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Pharmacovigilance risk assessment committee: Spikevax and Comirnaty mRNA vaccines

European Medicines Agency has published Meeting highlights from the Pharmacovigilance Risk Assessment Committee  (PRAC) 7-10 March 2022.

COVID-19 Vaccine Janssen: small vessel vasculitis added as a side effect

EMA’s medicines safety committee (PRAC) has recommended that small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin’s surface and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency.

Small vessel vasculitis can be caused by viral or bacterial infections as well as by medicines and vaccines. Generally, manifestations of the disease spontaneously resolve over time with appropriate supportive care.

PRAC has reviewed a total of 21 cases reported globally in the context of the latest summary safety report, including 10 cases consistent with the established definition of single organ cutaneous vasculitis (vasculitis affecting a single organ). For most of these 10 cases no other obvious explanation was identified; eight of these cases occurred soon after the administration of the vaccine.

As of 31 December 2021, approximately 42.5 million doses of the vaccine had been administered worldwide.

The PRAC will continue to monitor for cases of vasculitis and will communicate further if new information becomes available.

Spikevax: new warning for flare-ups of capillary leak syndrome

The PRAC has recommended that a warning for flare-ups of capillary leak syndrome (CLS) should be added to the product information for the COVID-19 vaccine Spikevax.

CLS is an extremely rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in rapid swelling of the arms and legs, sudden weight gain, feeling faint, thickening of the blood, low blood levels of albumin (an important blood protein) and low blood pressure. CLS is frequently related to viral infections, some blood cancers, inflammatory diseases and some treatments.

The PRAC assessed all the available data as well as all the cases of CLS reported in the Eudravigilance database after the administration of the mRNA vaccines Spikevax and Comirnaty.

The Committee concluded that there was insufficient evidence to establish a causal association between the two vaccines and the onset of new cases of CLS. However, the PRAC recommended the inclusion of a warning in the product information for Spikevax to raise awareness of the potential risk of flare-ups among healthcare professionals and patients. The Committee recommended this warning as some cases of flare-ups of CLS pointed towards an association with Spikevax, while the cases reported after vaccination with Comirnaty did not support such association.

Healthcare professionals should be aware of the signs and symptoms of CLS and of a possible risk of flare-ups in people with a history of CLS. Vaccinated individuals with a history of CLS should consult their treating physician when planning their vaccination.

In total 55 reported cases of CLS were reviewed, 11 with Spikevax and 44 with Comirnaty. Global exposure at the time of the assessment was estimated at approximately 559 million doses for Spikevax and 2 billion doses for Comirnaty.


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