The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC) containing important information for healthcare professionals who administer immunization with the Vaxzevria/COVID-19 AstraZeneca vaccine
Dear healthcare professional!
[
Applicant], in agreement with the European Medicines Agency (EMA) and [
the National Competent Authority], informs you of the following:
Summary
- In the first days after vaccination with Vaxzevria/COVID-19 AstraZeneca, very rare cases of capillary leak syndrome (CLS) were reported. In some cases, a history of this syndrome was evident. A fatal case was reported.
- Vaxzevria/COVID-19 AstraZeneca is now contraindicated in persons with a history of capillary leak syndrome.
- CLS is characterized by acute episodes of edema affecting mainly the limbs, hypotension, hemoconcentration and hypoalbuminemia. Patients with an acute episode of CLS after vaccination require immediate diagnosis and further treatment. Intensive supportive therapy is usually necessary.
Information on safety concerns
Vaxzevria/COVID-19 AstraZeneca is intended for active immunization of persons aged 18 years and older.
Very rare cases of TTS have been reported after vaccination with Vaxzevria/COVID-19 AstraZeneca. The estimated incidence is 1 case per 5 million doses. In some cases, a history of TTS in the past was noted.
Capillary leak syndrome is a rare disease characterized by a dysfunctional inflammatory response, endothelial dysfunction and extravasation of fluid from the vascular space into the interstitial space, which leads to shock, hemoconcentration, hypoalbuminemia and may theoretically lead to organ failure. Patients may experience rapid swelling of the arms and legs, sudden weight gain and a feeling of weakness due to low blood pressure.
Some cases of systemic CRPS reported in the literature were caused by COVID-19 infection. CRPS rarely occurs in the general population, with fewer than 500 international cases described in the literature (National Organization for Rare Disorders), however, it is quite likely that the estimates are lower than the actual figures.
The full text of the communication to healthcare professionals on the safety of the use of Vaccine Vaxzevria/COVID-19 AstraZeneca can be found at the corresponding linkhttps://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vaxzevria-previously-covid-19-vaccine-astrazeneca_en-1.pdf
