The European Medicines Agency's safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has recommended that individuals who have earlier had capillary leak syndrome should not get Vaxzevria vaccination (formerly COVID-19 vaccine AstraZeneca).
Additionally, the committee determined that capillary leak syndrome should be included to the vaccine's product description as a new adverse event, along with a warning to spread awareness of this danger among healthcare professionals and patients.
EMA's PRAC, the committee responsible for the examination of human medicines safety concerns, conducted the review.
The committee conducted an in-depth evaluation of six cases of capillary leak syndrome following the administration of Vaxzevria. The majority of incidents occurred in women and occurred within four days following immunisation. Three of the patients had a history of capillary leak syndrome, and one died as a result.
Health Canada is alerting healthcare providers about very rare occurrences of life-threatening capillary leak syndrome (CLS) following immunisation with AstraZeneca COVID-19 Vaccine [AZD-1222; ChAdOx1-S], including the AstraZeneca vaccine produced by the Serum Institute of India [COVISHIELD]. The use of these vaccinations is now prohibited in individuals with a prior history of CLS.
Capillary leak syndrome is an extremely rare but dangerous disorder in which fluid leaks from tiny blood arteries (capillaries), causing edema or swelling mostly in the arms and legs, hypotension, blood thickening, and lower albumin levels in the blood (an important blood protein).
Healthcare practitioners should be knowledgeable about the symptoms and signs of capillary leak syndrome, as well as the risk of relapses in previously diagnosed individuals. Persons who have received the Vaxzevria vaccine should seek emergency medical attention if they develop sudden swelling of the arms and legs or unexpected weight gain in the days after immunisation. These symptoms are commonly linked with fainting (due to low blood pressure).
The PRAC will keep monitoring for more cases of the illness and will take any required steps. Additionally, the PRAC has requested extra data from AstraZeneca, the firm that markets Vaxzevria, about a probable explanation for the occurrence of capillary leak syndrome following immunisation.
What you need to know:
- A relatively small proportion of patients who got Vaxzevria developed capillary leak syndrome (formerly COVID-19 Vaccine AstraZeneca).
- Vaxzevria is contraindicated if you have ever had capillary leak syndrome.
- Capillary leak syndrome is a potentially life-threatening disorder. Although the likelihood of developing the illness is extremely minimal you should be aware of the symptoms in order to receive quick medical care to aid in recovery and avoid consequences.
- You should seek emergency medical treatment if you have any of the following symptoms in the days following vaccination, which may occur in conjunction with feeling faint (due to low blood pressure): Abrupt arm and leg puffiness and significant weight gain