Operation Warp Speed Needed Again

Operation Warp Speed, under the Trump administration, produced three Covid-19 vaccines in record time. When President Trump promised effective vaccines to the new coronavirus in less than a year, liberals and the media mocked him. Yet he delivered. Now, the very same people are calling for another Operation Warp Speed to boost Covid therapies.

Dr. Ezekiel Emanuel, former Biden advisor and developer of ObamaCare, says it’s time to use the same methods to improve our therapeutic response to Covid. Operation Warp Speed also delivered the two monoclonal antibody treatments that were so effective with the Alpha and Delta variants, but less so with Omicron. These same critics of Trump are now criticizing Biden for failing to develop effective therapeutics this winter because they abandoned the program.

Allysia Finley, writing in The Wall Street Journal, says early in the pandemic, the government struggled to persuade drugmakers to invest in vaccines and therapies. Many companies lost money during previous public-health emergencies when treatments they developed turned out not to be needed. “I’m not like a drug company fan, but there’s no question that a lot of them lost a lot of money trying to produce an Ebola vaccine,” said Ron Klain, now White House chief of staff, in February 2020.

Operation Warp Speed shifted the financial risk to government by placing orders for vaccines and therapies before they were authorized by the Food and Drug Administration (FDA) or even shown to be effective. This encouraged pharmaceutical companies to expand manufacturing capacity so vaccines and therapies were ready to be distributed once they had the FDA’s green light.

Three Operation Warp Speed leaders explained the strategy in a September, 2020 commentary for the New England Journal of Medicine. “Predicting drug performance in a new disease is difficult,” Moncef Slaoui, Shannon E. Greene and Janet Woodcock wrote. “Many candidates may fail to demonstrate efficacy or have safety problems. It’s necessary, however, to take a financial risk early to scale up manufacturing in order to have drug supplies on hand if the results are positive. If we wait for clinical trial readouts before initiating large-scale manufacturing, developing an adequate supply could take months or years.”

In July 2020, Operation Warp Speed announced a $450 million manufacturing and supply agreement with Regeneron for up to 300,000 doses of its experimental monoclonal antibody. A few months later, it ordered 300,000 doses of Eli Lilly’s experimental antibody. The FDA granted Emergency Use Authorization (EUA) to both treatments in November, 2020. Supply of both monoclonals exceeded demand last winter because many people were unaware of the treatments. Still, during the final two months of the Trump presidency, Operation Warp Speed ordered another 1.25 million doses of Regeneron’s and 650,000 of Eli Lilly’s antibody treatments, leaving the Biden administration well supplied.

However, in an effort to dismiss “all things Trump”, the Biden team dismissed Mr. Slaoui, announced they were “phasing in a new structure,” and retired the Operation Warp Speed name. Cases and hospitalizations fell as vaccines rolled out. President Biden prematurely declared success last Fourth of July and failed to prepare for another wave by stockpiling treatments and investing in new ones.

When the Delta variant slammed the South in July, GOP governors promoted Regeneron and Eli Lilly monoclonal treatments. Supplies had to be rationed as demand surged. As the Delta wave crested in mid-September, the Pentagon and the Health and Human Services Department ordered 1.4 million more doses of Regeneron’s antibody and 388,000 doses of Eli Lilly’s. Florida Governor Ron DeSantis sought to circumvent the feds by ordering a monoclonal antibody treatment from GlaxoSmithKline and Vir. The antibody binds to a target on Covid-19 that is shared with the SARS virus, making it more difficult for variants to evade. It was authorized by the FDA in May, but the Biden administration then declined to add it to its meager treatment arsenal. Finley says this was a colossal mistake, since it was the only monoclonal treatment for infected patients that turned out to be effective against the Omicron variant. It is hard to escape the conclusion that political rivalry influenced this decision.

Why did the new administration abandon the successful Operation Warp Speed playbook? Ms. Finley says, “Most likely because progressives loathe pharmaceutical companies. Recall how congressional Democrats attacked Mr. Slaoui, a former GSK executive, without evidence, accusing him of profiting off his public service. Or maybe the Biden team believed their own cynical 2020 campaign line that Operation Warp Speed “lacks sound leadership, global vision, or a strategy.”

Asked by New York Times columnist Ezra Klein last week whether the government should adopt OWS’s strategy for other technologies, Mr. Klain replied: “I think we have to be careful about the level of government intervention in the economy and make sure that we’re not putting our judgment in the place of private-sector thoughts and consumer demand and whatnot. I think vaccines are a very, very special case, a public good we wanted everyone to get.”

Ms. Finley says, “He’s right, but life-saving Covid-19 therapies are also a special case. At the same time, the Biden administration wants to spend hundreds of billions of dollars intervening in the economy to support green energy technologies that consumers largely don’t want and are unlikely to do much public good.”

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