Biosecurity

The Strategic National Stockpile failed during COVID and monkeypox. Will it come through next time?

By Matt Field, September 29, 2022

In 1997, the bestselling author of a nonfiction page-turner that included the tale of an Ebola outbreak at a Virginia research center, had a new book out. This time he’d written a novel—a story about a madman who engineers a virus called “brainpox” before unleashing it on New York City.

By some accounts, the author, Richard Preston, had awkwardly tacked a thriller onto a scaffold of “explanatory exposition” about bioweapons. His book even had a glossary. One reviewer said The Cobra Event was full of “molecule deep” characters. “Sermons,” The New York Times wrote, “are for Sundays.” For all the critical reception, however, at least one high-profile reader was a fan: Bill Clinton.

At a retreat in Hilton Head, South Carolina, where the then-president was gathering with other high-fliers to ring in 1998, Clinton asked the tech entrepreneur J. Craig Venter a question: Could a terrorists engineer a worse version of the smallpox virus? Yes, Venter said, according to Clinton’s memoir. The “flamboyant” businessman recommended Preston’s thriller to the president. Clinton was impressed. The “[a]cknowledgements included more than 100 scientists, military, and intelligence experts and officials in my own administration,” Clinton wrote in My Life. “I urged several cabinet members and [US House] Speaker Gingrich to read it.”

Clinton and his staff went on to hold a tabletop exercise involving a smallpox attack and to meet about the bioweapons threat. “Everything I heard confirmed that we were not prepared for bio-attacks,” Clinton wrote. He announced a revival of an idea that had long-since fallen out of favor in the US government: a civilian medical stockpile that would contain antidotes and vaccines that authorities could distribute after an attack with weapons of mass destruction. Congress set aside $51 million in 1998 to make such a stockpile happen. Preston’s book may have been fiction, but the events it helped set in motion were not.

More than two decades after Clinton created it, the threats the stockpile was originally designed to address haven’t really materialized. By 2020, there hadn’t been a fatal bioterrorist attack in the United States since a government scientist allegedly sent letters tainted with anthrax to political and media figures in 2001, according to a terrorism tracking database. What there have been plenty of are outbreaks and epidemics of emerging diseases, like SARS, the coronavirus outbreak that began in China in 2002. Despite this historical record, observers widely consider the stockpile to have failed in the first crucial months of the COVID pandemic. Health authorities couldn’t get what they needed from a resource loaded with anthrax and smallpox countermeasures but few N95 masks. Earlier this summer, as experts worried that monkeypox was gaining a toehold in the United States, the stockpile again had little to offer. Although it held doses of a vaccine that works safely against both smallpox and monkeypox, the government had far too little of it and instead maintained a glut of a more dangerous, older smallpox jab.

The stockpile has weathered its share of criticism in the past few years, and its managers pledge that it will change, but there are questions about whether the necessary supplies will really be available for the next pandemic.

“Empirically … most of what the stockpile managers have been spending their funds on is still a bioterrorist attack,” Andrew Lakoff, a professor at the University of Southern California who has written about the stockpile, said.

The Stepnogorsk biological weapons complex in Kazakhstan, which was once part of the Soviet Union. Credit: US Department of Defense.

Bioweapons fears. As the Cold War wound down with the dissolution of the Soviet Union, threats other than nuclear annihilation became more salient. In 1992, Boris Yeltsin, the first president of the Russian Federation, acknowledged that the former Soviet Union had maintained a massive germ warfare program. US officials began to fear that out-of-work “bioweaponeers” were at risk of selling their know-how to rogue states or groups. Adding to these fears in the 1990s were a series of shocking terrorist attacks on the World Trade Center, the Oklahoma City federal building, the Tokyo subway system, and US embassies in Africa.

In 1998, Clinton began to ramp-up of government efforts to confront weapons of mass destruction, in part by re-creating a medical stockpile, an idea the US government had previously employed to deal with the aftermath of a nuclear attack. The threat of bioweapons, he told an interviewer, kept him “awake at night,” and from its inception, the stockpile was geared toward addressing such an attack.

