The European Union’s “do no harm” ethos may be doing more harm than good.
Even as Europe confronts worrying signs of a third wave of the coronavirus pandemic, most EU countries this week paused immunizations with the Oxford/AstraZeneca vaccine.
The decision followed the deaths of more than 581,000 people in the EU of COVID-19 — and a vaccination campaign that has struggled to get off the ground compared to the United States and the United Kingdom.
And yet, it was several dozen reports of rare blood coagulation disorders that drove countries to suspend one of the three most viable jabs available to European citizens. The European Medicines Agency has not changed its assessment — even after an intensive review that concluded Thursday. The shot is “safe and effective,” though a relationship to the reported cases can’t be definitively ruled out.
“When there are doubts, the principle of precaution prevails,” was how João Vale de Almeida, the EU’s ambassador to the U.K., put in an interview with the BBC, defending the thinking in Spain, Germany, France and Italy.
Vale de Almeida was referring to the so-called “precautionary principle,” a cornerstone of EU regulation intended to protect citizens from the slings of unchecked capitalism and the arrows of overzealous industry.
If there’s a scientific debate about some hot new thing — even if the existing evidence doesn’t point to a clear-cut problem — the EU is to err on the side of caution. The precautionary principle is why GMOs are heavily restricted in Europe, chlorine-washed chicken is a no-go and the world’s most popular weed-killer — glyphosate — is on a tenuous track despite an all-clear from EU-level watchdogs.
The thinking, especially given a public skeptical of big business and its interests, is: Why risk it?
When it comes vaccines, however, the biggest risks loom on the other side of the equation — especially on a Continent awash with vaccine skeptisicm.
“It’s really a distortion of the precautionary principle,” said Arūnas Vinčiūnas, who served as chief of Cabinet to former European Commissioner for Health and Food Safety Vytenis Andriukaitis and helped push Commission’s 2019 initiative to improve vaccine confidence.
During the first wave, EU capitals prided themselves on listening to public health experts, rather than industry lobbies, and locking down quickly and firmly. In comparison to conservative governments in the U.S. and the U.K. seemed to let the markets decide how to handle the pandemic, with deadly results.
Now, however, the U.S. and the U.K. are barreling ahead of the EU with coronavirus inoculations, putting them on track to safely reopen their economies months before the bloc. Their progress makes the EU’s cautious vaccination moves look increasingly dangerous — both to human health and to the EU’s economic recovery.
Vinčiūnas — whose native Lithuania is among the countries that suspended the AstraZeneca shot — fears “permanent damage” to people’s willingness to take the cheap vaccine, regardless of the EMA’s repeated backing of its safety and effectiveness.
The AstraZeneca scramble, according to Vinčiūnas, has echoes of the controversy over renewing the license for glyphosate amid fears it causes cancer. The chemical, an active ingredient in the weedkiller RoundUp, remains controversial even though the European Chemicals Agency and the European Food Safety Authority say it’s safe for use.
There have been “times when we don’t trust science,” Vinčiūnas said. It would help right the ship if leaders said they trusted the EU’s regulatory agencies, but “there is no such courage when there is doubt, and protection of your own image, for some, is more important.”
When it comes to AstraZeneca, while Germany’s national regulator made a detailed case for its recommendation to suspend the shots — noting the unusual increase in a specific type of clotting — others acknowledged that political precautions are a factor.
An Elysée official said Berlin’s decision had a “psychological impact” on Paris. Spain, which had only one case of severe thrombosis out of nearly 1 million AstraZeneca jabs, joined its fellow big countries by pausing AstraZeneca administration for two weeks “following the precautionary principle,” said Health Minister Carolina Darias.
The message from the EMA and the World Health Organization, meanwhile, has been consistent: Until we know if there’s a causal relationship, there’s no reason to stop using a vaccine that’s been shown to prevent serious illness and death from a highly contagious pathogen.
This isn’t the first time national governments jumped ahead of the centralized regulator and blew off its advice: France, Germany and others initially didn’t offer the AstraZeneca shot to people over 65, concerned about the small samples of this age group in the clinical trials — even though the EMA recommended it for older people from the get-go.
National leaders cite maintaining public confidence in vaccines as a big reason to hit pause on what might be a dangerous jab. The issue has divided public health experts. Some have suggested politicians’ willingness to halt the shots — despite immense pressure to immunize quickly — could indeed reassure the public. Others, including the prominent French immunologist Benjamin Davido, have warned that the suspensions “sow the seeds of doubt.”
For the moment, if France were to start offering the AstraZeneca jab again, there might not be many takers: According to a BFMTV survey, only 20 percent have confidence in the Oxford-backed jab, compared to more than 50 percent for the BioNTech/Pfizer shot. (Neither of these figures make epidemiologists smile.)
The fear is contagious. Although Croatia isn’t one of the countries suspending AstraZeneca shots, the refusal rate for that vaccine there is hitting 50 percent, a doctor told Index.
Beyond AstraZeneca, the Commission’s coronavirus vaccine procurement strategy has been marked by the precautionary principle and its appeal to consumer perception. Haggling over the ability to hold drugmakers liable if something goes wrong — a right essentially waived by the U.S. and U.K. — slowed down contract talks.
This was crucial, officials said, to reassure healthy, potentially hesitant Europeans that getting an injection would be have minimal risk. The Commission was also determined to get a good price, and succeeded, even though in the end, Brussels has struggled to get the manufacturers — especially AstraZeneca — to fulfill its orders on time.
The EU’s ongoing drama with AstraZeneca means the bloc is careening from desperation for more doses, to cabinets full of unusable vials.
The precautionary principle’s most ardent champions continue to insist that it’s still coming through for Europeans. French Green MEP Michèle Rivasi praised the “courageous” decision by national regulators to pause vaccinations. It’s not just a question of the risks versus benefits of vaccines, she said: If people are at risks of clots, they need to be offered something different.
On Thursday, the EMA’s drug safety committee determined that the vaccine is “not associated with an increase in the overall risk of thromboembolic events or blood clots.” Nonetheless, the EU regulator said it would recommend the product information include warnings to look out for such issues. Now it will be up to each country to decide how to proceed with the rollout.
The back-and-forth over AstraZeneca comes even as the precautionary principle is inconsistently applied.
When it comes to other aspects of the pandemic, the EU has shown boldness where the U.S. has not: Countries like Germany and Sweden were way ahead on school re-openings, for example. And the U.S. still isn’t even close to approving the AstraZeneca vaccine: The U.S. suspended clinical trials over in the fall, angry that the drugmaker wasn’t more forthcoming about a participant’s illness, and ordered the company to collect a massive new set of data in America.
“It’s not really a reflection of the fact that Europe has a tougher view of risk,” said Anthony Gardner, a former U.S. ambassador to the EU.
According to Gardner, the precautionary principle has always been something of a false trope. As Barack Obama’s negotiator for a transatlantic trade deal, he was constantly running up against resistance to hormone-treated beef and genetically modified crops. He said recalled the many times EFSA deemed certain foods safe, only to be ignored by national officials. “Member states just basically said, ‘our publics don’t care,’” Gardner said.
Viewed through that lens, he said, a decision to ban something — whether GMOs or a vaccine — is more likely to be a response to market demand from the European public than an attempt to protect the European public from market forces.
That may mean it’ll be up to politicans to try to rev up demand. British Prime Minister Boris Johnson, French Prime Minister Jean Castex and Austrian Chancellor Sebastian Kurz have all said they expect to receive the jab soon.
Helen Collis, Rym Momtaz and Marion Solletty contributed reporting.
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