On April 27, 2020, in the throes of coronavirus-induced shutdowns across the globe, the Wall Street Journal ran a little-remarked piece titled “The Secret Group of Scientists and Billionaires Pushing a Manhattan Project for COVID-19: They are working to cull the world’s most promising research on the pandemic, passing on their findings to policy makers and the White House.”
The article went into detail on how a cadre of scientists and billionaire benefactors was working to pull together an otherwise disparate research race for coronavirus cures and vaccines, emphasizing the need for “a Manhattan Project-style” effort to combat the growing pandemic.
Two days later, Bloomberg News reported that the Trump administration was already working on making this project a reality, and on May 15, Operation Warp Speed was born.
Upon the announcement of its inception, the Trump administration aimed “to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.”
At the time of this writing, two vaccines have been authorized by the Food and Drug Administration for emergency use, 36 million doses have been distributed, and more than 16 million shots have already been administered in the weeks since the effort began.
In a coronavirus response that was otherwise halting and oftentimes lacking coordination, Operation Warp Speed, which the Biden administration announced it will retire and rename, was a rare bright spot, serving as a key receptacle for investment and coordination between the pharmaceutical companies racing to produce the vaccine and the federal government aiming to get jabs in the arm.
The discussion around what has gone wrong in the U.S. response to the pandemic has been well-worn, but what about what has gone right? Every positive development has come with a chorus of reflexive media skepticism. Prior to the release of high-efficacy results from the vaccines, National Geographic confidently declared that a coronavirus vaccine “could take way longer than a year”; the Atlantic provided readers with a “Vaccine Reality Check,” which explained that “a COVID-19 vaccine is unlikely to meet all of [the] high expectations” that had been set; and CNBC cautioned readers that “a coronavirus vaccine cannot be reasonably expected until the end of 2021” — this last sentiment according to a professor who is also the chairman of the World Health Organization’s Global Outbreak Alert and Response Network. Luckily for America and the rest of the world, these dire predictions were wrong.
Cutting red tape
Watching the execution of Operation Warp Speed sometimes felt akin to watching a newsreel from a distant world where government can act quickly and work efficiently. From inception to execution, the triumvirate of Dr. Moncef Slaoui (who resigned at the request of the Biden transition team), Gen. Gustave Perna, and former Health and Human Services Secretary Alex Azar put on a masterclass for an all-hands-on-deck approach to beating back the pandemic.
The operation could be broken down into three areas, each of which was essential to delivering on its goal: First, taxpayer investment in manufacturing and clinical trials. Second, choosing vaccine candidates that had the ability to deliver on efficacy results by the first half of 2021. And third, a military-grade logistics operation to distribute the vaccine.
Companies are naturally wary of making large investments in manufacturing a vaccine that has yet to be proven, let alone for a genre of virus that at that point had yet to draw a successful vaccine candidate.
Vaccines tend not to be the biggest moneymakers for most pharmaceutical companies compared to other treatments they can invest in, and vaccine research for similar coronavirus outbreaks, such as SARS in the early 2000s and MERS in 2012, was shelved after the outbreaks dissipated and funding resources dried up.
With the SARS-CoV-2 outbreak showing no signs of burning out on its own and hospitals quickly filling up with COVID-19 patients around the country, Operation Warp Speed stepped in to the tune of $12.4 billion to take the financial risk component off of pharmaceutical companies. It funded clinical trials, invested in a rapid manufacturing scale-up, and guaranteed a customer for the eventual product by purchasing doses contingent on a successful clinical trial outcome.
Four criteria for companies
However, this process was far from a free-for-all for any pharmaceutical company that wished to get a large cash infusion from the federal government. Operation Warp Speed demanded that companies meet an array of criteria to ensure the operation could live up to its name, and that only the most promising candidates were receiving investment.
These four criteria included robust preclinical trial data to show their candidates were promising, the ability to enter into final, large-scale phase 3 trials by late summer or early fall, a vaccine candidate based on a technology that could easily be scaled up for mass manufacturing, and, finally, a candidate based on one of four vaccine platforms.
