Paul-Ehrlich-Institut

Coro­na Vac­ci­na­tion in In­di­vid­u­als Suf­fer­ing from Al­ler­gies

At the beginning of the vaccination campaign which has been carried out in the United Kingdom (UK) since 8 December 2020 with the RNA-based vaccine of BioNTech/Pfizer (trade name Comirnaty), two severe, suspected allergic intolerance reactions occurred. In the UK, they led to the official recommendation that the vaccine should not be administered to individuals who had experienced a severe allergic reaction (anaphylaxis) to a vaccine, medicine or food in their history. After the central European marketing authorisation of Comirnaty on 21 December 2020, many people suffering from allergies in Germany are asking the question of whether they can receive Comirnaty to protect themselves against COVID-19.

Experts from the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the European Medicines Agency (EMA) have explored the data in detail and have come to the following conclusions. According to the current data, a generally increased risk of severe adverse effects for persons with previously known allergic diseases cannot be deduced for a vaccination with Comirnaty. Therefore, the European Commission’s marketing authorisation does not impose any contraindication against vaccination in the case of known allergies to food and drugs.

Individuals with a history of a severe adverse reaction related to a vaccine and/or a known severe allergic reaction to an ingredient of Comirnaty were excluded from the pivotal studies. No clinical data on the tolerability (safety) of the vaccine are available for this group of people.

Severe reactions associated with vaccination with Comirnaty have been observed. Possible triggers could be the active substance or excipients. Excipients that could trigger a reaction include lipid nanoparticles containing polyethylene glycol (PEG). They are similar to liposomes, which have been used for many years in pharmaceuticals as carriers for drugs. Pseudoallergic (non-IgE-mediated) reactions to liposomes, which have the clinical appearance of allergic reactions but follow a different mechanism (complement-mediated), are known with other PEG-containing drugs.

During the post-marketing authorisation period, the marketing authorisation holder and the national competent authorities envisage further monitoring of hypersensitivity events.

Recommendation

According to current knowledge, there is no contraindication in the EU for individuals suffering from allergies or with a history of anaphylaxis. Such persons can be vaccinated against COVID-19 with Comirnaty. However, contraindications include a known allergy to the ingredients of the COVID-19 vaccine as well as an allergic reaction to the first dose. In that case, the second dose of the vaccine should not be administered. In principle, according to the European summary of product characteristics (SmPC), each person should be observed for at least 15 minutes after vaccination. In case of a severe (pseudo)allergic reaction such as anaphylaxis, appropriate medical treatment should always be available.

Updated: 29.12.2020