EU drug regulator backs AstraZeneca-Oxford COVID-19 vaccine after safety investigation

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Germany, France and other European nations announced plans to resume using the AstraZeneca-Oxford COVID-19 vaccine on Thursday after European Union and British regulators moved to shore up confidence in the shot, saying its benefits outweigh the risks.

Reports of rare brain blood clots had prompted more than a dozen nations to suspend use of the shot, the latest challenge for AstraZeneca’s ambition to produce a “vaccine for the world,” as the global death toll from the coronavirus continues to grow.

The European Medicines Agency’s (EMA) “clear” conclusion following an investigation into 30 cases of unusual blood disorders was that the vaccine’s benefits in protecting people from coronavirus-related death or hospitalization outweigh the possible risks, though the agency said a link between blood clots in the brain and the shot could not be definitively ruled out.

“This is a safe and effective vaccine,” EMA director Emer Cooke told a briefing. “If it were me, I would be vaccinated tomorrow.”

WATCH | EMA on the AstraZeneca-Oxford vaccine:

The AstraZeneca COVID-19 vaccine is safe and does not appear to cause blood clots, says the European Medicines Agency, after a review by an expert committee. But the EMA couldn’t rule out a link to blood clots entirely. 1:22

Within hours, Germany said it would resume administering the AstraZeneca vaccine beginning Friday morning. Health Minister Jens Spahn said suspending the vaccine out of caution had been the right call “until the clustering of this very rare type of thrombosis had been examined.”

France also said it would resume use of the vaccine, with Prime Minister Jean Castex saying he would receive the shot himself on Friday afternoon.

Italian Prime Minister Mario Draghi said Italy would do the same, and that his government’s priority remained to vaccinate as many people as quickly as possible.

Spain said it was evaluating the possibility of resuming use of the vaccine, while Cyprus, Latvia and Lithuania said they would resume administering the vaccine.

A vaccination centre in Erfurt, Germany, deserted on Tuesday after thousands of appointments were cancelled due to the country’s temporary suspension of the AstraZeneca-Oxford COVID-19 vaccine. (Martin Schutt/dpa/The Associated Press)

Many governments had said the decision to pause inoculations was out of an abundance of caution. But experts have warned political interference could undermine public confidence in vaccinations as governments struggle to tame more infectious variants of the coronavirus.

“We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe,” said AstraZeneca Chief Medical Officer Ann Taylor in a statement.

The EMA’s review covered 20 million people given the AstraZeneca shot in the U.K. and the European Economic Area (EEA), which links 30 European countries.

WATCH | Inside the race to get COVID-19 vaccines to Canadians:

CBC’s David Cochrane goes inside the processes of vaccine delivery and distribution as well as the challenges to deliver on the promise of at least one shot for every Canadian who wants it by July 1. 4:08

Safety concerns had led at least 13 European countries to stop administering the shot, slowing an already faltering inoculation campaign in the EU, which lags behind Britain and the United States.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said earlier that it was investigating five reported cases of the rare brain blood clot out of 11 million shots administered in the U.K.

It said it would investigate reports of clots in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination.

But the agency said use of the vaccine should continue and one official said Britain’s rollout would likely continue even if a link was proved.

British Prime Minister Boris Johnson, left, looks on as a man receives a dose of the AstraZeneca-Oxford COVID-19 vaccine at a Boots pharmacy in Uxbridge, England, Thursday. (Leon Neal/Getty Images)

‘Clarity about the safety’

The AstraZeneca shot was among the first and cheapest of the COVID-19 vaccines to be developed and produced at volume and is set to be the mainstay of vaccination programs in much of the developing world.

Clemens Wendtner, head of infectious diseases at Munich clinic Schwabing, said the EMA’s verdict “now provides clarity about the safety of this vaccine,” which he said should now be used at a high rate to prevent what he called “sometimes serious medical harm from COVID-19.” 

The drugmaker’s own review covering more than 17 million people who have received its shot in the EU and Britain found no evidence of increased risk of blood clots.

The World Health Organization this week also reaffirmed its support for the shot.

The EMA said it would update its guidance on the AstraZeneca vaccine to include an explanation for patients and health-care professionals about potential risks.

The agency said it is in touch with regulators around the world to keep tabs on possible side effects of all COVID-19 vaccines.

A midwife gets her first shot of the AstraZeneca-Oxford COVID-19 vaccine in San Jacinto, eastern Guatemala, on Thursday. (Moises Castillo/The Associated Press)



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