Abstract
SummaryTwo employees of the National Health Service (NHS) in England developed severe allergic reactions following administration of BNT162b2 vaccine against COVID-19 (coronavirus disease 2019). The British SmPC for the BNT162b2 vaccine already includes reference to a contraindication for use in individuals who have had an allergic reaction to the vaccine or any of its components. As a precautionary measure, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued interim guidance to the NHS not to vaccinate in principle in “patients with severe allergies”. Allergic reactions to vaccines are very rare, but vaccine components are known to cause allergic reactions. BNT162b2 is a vaccine based on an mRNA embedded in lipid nanoparticles and blended with other substances to enable its transport into the cells. In the pivotal phase III clinical trial, the BNT162b2 vaccine was generally well tolerated, but this large clinical trial, used to support vaccine approval by the MHRA and US Food and Drug Administration, excluded individuals with a “history of a severe adverse reaction related to the vaccine and/or a severe allergic reaction (e.g., anaphylaxis) to a component of the study medication”. Vaccines are recognized as one of the most effective public health interventions. This repeated administration of a foreign protein (antigen) necessitates a careful allergological history before each application and diagnostic clarification and a risk–benefit assessment before each injection. Severe allergic reactions to vaccines are rare but can be life-threatening, and it is prudent to raise awareness of this hazard among vaccination teams and to take adequate precautions while more experience is gained with this new vaccine.
Highlights
In the pivotal phase III clinical trial, the BNT162b2 vaccine was generally well tolerated, but this large clinical trial, used to support vaccine approval by the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration, excluded individuals with a “history of a severe adverse reaction related to the vaccine and/or a severe allergic reaction to a component of the study medication”
On December 9, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom informed of severe allergic reactions in two employees of the National Health Service (NHS) in England following administration of BNT162b2 vaccine against COVID-19 (Coronavirus disease 2019)
The British summary of product characteristics (SmPC) for the BNT162b2 vaccine already includes reference to a contraindication for use in individuals who have had an allergic reaction to the vaccine
Summary
A. Chaker Ear, Nose and Throat Clinic, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. S. Becker Ear, Nose and Throat Clinic, University of Tübingen, Tübingen, Germany. K. Nemat Practice for Pediatric Pneumology/Allergology at the Children’s Center Dresden (Kid), Dresden, Germany. W. Czech Practice and Clinic for Allergology/Dermatology Schwarzwald-Baar Clinic, Villingen-Schwenningen, Germany. R. Brehler Department of Skin Diseases, Outpatient Clinic for Allergology, Occupational Dermatology and Environmental Medicine, Münster University Hospital, Münster, Germany. T. Fuchs Department of Dermatology, Venereology and Allergology, University Medical Center, Georg-August University, Göttingen, Germany
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