Political zealotry aside, it’s hard to deny that Operation Warp Speed—the Trump administration project to develop and deliver vaccines to Americans to counter COVID-19—was anything less than a success.
But if there’s one aspect of Warp Speed that came up short, it was in the initial production of vaccines. After setting a highly ambitious goal of producing 300 million doses in 2020, the effort produced barely 100 million.
In his upcoming book, Warp Speed: Inside the Operation that Beat COVID, the Critics, and the Odds, Paul Mango discusses—with some interesting revelations—the manufacturing constraints that the operation faced and why the pledge proved unrealistic. Mango, the former deputy chief of staff at HHS, followed the agency’s chief Alex Azar when he took a major role with Warp Speed.
In the summer of 2020, when Warp Speed identified six vaccine candidates to pursue, the team kicked off a massive manufacturing scale-up from 27 facilities that either were starting from scratch or had to be expanded for vaccine production.
No expense was spared. For example, when 2,000-liter vats—used in the manufacture of bulk substance for vaccines—were needed in the U.S., a producer in Switzerland said it had extras on hand and could deliver them by ship in six weeks. But General Gus Perna of Warp Speed—by way of the Army Materiel Command—had an alternate solution.
“I’ll have military aircraft there tomorrow, so get ready to load,” Perna said, as Mango recalled in a recent interview with Fierce Pharma.
The immediate lack of equipment and raw materials needed to produce the vaccines early in the pandemic has been well documented. But according to Mango, the biggest impediment to a quick scale-up was the lack of trained labor.
Warp Speed’s manufacturing guru Carlo de Notaristefani, formerly the CEO at Teva, was fully aware of the potential problems posed by the human element in a quick scale up and warned of it.
“In pharmaceutical manufacturing, the typical approach is to perfect each step in the process and then pull it all together and when you do that, it never works like it’s designed to,” Mango said. “Carlo said, ‘99% of the time, it’s some worker, some trained technician who doesn’t follow procedure. That’s why we get ourselves in trouble with contamination.’ And by the way, that happened along the way.”
Mango’s reference, of course, was to the high-profile errors made at Emergent’s Baltimore plant, where millions of doses Johnson & Johnson vaccines had to be discarded because of cross contamination. Officials warned Emergent—which was producing both the J&J and AstraZeneca vaccines—of the potential for mistakes, Mango said.
For its part, Emergent maintains that Operation Warp Speed, FDA and other government officials were onsite on multiple occasions and were engaged in production decisions.
"Despite the risks that were discussed and well-known by all parties, including the federal government, OWS officials directed Emergent to move forward with tech-transferring and scaling up commercial production of two novel coronavirus vaccine candidates in the facility, due to the pressing needs of the pandemic," an Emergent spokesman said.
In addition, Warp Speed officials concluded that the concept of holding a facility in reserve—as the United States had done for a decade with Emergent—was flawed, Mango said. Their advice for the future was to have an active vaccine plant with excess capacity up and running with a trained workforce that can be flexed to add capacity. The site could be audited, tested and trained annually to ensure its readiness.
“It’s too expensive to just have an idle plant,” Mango said.
Emergent agrees that the program was not executed as it was designed.
"The initial plan for the [Center for Innovation in Advanced Development and Manufacturing] was for readiness for the production of only 50 million doses of flu vaccine over a four-month period, nowhere near the hundreds of millions of vaccine doses required by the pandemic," Emergent's spokesman said. "But even under the original concept, the government never delivered the drug development work necessary to build capacity, develop a skilled workforce, and maintain an adequate state of readiness at any of the CIADM facilities."
Another company that didn’t deliver, Mango said, was Pfizer. The company came up short on its pledge to supply the U.S. with 40 million doses, blaming manufacturing delays which Warp Speed said it wasn’t apprised of.
Pfizer did not respond to a request for comment. The company has said, while admitting that it didn't meet the pledge, that the promises were more flexible than portrayed by Mango.
Along with its vaccine partner BioNTech, Pfizer quickly overcame its early manufacturing delays to become the world's most prolific supplier of COVID-19 vaccines. In 2021, the company exceded its goal of producing 3 billion doses of the shot. Pfizer reported that its 2021 worldwide sales of Comirnaty totaled $36.8 billion and it expects to reach $32 billion in sales from the shot this year.
After an unsuccessful run as a Republican candidate for governor of Pennsylvania, Mango joined the administration in 2018 with his appointment to HHS.