Europe – COVID-19 vaccine safety update : COMIRNATY BioNTech Manufacturing GmbH

Specific allergic skin reactions will be added to the product information. There are no recommended changes to the product information regarding how to use this vaccine; Comirnaty is effective in preventing COVID-19..

Based on data from clinical trials and use in vaccination campaigns, PRAC requested the addition of the following hypersensitivity reactions (allergic reactions) to the product information of Comirnaty: skin rash and pruritus (itching of the skin) as uncommon side effects (occurring in less than 1 in 100 persons), and urticaria (raised, red and itchy skin rash) and angioedema (rapid swelling under the skin) as rare side effects (occurring in less than 1 in 1,000 persons)…