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European AstraZeneca suspensions threaten global COVID response

European AstraZeneca suspensions threaten global COVID response
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European countries are pausing the use of the Oxford-AstraZeneca coronavirus vaccine over concerns of blood clots, colliding with expert opinion and creating a crisis of faith in the shot that could hamper progress to stop the COVID-19 pandemic.

Sweden and Latvia on Tuesday joined more than a dozen other European countries, including Portugal, Germany and Italy, that have publicly announced they are temporarily suspending use of the vaccine following reports of blood clots.

Europe's top medical regulator is insisting the vaccine is safe and that the benefits of preventing hospitalization and death from COVID-19 outweigh any possible side effects. 

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"At present, there is no indication that vaccination has caused these conditions," Emer Cooke, executive director of the European Medicines Agency, said during a Tuesday press conference. "They have not come up in clinical trials, and they're not listed as known or expected side events."

The agency has convened a safety committee of experts from across the European Union (EU) and beyond for an emergency meeting on Thursday to discuss and release the findings of its investigation into reports of rare but dangerous blood clots in the brain and abnormal bleeding.

The overall number of events "seemed not to be higher" in vaccinated people than in the general population, Cooke said. People are going to get blood clots, and just because they occurred shortly after vaccination does not mean there's a link. 

Asked about countries’ decisions to suspend the vaccine, Cooke said they were taken "in the context of the information that is available at the national level, and it is the country's prerogative to do so."

The World Health Organization (WHO) has also been quick to back the vaccine's safety and has encouraged countries to continue using the shot.

Mariângela Simão, a WHO assistant director-general, last week said she thinks people have confused causation with correlation.

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"People die every day," she said. "There will be people who have been immunized who will die of other causes. So far the preliminary data we have seen does not lead to a causal relationship."

AstraZeneca has also said there is no evidence linking its vaccine to blood clots. 

The British pharmaceutical company released a statement after it reviewed 17 million vaccines administered in Europe, saying it found only 15 events of deep vein thrombosis and 22 events of pulmonary embolisms.

But the flurry of suspensions is concerning health experts, who say the decisions do not seem to be supported by medical data. Not only could the pauses set back vaccination efforts across Europe, but they could have ripple effects across the world. 

"I think that many of these countries will have done damage to what is a good vaccine" said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. 

Even if the countries resume vaccinating people in a few days, the damage might have been done.

"What people are going to remember is not the fact that this is ... not a causal effect. What they're going to remember is hearing something vaguely about blood clots, and that's going to undermine confidence in the vaccine, which I think is especially dangerous," Adalja said.

Hundreds of millions of Europeans are facing the prospect of another strict lockdown as the continent struggles with a new wave of COVID-19 infections and a flawed vaccine rollout. Suspending AstraZeneca's shots could slow it down even more.  

Only about 9 percent of the eligible population across all EU countries has received at least one dose, according to the European Centre for Disease Prevention and Control.

By contrast in the U.S., nearly 22 percent of the population has received at least one shot, with nearly 2.2 million doses getting administered a day.

Many European countries are relying heavily on the Oxford-AstraZeneca vaccine, as it is being sold using a nonprofit model and is far cheaper to make than other COVID-19 vaccines.  

It is also the main shot being used by Covax, the global program to deliver vaccines to low- and middle-income countries.

But AstraZeneca has also been plagued with production issues. Last week, the company said it would try to deliver 30 million doses to the EU by the end of March, much less than its contractual obligation of 90 million and down from a previous promise made last month to deliver 40 million doses.

AstraZeneca has not yet filed for authorization with the Food and Drug Administration (FDA) because the FDA wants to wait for U.S. clinical trial results, which could come shortly.