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.”

Omicron Variant 2.0

By now you may have heard there’s a newer version of the Omicron variant of Covid-19 that is making its presence felt. The original Omicron variant is known as BA.1 and the new version is called BA.2. Just when you thought we were nearly past the Omicron wave, now comes this new version of itself.

The BA.2 variant of Omicron is under observation by Denmark, India, and the U.K., reports Renee Onque and Denise Roland in The Wall Street Journal. This second variant arose around the same time as the first and comes from the same ancestor strain. According to Theodora Hatziioannou, associate professor of virology at Rockefeller University, the differences between this variant and the BA.1 can be seen in the spike protein of the virus.

This is the first time that two competing variants have emerged in parallel like this, according to Mark Zeller, a genomic epidemiologist at the Scripps Research Institute in San Diego, California. He expected this second variant will drive a rise in cases, but not as much as the original because people who were infected with the original likely have some immunity to BA.2.

The BA.2 variant has been detected in the U.S., according to the CDC. The CDC estimates show that Omicron was likely responsible for 99.9% of Covid-19 infections in the week ending January 22nd. The prevalence of other variants including BA.2 was included in that study. No further data is available yet.

The BA.2 variant has been detected in at least 40 countries including the U.K., Denmark, India, Sweden, Singapore and the Philippines. BA.2 appears to be displacing the BA.1 variant in Denmark. As yet, the World Health Organization has not designated the BA.2 as a “variant of concern.” It isn’t clear yet whether the BA.2 variant behaves any differently than the original Omicron strain. One study at the Serum Institute of Denmark suggested BA.2 may well be over one and a half times more contagious than BA.1. The CDC disputes this conclusion saying, “Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage.”

Those monoclonal antibody treatments originally developed by Regeneron for the Alpha and Delta variants have been less effective with Omicron. However, the monoclonal antibody treatment known as sotrovimab, made by GlaxoSmithKline PLC and Vir Biotechnology, has shown effectiveness against the BA.1 variant and likely will also be effective against BA.2. “We are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of Covid-19,” said George Scangos, chief executive of Vir.

Pfizer and Merck and its partner Ridgeback Biotherapeutics developed antiviral pills for Covid-19 that continue to work against the original Omicron variant and may have similar effects against BA.2. Vaccines are also expected to be just as effective against BA.2 as they are against BA.1.

“I can be pretty confident in saying that vaccines will continue to work really well at keeping people away from the hospital if they are boosted,” said Peter Chin-Hong, infectious disease specialist at the University of California, San Francisco. “When fully vaccinated and boosted, your cells adopt memory and are able to detect similar variants, preventing you from getting extremely sick if infected,” said Dr. Chin-Hong.

Lockdown Catastrophe

 

I’ve written about lockdowns before. In Lockdowns Historically Failed, we discussed the historical record of lockdowns going back to 1918 and the Spanish flu pandemic. In reviewing that history, the World Health Organization (WHO) issued a report in 2006 which concluded “forced isolation and quarantine are ineffective and impractical.” In 2009, a statement was written in a report by medical historian John Barry, that said, “Historical data clearly demonstrate that quarantine does not work unless it is absolutely rigid and complete” – a standard that not even the U.S. military was able to achieve.

More recently, in The Economics of Lockdowns, I reported on the economic analysis from the University of Chicago. Economists Tomas J. Philipson and Casey B. Mulligan said, “Reducing the incidence of disease isn’t necessarily desirable if excessive prevention, in the form of lockdowns or school closures, is more costly to society than the damage done by an illness.”

The rationale for all these lockdowns has always been to contain the spread of the virus and to “save lives.” We have tolerated this new world of lost freedom mostly in the hope that we were indeed saving lives. Indeed, that has been the mantra of our politicians and public-health officials. But what if they were actually wrong? What if all those lockdowns didn’t really save lives?

Now we know the answer to those questions. James Freeman, writing in The Wall Street Journal tells us of a new report from Johns Hopkins economist Steve Hanke, and from other researchers in Denmark and Sweden. They employed a systematic search and screening procedure in which 18,590 studies are identified that could potentially address the belief posed. After three levels of screening, 34 studies ultimately qualified for final analysis. Of these, 24 qualified for inclusion in their meta-analysis.

The study authors said, “This systemic review and meta-analysis are designed to determine whether there is empirical evidence to support the belief that “lockdowns” reduce COVID-19 mortality. Lockdowns are defined as the imposition of at least one compulsory, non-pharmaceutical intervention (NPI).”

The 24 studies were separated into three groups: lockdown stringency index studies, shelter-in place order (SIPO) studies, and specific NPI studies. They report, “An analysis of each of these three groups support the conclusion that lockdowns have had little to no effect on COVID-19 mortality. More specifically, stringency index studies find that lockdowns in Europe and the United States only reduced COVID-19 mortality by 0.2% on average. SIPOs were also ineffective, only reducing COVID-19 mortality by 2.9% on average. Specific NPI studies also find no broad-based evidence of noticeable effects on COVID-19 mortality.

There you have the answer – lockdowns reduced COVID-19 mortality by 0.2% – 2.9% or not at all. Sure, the lives saved in that 0.2% – 2.9% are important, but at what cost? We don’t know the answer in terms of increased deaths due to suicides from mental illness, increased deaths from drug abuse overdoses, increased deaths due to undiagnosed, treatable cancers because people didn’t go for regular screening exams, increased deaths due to uncontrolled diabetes, heart disease and other illnesses. Those are all very real costs of lockdowns.

But we do have some information on the economic costs. A report from WSJ says, “The U.S. national debt exceeded $30 trillion for the first time, reflecting increased federal borrowing during the coronavirus pandemic. Total public debt outstanding was $30.01 trillion as of January 31, according to Treasury Department data released Tuesday. That was a nearly $7 trillion increase from late January 2020, just before the pandemic hit the U.S. economy.”

This should be the last word on the issue of lockdowns. Any politician or public-health official calling for lockdowns in the future must be held accountable. In my business, they would call it malpractice.