Europe has been in a full-blown panic over a coronavirus vaccine the science shows to be safe and effective. Beginning early this month, 20 countries halted distribution of the two-dose vaccine from the consortium of Oxford University and U.K. pharma AstraZeneca, after a Danish woman died of blood clotting shortly after getting a dose.
But experts and top health officials are nearly unanimous in objecting to the stoppage, which Europe’s top medical authority on Thursday affirmed was not warranted. There’s no clear link between the clotting and the vaccine, and the panic, experts point out, has been stoked by misinformation. But halting vaccinations—even briefly—could do a whole lot of harm as many European countries experience a fresh surge in coronavirus infections. And the unjustified meltdown over the AstraZeneca jab isn’t just a major setback for Europe’s faltering effort to vaccinate people and slow the pandemic; it has implications for America’s own, more successful effort as well.
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AstraZeneca is on track to submit, any day now, its vaccine to the U.S. Food and Drug Administration. The FDA could swiftly authorize the jab for emergency use, adding potentially hundreds of millions of doses to the U.S. supply in the near future.
But even if the FDA gives AstraZeneca the nod, the shot’s sullied reputation in Europe could weigh on uptake in the United States. Tens of millions of Americans are already unjustifiably skeptical of vaccines. The panic in Europe could make them even more skeptical.
“If you ban the use of one of the few approved COVID vaccines in a whole country, you’re talking about a real setback in the real progress we’ve been making in controlling the pandemic,” Irwin Redlener, the founding director of Columbia University’s National Center for Disaster Preparedness, told The Daily Beast. “These decisions should not be taken lightly.”
Regulators from the European Medicines Agency approved the AstraZeneca vaccine for distribution in late January. The Oxford-AstraZeneca consortium pledged to supply 40 million doses across the continent by the end of March. Officials quickly administered 20 million doses across the United Kingdom and the European Union.
Inoculations were just ramping up when they came to a screeching halt. On March 11, the Danish Medicines Agency froze administration of the AstraZeneca shot for two weeks. The reason: A 60-year-old woman had died of a blood clot—“thromboembolism” is the medical term—10 days after getting the vaccine. “It was an unusual course of illness around the death,” the agency stated.
The stoppage sparked a flurry of panicky media coverage. A few scattered reports of blood-clotting among recently vaccinated people—and at least one more clotting-related fatality, in Italy—only stoked the fear and outrage.
Soon Norway, Iceland, Romania, Bulgaria, Ireland, Italy, Spain, Germany, the Netherlands, Slovenia, and nearly a dozen other countries had joined Denmark in temporarily withdrawing the AstraZeneca vaccine.
AstraZeneca pointed out that its own review of the vaccine’s safety data showed “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis, or thrombocytopenia, in any defined age group, gender, batch or in any particular country.” The company didn’t respond to a request for further comment.
The European Medicines Agency and the World Health Organization also objected. “There is currently no indication that vaccination has caused these conditions,” the EMA stated.
Still, amid the uproar, the EMA conducted an extensive review and found seven cases of clotting among the millions of people who have received the vaccine in the EU and the United Kingdom. The review, released Thursday, effectively reaffirmed the agency’s earlier insistence that the AstraZeneca shot “is not associated with an increased overall risk of blood clotting disorders.”
“There have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination,” the EMA acknowledged. But the agency found no causal link.
The clotting cases are almost certainly coincidences, the WHO has likewise pointed out. “Vaccination against COVID-19 will not reduce illness or deaths from other causes,” the organization stated. “Thromboembolic events are known to occur frequently. Venous thromboembolism is the third most common cardiovascular disease globally.”
The problem is a philosophical one: Correlation isn’t causation. Yes, a few people had clotting problems after getting vaccinated. No, there’s no reason to believe the two things are related.
“The key is to look at the frequency of those potential side effects and see if they are more than expected,” Jeffrey Klausner, a USC clinical professor of preventive medicine who previously worked at the U.S. Centers for Disease Control and Prevention, told The Daily Beast. “Currently, the frequency of blood clots is as expected, not increased with AstraZeneca vaccination.”
Halting vaccination probably won’t save people from unrelated blood clots. But it could end up prolonging their risk of catching COVID. And at a bad time. After a sharp decline in new COVID cases last month, infections are now increasing in many European countries. New cases have increased to around 190,000 a day continent-wide, up from a recent low of around 150,000 a day in mid-February. Some countries are enacting new lockdowns.
It’s a spring surge. And there’s just one thing that can end it for good: vaccines.
For Europe, withholding the AstraZeneca jabs, however briefly, is unilateral immunological disarmament. And it baffles experts.
“We can’t make decisions that will derail the majority of the population from getting vaccinated against SARS-CoV-2 without scientifically significant evidence,” Aimee Bernard, a University of Colorado immunologist, told The Daily Beast.
To be fair, other vaccines are available in Europe, including two-dose jabs from Pfizer and Moderna and a single-dose shot from Johnson & Johnson. The FDA has approved all three of those vaccines for distribution in the United States.
But the AstraZeneca vaccine is unique. It includes a chimpanzee adenovirus—a cold virus, essentially—that the consortium has modified to carry a chunk of the novel coronavirus’ distinctive spike protein.
That protein prompts an immune response in human beings, as the consortium’s large-scale, phase 3 trials—involving 17,000 people in the United Kingdom, Brazil, and South Africa—definitively proved. The vaccine is 82 percent effective at preventing infection and 100 percent effective at preventing serious COVID or death, making it nearly as effective as the gold-standard messenger-RNA vaccines from Pfizer and Moderna.
There are signs the AstraZeneca jab is somewhat less effective against some of the new SARS-CoV-2 variants. But then, the other leading vaccines almost certainly have the same problem. At the same time, the AstraZeneca shot is cheaper to produce and easier to handle than many of the other vaccines.
“The AstraZeneca vaccine is going to be the engine that vaccinates the world,” Lawrence Gostin, a Georgetown University global health expert, told The Daily Beast. Taking the jab out of circulation, even if only for the review period, stalls that engine.
And there’s some danger the European panic could spread to the United States. Most Americans are eager to get vaccinated, but even among this majority there are strains of skepticism toward particular vaccines—often without any scientific basis.
Consider the controversy surrounding the Johnson & Johnson vaccine. There’s a sense in the United States that the jab is less effective than the Pfizer and Moderna vaccines. And that prompted some local officials to reject shipments from Johnson & Johnson.
In fact, the Johnson & Johnson shot is more thoroughly tested against a wider range of COVID variants than the other vaccines. That extensive testing may have had the side effect of driving down the jab’s average effectiveness. It’s simply been up against more different variants, some of them quite nasty.
But it’s unfair to ask everyday Americans to understand that kind of scientific nuance. “The general public is often quick to connect dots that don’t exist,” Bernard said.
When European governments blocked the AstraZeneca vaccine on the basis of a logical fallacy, they sent a misleading message to skittish people all over the world that the shot is unsafe.
Redlener said he expects an “explosion of bullshit on the web” if and when the FDA approves the AstraZeneca vaccine. And that could scare people away from all coronavirus vaccines. “It doesn’t take much to turn someone off,” Redlener warned.
The science is on AstraZeneca’s side, regardless of what the media and politicians say and do. Experts are clear that if the AstraZeneca vaccine becomes available to you, you should take it. It almost certainly won’t hurt you. And it almost certainly will protect you from COVID-19.
“I would personally feel comfortable getting the AstraZeneca vaccine,” Redlener said. “And I think others should, too.”
