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ARIA-EAACI statement on severe allergic reactions to COVID-19 vaccines - An EAACI-ARIA Position Paper
Ludger Klimek1, Marek Jutel2, Cezmi A Akdis3
1Center for Rhinology and Allergology, Wiesbaden, Germany.
Insights
Severe allergic reactions to the COVID-19 vaccine (BNT162b2) are rare. Healthcare providers should prepare for anaphylaxis, but most allergic individuals can be safely vaccinated, as benefits outweigh risks.
Area of Science:
- Allergy and Immunology
- Vaccinology
- Public Health
Background:
- Post-authorization surveillance of the BNT162b2 COVID-19 vaccine identified rare cases of severe anaphylaxis.
- Concerns exist regarding potential severe adverse events with widespread global vaccination.
- The European Academy of Allergy and Clinical Immunology (EAACI) provides preliminary recommendations based on emerging data.
Purpose of the Study:
- To investigate the nature and triggers of severe allergic reactions to the BNT162b2 COVID-19 vaccine.
- To inform preliminary recommendations for safe vaccination practices.
- To address concerns and provide guidance for healthcare practitioners and patients.
Main Methods:
- Collection and reporting of all available clinical and laboratory information on severe allergic reactions.
- Review of existing data regarding vaccine risk in individuals with allergic conditions.
- Expert consensus and position statement from EAACI.
Main Results:
- Current data do not indicate a higher risk of adverse events for patients with allergic rhinitis or asthma.
- The benefits of COVID-19 vaccination significantly outweigh the risks, even for individuals with allergic diseases.
- Mild and moderate allergic patients should not be excluded from vaccination to achieve population immunity.
Conclusions:
- Healthcare practitioners must be prepared to recognize and manage anaphylaxis following vaccination.
- A mandatory observation period of at least 15 minutes post-vaccination is recommended for all individuals.
- Clear communication is essential to build patient trust in vaccine safety, particularly for those with allergies.
Abstract:
Further to the approval of the Coronavirus disease 2019 (COVID-19) vaccine BNT162b2, several severe anaphylaxis cases occured within the first few days of public vaccination. An investigation is taking place to understand the cases and their triggers. The vaccine will be administered to a large number of individuals worldwide and there are raising concerns that severe adverse events might occur. With the current information, the European Academy of Allergy and Clinical Immunology (EAACI) states its position for the following preliminary recommendations that are to be revised as soon as more data emerge. To minimize the risk of severe allergic reactions in vaccinated individuals, it is urgently required to understand the specific nature of the reported severe allergic reactions, including the background medical history of the individuals affected and the mechanisms involved. To achieve this goal, all clinical and laboratory information should be collected and reported. Mild and moderate allergic patients should not be excluded from the vaccine as this could have a significant impact on reaching the goal of population immunity. Healthcare practitioners vaccinating against COVID-19 are required to be sufficiently prepared to recognize and treat anaphylaxis properly with the ability to administer adrenaline. Further to vaccine administration, a mandatory observation period of at least 15 minutes should be followed for all individuals. The current data have not shown any higher risk for patients suffering from allergic rhinitis or asthma, and this message should be clearly stated by physicians to enable our patients to trust the vaccine. More than 30% of the population suffers from allergic diseases and the benefit of the vaccination clearly outweighs the risk of severe COVID-19 development.
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