The European Medicines Agency (EMA) has identified a possible link between the Johnson & Johnson coronavirus vaccine and rare cases of deep vein blood clots. The agency has recommended that this condition be listed as a side effect of the vaccine. This determination comes after a review of safety data following the administration of the vaccine.
Adverse Reactions and Recommendations
In addition to the blood clot link, the EMA has also recommended that immune thrombocytopenia, a bleeding disorder caused by the body attacking platelets, be added as an adverse reaction with an unknown frequency for both the Johnson & Johnson and AstraZeneca vaccines. These recommendations are based on ongoing monitoring and assessment of post-vaccination adverse events.
Johnson & Johnson has responded to the EMA's findings by stating that the chances of experiencing these conditions are very small. The company has committed to updating product information accordingly, reflecting close cooperation with regulatory authorities, including the EMA. "We strongly support raising awareness of the signs and symptoms of rare events to ensure their prompt identification and effective treatment," the company stated.
Thrombosis with Thrombocytopenia Syndrome (TTS)
Both the Johnson & Johnson and AstraZeneca vaccines have previously been associated with a very rare combination of blood clotting and low platelet counts known as thrombosis with thrombocytopenia syndrome (TTS). These vaccines are based on harmless vector viruses that instruct human cells to produce a protein that prevents infection. The EMA's latest findings differentiate venous thromboembolism (VTE) from TTS.
Venous Thromboembolism (VTE)
The EMA stated that the new life-threatening clotting condition is known as venous thromboembolism (VTE), which will be added to Johnson & Johnson product labels separately from TTS. VTE typically begins with a clot forming in a vein in the leg, arm, or groin, which can then travel to the lungs and block blood flow. While vaccine use is a consideration, VTE is most often caused by injury or lack of movement in patients who spend a lot of time lying down. Other risk factors include birth control pills and certain chronic conditions.
