Crystal Jones, 52, head of the Athens City Department of Health, loads syringes of the vaccine on the first day of Johnson and Johnson’s vaccine.
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LONDON – The European Medicines Agency said Wednesday that the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh the risk of side effects following reports of extremely rare blood clotting.
It comes shortly after the US Food and Drug Administration asked states to temporarily suspend the use of J & J’s vaccine “out of caution” after six cases of bleeding disorder were detected from more than 6.8 million shot doses.
All six cases in the United States occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the shot. The FDA said one woman died from complications from blood clotting and another was in critical condition.
The European Medicines Agency has currently investigated all reported cases and will decide whether regulatory action is required.
“The EMA is currently accelerating this assessment and is currently expecting to issue a recommendation next week,” the European Medicines Agency said in a statement.
“During the ongoing review, the EMA continues to believe that the vaccine’s benefits in preventing COVID-19 outweigh the risks of side effects.”
South Africa has stopped the launch of the shot while J&J has announced it is “proactively delaying” delivery of its vaccine to Europe, which began last week.
The vaccine was approved in the EU on March 11, but widespread use of the shot has not yet started.
“Right now, these adverse events seem extremely rare,” the FDA said on Tuesday in a joint statement with the Centers for Disease Control and Prevention. “The safety of COVID-19 vaccines is a top priority for the federal government and we take all reports of health problems following COVID-19 vaccination very seriously.”
Last week, the European Medicines Agency said it had identified a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems. AstraZeneca has not received approval for use in the United States
Oxford-AstraZeneca and J&J vaccines work in a similar way, and both use an adenovirus, a common type of virus that typically causes mild cold symptoms.