EMA Expands AstraZeneca Safety Probe After Reports of Rare Disorder

In more bad news for AstraZeneca, the European Medicines Agency (EMA) announced that its safety committee is investigating reports of capillary leak syndrome, a rare, potentially life-threatening disorder, in individuals inoculated with the company’s COVID-19 vaccine.

The agency said five cases of the syndrome — which can lead to tissue swelling, low blood pressure and organ failure — have been reported so far, but it’s not clear that there is a causal link to the vaccine.

The latest safety probe followed the EMA’s recommendation last week that the AZ vaccine  should include the risk of very rare blood clots on its list of possible vaccine side effects, a call that had already shaken public confidence in the shot, with some EU member states requiring various levels of age restrictions (DID, April 8).

The agency has also launched a separate safety review to assess reports of blood clots potentially linked with the Johnson & Johnson (J&J) vaccine (see related story).

In addition, the EMA is reportedly investigating whether the clinical trials supporting Russia’s Sputnik V vaccine violated ethical standards by allegedly coercing Russian citizens into participating.

In the U.S., meanwhile, the federal government’s stockpile of the AstraZeneca COVID-19 vaccine has grown to more than 20 million doses, although the company has yet to file for Emergency Use Authorization from the FDA. ― Jason Scott