The Vaccine Issue

LISTEN: Covid Vaccine: Nationalism Will Only Make the Coronavirus Pandemic Much Worse



Trump, Putin, Merkel, Conte, Johnson, Xi
▲ Trump, Putin, Merkel, Conte, Johnson, and Xi.
Photo Illustration by 731; Water: Getty Images. Trump: Bloomberg; Putin: Kremlin; Merkel, Conte, Johnson, Xi: AP Photos (4)

Vaccine Nationalism Makes a Deadly Disease Even Worse

The world’s governments have opted to lock themselves in a lethal version of the prisoner’s dilemma.

In a valley south of Rome where tourists rarely tread, the scene playing out on a recent morning was reminiscent of the climax of Star Wars, with the rebel pilots preparing for battle. Just past the vineyards, inside a sprawling modern pharmaceutical complex, clutches of young women and men marched down corridors in steel-toed boots, mint-green jumpsuits, and surgical masks. One group of cadets watched a training video. Another took turns assembling and disassembling equipment. Behind glass walls, droidlike robots rolled around performing automated tasks.

This Italian version of a rebel base is an outpost of an American company, Catalent Inc. The Death Star is Covid-19, which devastated this country in early spring. Catalent has a contract to fill tiny glass vials with as many as 450 million doses of the Oxford University-AstraZeneca Plc vaccine, which in late May became the first coronavirus candidate to enter large-scale human trials. The stakes, perils, and opportunities could hardly be higher for Italy: going from the West’s first victim to, potentially, having within its borders almost a quarter of Earth’s supply of a vaccine.

Bloomberg Businessweek cover image for issue dated Aug. 17, 2020.
▲ Featured in Bloomberg Businessweek, Aug. 17, 2020. Subscribe now.
Photo Illustration by 731; Getty Images (9); Alamy (4)

If the mission succeeds, the precious hoard will start piling up next month in a refrigerated warehouse at the Catalent plant. By early November, Italian regulators should be in a position to release the first doses to the international market, according to Mario Gargiulo, global head of biologics operations for Catalent, which is based in Somerset, N.J.

“The nation that was hardest hit—to be part of the solution—is a great story,” Gargiulo says as he shows off the plant, located in the ancient town of Anagni. “The people here feel a strong responsibility. It will be the first, or one of the first, on the market. This is a race.”

The competition has spurred a phenomenon known as vaccine nationalism—the jockeying of governments to secure doses of promising candidates for their citizens. The means of doing that are numerous, and the field of combat is vast: There are more than 160 efforts under way, with 26 in clinical evaluation as of July 31, according to the World Health Organization. Front-runners in final, Phase III trials include the Oxford vaccine; another from Moderna Inc., based in Cambridge, Mass.; and a third from Germany’s BioNTech SE, which has partnered with Pfizer Inc. All of these have investments from or purchase agreements with the U.S. government and at least one other nation. China, Russia, and (starting this month) Italy are also among those with vaccine candidates being tested on humans.

With bragging rights and economies at stake, not everyone is playing nice. China and Russia have tried to hack various Western vaccine efforts, according to the intelligence services of the U.S. and its allies. Some nations and pharmaceutical companies are planning for the possibility that vaccines or their components might be blocked from crossing borders. The contest may also be putting medical safety at risk. It normally takes years to develop a vaccine, and the compressed timelines raise concerns about leaders’ ambitions bending the judgment of regulators. Russia announced on Aug. 1 that it will start mass inoculations in October with a vaccine that hasn’t yet finished clinical trials. In the U.S. there are concerns, including those raised by members of Congress at a July hearing with pharmaceutical executives, that President Trump could pressure the Food and Drug Administration to cut corners as the November election nears.

Trump has embraced the competition with his Operation Warp Speed, which is spending as much as $10 billion in the hope of having some 300 million doses of a winner available for Americans. As the deep-pocketed spoiler, Trump is placing bets on almost every major Western vaccine effort. “We will achieve a victory over the virus by unleashing America’s scientific genius, which is what it is,” Trump said during a July 27 visit to a biotech facility in North Carolina.

AstraZeneca has committed to creating autonomous supply chains for the Oxford shot on four continents—a frank acknowledgment that it isn’t counting on a normal flow of goods. “Because of some of the politics, there’s a risk of people ordering but not letting the vaccine across country borders,” says Mene Pangalos, the company’s head of research and development for biopharmaceuticals. “We’ve been looking at that pretty carefully and wondering what will happen if that moment comes. So we’re being very careful about trying to create independent supply chains that will enable full access to the vaccine around the world.” AstraZeneca is setting up production of its 2 billion initial doses in Europe, Brazil, India, Russia, and the U.S. India alone will account for half those doses, which are being made with an understanding reached with Prime Minister Narendra Modi’s government that about 500 million will stay in the country.

