AstraZeneca’s COVID-19 vaccine rollout has gotten off to a rocky start in Europe—to put it mildly. First, a supply shortfall triggered a public back-and-forth between executives and government officials. Then several countries expressed doubts about how well the vaccine works in people over 65. Now seven countries are raising safety concerns.
Denmark, Norway, Austria, Estonia, Latvia, Lithuania and Luxembourg have halted some or all of their AstraZeneca COVID-19 vaccinations over fears of blood clots, France24 reports.
Previously, Austria had stopped using a single batch of the vaccine after a clotting issue turned up in one recipient. In the wake of the news, Estonia, Latvia, Lithuania and Luxembourg stopped using vaccines from the same batch, France24 reports. Denmark and Norway temporarily stopped all vaccinations with AZ shots, according to the report.
An AstraZeneca spokesperson said patient safety is the company's "highest priority."
"Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 Vaccine AstraZeneca," she said. "The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated."
Thursday's news is only the latest negative development for the rollout of AZ's product. Since the vaccine's debut in Europe, public comments from governments, officials and even doctors have raised questions about the vaccine. Germany restricted its use in people 65 and older, citing a lack of data in the age group, and then reversed course.
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When the shot was initially restricted in her age group, German chancellor Angela Merkel said she doesn’t “belong to the group recommended for AstraZeneca.” Some publications ran with headlines that she’d refused the shot, creating confusion for citizens.
In January, French President Emmanuel Macron said the vaccine was “quasi-ineffective” in people 65 and older before his country gave the green light in the age group.
Adding to all the confusion, thousands of healthcare workers in Europe have refused the shot, Forbes reported last month. They argued they should receive the mRNA vaccines from Pfizer/BioNTech or Moderna.
The result? Europe’s vaccination program is lagging in other developed countries, as many AstraZeneca shots go unused.
As of Thursday, France, Germany, Italy and Poland had used less than half of the AstraZeneca vaccine doses on stock, according to data from the European Centre for Disease Prevention and Control. Those countries have received the highest number of doses, followed by Spain, which has used around 60% of its available stock and is pressing ahead with vaccinations.
Meanwhile, Europe significantly lags Israel, the UAE, the U.K., Chile and the U.S. in vaccinations given per 100 people, according to Our World In Data.
When the European Medicines Agency endorsed the AstraZeneca vaccine in late January, it said the product was OK to use in people 18 and older. At that time, study participants were mostly aged 18 to 55, so there wasn’t much available data on the vaccine’s effectiveness in older people, the EMA said. Still, EMA concluded that “protection is expected” for people 55 and older and there was “reliable information on safety in this population.”
That didn't satisfy health officials in several European countries, who moved to prioritize giving the AZ vaccine to those who they perceived would get the most benefit.
But in recent real-world data, U.K. authorities said the AstraZeneca vaccine cut symptomatic COVID by between 60% and 73% for people 70 and older. The results came via a pre-print, so the data haven't been peer-reviewed.
As a result of all the conflicting headlines, European countries could very well see demand fall for the AstraZeneca vaccine. Last month, Merkel acknowledged that there was an “acceptance problem,” according to reports. A new YouGov poll also contained troubling findings for the vaccine in Europe, even as people in the U.K. are proud of the shot.
Before the safety and efficacy doubts cropped up, officials were worried about supply. AstraZeneca had originally pledged 80 million doses of the shot for the first quarter but ran into issues bringing its supply chain up to speed. The company cut its expected first-quarter deliveries to 31 million, but then bumped the figure to 40 million after a public back-and-forth between government officials and executives.
For the second quarter, the company is planning to tap its global supply chain to deliver half of the 180 million doses slated to go to Europe.