By Jenny Ortuoste
The European Medicines Agency (EMA) said Tuesday (April 20) that its safety committee (PRAC) concluded that the “overall benefit-risk remains positive” for the Janssen vaccine, while also recommending that a warning be included in the vaccine’s product information.
In a statement, the EMA said “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.”
Janssen is the vaccine development division of Johnson & Johnson.
PRAC said the warning label should alert the public about “unusual blood clots with low blood platelets” and added that these events “should be listed as very rare side effects of the vaccine.”
In coming up with its recommendation, PRAC considered “all currently available evidence,” including “eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome.”
Over 7 million people have received the Janssen vaccine in the United States as of April 13 this year.
“The risk of having this side effect is very low, but people who will receive the vaccine should still be aware of symptoms so they can get prompt medical treatment to help recovery and avoid complications,” EMA said.
“All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed.”
The cases they reviewed were “very similar” to the cases that occurred with Vaxzevria, the COVID-19 vaccine developed by AstraZeneca.
EMA said they will “continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.”