With these criteria applied, a handful of companies received direct assistance from Operation Warp Speed: Moderna, AstraZeneca, Merck and IAVI, Sanofi and GlaxoSmithKline, and Johnson & Johnson. Pfizer did not receive direct assistance from Operation Warp Speed in the research and development of its vaccine candidate; however, Operation Warp Speed did buy 100 million doses and assisted with distribution.
Prioritizing quick-to-market vaccines was essential in the race against time to beat back the pandemic. The average vaccine takes about 10-15 years to develop, mostly due to red tape, relatively fewer funding resources, and lower disease transmission in the community, which can drag out the timeline to get efficacy results. Prior to the coronavirus vaccine effort, the fastest vaccine candidate to go from development and testing to deployment to the general public was the mumps vaccine, which was developed 50 years ago. Operation Warp Speed provided the resources and logistical support necessary to scale up to large-scale, 30,000-person trials in a matter of months.
The operation’s financial and logistical assistance not only gave pharmaceutical companies the financial certainty to pursue a vaccine, but this move also ensured there would be no lag time between approval and distribution. Early investment by Operation Warp Speed paid dividends upon approval of both the Pfizer and Moderna vaccines, when close to 40 million doses were already manufactured by the end of 2020 and deployment began days following authorization.
Logistical challenge in distribution, rollout
Early manufacturing would be all for naught if the vaccines could not be distributed due to the typical bureaucracy of the federal government and therefore required a logistics expert to lead the effort. The logistics behind manufacturing and delivering a vaccine to over 300 million people are overwhelming, especially trying to do so in the span of a few months. Confirmed on July 2, 2020, by the U.S. Senate to take on this logistical behemoth as chief operating officer, Perna led the effort to connect the dots between manufacturer and distribution sites.
The vaccine distribution effort can GPS track each individual box of vaccines to confirm each shipment arrives at its distribution center on time, in addition to having live temperature readings from each box to ensure the vaccines remain at their specified temperature. Recently, one box carrying a shipment of the Pfizer vaccine was flagged as having become too cold for the vaccine’s specified temperature, at which point, the box was halted midtransit and removed from the shipment, with a new batch sent to the distribution site within hours.
A similar intervention occurred during the manufacturing process. The New York Times described an incident in which Moderna had realized that a specialized pump needed to manufacture doses of its vaccine for clinical trials had been delayed en route to the manufacturing site. Lest the manufacturing process be delayed, Operation Warp Speed officials identified the train that was transporting the pump, searched its cargo, and flew the pump out to the manufacturing facility to prevent any delay in Moderna’s scale-up.
There was also more transparency. Holding press conferences twice a week, Perna, Slaoui and Azar avoided giving the routine D.C. press conferences that are full of dithering and dodges. Each would give a full update on actions taken by HHS in working with state and local health departments to ensure vaccines were going where needed, an update on clinical trials and approved vaccines, and an update on distribution and logistics. Perhaps most unique among its federal government peers, the question-and-answer portion of these press conferences would yield important information. When errors occurred, as one did several weeks ago involving a miscommunication between Operation Warp Speed and the states regarding doses that had been cleared by the FDA for distribution, Perna took full responsibility and worked to address the problem without delay.
Vaccines were administered to healthcare workers, and the vaccination of long-term care facilities began in earnest due to a partnership between Operation Warp Speed, CVS and Walgreens to administer doses to these facilities. Some states such as Florida started to administer the vaccine to members of the general public when extra doses became available.
Yet Operation Warp Speed came under fire for a seemingly slow rollout of the vaccine, as the number of doses administered lagged behind the supply distributed. While there was a bottleneck for giving shots, the distribution of the vaccine to states went comparatively smoothly. Operation Warp Speed was created to develop, manufacture, and distribute the doses, leaving it to state and local governments to coordinate the administration of the vaccine. Regardless of whether relying on state governments is a sound public policy decision, these are the guidelines Operation Warp Speed had to work under.