Nations tend to flatter themselves in terms of how central they are to the action. Some Italian newspapers refer to the Oxford shot as the “Anglo-Italian vaccine” because of the support roles Italian companies have played in readying it for distribution. For months, Advent Srl, based in Pomezia, a 45-minute drive south of Rome, has been cranking out the doses AstraZeneca has been using for clinical trials in Brazil, South Africa, and the U.K. The production deal with Catalent was political gold for the government of Prime Minister Giuseppe Conte. It helped to abate the legal and political pressure that had been building around his administration’s handling of the crisis, which has killed 35,000 Italians.

Filled and capped vials at Catalent’s facility in Anagni, Italy.
▲ Vials in Anagni.
Source: Catalent

When he announced the deal in June, Conte was able to crow, “Italy, which was the first in Europe to get to know this virus closely, today has been recognized to be among the first countries to give an adequate response.” Hopes for a vaccine replaced probes of the pandemic response on the nation’s front pages. The moment provided a lesson in the power that even marginal victories in vaccine nationalism have right now. The moonshot race may determine not just who lives and dies, but which economies, and governments, rise and fall.

Countries are eyeing one another warily in part because of how they behaved during the first wave of outbreaks. Starting in March, governments blocked borders as they competed for masks, medicines, and ventilators, with at least 90 jurisdictions putting restrictions on exports of protective equipment and other medical material, according to the Global Trade Alert project at Switzerland’s University of St. Gallen.

The Trump administration, for example, asked 3M Co. to stop exporting N95 masks to Canada and Latin America as shortages mounted at U.S. hospitals. In March, Germany temporarily banned most exports of protective medical equipment. Italy then went tit-for-tat, seizing mask exports. China capitalized on Italy’s moment of need (and perceived abandonment by its allies) and sent planeloads of Chinese Red Cross teams with ventilators, protective suits, and other gear. It was a classic use of soft power—be a friend and ally now, see how that might pay off later.

Maj. Gen. Chen Wei is leading a vaccine research team in Wuhan, China.
▲ General Chen Wei is leading a vaccine research team in Wuhan, China.
FeatureChina/AP Photo

The West’s next rude awakening to vaccine nationalism came on May 13, when the French drugmaker Sanofi SA said Americans would likely get its vaccine before the rest of the world, because the U.S. had financially backed early research. “The U.S. government has the right to the largest preorder because it’s invested in taking the risk,” Chief Executive Officer Paul Hudson said in an interview with Bloomberg News. The company reversed course under pressure from its home country and others, but the message was plain: Put in your orders or wait in line.

A second shock followed days later, when the British government announced plans to spend £65.5 million ($86 million) on the Oxford tieup with AstraZeneca. “This deal with AstraZeneca means that if the Oxford University vaccine works, people in the U.K. will get the first access to it,” said Alok Sharma, secretary of state for business, energy, and industrial strategy, in a news release, which promised that as many as 30 million doses would be available in the U.K. by September.

The moment was a wake-up call in Italy. The next morning’s headline in La Repubblica framed the announcement as nearly a betrayal: “London Reserves 30 Million Doses of the Vaccine Born Between Oxford and Pomezia.” The first words of the story quoted Sharma saying the U.K. would get the shot first. “It is not clear what will go to Italy,” the article added. Behind the scenes, the Italian government began its own negotiations with European allies and AstraZeneca to put in an order.

Meanwhile, Trump’s spending spree spurred fears in Germany that the U.S. was angling to buy CureVac AG, one of the country’s leaders in the vaccine race, or its technology. To head off the Americans, Berlin agreed in June to buy about 23% of the company for €300 million ($355 million). “Germany is not for sale,” Economy Minister Peter Altmaier said at a press conference. “We aren’t selling off the family silver. I am a great supporter of a global free-market economy, but there are certain areas where our position must be very clear.”

Germany was right to understand Trump’s government as putting allies second. In his July visit to the North Carolina plant, the president laid out a vaccine nationalism doctrine that boils down to this: America first, maybe some other countries later, and it’s all China’s fault. “We’re mass-producing all of the most promising vaccine candidates in advance so that on the Day 1 that it’s approved, it’ll be available to the American people immediately,” he said. “And we’ll probably have a lot for a lot of other people throughout the world. The world is suffering from this China virus.”

Brazil’s plan to produce the Oxford vaccine for its own population could give a boost to President Jair Bolsonaro—himself recovering from Covid-19—as he presides over the world’s second-worst outbreak while simultaneously downplaying its harm. The $287 million deal the health ministry announced in June foresees Brazil taking delivery of 30.4 million doses in December and January, and then, following a technology transfer, making 70 million doses domestically.

