EMA Recommends Updated Product Information for Moderna and Janssen COVID-19 Vaccines

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EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the product information of Moderna’s COVID-19 vaccine Spikevax and COVID-19 vaccine Janssen should be updated to include new possible side effects after a March 7–10 PRAC meeting.

The medicines safety committee was concerned about a possible side effect of unknown frequency for COVID-19 vaccine Janssen: small vessel vasculitis with cutaneous manifestations. This side effect is an 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. Manifestations of small vessel vasculitis can be the result of viral or bacterial infections and generally spontaneously resolve over time with appropriate care. PRAC reviewed a total of 21 cases reported globally, including 10 cases consistent of single organ cutaneous vasculitis, with most of these 10 cases having no other obvious explanation.

PRAC also recommended a warning regarding flare-ups of capillary leak syndrome (CLS) to 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, feeling faint, thickening of the blood, low blood levels of albumin, and low blood pressure. While PRAC concluded that there was insufficient evidence to establish a casual association between the vaccine and the onset of new cases of CLS, it recommended the inclusion of a warning in the product information to raise awareness of the potential of flare-ups. The Committee found that some cases pointed towards an association with Spikevax, but the cases reported after vaccination with Comirnaty did not support such association. PRAC reviewed 55 reported cases of CLS (11 with Spikevax and 44 with Comirnaty); at the time of the assessment, global exposure was estimated at approximately 559 million doses for Spikevax and 2 billion doses for Comirnaty.


Source: EMA