AstraZeneca’s COVID vaccine suspended in more European nations over blood clot concerns

London — A growing number of European nations have suspended use of AstraZeneca’s COVID-19 vaccine over fears of health complications, despite the drug company and independent pharmaceutical regulators in the EU, the U.K. and the World Health Organization insisting there’s no evidence that it causes problems.

Denmark, Iceland and Norway were among the first to halt use of the Oxford University-developed vaccine on Thursday, March 11, due to concerns about several reports of recipients who later experience blood clots.

The following day, Thailand abruptly slammed the brakes on the vaccine the very day it was scheduled to be rolled out. Bulgaria also halted use of the vaccine on March 12, noting that a woman with severe underlying conditions died days after receiving it. A preliminary investigation found that she’d died of heart failure, and an autopsy found no link to the AstraZeneca shot.

Nonetheless, the blood clotting fears have kept spreading. On Saturday, Norwegian health officials said there were three more cases of younger adults experiencing blood clots or brain hemorrhages after getting the vaccine, though they noted they could not yet say whether there was any link to the drug. The next day Ireland and the Netherlands suspended use of the vaccine. 

On Monday, several major European countries joined in. Germany issued a blanket suspension — as a “precaution,” it said — while the clotting cases were investigated. France decided to suspend shots at least until Tuesday, when the European Medicines Agency will issue its recommendation over the vaccine. French President Emmanuel Macron said he hoped to resume using the shots “soon.” And Italy, which had previously suspended use of one batch of the AstraZeneca vaccine, extended the ban nationwide as a “precautionary and temporary measure” until the agency’s findings come in. Italy is investigating the death of one woman said to have had no major underlying conditions who died after getting the shot.

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Estonia, Lithuania, Latvia and Luxembourg have all suspended use of at least one batch of AstraZeneca vaccines delivered to various nations.

“No evidence”

The drug’s maker has remained adamant that there’s simply no data to suggest any link between its vaccine and any serious side effects, and several independent health authorities have backed up that stance. The AstraZeneca vaccine has now been given to tens of millions of people across Europe and elsewhere, and the Anglo-Swedish pharmaceuticals giant told CBS News last week there’s no link between its vaccine and blood clotting.

The European Union and the World Health Organization both said last week that there’s no evidence the drug is causing clots.

“An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country,” an AstraZeneca spokesman said. “In fact, the observed number of these types of events are significantly lower in those vaccinated than what would be expected among the general population.”

Officials from the European Medicines Agency stressed last week that “there is currently no indication that vaccination causes these conditions,” and “the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered.” 

On Monday, however, Germany officials suggested that the pan-EU agency could be reconsidering “whether and how the new information will affect the authorization of the vaccine.”

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Britain’s pharmaceuticals regulator issued fresh backing on Monday for the vaccine, which has been widely used for weeks across the U.K.

Dr. Phil Bryan, head of vaccine safety for the British Medicines and Healthcare products Regulatory Agency (MHRA), said people “should still go and get their COVID-19 vaccine when asked to do so.”

“We are closely reviewing reports but given the large number of [AstraZeneca] doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause,” he said, according to the BBC.

Even the countries that have paused the use of the vaccine in Europe have said there’s no evidence the clots were caused by the AstraZeneca shot — only that they occurred after it was administered.

Professor Andrew Pollard, Director of the Oxford Vaccine Group and a professor of Paediatric Infection and Immunity, receives the Oxford University/AstraZeneca COVID-19 vaccine from nurse Sam Foster at the Churchill Hospital in Oxford, England, January 4, 2021. Steve Parsons/Pool/REUTERS

The head of the Oxford Vaccine Group, Andrew Pollard, said real-world data from the U.K.’s mass-vaccination program recently showed a 94% drop in hospital admissions for those who have received the Oxford vaccine — even more impressive figures than with the Pfizer formula.

“We haven’t had any hospitalizations or deaths [from COVID] in those individuals who were vaccinated with the vaccine,” Pollard said. “So the real-world evidence confirms in real life what we saw in the clinical trials — it absolutely exceeded the expectations of the trials.”

U.S. approval, and PR problems

The United States has stockpiled tens of millions of doses of the vaccine, but AstraZeneca has yet to apply to the Food and Drug Administration for emergency medical use authorization, pending the results of U.S. clinical trials. An executive with the company told CBSN on March 5 that AstraZeneca hoped to apply for that authorization “in the next few weeks.”

Last year the Trump administration pledged almost $1.2 billion to AstraZeneca to help with the development of the vaccine at Oxford University in exchange for 300 million doses.

Easier and cheaper to manufacture and distribute than the other vaccines already approved in the U.S., the Oxford shot had long been considered the front-runner candidate for inoculation programs not only in America, but around the globe.  

More than 70 countries worldwide had been using it until last week.

The recent safety scares are just the latest in a series of publicity setbacks for the vaccine.

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With trial data showing efficacy that fell short of the Pfizer-BioNtech and Moderna vaccines, some people in Germany and other countries were reluctant to take a “second class” shot. The government there also stalled in approving its use for people over the age of 65, citing a lack of specific trial data, but that decision was reversed and German officials have been among those critical of the halt to vaccination programs in the other European countries this week.

South Africa also temporarily suspended the vaccine after a small clinical trial found that it failed to sufficiently protect against infection with the COVID-19 variant that has swept through that country.

The Associated Press and AFP contributed reporting.