The EMA Safety Committee (PRAC) has advised people with a history of capillary leakage syndrome not to get vaccinated COVID-19 Janssen. The committee also suggested 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 panel looked at three cases of capillary leakage syndrome in people who received the vaccine COVID-19 Janssen, who appeared within 2 days of vaccination. One of those infected had a history of capillary leakage syndrome and two of them later died. As of June 21, 2021, more than 18 million doses of vaccine COVID-19 Janssen had been administered worldwide.
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 the vaccine COVID-19 Janssen should seek immediate medical attention if they experience rapid swelling of the arms and legs or sudden weight gain in the days following 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. The Commission also asked Janssen, the vaccine trading company, for more information on a possible mechanism for developing capillary leakage syndrome after vaccination.
For all vaccines, the EMA will continue to monitor the safety and efficacy of the vaccine and provide the public with the latest information.
A similar review was recently completed for another vaccine COVID-19, Vaxzevria (formerly a vaccine COVID-19 AstraZeneca).
Information for the public
Very few cases of capillary leakage syndrome have occurred in people who have received the vaccine COVID-19 janssen.
You should not get this vaccine if you have previously had capillary leakage 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 authority if you have any questions about the availability of the vaccine in your country.
Information for health professionals
EMA examines cases of capillary leakage syndrome in people who have received the vaccine COVID-19 janssen.
Health professionals should not give this vaccine 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.
Health 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 vaccine
The vaccine COVID-19 Janssen 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. The vaccine consists of another virus (of the adenovirus family) that has been modified to contain the gene for S protein production by SARS-CoV-2. The vaccine COVID-19 Janssen 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
The review was carried out by the EMA Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for evaluating safety issues for human medicines, in a process known as "type II modification". The PRAC recommendations will be submitted to the EMA Human Medicines Committee, CHMP, for approval.