JOHNSON & JOHNSON AZIENDA FARMACEUTICA VACCINO VACCINI JANSSEN FIALA FIALE FLACONE FLACONI

Covid, Ema: 'Cutaneous vasculitis among side effects of Johnson vaccine'

By Cristiano Antonino Last updated Mar 11, 2022

The Ema’s drug monitoring committee, Prac, has recommended adding small vessel vasculitis with skin manifestations (inflammation of blood vessels on the skin, which may lead to rashes, flat or acute, red spots under the skin surface and excoriations) to the list of possible side effects of Johnson’s Covid-19 vaccine with unknown frequency

Small vessel vasculitis, the Ema note states, “can be caused by viral or bacterial infections as well as by medicines and vaccines”

“Generally, the manifestations of the disease resolve over time with appropriate treatment,” it added.

Prac, as part of its latest safety report, reviewed 21 reported cases globally, of which 10 were found to fall within the established definition of single-organ skin vasculitis.

For most of these 10 cases, it says, ‘no other obvious explanation was identified; eight of these cases occurred immediately after vaccine administration’.

As of 31 December 2021, some 42.5 million doses have been administered worldwide.

Prac, the note concludes, ‘will continue to monitor cases of vasculitis and will communicate new information when available’.