Wie kann das möglich sein?? Abschluss der Versuche in 2023!!
31.03.2024
ema.europa.eu/en/documents/ass…-assessment-report_en.pdf
In order to confirm the efficacy and safety of Comirnaty, the MAH should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591001. - December 2023
C4591012 - Assessment of occurrence of safety events of interest, including severe or atypical COVID-19 in real-world use of COVID-19 mRNA vaccine. - Final CSR submission: 31-Dec-2023
C4591010 - Assessment of occurrence of safety events in real-world use of COVID-19 mRNA vaccine. - AnaphylaxisAESI-based safety events of interest Use in pregnancy Long-term safety data. - Final CSR submission: 31-Mar-2024
C4591014 - Estimate the effectiveness of 2 doses of COVID-19 mRNA vaccine against potential COVID-19 illness requiring admission to the ED or hospital where SARS-CoV-2 is identified - Final CSR submission: 30-Jun-2023
ACCESS/VAC4EU - Assessment of occurrence of safety events of interest, including severe or atypical COVID-19 in real-world use of COVID-19 mRNA vaccine. - AnaphylaxisAESI-based safety events of interest including vaccine associated enhanced disease Use in pregnancyUse in immunocompromised patientsUse in frail patients with co-morbidities (e.g, chronic obstructive pulmonary disease (COPD), diabetes, chronic neurological disease, cardiovascular disorders)Use in patients with autoimmune or inflammatory disorders - 31-Jan-2024