The Morning Dispatch: Much Ado About Monoclonal Antibodies

Happy Wednesday! Some much-needed good news on this dreary winter day: MLB players and owners appear to be inching  closer to an agreement on a new labor agreement that would end the lockout.

If all goes well, pitchers and catchers could report to spring training in less than three weeks.

Quick Hits: Today’s Top Stories

• One day after Defense Department officials said they had placed about 8,500 U.S. military personnel on “a heightened preparedness to deploy” to Eastern Europe, President Joe Biden told reporters there will not be “any American forces moving into Ukraine.” Biden added that the United States could personally sanction Russian President Vladimir Putin if he follows through with an invasion of Ukraine.

• A senior Biden administration official—briefing reporters on the condition of anonymity yesterday—said the White House has been working with global oil and gas suppliers to boost production in case Russia decides to further limit, or halt, natural gas shipments to Europe over Ukraine tensions. “To ensure Europe is able to make it through the winter and spring, we expect to be prepared to ensure alternative supplies covering a significant majority of the potential shortfall,” the official said.

• A Centers for Disease Control study released Tuesday found that, although the Omicron variant is resulting in significantly more COVID-19 infections than previous strains of the virus, it tends to cause milder disease. In the study, those hospitalized with the Omicron variant—compared to the Delta or original strain—had shorter stays and were less likely to end up in the ICU.

• The Food and Drug Administration announced Monday it had withdrawn its authorization of Regeneron and Eli Lilly’s COVID-19 monoclonal antibody treatments after a series of studies had shown them to be ineffective against the Omicron variant. “If [future] patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” the FDA said in a statement.

• South Korean military officials said North Korea launched two cruise missiles on Tuesday morning, a move that, if confirmed, would represent the regime’s fifth such test this month. 

• Accusing Tennessee’s General Assembly of “dismembering” his district in the redistricting process, 16-term Rep. Jim Cooper of Tennessee announced Tuesday he will not seek reelection in 2022, becoming the 29th House Democrat to do so this cycle.

FDA Revokes EUA for Monoclonal Antibodies

The Omicron COVID-19 variant may be milder than its predecessors, but the new strain is still wreaking havoc, in large part because it’s proven able to chip away at the effectiveness of several tools in our existing pandemic toolbox. The vaccines—particularly three doses of them—still do a strong job at keeping people alive and out of the hospital, but their ability to prevent infection and transmission entirely has taken a hit. Rapid antigen tests are still able to detect an Omicron infection, but less reliably than infection with previous variants.

Earlier this week, the Food and Drug Administration announced another casualty of the Omicron wave: Two monoclonal antibody treatments, manufactured by Regeneron and Eli Lilly. 

“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said on Monday. “In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”

Even with other COVID treatments coming down the pike, losing monoclonal antibodies (at least in the short term) is a blow. Tens of thousands of Americans are currently hospitalized with COVID-19, and—while Omicron does tend to send fewer people to the ICU—many current and future patients would have benefited from an effective version of the treatments. But you wouldn’t necessarily expect the move to be controversial—who wants to take an expensive drug that’s known not to work?

Nevertheless, many prominent Republicans and conservative entertainment figures furiously denounced the move. Gov. Ron DeSantis accused the Biden administration of revoking access to the treatments “without a shred of clinical data to support its decision,” attributing the change to “the whims of a floundering president.”

But DeSantis’ response was tame compared to that of his press secretary, Christina Pushaw, who retweeted this claim from conspiracy theorist Mike Cernovich: “The FDA is trying to make it so that people in Florida die of Covid. They’ll kill people to harm Republicans. Steel yourselves for the evil that is being unleashed.”

There have been plenty of partisan debates about various COVID-19 treatments the past two years—hydroxychloroquine, ivermectin, etc.—but there’s long been a consensus about the efficacy of monoclonal antibodies. For months, DeSantis—in an apparent attempt to position himself as serious about the pandemic without riling up his base’s anti-vaccine cohort—has been a major cheerleader for the therapy, holding press conferences from clinics where it was being offered and promoting it in his regular cable news appearances. Last September, he pushed back strongly against the Biden administration’s shift toward rationing the government’s weekly allotment of the treatments more equitably among the states—a move that reduced Florida’s supply while Delta was still raging. 

If there was always going to be a contingent of Floridians who insisted on going unvaxxed—and there would have been, no matter what DeSantis did—it made sense that the governor would spend his time and political capital pumping an effective treatment.

But Omicron, with its dozens of mutations, has changed the game. In study after study after study after study—dating back well over a month—researchers have lamented the variant’s ability to evade previous defenses. “A minor form of omicron is completely resistant to all antibodies in clinical use today,” one report from Columbia University and Hong Kong researchers found. “The authors note that omicron is now the most complete ‘escapee’ from neutralization that scientists have seen.” 

