EMA Says J&J Covid Vaccine’s Benefits Outweigh Rare Blood Clot Risks
European Medicines Agency Tuesday said it has found a possible link between the Johnson & Johnson’s (JNJ) Covid-19 vaccine and rare blood clots. However, the Europe’s medicines regulator pointed out that the overall benefits of getting the vaccine outweigh the risks.
EMA’s safety committee PRAC concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for Johnson & Johnson’s COVID-19 vaccine. PRAC also concluded that these events should be listed as very rare side effects of the vaccine.
PRAC said it considered all currently available evidence including eight reports of serious and unusual blood clots from the United States, where more than 7 million Johnson & Johnson Janssen vaccines have been given.
“All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women,” the EMA said. “Based on the currently available evidence, specific risk factors have not been confirmed.”
The agency added that “the 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.”
Despite EMA saying that the vaccine’s benefits outweigh its side effects risks, the agency’s findings is a setback to Johnson & Johnson, as it awaits the U.S. Food and Drug Administration’s decision after the vaccine was temporarily halted last week.
Last week, the FDA announced a temporarily halt on the usage of Johnson & Johnson’s Covid-19 vaccine after six recipients developed a rare blood clotting disorder.
Meanwhile, no new blood clotting cases have been confirmed one week after FDA halted the vaccine.
A spokesperson for the Centers for Disease Control and Prevention told Yahoo News on Monday that the agency’s database of vaccine-related medical complications, known as VAERS, “is constantly receiving reports from individuals and providers. CDC scientists have received a handful of adverse events reported in VAERS since the pause announced last week. At this time, no additional cases of the rare form of blood clots post-vaccination with the Johnson & Johnson vaccine have been confirmed.”
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