Russia has taken some unorthodox shortcuts. The government’s planned mass inoculations will use a vaccine developed by the state-run Gamaleya Institute of Epidemiology and Microbiology in Moscow, for which it used 50 military personnel as subjects for its first trial phase. Scores of Russia’s business and political elite have also been given early access to the experimental vaccine, Bloomberg News reported in July. As early as April, top executives at companies including aluminum giant United Co. Rusal Plc, as well as tycoons and government officials, began getting shots.

At the same time, Russia has denied the West’s hacking allegations—in part saying it doesn’t need to steal any technology because it’s already signed with AstraZeneca to become a regional production hub for the Oxford vaccine. Under the deal, R-Pharm, one of Russia’s largest pharmaceutical companies, will make and export doses of the Oxford shot to more than 30 countries, including in the Balkans, the Middle East, and some former Soviet republics.

Even the Canadian government is making sure it can make and keep an inoculation within its borders. It’s spending C$44 million ($33 million) to upgrade a facility in Montreal so it can make vaccines and has set up partnerships with researchers at home and abroad, including China’s CanSino Biologics Inc. “Canada is prioritizing domestic capacity to manufacture a vaccine candidate when one becomes available,” the government’s innovation, science, and economic development department said in a statement. Once fully operational, the Montreal facility will produce up to 100,000 doses a month. “This investment and research collaboration will help ensure that Canadians and frontline workers have access to potential vaccines as soon as possible.”

In game theory, there’s a puzzle called the prisoner’s dilemma, which provides lessons on the choices people make as they weigh self-interest and cooperation. The premise is that two members of a gang are imprisoned in separate jail cells where they can’t communicate with each other. A prosecutor who doesn’t have evidence to convict either of a serious crime gives each prisoner the same deal: Snitch on your friend and you go free—unless he snitches on you, too. Of the various combinations, the best overall outcome is each prisoner staying mum and dealing with lesser charges.

What’s happening now with the vaccine race is the prisoner’s dilemma in action, says Thomas Bollyky, director of the Global Health Program at the Council on Foreign Relations, and Chad Bown, a senior fellow at the Peterson Institute for International Economics. Nations are eschewing the best case of cooperation for the risk of going it alone. “Vaccine nationalism is not just morally and ethically reprehensible: It is contrary to every country’s economic, strategic, and health interests,” Bollyky and Bown write in a Foreign Affairs article titled “The Tragedy of Vaccine Nationalism.” As countries speed to secure their own early access to vaccines, the authors say, they’re failing to slow the spread of the virus elsewhere, fostering supply chain disruptions, inefficiently spurring economies, and possibly sparking geopolitical conflict.

Rich countries are responding to these concerns by supporting the Covax Facility, a mechanism that’s raising money to guarantee access to vaccines for some 90 lower-income countries. At least 75 countries say they’ll support the Covax Facility. But they’re simultaneously putting their own interests first.

The European Union, for example, is supporting global initiatives for equitable vaccine access but isn’t participating in such a program for its own purchases—it’s taking its pool of money to place vaccine orders for member states. The U.K., in turn, has decided not to participate in an EU purchasing pool, because the government wants to be able to negotiate its own deals. Drill down further, and there’s the deal that’s leading Italy to bottle from 400 million to 450 million doses of the Oxford vaccine in its four-country pact with France, Germany, and the Netherlands. They’re in it together, but exactly how and when those doses get distributed hasn’t yet been announced.

Step back for a moment, though, and there’s something to be said for a nation and its people working together to dig out of a crisis—especially if their efforts can help the rest of the world, too. That was the case with biochemist Stefania Di Marco, the scientific director at Advent. Di Marco became a crucial part of the Oxford effort in the earliest days of the outbreak, working out of a 1,000-square-meter production facility that was once a staff gym for pharma giant Merck & Co., the campus’s previous owner.

Stefania Di Marco, lead scientist at Advent
▲ Di Marco (center) and her team worked nonstop to quickly get Advent’s vaccine into human trials.
Photographer: Geraldine Hope Ghelli/The Washington Post/Getty Images

In early February, a full month before Italy went into lockdown, Oxford’s Jenner Institute signed a deal with Advent to produce doses of its vaccine. Having worked with the Oxford scientists on previous vaccines, Di Marco began familiar processes for the arrival of the “seed stock” that would allow her team to produce thousands of doses for Oxford’s clinical trials. In the weeks that followed, Italy became the first coronavirus epicenter outside of China. Businesses around the country shuttered, but Di Marco’s team of about 25 women and men kept working as part of a government-designated essential industry.

After weeks of preparation, Oxford shipped the precious seed stock. The arrival on March 23 of the samples, totaling just a few milliliters in fewer than 10 vials, packed in dry ice, set in motion a nonstop process. “There were no spare days,” Di Marco says. They worked Saturdays and Sundays and nervously scanned headlines about small pockets of local infections. During that time, Di Marco was in daily touch with colleagues at Oxford.

