AstraZeneca

Will the AstraZeneca Vaccine Be Approved in the US? What We Know as Europe Divides

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AstraZeneca has been eyeing a spring approval in the U.S. for its COVID vaccine, but as the shot sits at the center of concerns in Europe, with countries divided over how to handle the rollout, could that impact what happens here?

Germany, France and Italy on Monday became the latest countries to suspend use of AstraZeneca’s COVID-19 vaccine over reports of dangerous blood clots in some recipients, though the company and European regulators have said there is no evidence the shot is to blame.

AstraZeneca said on its website that there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country European Union and Britain. The drugmaker said there is no evidence the vaccine carries an increased risk of clots.

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In fact, it said the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.

The European Medicines Agency and the World Health Organization have also said that the data does not suggest the vaccine caused the clots and that people should continue to be immunized.

The European Medicines Agency said "there is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine."

"The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing," the agency stated.

Denmark was the first to temporarily halt use of the AstraZeneca vaccine Thursday after reports of blood clots in some people. Norway, Iceland and Bulgaria followed suit and suspended use of the vaccine.

Thailand and Congo have also delayed use of the vaccine, pending an investigation, while Italy and Romania stopped using shots from one particular batch. Austria has also halted use of doses from a single, but different, batch.

France, Poland and Nigeria, meanwhile, said they would continue using the AstraZeneca shot even as national regulators investigate.

The blood clots aren't the only concern to arise with the AstraZeneca vaccine, however.

Chicago's top doctor said earlier this month that the COVID-19 vaccine developed by AstraZeneca and the University of Oxford "has performed well broadly," but there were concerns it may not be as effective against the coronavirus variant that emerged in South Africa.

"There's been some extra attention sort of looking at looking at the vaccine in that context, but it has generally also been a very good vaccine," Arwady said.

She added the vaccine could appear before the U.S. Food and Drug Administration sometime in April.

"In addition to the three that have been approved or have been authorized here in the U.S., we're keeping our eye on AstraZeneca," Arwady said Thursday. "It's already in use in Europe and some other countries and it's been, you know, it's been having its studies here... we'll see. They weren't done yet, but there's been some speculation that, you know, possibly in April we could see that vaccine."

Concerns over vaccine effectiveness with newer variants of the virus, particularly the South African variant, have also been raised with other vaccines.

The variant from South Africa, for example, reduced Pfizer-BioNTech's antibody protection by two-thirds, according to CNBC, citing a February study. Meanwhile, Moderna's neutralizing antibodies dropped six-fold, according to the report.

To compare each of the three coronavirus vaccines currently available to Illinois residents, click here.

The AstraZeneca shot has become a key tool in European countries’ efforts to vaccinate their citizens against COVID-19. But Pfizer's and Moderna's vaccines are also used on the continent, and Johnson & Johnson's one-shot vaccine has been authorized but not yet delivered.

In the U.S., which relies on the Pfizer and Moderna vaccines, AstraZeneca is expected to apply any day now for authorization.

NBC Chicago/Associated Press
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