed with which these vaccines were produced caused many Americans to worry that corners had been cut—or, worse, that safety guidelines had been ignored. The term “Warp Speed” did little to allay those fears. In retrospect, it might have been better to call the program by a different name, such as Operation Defeat COVID or Operation End the Pandemic or something less about speed and more about the battle ahead.

December 2020

Emergency Use Authorization

In December 2020, when Pfizer and Moderna’s vaccines were first made available to the American public, they weren’t licensed by the FDA. Rather, they were authorized by the FDA through a process called Emergency Use Authorization (EUA). Typically, the FDA licenses a vaccine only after reviewing detailed protocols for every step of the manufacturing process. In essence, the FDA licenses not only the vaccine, but the process by which the vaccine is made. The FDA also licenses the building in which the vaccine is produced. Once all the data from the phase 3 trials are collected and analyzed, the FDA licensing process typically takes about 10 months. For COVID vaccines, FDA oversight of the processes and building occurred during, not after, the final vaccine was made. The FDA was still subjecting these vaccines to the same three-step approval process. It was just quicker. As a result, approval through Emergency Use Authorization following completion of the phase 3 trials took about 2 weeks, not 10 months. In the end, however, there were no differences between licensed vaccines and those approved through Emergency Use Authorization. They were the exact same product. 

Robert F. Kennedy, Jr., Senator Ron Johnson (R, Wisconsin), and Fox News host Tucker Carlson argued that vaccines approved through Emergency Use Authorization weren’t the same as licensed vaccines. They urged the American public to wait for the real vaccines to be made and tested before taking this lesser product. In retrospect, the FDA could have done a better job of explaining how vaccines are regulated and tested to reassure the public about the final product. The term “Emergency Use Authorization” didn’t help. Perhaps “Authorization” alone would have sufficed. (I am a voting member on the FDA’s Vaccine Advisory Committee. In December 2020, when we were discussing authorization of Pfizer’s and Moderna’s mRNA vaccines, the issue of dropping the word “Emergency” was discussed.)

The phrasing used to describe COVID vaccines influenced uptake. As it turned out, words mattered.