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Wednesday, April 28, 2021

When the EU's Covid-19 Vaccine Drive Stumbled, It Turned to Mr. Fixit

 Thierry Breton knew the European Union's vaccine campaign needed help when his boss called him in January.

Covid-19 cases were surging and EU deaths linked to the coronavirus had topped 400,000. The bloc lagged behind weeks behind the U.S. and U.K. in approving vaccines and even further behind in inoculating people. Then Pfizer Inc. and AstraZeneca PLC stunned EU officials by saying deliveries would arrive late.

European Commission President Ursula von der Leyen summoned Mr. Breton to join an emergency videoconference with top pharmaceutical executives and then other calls with German Chancellor Angela Merkel and French President Emmanuel Macron.

Over the previous year, Mr. Breton had become the bloc's Mr. Fixit, spearheading efforts to boost supplies of masks and ventilators when the pandemic first hit. Enlisting him on the vaccine calls meant plans to inoculate the bloc's 450 million people were already stumbling.

"It's the same thing all over again," an aide told Mr. Breton.

Today, hopeful signs are emerging for EU vaccinations, even as case numbers remain high. The bloc is now confident of receiving more than 400 million vaccine doses in the quarter through June, up from 107 million in the first quarter.

Mr. Breton has helped build that confidence through a mix of business savvy and political theatrics that he displayed on Easter Sunday. The former French finance minister and ex-chief executive of multinationals donned a white lab coat, protective glasses and a blue hard hat to tour a French factory making vaccine ingredients.

"I look a bit ridiculous, no?" he said before touring the production hall with its manager. But such visits have allowed Mr. Breton to build a clear picture of the 53 plants across 12 EU countries -- a vital information source that has shaped policy in Brussels and across the bloc.

Europe's vaccine campaign in January had hit a familiar foe of EU crisis-fighting: a lack of centralized control. The bloc's 27 countries had entrusted Brussels with procuring shots for everyone but didn't include the means to keep tabs on their production or hold the pharmaceutical companies accountable. Nobody knew how many vaccines were being made and when they would be delivered. EU countries as a result felt little pressure to accelerate preparations.

Mr. Breton set out on a mission to save the EU's vaccine drive -- and his fellow EU politicians. He dug into vaccine problems just as popular outrage over Europe's slow inoculation drives battered leaders in Brussels and countries including France and Germany.

The 66-year-old Mr. Breton, who has taught at Harvard University and drives to public events in a 20-year-old Volkswagen Beetle, sought to deflect anger and redirect public debate. Flexing political muscle, he publicly berated under-performing vaccine makers, especially AstraZeneca.

"I'm not doing the work of a CEO, I'm doing the work of a politician," said Mr. Breton, in an interview. "You can't send a CEO to do this job -- they'd die."

EU vaccinations are now running about six weeks behind the U.S., relative to population. Europe's initial lack of central coordination contrasts with the U.S., where under Operation Warp Speed the federal government oversaw vaccine development, production and distribution, even tapping military leaders for logistics expertise.

Europeans had relied on their world-leading pharmaceuticals industry, which had led development of many vaccines. Companies had developed and tested shots -- last year considered the biggest hurdle -- so quickly that authorities believed they were home free. But the producers, unprepared for their sudden ramp-up, struggled to deliver on contracts.

"We have underestimated the difficulties inherent in mass production," said Ms. von der Leyen in early February. "Industry has to match the groundbreaking pace of science."

The Breton team's crash course in vaccine production also taught them which companies could boost production fastest and most reliably. Pfizer's January delay, for example, was only temporary -- to add manufacturing capacity. Within weeks, as AstraZeneca continued struggling, Pfizer and partner BioNTech SE were hitting ambitious targets. Their European deliveries rose and accelerated.

Confident in Pfizer-BioNTech's production capacity and the efficacy of their vaccine, the EU recently announced talks to buy up to 1.8 billion more doses next year and in 2023. The duo "has proven to be a reliable partner," Ms. von der Leyen said, in a dig at other suppliers.

Europe's vaccine problems date back a year, to when contract negotiations began. Of six vaccines the EU ordered, none of the first three approved came from a supplier seasoned in mass-producing shots.

BioNTech, a small German firm, had joined with Pfizer to produce its formulation, and while the U.S. company is a global giant, its European production expanded slowly. Boston-based Moderna Inc. also had modest production in Europe, requiring it to tap contract manufacturers to meet output targets.

AstraZeneca had to do the same. Scientists at University of Oxford, who developed the vaccine, in April 2020 selected AstraZeneca as their partner for manufacturing and distribution, but AstraZeneca underestimated the difficulty of delivering the billions of doses they had pledged, according to people familiar with the events.

When AstraZeneca revealed its delays in January, Mr. Breton assembled more than two-dozen staffers, as he had done last spring, assigning some to mapping European vaccine production and others to grasping supply chains for vaccines and related products such as filters and needles. The EU's commissioner for internal markets, Mr. Breton is responsible for ensuring that business functions smoothly across EU countries, which have linked their economies but remain sovereign states.

To untangle incoming information, Mr. Breton arranged video calls directly with drug company chief executives, some over weekends, to get their perspectives and identify bottlenecks. He reminded them he had served as CEO of France Telecom and French tech-consulting firm Atos, earning a reputation as a turnaround specialist.

While most CEOs gave Mr. Breton confidence that they would quickly increase, he said, AstraZeneca CEO Pascal Soriot repeatedly blamed suppliers for production problems that slashed expected deliveries from 120 million to 30 million in the first three months of the year.

"I said, Come on -- I've been a CEO myself. You never give that as an excuse," Mr. Breton recalled saying.

Dr. Soriot hasn't blamed suppliers but pointed to low yields at plants, which have hit European deliveries particularly hard, said a person familiar with the discussions. AstraZeneca tried to close the shortfall by importing doses but faced export curbs, the person said.

Weeks of factory visits, analysis and haggling failed to increase AstraZeneca deliveries. On April 23, the EU sued the company for breach of contract, in an attempt to force deliveries. AstraZeneca said it regretted the commission's decision to take legal action and looked forward to working with it "to vaccinate as many people as possible."

Mr. Breton, by that point, had moved on to helping ensure future production can run more smoothly. That is why at Easter, with most of France observing the holiday or under lockdown, he traveled by train to Dijon to visit a factory making ingredients for Moderna and other pharmaceutical companies.

The plant, owned by Luxembourg-based CordenPharma GmbH, has increased production several hundredfold over recent months and now employs five teams running nonstop.

Arriving on the sunny Sunday morning, Mr. Breton greeted workers like a general reviewing troops. "It's thanks to women and men like you that we will win this fight," he exhorted them.

Inside, CEO Michael Quirmbach explained his rising output and the limits he faces, including a need to send some ingredients to foreign plants -- including in the U.S. -- for purification. A EUR30 million investment, equivalent to $36.3 million, would let the plant handle the task and increase production, while another EUR30 million investment would allow the company to fill vials and finish packaging for more than 100 million extra vaccine doses annually at a plant in Italy, he said.

Mr. Breton told his chief of staff to note the amounts, which the EU could help fund. "This is something very important for us," he said.

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