Us covid deaths came than previously8/13/2023 ![]() In June 2022, EMA hosted a workshop with regulators, medical experts and researchers to review the understanding of the TTS and to discuss the related research agenda.ĮMA is following up with manufacturers and academic groups to ensure further research to investigate the pathophysiological mechanisms that cause these adverse reactions.For every 100,000 residents, 303 people have died from Covid-19, according to the Johns Hopkins University Coronavirus Resource Center. Up to May 2023, around 900 cases of TTS had been reported following vaccination with Vaxzevria and Jcovden, about 200 of which were associated with a fatal outcome.Īlthough the outcome is not necessarily linked to the vaccine’s side effect, it cannot be excluded that TTS caused death in some of these cases. Very rare events of TTS may occur after vaccination with COVID-19 vaccines Vaxzevria (previously COVID-19 Vaccine AstraZeneca) and Jcovden (previously COVID-19 Vaccine Janssen). Thrombosis with thrombocytopenia (TTS) is a rare syndrome, characterised by the formation of clots in the blood (thrombosis) combined with low blood platelets (thrombocytopenia) that can be fatal.īlood clots can appear in different and unusual parts of the body, such as the brain or the abdomen. EMA virtual workshop on myocarditis post COVID-19 vaccination ().In January 2023, EMA hosted a workshop to review the understanding of the epidemiology, clinical manifestation and pathophysiology of myocarditis. The Agency also works with researchers from around the world to help shape the research agenda on numerous safety topics. Nature: Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infectionĮMA continuously reviews data and studies likley to provide new relevant information.The infection with SARS-CoV-2, the virus that causes COVID-19, is a risk factor for myocarditis and pericarditis, and some studies suggest that it comes with a substantially increased risk of hospitalisation or death.įor more information, read the scientific article below: They have also been reported as side effects of Jcovden (previously COVID-19 Vaccine Janssen) and Nuvaxovid, with unknown frequency. Myocarditis and pericarditis usually occur within 14 days of vaccination. This happens more often after the second vaccination and in younger males. ![]() Myocarditis and pericarditis are conditions that cause the inflammation of the heart muscle or outer lining of the heart.īoth have been observed in very rare cases – less than 1 in 10,000 people vaccinated – with Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna). ![]() Serious side effects may occur, but they are very rare. Fatal outcomes have been reported in very few of these rare cases.įor a visual summary of how EMA monitors vaccine safety, watch the video below: The vast majority of known side effects are mild and short-lived. The safety profiles of the COVID-19 vaccines authorised in the EU are very reassuring. This ensures that healthcare professionals and patients have up-to-date information to hand. If there is at least a reasonable possibility that a vaccine could have caused a suspected side effect, it is included in the vaccine’s product information.
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