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In addition to the unusual blood clots linked to the AstraZeneca COVID-19 vaccine, which have received extensive attention in the past couple of weeks, other safety signals are also being investigated with this vaccine, and now with Johnson & Johnson’s Janssen vaccine as well, the European Medicines Agency (EMA) reports.
Highlights of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) meeting April 6-9 include that the agency has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
It also reports that PRAC has started a review of a safety signal to assess reports of thromboembolic events with low platelets in people who received the COVID-19 Vaccine Janssen.
Capillary Leak Syndrome with AZ Vaccine
An EMA press release issued today notes that five cases of capillary leak syndrome, characterized by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure in individuals receiving the AstraZeneca vaccine, were reported in the EudraVigilance database.
“At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome. These reports point to a ‘safety signal’ — information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation,” the EMA states.
PRAC will evaluate all the available data to decide if a causal relationship is confirmed or not, it adds.
Thromboembolic Events with J&J/Janssen Vaccine
Four serious cases of unusual blood clots with low blood platelets have been reported postvaccination with COVID-19 Vaccine Janssen, EMA reports. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the US. One of them was fatal.
COVID-19 Vaccine Janssen is currently only used in the US, under an emergency use authorization. COVID-19 Vaccine Janssen was authorized in the EU on March 11. The vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.
The Janssen vaccine uses an adenovirus vector, as does the AstraZeneca vaccine.
PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information, it adds.