Saturday, July 3, 2021

AstraZeneca’s COVID vaccine faces new round of restrictions—even after the EMA’s renewed backing


Several countries stopped using AstraZeneca’s COVID-19 shot earlier this month after reports of rare blood clots following vaccination. The European Medicines Agency sought to add clarity to the issue after an urgent safety review, but now regulators are slapping a fresh batch of restrictions on the shot.

Even after the European Medicines Agency endorsed the shot’s overall profile two weeks ago, Germany has suspended its use in people under 60, CNBC reports. It’s a complete turnabout for the country, which previously recommended against the vaccine in people 65 and older. 

Germany’s vaccine regulator has recorded 31 cases of rare blood clots in the brain following the AZ shot, Reuters reports. Nine resulted in deaths. In 19 cases, patients had low levels of blood platelets. 

RELATED: 7 European countries clamp down on AstraZeneca COVID-19 vaccine as safety worries threaten rollout 

Germany was one of several countries to suspend vaccinations with AZ shots earlier this month on the heels of reports of rare blood clots. European officials quickly kicked off a safety review, and concluded on March 18 that the shot’s benefits still outweigh the risks.  

Still, officials with the European Medicines Agency couldn’t rule out the possibility of rare blood clots, so they moved to raise awareness of potential risks. The hope was that if people knew what to look out for, they could “spot and mitigate” any possible side effects, EMA executive director Emer Cooke said at the time. 

But even after the EMA’s backing of the vaccine, Denmark extended its suspension. The country was among those to clamp down on vaccinations before the review.

On Wednesday, the EMA said it was continuing its review of “very rare cases of unusual blood clots associated with low numbers of platelets.” The agency convened an expert meeting Monday on the subject. 

Meanwhile, in Canada, officials this week halted vaccinations in people 55 and younger. The rare clots have been seen mostly in women under 55, CNN reports.

An AstraZeneca representative said that numerous regulatory authorities have “concluded that the benefits of using our vaccine to protect people from this deadly virus significantly outweigh the risks across all adult age groups.” The company respects the decisions taken by officials in Germany and Canada and will work with authorities to address their concerns, she said.

“Patient safety remains AstraZeneca’s highest priority and the company has robust processes in place for the collection, analysis and reporting of adverse events and these are shared with regulatory authorities around the world,” she added.

RELATED: Europe endorses AstraZeneca’s COVID-19 vaccine’s safety amid blood clot concerns 

Safety concerns haven’t been the only stumbling block for the vaccine’s rollout. Supply issues have featured throughout the launch, and AstraZeneca earlier this month cut its overall supply projection in Europe for the first half of 2021. After originally pledging 300 million doses to Europe through June, the pared that number down to 100 million doses.  

Plus, confusion over U.S. trial data spawned a whole new controversy last week. After the company reported that its shot was 79% effective in a phase 3 trial, U.S. officials published an unusual statement raising concerns about the data and calling on the drugmaker to get with the data monitoring board to update its findings. Days later, AZ said the shot was 76% effective. Experts have said the episode could contribute to vaccine hesitancy. 



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