Deutsche Welle (English edition)
EMA issues warning over Johnson & Johnson vaccine, stops short of ruling against use
The EU's medicines regulator said that the benefits of the Johnson & Johnson coronavirus vaccine outweighed the risks, despite finding possible links to "very rare" cases of blood clots.
The European Medicines Agency (EMA) said Tuesday the Johnson & Johnson (J&J) COVID-19 vaccine has possible links to "very rare" cases of blood clots — but stopped short of ruling against using the oneshot dose.
The EMA said its safety committee had decided that a warning over unusual blood clots would suffice on the labels of J&J's vaccine, just as the health body did for AstraZeneca's doses.
The EU drug regulator said in a statement: "The EMA concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen [the market name for the J&J vaccine]." The EMA "also concluded that these events should be listed as very rare side effects of the vaccine."
"In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots."
Last week, J&J halted its European rollout after the US Food and Drug Administration (USFDA) recommended a pause to administering the shot while rare blood clot cases are investigated.
US health officials identified a very small number of unusual blood clotting disorders among nearly 7 million people who were immunized with the one-dose vaccine across the country.
US decision expected on Friday
Washington's pandemic chief Anthony Fauci said the United States is likely to announce its decision by Friday.
Fauci said he'd be, "very surprised if we don't have a resumption in some form."
Johnson & Johnson advised European governments to store their doses until the EMA had come to a conclusion.
The delay was a further blow to vaccination efforts in the European Union, which have been plagued by logistical problems and concerns over rare instances of blood clots in people who received the AstraZeneca vaccine.