Дана проблема з безпеки вже була висвітлена Європейською медичною агенцією (EMA), зокрема опубліковано звернення до спеціалістів системи охорони здоров’я (https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vaxzevria-previously-covid-19-vaccine-astrazeneca_en-1.pdf) та розміщена на сайті Державного експертного центру МОЗ України (https://www.dec.gov.ua/materials/shhodo-vnesennya-zmin-do-instrukcziyi-dlya-medychnogo-zastosuvannya-vakczyna-covid-19-chadox1-s-rekombinantna-vaxzevria-covid-19-astrazeneca-5/?role=applicant)
Audience
Healthcare professionals, including infectious disease specialists, family doctors, hematologists, neurologists, pharmacists, nurses.
Key messages
- Very rare cases of capillary leak syndrome (CLS) have been reported following the use of the AstraZeneca COVID-19 vaccine. Some reports include a history of CLS in the vaccinated persons. A fatal case has been recorded.
- AstraZeneca COVID-19 vaccine and COVISHIELD (a version of the AstraZeneca COVID-19 vaccine manufactured by Serum Institute of India) are now contraindicated in persons with a history of capillary leak syndrome.
- Capillary leak syndrome (CLS) is characterized by edema affecting mainly the extremities, hypotension, hemoconcentration and hypoalbuminemia. Patients with CLS after vaccination require immediate examination and further treatment. This life-threatening condition usually requires intensive supportive therapy.
- Health Canada has worked with the manufacturers of the AstraZeneca COVID-19 vaccine and COVISHIELD to update the package insert with new safety information.
- The benefits of the AstraZeneca COVID-19 and COVISHIELD vaccines continue to outweigh the risks. Canadian citizens are recommended to get vaccinated with any of the COVID-19 vaccines authorized for use in the country.
Reference information
AstraZeneca COVID-19 vaccine and COVISHIELD are intended for active immunization of persons aged 18 years and older.
As of June 18, 2021, one case of capillary leak syndrome after AstraZeneca COVID-19 vaccination had been registered in Canada.
The European Medicines Agency (EMA) reviewed 6 cases in detail, of which 3 had information on a history of capillary leak syndrome in the vaccinated individuals. One of these cases was fatal.
Persons who have been vaccinated with AstraZeneca COVID-19 or COVISHIELD should seek medical attention immediately if they develop symptoms such as rapidly developing swelling of the arms and legs, sudden weight gain, and a feeling of weakness due to low blood pressure.
The original text of this publication is available at the corresponding linkhttps://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75947a-eng.php
