Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment


News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021 (new)
PRAC, Last updated: 09/04/2021
PRAC conclusion on very rare cases of unusual blood clots with low blood platelets with Vaxzevria (AstraZeneca’s COVID-19 vaccine)
EMA’s safety committee (PRAC) has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.
EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of blood clots combined with low levels of blood platelets occurring very rarely within 2 weeks of vaccination…
PRAC reviews signal of capillary leak syndrome with Vaxzevria (AstraZeneca’s COVID-19 vaccine)
PRAC has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
Five cases of this very rare disorder, characterised by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure, were reported in the EudraVigilance database.
At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome. These reports point to a ‘safety signal’ – information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation…



European Commission

European Commission [to 10 Apr 2021]
Press release 7 April 2021
Coronavirus: Commission mobilises €123 million for research and innovation to combat the threat of variants
The Commission is mobilising €123 million from Horizon Europe, the new EU research and innovation programme, for urgent research into coronavirus variants. This first emergency funding under Horizon Europe adds to a range of EU-funded research and innovation actions to fight the coronavirus and contributes to the Commission’s overall action to prevent, mitigate and respond to the impact of coronavirus variants, in line with the new European bio-defence preparedness plan HERA Incubator