(The studies found one exception among drugs already authorized by the FDA: sotrovimab, an antibody treatment produced by GlaxoSmithKline, retained some effectiveness against Omicron. The FDA is keeping that in circulation, and at least one antibody infusion center in Florida has already switched from Regeneron’s drug to sotrovimab this week.)

Perhaps most surprised by DeSantis’ “without a shred of data” claim would be Regeneron and Eli Lilly themselves, as both drugmakers publicly backed the FDA’s decision and pledged to come back with updated treatments that work for newer variants.

“The original REGEN-COV antibody cocktail has been administered to millions of people globally and works well against Delta and other serious variants of concern,” a Regeneron spokesperson said in a statement. “However, it does not work against the Omicron variant in lab tests, which tells us that it is also not going to work in people who are infected with this variant. According to the CDC, over 99 percent of COVID cases in the U.S. are now caused by the Omicron variant, and thus the FDA’s decision to amend the Emergency Use Authorization was appropriate at this time.”

Why is it that monoclonal antibodies have become essentially useless against Omicron, when the COVID vaccines, although diminished in their effectiveness, continue to provide some protection? The likely cause is the difference in the sort of protection each therapy offers. The immune response triggered by a COVID vaccine does result in the production of antibodies that strongly resemble those acquired directly in Regeneron or Eli Lilly’s treatments. But a vaccine also triggers the body to produce more broad-spectrum defenders against infection known as T-cells. And T-cells are thought to be much better at retaining their efficacy against variant forms of viruses than are antibodies alone.

You like strained military metaphors? Think of a body at war with COVID, with an individual virus as an enemy fighter jet. If the defense knew of and could access an exploit in the plane’s computers’ programming, they might be able to bring it down with no fuss—that’s antibody protection. But that strategy could be defeated if the exploit was patched—that’s a new viral variant. Fortunately, patch or no patch, you can still shoot the plane out of the sky with a good old missile—that’s T-cell protection.

Of course, T-cell protection alone isn’t as good as a combination of T-cells and functional antibodies, which may explain why the vaccines too are flagging somewhat in the face of Omicron—particularly against infection. But the difference does illustrate why the current generation of monoclonal treatments seems to be dead in the water.

Civil War Escalates in Yemen

In a startling development of a seven-year conflict, Yemen’s Houthi rebels in recent days targeted the United Arab Emirates (UAE) with drones and missiles for the first time.

On January 17, drone and missile attacks targeting the UAE killed two Indian civilians and one Pakistani national at a construction site near Abu Dhabi International Airport and a fuel storage facility. On Monday, U.S. and Emirati forces intercepted two ballistic missiles near Al Dhafra Air Base, which currently houses 2,000 U.S. service members. Each was accompanied by attacks on Saudi Arabia, the more frequent target of the Houthis’ cross-border rocket fire. 

“U.S. forces at Al Dhafra Air Base, near Abu Dhabi in the United Arab Emirates (UAE), engaged two inbound missile threats with multiple Patriot interceptors coincident to efforts by the armed forces of the UAE in the early morning hours of Jan. 24, 2022,” U.S. Central Command said in a statement. “The combined efforts successfully prevented both missiles from impacting the base. There were no U.S. casualties.”

The UAE’s ambassador to the U.S., Yousef Al Otaiba, urged action to interrupt the flow of arms and cash to the Houthis on Monday, adding that the U.S. “should move now to put the Houthis back on the terrorist list.” The country’s defense ministry also posted footage of its retaliatory air strike by an F-16 targeting a missile launcher in Al Jawf, Yemen. 

The Saudi Arabia-led coalition also carried out strikes in Houthi-occupied areas following last week’s attacks, in one instance hitting a prison and killing more than 80. The coalition’s spokesman, Brigadier General Turki al-Malki, said afterward that the Houthis had failed to report the target as a civilian site either to the United Nations or the Red Cross. Another coalition strike in the city of Hodeidah reportedly killed six people, including three children. 

State Department spokesman Ned Price said Monday that the Houthis’ recent attacks and the coalition’s retaliation represented a “troubling escalation,” calling for a “diplomatic solution” to the ongoing conflict. 

A possible source of the resurgence in cross-border fighting is recent success by the Giants Brigade, an Emirati-backed militia fighting on behalf of the internationally recognized Yemeni government. Earlier this year, the group picked up territory in Shabwah province. Following the Houthi attack on the UAE Monday, the group successfully pushed into Harib. 

Houthi leadership said that it had been targeting Al Dhafra in its launch on Monday, claiming to have successfully hit the air base. “As long as the aggression against us continues, we will continue to respond, and this is a defensive and legitimate position,” Houthi negotiator Mohammed Abdulsalam said Tuesday, according to a Houthi news site. “If the UAE decides not to be targeted, it should not target others, and when the enemy stops attacking our country, only then do our retaliatory attacks stop.”

The same source reported that Abdulsalam had visited Iran’s capital city of Tehran on the day of the first attack on UAE, January 17, to meet with Islamic Republic President Ebrahim Raisi. Given Iranian financial and military support for the Houthis, it’s likely not a coincidence amid a diplomatic stalemate in indirect negotiations to revive the 2015 Iran Nuclear deal in Vienna.

