EMA Finds Possible Link Between Johnson & Johnson Vaccine and Rare Blood Clots

• The European Medicines Agency (EMA) has identified a potential connection between the Johnson & Johnson COVID-19 vaccine and very rare cases of unusual blood clotting disorders.
• The EMA's safety committee recommends adding a warning to the vaccine's product information, emphasizing that the benefits of the vaccine still outweigh the risks.
• The review included eight cases of serious blood clotting with low platelet levels in the U.S., where over seven million doses of the vaccine have been administered, primarily in women under 60.
• Health officials should be aware of the possibility of very rare blood clots combined with low blood platelet levels occurring within three weeks of vaccination.

Europe's medicines regulator, the European Medicines Agency (EMA), has identified a possible link between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual clotting disorders. This announcement has prompted authorities in Europe and the US to consider the implications for vaccination programs.

The EMA, based in Amsterdam, stated that its safety committee concluded a warning should be added to the vaccine's product information. Despite this finding, the agency maintains that the benefits of the vaccine outweigh its risks.

The EMA's review included eight serious cases of unusual blood clotting associated with low blood platelet levels. These cases, including one fatality, occurred in the US, where more than seven million people have received the Johnson & Johnson vaccine. All cases were in individuals under 60, predominantly women, within three weeks of vaccination. Similar to the AstraZeneca vaccine, the clots were primarily found in the brain and abdomen. The EMA has concluded that these events "should be listed as very rare side effects" of the vaccine.

The agency advises healthcare professionals and individuals receiving the vaccine to be aware of the potential for very rare cases of blood clots combined with low blood platelet levels within three weeks post-vaccination. The EMA emphasized that "Covid-19 is associated with a risk of hospitalization and death. The reported combination of blood clotting and low blood platelets is very rare, and the overall benefits of the [vaccine] in preventing the virus outweigh the risks of side effects."

With 200 million doses of the Johnson & Johnson vaccine ordered, the vaccination program is now accelerating after initial supply shortages and logistical challenges.