With that seed stock, Advent made about 3 liters of vaccine, yielding 13,000 doses. On May 20, the team sent its first shipment, in about 400 multidose vials, to Oxford in temperature-controlled Styrofoam boxes that kept them between 2C and 8C. Eight days later, British regulators released that first batch to the Oxford scientists. That evening, a Thursday, they began injecting the Advent doses into the arms of trial volunteers.

I met Di Marco the next morning during a visit to the Pomezia lab. She wore a surgical mask as she entered a conference room for the interview and squirted sanitizer from a dispenser onto her hands. She was practically giddy with the news that the vaccine candidate her team had made had started coursing through British veins just hours earlier.

For the next hour, Di Marco was all business—until I asked which moment in the months of work had meant the most to her. She paused. Because of the mask I couldn’t see her whole expression, but her eyes turned glassy with tears. “The filling,” she said. That moment, at about 9 p.m. on May 4, when technicians began the semi-automated process of transferring the precious vaccine into glass vials, meant she and her team had threaded the needle at a sprint. “There was a lot of tension that something could go wrong,” Di Marco said. Italian politicians might be paying tribute to the national effort, but for Di Marco and her team, which includes scientists and technicians from all over the world, her story of Italian perseverance had been one of cooperation that she expects will save lives everywhere.

Vial filling line at Catalent’s facility in Anagni, Italy.
▲ The vial filling line at Catalent’s plant in Anagni.
Source: Catalent

At Catalent’s fill-and-finish facility, Gargiulo says he has no interest in promoting vaccine nationalism. The threat of cross-border hijinks is real enough, he says, that he’s taken steps to mitigate possible disruptions.

Take the supply of glass vials. Globally, vaccine producers are braced for a potential shortage of the bottles, which are made of a special glass. AstraZeneca has mitigated the risk, in part, by having contractors pack 10 doses into each multidose vial. For Gargiulo, that was just a first step. On the ground in Italy, allies’ border-blocking of material in the pandemic’s early days is still a fresh memory, so he reasoned he’d need to lock in a vial supply wholly within the country.

He turned to a company in Italy’s northwest, Soffieria Bertolini SpA. But he had to be careful: The company obtains its specialty glass from a German glassmaker. Before he could assure AstraZeneca that Soffieria Bertolini could supply the vials, Gargiulo did due diligence on the bottle maker’s hoard of raw German glass. “They told us their inventories,” he says. Only once he was assured there was enough on Italian soil was the vial-buying deal a go. Now, as he hires 100 employees and trains them on the bottling line, Catalent is awaiting the arrival, as soon as September, of massive bags of the vaccine “drug substance” being produced elsewhere in Europe. “Once the drug substance is available, there will be a supply chain in Italy, because everything after that will be done in Italy—formulation, filling, packaging,” he says.

Those are the processes Catalent’s jumpsuit-clad workers are preparing for—adding final ingredients to the mix, pumping it into the filling line of sterilized bottles, moving the cargo into an inspection machine that scrutinizes each vial with nine cameras from different angles, and then racking the vials into boxes that are ready for transport. As Gargiulo gives a walk-through of the stages, two engineers at the end of a long corridor pore over poster-size flowcharts that map the steps the machines will go through. Once the machines start, they’ll go almost nonstop, cranking out 24,000 vials per hour around the clock.

Roberto Speranza
▲ In official statements, Italian Health Minister Roberto Speranza (right) tends to muddle just where Catalent’s vaccines are going.
Photographer: Independent Photo Agency/Alamy

As batches are completed, they’ll be moved to a refrigerated warehouse in the Catalent complex and stacked on aluminum and plastic pallets, ready for regulatory approvals and shipping. Gargiulo says he’s sure the government will fast-track any bureaucratic steps. Among the last of those, the Superior Institute of Health will decide whether to release the finished product for export. While there are no signs this scientific process has been politicized, how it plays out could determine whether Italy is perceived as getting the vaccine first or, in the style of Chinese soft power, being a European hero for quickly distributing the supply.

In Italian politics, however, there are hints that the leadership expects its citizens to be first in line, even if all official statements about the deal portray it as being for Europeans and the EU has taken a role in managing the program. Health Minister Roberto Speranza has repeatedly said, including in a speech to Parliament, that if all goes well, some 60 million doses will be ready before the end of the year. That number is roughly equal to Catalent’s capacity on the current schedule.

It also matches the population of Italy. Yes, these doses are meant for Europe. But Italians who are casual listeners to the news could be forgiven for assuming that the first batch is going entirely to them. —With Stephanie Baker

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