Discrepancies in vaccination administration efficiency have varied widely state to state as a result of the decentralized nature of this “last mile.” At the time of writing, according to a tracker set up by the New York Times, Washington, D.C., West Virginia, and North Dakota lead the way with vaccine utilization. All have administered 70% or more of the shots they have on hand. California, Virginia, and Alabama are bringing up the rear, with under 40% of shots given in relation to those available.
While there are myriad reasons for the discrepancies in rollout, putting the onus on already stretched state public health departments and overwhelmed hospitals sits high on the list. Hospitals already battling a COVID-19 surge have little time to take healthcare workers off the job for 30 minutes to get their vaccines and have been forced to stagger the administration of doses to prevent too much of the workforce from being out for a day with possible 12- to 24-hour flu-like side effects after the second dose.
In nursing homes, federal partnerships with Walgreens and CVS faced unique challenges to begin their vaccination campaigns quickly, as providers needed consent from the medical proxies of nursing home patients, health data for each patient, and staff levels to cover the tens of thousands of nursing homes in America sufficiently. States such as West Virginia and South Dakota were able to avoid this bottleneck by relying on a vast network of local, independent pharmacies that already had data for their patients and contact info for their medical proxies.
Similarly, state public health departments conducting mass testing and contact tracing have little resources to spare for setting up mass vaccination sites (state and local public health departments have informed governors' offices that they can either conduct mass testing or mass vaccination, but not both). All of these factors contributed to a bottleneck in which just 200,000 people were getting vaccinated each day in mid-December as supply continued to grow exponentially.
It is important to put in context America’s slow rollout, however. Israel and a handful of Gulf nations lead the world in vaccination rates, with nearly 30% of Israel’s population already receiving its first dose. But among Western nations, the U.S. is only slightly behind the United Kingdom, which began its rollout of the Pfizer vaccine the week before the U.S., and far ahead of Canada, which began vaccinations around the same time.
$8 million assist from relief bill
And the vaccine efforts are getting a boost. The recently signed relief bill provides more than $8 billion to states for vaccine distribution. This money can go toward opening mass vaccination sites, increased staffing (which would remove the need to have to choose between testing and vaccinations), and possible mobile vaccination units. In addition, the U.S. is currently awaiting Phase III trial data from Johnson & Johnson’s one-dose coronavirus vaccine. If the data is positive, the authorization for use of this vaccine will dramatically increase vaccination capacity, as the dose can be kept at normal refrigerated temperatures and does not require a booster dose. The Trump administration changed protocols to allow for the release of additional vaccine supply that had originally been held back for second doses. This action will go a long way in relieving some of the remaining bottlenecks as states begin to open up vaccinations to people 65 years and older.
It should also be noted that the vaccination rate continues to increase. During the week of Dec. 23 to Dec. 30, an additional 1,581,100 first doses were administered. From Dec. 30 to Jan. 6, 2,717,682 additional first doses were administered, a 72% increase.
The battle is far from over: A mutant strain of the virus discovered in the U.K. is causing cases and hospitalizations to spike, and another strain has grown in prevalence in South Africa. While the strains are not more severe than their predecessors, there is evidence that they are more transmissible and, as a result, could lead to a higher death toll. Luckily, currently authorized vaccines do seem to be effective against both the U.K. strain and the South Africa strain.
With two coronavirus vaccines now authorized by the FDA for emergency use, and a new administration in charge, vaccine distribution is entering a critical phase. States will continue to try to work around bottlenecks and expand availability in the months ahead, and distribution from the operation will continue to scale at a rapid pace, hopefully making the vaccine available to the general public by this summer. With mutant strains on the rise and two-dose vaccine-complicating coordination, communication between the federal government and state governments will be more essential than ever to ensure the public receives the second dose in time, all in an effort to reach herd immunity.
Alicia Smith is a public policy consultant based in Washington, D.C., with experience in both U.S. and European policy and political economy.