EU regulator finds potential link between rare blood clotting and J&J vaccine
The European Medicines Agency said on Tuesday that Johnson & Johnson's Covid-19 vaccine may have links to rare blood- clotting cases, but assured that the benefits of the shot outweigh the risks.
″(The) 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 Covid-19 Vaccine Janssen,” the agency said in a press release.
“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.”
“Covid-19 is associated with a risk of hospitalisation and death. The reported 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,” the EMA stated on Tuesday, using the name of J&J’s Belgian unit.
The EMA released its statement after researching all available evidence, including US reports and the decision from the Food and Drug Administration to suspend its use temporarily.
J&J's shot, which only requires one does, was initially greenlighted in the European Union on 11 March.
Countries will have to interpret the latest guidance from the EMA individually and decide its use.