How Europe Injected More Doubt Into a Vaccine the World Needs
How Europe Injected More Doubt Into a Vaccine the World Needs
Charles Michel sat in his office in Brussels on Monday afternoon busy preparing to host a summit of European leaders eager to know plans for accelerating the continent’s listless vaccination program. Then the media reports started coming in: Germany was suspending use of the AstraZeneca Plc shot over concerns it was linked to blood clots.
With no warning or consultation, the president of the European Council—like other top European Union officials—was blindsided. The decision quickly set off a chain reaction that not only laid bare the mess of the vaccine program, but undermined the very institutions that preside over it. Other countries felt compelled to follow Germany’s lead and stop administering the vaccine, going against the advice of the European Medicines Agency.
The week of drama ended with most countries reinstating Astra doses after the EMA, the EU’s regulator, reiterated on Thursday any risks were far outweighed by the benefits. Germany’s decision to hit the brakes came at a terrible time, setting back the vaccine rollout just as Europe confronts a new wave of infections that have led countries to reimpose or extend restrictions.
The chaotic campaign also threatens to deal a huge blow to the EU’s credibility both globally and with its own citizens, and delay the reopening of Europe’s shattered economies. The 27 states of the EU have only given first doses to 8.3% of their combined population compared with 39% in the U.K. and 23% in the U.S., according to the Bloomberg Vaccine Tracker. The question is how the bloc emerges from what’s arguably its biggest test of unity yet.
The danger too is that fresh seeds of doubt have inflicted lasting damage on a vaccine that’s being used around the world and is the workhorse of the global effort to end the pandemic. Just days after receiving millions of doses of the Astra shot via Covax, the World Health Organization-backed facility to provide doses to lower-income nations, countries ranging from Indonesia to the Democratic Republic of Congo followed Europe’s lead and halted its use.
“I worry about the wider impact of these decisions to suspend the rollout,” said Anna Marriott, head of health policy at U.K.-based charity Oxfam. “This could reverse a lot of investment that’s gone into combating vaccine hesitancy. European leaders have a huge responsibility to publicly communicate in every corner of the world what the data says to redress some of the harm done in the last few days.”
Suspending the Astra shot was just the latest chapter in the continent’s love-hate relationship with the vaccine, developed by scientists at the University of Oxford. Over the past two months, European leaders had taken turns denigrating the shot as ineffective and then lambasting the British-Swedish company for failing to deliver doses as promised, even threatening to sue over the lack of supplies.
This account of the decisions taken on Astra’s vaccine is based on public moments and conversations with six people with knowledge of private discussions.
The latest turmoil kicked off on March 7 when Austria stopped using a batch of the vaccine after the death of one person and an illness in another connected to blood clots after inoculation.
Four days later, Denmark became the first country to suspend Astra altogether after a 60-year-old woman formed a blood clot and died, despite authorities admitting it wasn’t possible to determine if there was a link to the vaccine. Austria, Norway and Iceland quickly followed suit while Italy announced it would just ban one batch.
Germany and France pledged to keep using Astra, while the company hit back at suggestions the vaccine is unsafe, saying 17 million people had been vaccinated across the EU and the U.K. with no evidence of an increased rate of blood clots.
The political price of the bungled response to getting out of the Covid pandemic and the sluggish pace of vaccinations came on Sunday, when German Chancellor Angela Merkel’s Christian Democratic Union suffered defeat in state elections. When party leaders convened by video on Monday morning to discuss what went wrong, Health Minister Jens Spahn, widely blamed for the government’s poor handling of the crisis, attempted to defend his record.
He recounted his visit to a vaccine center in the city of Muenster where he saw people “coming out happy” after getting the Astra shot, people familiar with the deliberations say. Spahn told party leaders they should tell positive stories like that to show the vaccine program isn’t as bad as many people think. As well as the U.K., Germany is also behind countries like Serbia and Hungary.
Just hours later, Spahn made a complete volte-face. Scientists at the Paul-Ehrlich-Institut, which advises the German Health Ministry on medicine safety, had just received reports of two additional people developing cerebral venous thrombosis—a blood clot in the brain—after getting the Astra vaccine. The new cases put the number of blood clots above what the institute concluded was normal in non-vaccinated people.
In the early afternoon, it recommended to Spahn that the vaccine be temporarily suspended pending an investigation by the EMA. At that point, there had been seven cases of cerebral venous thrombosis with platelet deficiency in people aged 20-50 out of a total of 1.6 million vaccinations in Germany with the Astra shot. Three people had died.
Germany’s Health Ministry announced the ban that afternoon on Twitter, calling a hastily assembled press conference where Spahn sounded perturbed by questions about how much the decision would set back the vaccine campaign. “For me, what’s most important for trust is transparency, and to follow the advice of professional experts,” he told reporters. “I’ve only known about this whole thing for a short bit of time, that this expert opinion exists. And please forgive me that I can’t answer questions about the consequences.”
Across Europe, in the small town of Montauban, 600 kilometers south of Paris, French President Emmanuel Macron and Spanish Prime Minister Pedro Sanchez were in the middle of the plenary session of their summit when they got wind of the German suspension. Macron consulted his health ministry back in Paris and decided on the spot to follow Germany’s lead, announcing the decision just hours later.
He said it was a precautionary move and that he hoped to resume vaccinations quickly after a green light from the EMA. One official close to Macron said it would have been politically difficult to continue administering the Astra shots after Germany and other countries stopped.
