The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine hRVFV-4s against the Rift Valley fever virus. The public consultation will run from 30 April 2021 to 30 May 2021.
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PRAC April 2021 – Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen
During its April 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded on very rare cases of unusual blood clots with low blood platelets reported with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and started reviewing a safety signal of capillary leak syndrome in patients vaccinated Vaxzevria. Furthermore, the PRAC is also investigating thromboembolic events reported following vaccination with COVID-19 Vaccine Janssen.
Pilot project on Clinical Trial Regulation (CTR): webinar on the new temporary procedure for submission of initial dossiers
From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. This procedure will be explained during a webinar on 4 February 2021 at 2 PM.