The EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to the product information.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the product information on Moderna’s COVID-19 vaccine Spikevax and COVID-19 vaccine Janssen be updated to include new possible side effects after a PRAC meeting on 7-10. March.
The Committee for Medicinal Products was concerned about a possible side effect of unknown frequency with the COVID-19 vaccine Janssen: vasculitis in small vessels with cutaneous manifestations. This side effect is an inflammation of the blood vessels in the skin, which can result in a rash; sharp or flat red spots beneath the surface of the skin; and bruises. Manifestations of vasculitis in small vessels can be the result of viral or bacterial infections and generally disappear spontaneously over time with appropriate care. The PRAC reviewed a total of 21 cases reported globally, including 10 cases consistent with cutaneous vasculitis in a single organ, most of which have no other apparent explanation.
The PRAC also recommended that a capillary leak syndrome (CLS) flare-up warning be added to the product information for the COVID-19 vaccine Spikevax. CLS is a serious and extremely rare condition that causes fluid leakage from capillaries, resulting in rapid swelling of the limbs, sudden weight gain, fainting, thickening of the blood, low blood levels of albumin and low blood pressure. While the PRAC concluded that there was insufficient evidence to establish a random link between the vaccine and the emergence of new cases of CLS, it recommended that a warning be included in the product information to increase awareness of the potential for flare-ups. The Committee found that some cases indicated a connection with Spikevax, but the cases reported after vaccination with Comirnaty did not support such a connection. The PRAC reviewed 55 reported cases of CLS (11 with Spikevax and 44 with Comirnaty); at the time of the assessment, the global exposure was estimated at approx. 559 million doses for Spikevax and 2 billion doses for Comirnaty.