Getting the facts right on Operation Warp Speed

Former President Donald Trump formally announced Operation Warp Speed (OWS) on May 15, 2020. OWS was constituted as a projected $18 billion business-government-military partnership, charged to “produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” No date was set for fulfilling the 300 million doses target, other than the understanding that it would be “accelerated” relative to conventional standards.

The most innovative feature of OWS was government purchases of large quantities of vaccine types undergoing clinical trials, irrespective of the outcome (such as $2 billion and $483 million in early purchases from Pfizer and Moderna, respectively).

OWS called for clinical trials, manufacturing, and logistics to be conducted on a parallel rather than a sequential basis. The pursuit of multiple vaccine types built redundancy into the program to insure as many approved vaccine types as possible. (Currently, 251 vaccines are in the process of development).

Some ten months later, the results of OWS are as follows:

On Dec. 11, 2020, the Food and Drug Administration (FDA) approved for emergency use authorization (EUA) a vaccine produced by Pfizer for “the prevention of coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older.” Approval of Moderna’s vaccine followed seven days later. The first Americans were vaccinated on Dec. 15, 2020, only four days after FDA approval of the Pfizer vaccine.

Consistent with OWS’s stated goal, some 50 million initial doses of approved COVID-19 vaccine were available on Jan. 31, 2021. Of these, nearly 30 million had already been administered. On a peak day, 1 million vaccinations were being administered, and hundreds of millions of doses had already been ordered by the Trump administration.

As to the OWS goal of 300 million doses, delivery data shows that 80 percent of the target will have been met by the end of this month. Moreover, the Government Accountability Office (GAO) reports that the Trump administration had already ordered some 800 million doses for delivery by July 31, 2022. Pfizer alone is planning to deliver 200 million doses to the United States by May 2021 and claims it can deliver 2 billion doses worldwide by the end of 2021.

The data therefore suggest that the OWS goal of 300 million doses is being met much sooner than would have been conceived as the program was launched.

It was OWS’s buying of vaccines prior to regulatory approval that shortened the time between approval and scaling-up of manufacturing. Remarkably, the Pfizer vaccine was administered five days after FDA approval. A $483 million grant facilitated Moderna’s partnering with a major U.S.–Swiss pharma manufacturing company back in July 2020. Other contenders for FDA approval, such as Pfizer and Johnson & Johnson, entered early on into similar manufacturing arrangements.

In sum, judged by its own benchmarks — regulatory approval and vaccinations by the end of 2020 and the accelerated delivery of 300 million doses — OWS is a rare private-public partnership that has met its performance benchmarks.

The heavy lifting of ushering vaccines through clinical-trials, scaling-up mass production, and initiating the complicated process of distribution to the states were well on their way as the Biden administration took office.

It should be emphasized that OWS was launched to almost universal skepticism and even scorn. At the time of OWS’s launch in Spring 2020, a strong consensus prevailed among media, public-health experts, consultants, and betting markets that regulatory approval by the end of 2020 and the accelerated delivery of 300 million doses were unrealistic goals. Consider some typical examples:

The June 6, 2020 issue of  the medical journal Lancet opined that “on average, it takes 10 years to develop a vaccine. With the COVID-19 crisis looming, everyone is hoping that this time will be different. Although many infectious disease experts argue … even 18 months for a first vaccine is an incredibly aggressive schedule.”

The federal government’s top COVID advisor, Dr. Anthony Fauci, joined the skeptics: In February 2020 and again in April 2020 he predicted that a year to a year and a half would be required for vaccine approval — versus the half year that was actually required.

The media echoed general skepticism about OWS in the Spring of 2020. Vanity Fair in its May 28, 2020 edition characterized OWS “as dangerous and likely to fail.” CNN complained that OWS neglected “tried and true” procedures for vaccine development in favor of new and untested methods. A New York Times article dated April 30, 2020 somberly states: “Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.”

Similar skepticism was expressed by McKinsey Consulting. In its June 1, 2020 COVID report, McKinsey warned that only one vaccine had started phase 2 clinical trials and that 21 months has been the shortest time between phase 2 and 3.

Prediction and betting markets were also wagering as late as July 15, 2020 against timely approval. One of the largest public prediction markets put the odds of approval by January 2021 at less than one in three and that the best chance was after the first quarter of 2021. Another major online prediction market put the chances of a vaccine being mass-produced before January 2021 at one in five.

OWS’s critics did more than cast doubt on the FDA approval date. They also cast doubt on the ability of OWS to scale up production: Dr. Fauci cautioned that an additional year could be required to scale up production “to get enough doses to be meaningful to anyone.” In its June 1, 2020 COVID report, McKinsey warned that it usually takes five years to build a production facility for an entirely new virus vaccine.

Thus, the actual history of OWS diverges dramatically from that anticipated by its skeptics at the time it was launched. Based on their knowledge as of Spring 2020, experts, media, public health officials, and betting markets predicted FDA approval, at best, near spring or summer of 2021 (versus the actual approval in December 2020). They warned of the possibility of at least another year to scale up to large orders. In other words, our “specialists” grossly underestimated the power of OWS to accelerate vaccine approval, manufacturing, and distribution.

The New York Times recently fact-checked President Biden’s characterization of the Trump OWS program as too little, too late. Biden was particularly critical of the vaccine roll-out, not noting that the states and communities were responsible. Ignoring the speedy FDA approval and guaranteed orders to scale-up production, Biden promised a “new and improved” COVID-vaccination program that seems to me to be identical to Trump’s OWS. Notable is the nuanced fact-checker language: “… contrary to Mr. Biden’s suggestions, both administrations deserve credit for the current state of the vaccine supply.”

Indeed, if both Trump and Biden deserve credit (rather than blame), The Times is begrudgingly admitting that Trump did a good job.

The increasingly obvious success of OWS has silenced the more outrageous claims, such as that Trump and Republicans are responsible for 500,000 COVID deaths. Instead, OWS critics reluctantly admit that “in many ways, it was successful, living up to the highest expectations of its architects.” But despite its manifold successes, OWS “appears to be limping to the finish” because of flawed distribution, they say. The critics fail to note that the actual vaccination plans are the responsibility of the states.

Paul Roderick Gregory is a professor emeritus of economics at the University of Houston, a research fellow at the Hoover Institution at Stanford University and a research fellow at the German Institute for Economic Research. Follow him on Twitter @PaulR_Gregory.

Tags Anthony Fauci Clinical trials coronavirus pandemic COVID-19 vaccines Donald Trump Joe Biden johnson & johnson Moderna operation warp speed Pfizer Presidency of Donald Trump public-private partnership vaccine rollout

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