Filenews 11 June 2021
The EMA Safety Committee (PRAC) concluded that people who previously had capillary leakage syndrome should not be vaccinated with Vaxzevria (COVID-19 AstraZeneca vaccine). 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 awareness among 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 subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the United Kingdom.
Capillary leakage syndrome is a very rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in swelling mainly in the hands and feet, low blood pressure, thickening of 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 leakage syndrome and the risk of recurrence in people previously diagnosed with the condition.
People vaccinated with Vaxzevria should seek immediate medical attention if they experience rapid swelling of the hands and feet or sudden weight gain in the days after vaccination. These symptoms are often associated with feeling faint (due to low blood pressure).
Prac will continue to monitor cases of the condition and will take the necessary further action. PRAC also asked AstraZeneca, the vaxzevria marketing company, for more information on a possible mechanism for developing capillary leakage syndrome after vaccination.
Information for patients
- A very small number of cases of capillary leakage syndrome have occurred in people treated with Vaxzevria (COVID-19 AstraZeneca vaccine).
- You should not take Vaxzevria if you have previously developed capillary leakage syndrome.
- Capillary leak 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 with recovery and avoid complications.
- You should seek medical attention immediately if you have the following symptoms in the days after vaccination, which may occur with a feeling of fainting (due to low blood pressure):
- rapid swelling of the hands and feet
- 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 country.
Information for health professionals
- Ema examined cases of capillary leakage syndrome in people treated with Vaxzevria (COVID-19 Vaccine AstraZeneca vaccine).
- Health professionals should not administer Vaxzevria to anyone with a history of capillary leakage syndrome.
- Capillary leakage syndrome is a very rare, serious condition, which can be fatal if not treated. It causes fluid leakage from the capillaries, resulting in swelling mainly affecting the extremities, hypotension, haemoconcentration and subalucidemia.
- Health professionals should be aware of the risk of recurrence of capillary leakage syndrome in people who had previously experienced the condition.
- Health professionals should be aware of the signs and symptoms of capillary leakage syndrome. Patients with acute episode of capillary leakage syndrome after vaccination need immediate treatment and may require continuous specialized monitoring and intensive supportive treatment.
- Health professionals should tell people receiving the vaccine that they should seek medical attention if they have the following symptoms in the days after vaccination, which may be related to feeling faint (due to low blood pressure):
- swelling in the extremities
- sudden weight gain.
- Product information will be updated to include contraindication in people with a history of capillary leakage syndrome. The condition will also be reported as a side effect with unknown frequency.
A direct contact of a healthcare professional (DHPC) will be sent in due course to health professionals who prescribe, distribute or administer the vaccine. THE DHPC will also be published on a dedicated page on the EMA website.
More about the drug
Vaxzevria (COVID-19 AstraZeneca vaccine) is a vaccine for the prevention of coronvirus disease 2019 (COVID-19) in people aged 18 years and over. COVID-19 is 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 from SARS-CoV-2. The vaccine does not contain the virus itself and cannot cause COVID-19.
The most common side effects are usually mild or moderate and improve within a few days after vaccination.
More about the process
This overview was conducted as part of a security signal. A safety signal is information about a new or poorly documented adverse event possibly caused by a drug such as a vaccine that requires further investigation.
The review was carried out by the EMA Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for assessing safety issues for human medicines. Prac's recommendations will be submitted to the EMA's Committee on Human Medicine, CHMP, for approval.
Ema's scientific evaluation supports the safe and effective use of COVID-19 vaccines. The EMA's 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.
