Johnson & Johnson/Janssen vaxx gets new risk rating factors from European Medicines Agency regarding deep vein blood clotting and targeting of blood platelets by the immune system.
"The PRAC has concluded that there is a possible link to rare cases of venous thromboembolism (VTE) with COVID-19 Vaccine Janssen.
VTE is a condition in which a blood clot forms in a deep vein, usually in a leg, arm or groin, and may travel to the lungs causing a blockage of the blood supply, with possible life-threatening consequences. This safety issue is distinct from the very rare side effect of thrombosis with thrombocytopenia syndrome (TTS) (i.e. blood clots with low blood platelets)."
"The PRAC assessed cases of immune thrombocytopenia (ITP) reported following vaccination with Vaxzevria (formerly AstraZeneca COVID-19 Vaccine) as well as COVID-19 Vaccine Janssen.
ITP is a condition in which the immune system mistakenly targets blood cells called platelets that are needed for normal blood clotting. Very low levels of blood platelets can be associated with bleeding, and have serious health consequences.
The committee assessed all the available data and recommended updating the product information of both vaccines to include ITP as an adverse reaction with an unknown frequency.
Furthermore, a warning statement has been agreed to highlight that cases of very low levels of blood platelets have been reported very rarely, usually within the first four weeks following vaccination with COVID-19 Vaccine Janssen or Vaxzevria."
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-september-2021