EMA recommendation for non-use of AstraZeneca in people with capillary leakage syndrome
All information on the new recommendation of Coreper
The EMA Safety Committee (PRAC) has concluded that people with a history of capillary leakage syndrome should not be vaccinated with Vaxzevria (vaccine COVID-19 AstraZeneca). The committee also concluded that capillary leakage syndrome should be added to the product information as a new side effect of the vaccine, along with a warning to raise the awareness of health professionals and patients about this risk.
The committee conducted an in-depth review of 6 cases of capillary leakage syndrome in people who had received Vaxzevria. Most cases occurred in women and within 4 days of vaccination. Three of those infected had a history of capillary leakage syndrome and one of them later died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered to the EU / EEA and the United Kingdom.
Capillary leakage syndrome is a very rare, serious condition that causes fluid to leak from small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low levels of albumin in the blood (a major blood protein).
Health professionals should be aware of the signs and symptoms of capillary leak syndrome and the risk of recurrence in people who have previously been diagnosed with the condition.
People who have been vaccinated with Vaxzevria should seek immediate medical attention if they experience rapid swelling of the arms and legs or sudden weight gain in the days following the vaccination. These symptoms are often associated with fainting (due to low blood pressure).
PRAC will continue to monitor cases of the disease and will take the necessary further action. PRAC also asked AstraZeneca, the marketing company Vaxzevria, for more information on a possible mechanism for developing capillary leakage syndrome after vaccination.
Very few cases of capillary leak syndrome have occurred in people who have received Vaxzevria (vaccine COVID-19 AstraZeneca).
You should not take Vaxzevria if you have previously had capillary leak syndrome.
Capillary leakage syndrome is a serious condition. The chance of developing the condition is very low, but you should still be aware of the symptoms so that you can receive immediate medical attention to help you recover and avoid complications.
You should seek medical attention immediately if you have any of the following symptoms in the days after vaccination, which may be accompanied by fainting (due to low blood pressure):
rapid swelling of the arms and legs
sudden weight gain.
Talk to your healthcare professional or contact the relevant national health authorities if you have any questions about the availability of the vaccine in your home country.
Information for health professionals
EMA looked at cases of capillary leakage syndrome in people who received Vaxzevria (vaccine COVID-19 AstraZeneca Vaccine).
Health professionals should not give Vaxzevria to anyone with a history of capillary leak syndrome.
Capillary leak syndrome is a very rare, serious condition that can be fatal if left untreated. It causes fluid to leak from the capillaries, with the result that the swelling mainly affects the extremities, hypotension, hemoconcentration and hypoalbuminemia.
Health professionals should be aware of the risk of recurrence of capillary leak syndrome in people who have previously experienced the condition.
Health professionals should be aware of the signs and symptoms of capillary leak syndrome. Patients with an acute episode of capillary leakage syndrome after vaccination need immediate treatment and may require ongoing specialized monitoring and intensive supportive care.
Healthcare professionals should tell people receiving the vaccine that they should seek medical help if they have the following symptoms in the days after the vaccination, which may be associated with fainting (due to low blood pressure):
swelling in the extremities
sudden weight gain.
Product information will be updated to include contraindications in people with a history of capillary leakage syndrome. The condition will also be reported as a side effect of unknown frequency.
A direct healthcare professional (DHPC) will be sent in a timely manner to healthcare professionals who prescribe, dispense or administer the vaccine. DHPC will also be published on a special page on the EMA website.
More about the drug
Vaxzevria (vaccine COVID-19 AstraZeneca) is a vaccine for the prevention of coronavirus disease 2019 (COVID-19) to people aged 18 and over. THE COVID-19 caused by the SARS-CoV-2 virus. Vaxzevria consists of another virus (of the adenovirus family) that has been modified to contain the gene for the production of protein S by SARS-CoV-2. The vaccine does not contain the virus itself and cannot cause it COVID-19.
The most common side effects are usually mild or moderate and improve within a few days after vaccination.
More on the process
This review was performed as part of a security signal. A safety signal is information about a new or poorly documented adverse event that may be caused by a drug such as a vaccine and that requires further investigation.
The review was carried out by the EMA Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines. PRAC recommendations will be submitted to the EMA Human Medicine Committee, CHMP, for approval.
EMA scientific evaluation supports the safe and effective use of vaccines COVID-19. The EMA recommendations are the foundation on which individual EU Member States will design and implement their own national vaccination campaigns. These may vary from country to country depending on their national needs and circumstances, such as infection rates, priority populations, vaccine availability, and hospital rates.