Following Clinton’s lead, George W. Bush accelerated spending on biodefense priorities. In 2001, letters tainted with anthrax spores were mailed to senators and media figures, a bioattack that killed five and sickened 17 others. The so-called “Amerithrax” attacks raised the level of official anxiety over bioterrorism, and in fiscal year 2005, the Bush administration requested $7.6 billion for civilian biodefense, 18 times more than was spent in 2001. 

Clinton once said he hoped that biological and chemical weapons would be “the dog that didn’t bark.” But preparation was necessary, he argued. In the decade-and-a-half after the anthrax letters, the public health threats that the country faced did not involve bioweapons, but natural disease outbreaks: SARS, highly pathogenic avian influenza in 2005, and swine flu in 2009, to name a few. Another dog, as it turned out, was barking, but the officials in charge of the stockpile never seemed to listen, at least for more than a moment.

An effort to align the country’s biodefense efforts to focus on natural threats as well as deliberate attacks never fully trickled down to the stockpile. Masks were put in after the avian flu scare in 2005, but the government distributed 85 million N95s during the H1N1 pandemic in 2009 and didn’t replenish them in time for COVID.

The stockpile benefited from the focus on bioterrorism, with the government funding it to the tune of about $500 million per year beginning in 2004, much of that dedicated to bioweapons countermeasures. Between 2010 and 2018, The New York Times found, 40 percent of the stockpile budget was spent on anthrax vaccine alone.

The government continued to splurge on these countermeasures even during the Obama administration, which watchers viewed as representing a “shift in thinking” toward the idea of “biosecurity,” a mindset that meant preparing for both naturally occurring disease outbreaks as well as deliberate attacks. Then, under the Trump administration, the tendency to emphasize bioterror over emerging diseases grew even stronger. The head of the stockpile, a bioweapons expert, had a reputation for being most concerned with the threat of deliberate attacks.

Robert Kadlec made buying bioweapons countermeasures a “priority over preparing for a natural pandemic,” according to a Washington Post investigation about his ties to biodefense contractors. In his role as assistant secretary of preparedness and response for Trump, Kadlec cut an Obama-era imitative to manufacture N95 masks, for instance, while instead agreeing to pay billions for smallpox vaccines, even though smallpox was declared eradicated as a naturally occurring disease in 1980.

“The bio preparedness world tended to be focused on bioterrorism,” Lakoff said. “Even though you can certainly make the case, and many public health people and scientists made the case, that a much more serious threat was coming from zoonotic disease emergence than from some possible terrorist group that had gotten hold of anthrax.”

COVID and monkeypox. When the COVID pandemic began, there were 35 million N95 masks in the stockpile—a seemingly large amount that was entirely insufficient in the face of a national public health emergency. Supply chains shut down, and states, local governments, and hospitals desperately tried—and in the pandemic’s early months, often failed—to source these goods on their own. The stockpile had been set up to provide what the market couldn’t—there aren’t many buyers, or for that matter, suppliers, of the bioweapons antidotes the stockpile specializes in—but during the early days of the pandemic, the private market ground to a halt, and the stockpile was of little help. Media reports and expert analyses about the shortcomings were abundant.

“We were always kind of talking about terrorism type events. And when you’re thinking about a terrorism type event, you’re probably not thinking a national event,” Dan Gerstein, a former official in the Department of Homeland Security and a disaster response scholar, said. “One of the things to happen is that, right away, your stockpile isn’t scaled to meet a national event; it’s scaled to meet maybe a series of localized events.”

When monkeypox began spreading rapidly in countries outside of Africa this spring, the stockpile did have something to offer. Although smallpox, a deadly cousin of monkeypox, had been eradicated by the time Clinton created the stockpile, officials still feared its potential as a bioweapon. The Soviet Union’s massive bioweapons program, after all, had included smallpox as a major component. The disease even gets specific mention in the legislation authorizing the stockpile. But a smallpox attack has yet to happen. “Seems unlikely,” at this point, Lakoff said. “Interestingly, and totally strangely, and contingently, we have all the smallpox vaccine, and it sort of works … for monkeypox. Eighty-five percent efficacy.”

