Meanwhile back home, schoolgirls jumped rope to a new chant: I had a little bird
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.Estimates of the number of deaths from the pandemic range from 21 million to 50 million worldwide. 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.
#Us covid deaths came than previously trial#
Regulators have an unprecedented amount of data to confirm the safety and efficacy of COVID-19 vaccines.īefore their authorisation, the vaccines were tested in tens of thousands of clinical trial participants to confirm they met EMA’s scientific standards for safety, efficacy and quality.Īs always, the benefits of these vaccines were weighed against the risks of side effects. Since December 2020, people in the EU and EEA received almost 1 billion doses of COVID-19 vaccines, making it the largest vaccination programme in history. It remains particularly dangerous for older or sick people with low immunity and those with faulty immune systems.Įstimates indicate that millions of lives have been saved by COVID-19 vaccination. Infection can cause severe disease and long-term damage, including in healthy adults and children. Vaccination is the best tool to prevent the consequences of infection. COVID-19 vaccines continue to protect people from severe disease and death caused by infection with SARS-CoV-2, the virus that causes COVID-19.
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