Product information

EMA recommends updated product information for COVID-19 Moderna and Janssen vaccines

The EMA has recommended that possible side effects of the 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 for Moderna’s Spikevax COVID-19 vaccine and Janssen’s COVID-19 vaccine be updated to include new effects possible secondaries after a PRAC meeting from 7 to 10 March.

The Medicines Safety Committee expressed concern about a possible adverse reaction of unknown frequency for the Janssen COVID-19 vaccine: small vessel vasculitis with skin manifestations. This side effect is inflammation of the blood vessels in the skin, which can lead to a rash; sharp or flat red spots under the surface of the skin; and bruises. Manifestations of small vessel vasculitis can be the result of viral or bacterial infections and usually resolve spontaneously over time with proper care. The PRAC reviewed a total of 21 reported cases worldwide, of which 10 cases corresponded to single-organ cutaneous vasculitis, most of these 10 cases having no other obvious explanation.

The PRAC also recommended that a warning about outbreaks of Capillary Leak Syndrome (CLS) be added to the product information of the COVID-19 vaccine Spikevax. SLC is a serious and extremely rare condition that causes fluid to leak from the capillaries, leading to rapid swelling of the limbs, sudden weight gain, feeling faint, thickening of the blood, low albumin in the blood and low blood pressure. Although the PRAC concluded that there was insufficient evidence to establish a chance association between the vaccine and the occurrence of new cases of CLS, it recommended the inclusion of a warning in the information on the produced to raise awareness of the potential for flare-ups. The committee found that some cases indicated an association with Spikevax, but the cases reported after vaccination with Comirnaty did not support such an association. The PRAC reviewed 55 reported cases of CFS (11 with Spikevax and 44 with Comirnaty); at the time of the assessment, the overall exposure was estimated at approximately 559 million doses for Spikevax and 2 billion doses for Comirnaty.

Source: EMA