Most of the government’s vaccine, however, is of an older variety. ACAM2000, which contains live replicating vaccina, a mild relative of the smallpox virus, isn’t suitable for people with HIV or other immune-system problems because it can cause infections, which can also spread to others. Since the September 11 attacks, the government has stockpiled more than 100 million doses of ACAM2000. To compensate for this, authorities also funneled hundreds of millions of dollars into a newer vaccine now called Jynneos.

At one point, the government had some 20 million doses of Jynneos, which doesn’t contain replicating virus, making it much safer for immunocompromised patients. But when the monkeypox outbreak began in the United States, the government had fewer than 3,000 Jynneos vaccine doses on hand, according to The New York Times. It had let millions of doses expire as officials waited for a new freeze-dried version of the product.

Few officials seemed to feel a sense of urgency as those Jynneos doses expired. Monkeypox, afterall, wasn’t a priority threat for the stockpile, smallpox was. “In fairness, I’m not sure anybody in their right mind would have thought we needed more smallpox vaccine,” Nicole Lurie, who directed the stockpile under former President Barack Obama, told the newspaper.

The government has since acquired more Jynneos vaccine, but shortfalls continued throughout the summer. Many experts began to fear the country had lost its chance to contain monkeypox and were allowing it to become yet another endemic virus that sickens large numbers of people and strains the health care system.

Can the stockpile change? Officials say the future medical stockpile will be much more suited to dealing with a pandemic than the one on hand in early 2020. A Biden administration vision statement on the public health supply chain calls for a “larger, broader, and smarter Strategic National Stockpile … so that the US is prepared for intentional, natural, and emerging pandemic threats.” Historically, the document says, the stockpile, geared toward weapons threats, has been “underfunded for pandemic response and needs clear, long-term, stockpiling goals for pandemic preparedness aligned with annual appropriations to successfully prepare for the next pandemic.”

Whether the stockpile will be prepared for another pandemic like COVID, or monkeypox, remains to be seen. The government is still on the hook for big orders of bioterror antidotes going forward. In 2019, Emergent Biosolutions, a contractor with ties to Kadlec, the Trump-era stockpile chief, won a $2 billion contract for 10 years to supply its old smallpox vaccine, the kind likely too risky for use against monkeypox. Two years later, under the Biden administration, the company won a $400 million contract modification to supply anthrax vaccine until 2023.

Similarly, there are signs that the country is losing some of the gains it made in bolstering domestic manufacturing of pandemic supplies, supplies which could feed the stockpile. US mask makers, propped up when foreign supplies dwindled, have, once again, been shutting down their operations. “Health care providers have gone right back to the Chinese masks, because there’s so much less expensive than the American-produced domestic masks,” Rob Handfield, a supply chain expert at North Carolina State University, said, “We didn’t learn anything from that situation.”

After World War II, the government began storing penicillin doses, blood transfusion kits, and radiation monitors, mainly in the event of a nuclear war. But as the Cold War dragged on, and its weapons became ever more powerful, the prospect of surviving a thermonuclear exchange began to seem unlikely. After letting supplies decay for years, the government shuttered the stockpile in 1974.  After all, what would be the point, Americans figured, of a stockpile in a city hit by a “Tsar Bomba”—the Soviet weapon more than 3,000 times as powerful as the bomb dropped on Hiroshima?

The federal government’s task today is to make sure that when another pandemic crops up, when transit and trade are shut down and the whole world is scrambling for medical supplies, that the stockpile has what people will likely need. Officials have talked and written about doing better, in congressional hearings, strategy papers, and even obscure intra-governmental budget communiques. A document meant for congressional funders refers to the “challenges at the beginning of the COVID-19 response,” and  “modernization efforts” that will “ensure the [stockpile has the] breadth and depth to meet any future pandemic or public health emergency.” Another pandemic may put these pledges to the test in the coming years. We may soon find out whether officials have turned lessons learned into action—whether their pledges reflect genuine change, or whether, in fact, they’re just pleasant stories.

As the coronavirus crisis shows, we need science now more than ever.

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