The Hague, Apr 20 (EFE).- The European Medicines Agency on Tuesday found a “possible link” between the Johnson & Johnson’s Covid-19 vaccine and the occurrence of rare blood clots but insisted the benefits of the jab continued to outweigh the risk.
The EMA said a warning message should be added to the Janssen vaccine packaging but it continues to recommend its use in the European Union.
The medicine regulator came to these conclusions after a two-week investigation into eight blood clots cases detected in patients who received the vaccine in the United States.
“These events should be listed as very rare side effects of the vaccine,” the EMA said in a statement following a safety committee meeting held on Tuesday.
The use of the vaccine, administered to over 7 million people in the United States as of 13 April, has been suspended by the American authorities until the clots are investigated.
“The Committee took into consideration 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,” EMA said in a statement.
The vaccinated people in question were all under 60, mainly women. They developed the clots over the course of three weeks after being administered the jab.
“Based on the currently available evidence, specific risk factors have not been confirmed,” the statement added.
EMA considered the risk the coronavirus poses, which could lead to hospitalization or even death, is higher than the blood clots linked with the vaccine.
“The overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects,” it added.
“Use of the vaccine during vaccination campaigns at national level will take into account the pandemic situation and vaccine availability in individual Member States,” it continued.
Following a separate investigation at the end of March, the EMA said rare blood clot events with low platelets could also be a side effect of the AstraZeneca vaccine. EFE
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