Confirms overall benefit-risk remains positive
EMA’s safety committee (PRAC) recently concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC 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 US of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of April 13, 2021, over seven million people had received Janssen’s vaccine in the US.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed.
PRAC noted that the blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and arteries, together with low levels of blood platelets and sometimes bleeding. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
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.
EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. The use of the vaccine during vaccination campaigns at the national level will take into account the pandemic situation and vaccine availability in the individual Member States.
One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin-induced thrombocytopenia, HIT.
PRAC emphasises the importance of prompt specialist medical treatment. By recognising the signs of blood clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications. Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.
As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.
A similar signal evaluation was recently finalised for another COVID-19 vaccine, Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
Information for the public
- Cases of unusual blood clots with low platelets have occurred in people who received Janssen’s COVID-19 vaccine in the US.
- The risk of having this side effect is very low, but people who will receive the vaccine should still be aware of symptoms so they can get prompt medical treatment to help recovery and avoid complications.
- Individuals must seek urgent medical attention if they have any of the following symptoms in the three weeks after being vaccinated with COVID-19 Vaccine Janssen:
- shortness of breath
- chest pain
- leg swelling
- persistent abdominal (belly) pain
- neurological symptoms, such as severe and persistent headaches or blurred vision
- tiny blood spots under the skin beyond the site of the injection.
- Speak to your healthcare professional or contact your relevant national health authorities if you have any questions about your vaccination.
Information for healthcare professionals
- EMA has reviewed eight cases of thrombosis in combination with thrombocytopenia in people who received Janssen’s COVID-19 vaccine in the US.
- These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis mostly in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis, as well as arterial thrombosis, and fatal outcome in one case. All cases occurred in people below 60 years of age, and most were in women, within three weeks of the person being vaccinated.
- The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
- As for the mechanism, it is thought that the vaccine may trigger an immune response leading to a heparin-induced-thrombocytopenia like disorder. At this time, the pathophysiological mechanism has not been established, and it is currently not possible to identify specific risk factors.
- Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia so that they can promptly treat people affected in line with available guidelines.
- Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.
- Healthcare professionals should tell people receiving the vaccine that they must seek medical attention if they develop:
- symptoms of blood clots such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
- neurological symptoms such as severe and persistent headaches and blurred vision
- petechiae beyond the site of vaccination after a few days.
- The benefits of the vaccine continue to outweigh the risks for people who receive it. The vaccine is effective at preventing COVID-19 and reducing hospitalisations and deaths.