Germany’s decision to hit the pause button set off a flurry of phone calls across Europe and the dominos quickly started falling as more and more countries announced they were halting the Astra shot. Merkel spoke with Italian Prime Minister Mario Draghi on Monday while Spahn contacted his counterparts in France and Italy.
Spain, Italy and Sweden soon announced they would wait until the EMA ruling on Thursday before resuming use of the Astra shot, while countries including Belgium and Poland broke ranks and vowed to continue to use it. “The choice is a political one,” Nicola Magrini, the director general of Italy’s medicines authority, told the newspaper la Repubblica, adding that he thought the vaccine was safe.
The EU’s vaccine campaign has been bedeviled by problems from the start, beginning with its decision to pool procurement across 27 member-states, a noble strategy aimed at fair access but one that slowed down the EU’s ability to clinch vaccine contracts. Authorization of vaccines by the EMA also lagged, delaying the start of the program.
Multiple senior officials in Brussels were frustrated at the decision by countries to suspend the vaccine, seeing it as yet another episode in Europe’s tortured rollout. Some of that irritation stems from the data, which didn’t indicate that the Astra shot was any less safe than the Pfizer-BioNTech one. Plus, the EMA was still endorsing it.
The U.K. regulator, the Medicines and Healthcare Products Regulatory Agency, reported a total of 30 adverse events associated with blood clots out of 9.7 million shots of the Astra vaccine as of Feb. 28. There were 38 blood clot reports out of a total of 10.7 million Pfizer-BioNTech first shots and 800,000 second doses given during the same period.
The MHRA is conducting a detailed review of five reports of a rare blood clot in the brain with lowered platelets, as seen in other parts of Europe, but it’s been reported in fewer than one in a million people and a causal link with the vaccine hasn’t been established.
Right after the EMA reiterated that the vaccine is safe, France, Germany, Italy, Spain, Portugal, Bulgaria, Slovenia and Luxembourg said they would resume using the shots on Friday. Scandinavian countries said they would wait more days to decide.
The damage has been “potentially huge,” but it can still be recovered, said Guido Rasi, who was executive director of the EMA for nine years until he stepped down in November. “It’s a lesson to be less emotional, to be confident in science and confident in the institutions who are interpreting the data.”
Europe now faces an uphill battle to convince more people to get the shot. French Prime Minister Jean Castex took the first step toward trying to restore confidence by getting an Astra dose on Friday. France, though, restricted the use of the vaccine to people over 55 until further data is reviewed.
The Astra vaccine has been dogged by controversy ever since September, when it was forced to pause its global trials after a U.K. volunteer suffered a neurological condition affecting the spinal cord called transverse myelitis. It couldn’t be determined whether the symptoms were linked to the vaccine or not. The U.K. trial resumed days later but the U.S. trial was paused for almost seven weeks.
Then in November, Astra and Oxford released data that suggested a half-dose followed by a full dose of the two-shot vaccine gave better protection, but it only emerged later that the dosing schedule was the result of an error. Partial disclosure of these details led to complaints of a lack of transparency.
The company announced in January there would be a 60% shortfall in European vaccine deliveries because of production delays at its Belgian facility. That was followed by a number of European countries restricting use of the shot to under 65s because they said the trials didn’t have enough data showing its effectiveness in older people.
On Jan. 29, the same day that the EMA approved the shot for use in over 18s, Macron claimed it was “quasi ineffective on people over 65,” a comment that many believe has sowed a deep and lasting skepticism of Astra.
After more than a dozen EU member states suspended the use of Astra questioning its safety, European Commission President Ursula von der Leyen on Wednesday threatened to use legal powers to stop vaccines from being exported to countries that weren’t reciprocating.
Officials admitted privately there was a contradictory message emanating from Europe—that the vaccine might be unsafe but they still wanted to stop doses leaving the bloc—while diplomats from several member states urged caution, warning that such a move could hurt European companies too.
Brussels has blamed shortages for its botched rollout, but the European Centre for Disease Prevention and Control says that more than 7 million Astra doses remain unused. The recent suspensions left vaccination centers empty across Europe as tens of thousands of appointments were cancelled amid reports that doses were being destroyed because they would be spoiled by the delays.
All eyes were on the EMA, which was hastily conducting an investigation into whether the vaccine was indeed the cause of blood clots. When its head, former WHO official Emer Cooke, announced the agency’s findings on Thursday, few were surprised. She said the shot was not associated with an increased risk of blood clots, though she couldn’t “rule out definitively a link.”
Spahn, the German health minister, had initially planned to give an immediate statement as well. But he first waited for the EMA’s written report and then called European and German state counterparts to make sure that everybody was on board with the decision to resume Astra vaccinations.
At 8 p.m., he finally appeared before the cameras alongside the head of the Paul-Ehrlich-Institut, Klaus Cichutek. Visibly nervous, he said the week’s events were proof of the government’s transparency. A potential successor for Merkel just a few weeks ago, Spahn had turned into a national scapegoat for everything that’s gone wrong with Germany’s inoculation program.
The following morning, Spahn sat uncomfortably at a press conference together with the health spokesman for the Social Democrats, Karl Lauterbach, who had earlier criticized the decision to pause Astra vaccinations. “I've undoubtedly also made mistakes,” Spahn said.
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