“I don’t think that the Houthis would have undertaken these operations in the UAE without at least Iran’s advance knowledge of what is going on,” Jason Brodsky, policy director at United Against Nuclear Iran, told The Dispatch. “And I think it has the added benefit for the Iranians in demonstrating their own leverage in the region.”

On Monday, Price told reporters the administration is “taking a close look at the appropriate response” in response to a question about possible plans to re-list the Houthis as a terrorist organization. Biden lifted the designation shortly after taking office last year, which some experts believe to have emboldened the group’s leadership. 

Asked why the Houthis are taking escalatory steps now, Michael Rubin—a former Pentagon official and resident scholar at the American Enterprise Institute—said:  “Frankly, because they feel they can. Appeasement never works. From its start, the Biden team has sought to relieve pressure on both the Houthis and Iran. The result hasn’t been effective diplomacy, it has been an empowerment of terrorism.”

Similarly, Brodksy argued that keeping the designation lifted set a “troubling precedent.” 

“The Houthis are terrorists. There is no reason, there is no evidence, to suggest anything other than that conclusion. They’re aiming missiles and drones at civilian sites in the United Arab Emirates, they’re trying to interrupt maritime activities in the area, and they are trying to hold hostage the global economy,” he said. “We have Americans who are at risk in the Emirates, and also in Saudi Arabia. So I think this is a real challenge for the United States.”

Worth Your Time

• A year into Joe Biden’s presidency, Washington Post reporters Sean Sullivan and Tyler Pager spoke with more than 60 lawmakers and administration officials to gauge the performance of White House Chief of Staff Ron Klain. “Biden, with Klain’s help, secured a $1.9 trillion coronavirus relief bill and a landmark infrastructure package, which Klain’s supporters cite as evidence of his effectiveness,” they write. “But the president also has faced setbacks in taming the pandemic, failed to pass his marquee social spending and climate legislation, and spent much of the year enmeshed in messy congressional negotiations. Along the way, Klain has drawn criticism that he is overly concerned with elite opinion, as reflected in his active Twitter presence, and that he is aligned too closely with Democrats’ left wing. … Klain rejected the critique from some centrists that the White House agenda has been too ambitious, turning off swing voters. ‘I think the challenge here is not that we’ve tried to do too much—it’s that we still have work left to do,’ Klain said. Rep. Stephanie Murphy (D-Fla.), a centrist who is retiring from Congress, ridiculed that assertion, saying, ‘Has he read a poll lately?’ She added, ‘Hopefully we’re moving away from progressive aspirations and towards pragmatic results.’”

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Toeing the Company Line

• Yesterday’s Sweep touches on Alabama’s GOP Senate primary, Democratic calls to challenge Sen. Joe Manchin from the left, Biden’s approval among independents, and red states’ efforts to stand up police units dedicated to snuffing out election fraud. “If you’ve got extra police laying around, then the dramatic rise in violent crime in pretty much every major U.S. city (in Georgia, homicides jumped 55 percent last year) coupled with the low clearance rate is a more pressing problem for the vast majority of people,” Sarah writes.

• David’s latest French Press (🔒) looks at the Supreme Court’s decision to grant cert in two college admissions lawsuits. “In both cases the plaintiffs make a compelling case—that efforts to increase the diversity of the student body have resulted in sometimes-crass discrimination, mostly against Asian students,” he writes. “The Supreme Court has a golden opportunity to correct its mistakes and address discrimination in higher education.”

• Can Congress do anything to stave off a Russian invasion of Ukraine? In Tuesday’s Uphill, Haley and Harvest took a closer look at what a potential sanctions package could look like and gauge lawmakers’ temperature on the escalating crisis. “We should look for creative ways to arm our Ukrainian friends to the teeth and consider forward positioning NATO forces to deter Russia,” Sen. Roger Wicker of Mississippi* told them. “The world is watching this test of our resolve.”

• Leon Aron—director of Russian studies at the American Enterprise Institute—joined Jonah on today’s episode of The Remnant for a conversation about all things Russia and Ukraine. Would the Russian people support an invasion of Ukraine? How is Russia influencing European politics? And is there any chance of Russia becoming a quasi-democratic country in the near future?

Let Us Know

Do you think, given the data, that the Food and Drug Administration made the correct decision in revoking its authorization of monoclonal antibodies? Or should the agency allow Americans to pursue the treatment if they want, despite growing evidence of its ineffectiveness against Omicron?

Reporting by Declan Garvey (@declanpgarvey), Andrew Egger (@EggerDC), Charlotte Lawson (@lawsonreports), Audrey Fahlberg (@AudreyFahlberg), Ryan Brown (@RyanP_Brown), Harvest Prude (@HarvestPrude), and Steve Hayes (@stephenfhayes).

Correction, January 26, 2022: Sen. Roger Wicker is from Mississippi, not Missouri.