EMA Says Johnson & Johnson’s COVID-19 Vaccine’s Benefits Outweigh Side Effects
The European Medicines Agency Wednesday said that it believes the benefits of Johnson & Johnson’s (JNJ) COVID-19 vaccine outweigh the risks of side effects. The regulator issued the statement following a temporary halt of the vaccine in the US after reports of extremely rare blood clotting.
The other day, the U.S. Food and Drug Administration announced a temporarily halt on the usage of Johnson & Johnson’s Covid-19 vaccine after six recipients developed a rare blood clotting disorder.
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
All six recipients who developed the rare blood clotting disorder were women aged between 18 and 48. All of them developed the symptoms within one to three weeks of vaccination. One woman died and a second woman in Nebraska is in critical condition. More than 6.8 million doses of the vaccine have been administered in the US.
Meanwhile, the European Medicines Agency said it is currently investigating all the reported cases and will decide whether regulatory action is required.
“EMA is expediting this evaluation and currently expects to issue a recommendation next week,” the regulator said in a statement.
“While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.”
Johnson & Johnson’s Covid-19 vaccine was authorized in the EU on March 11, but the widespread use of the shot has not yet started.
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