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COVID-19 vaccination including 198 patients with history of severe anaphylactic reaction - own observations
Łukasz Wentrys1, Lidia Stopyra1,2
1Department of Infectious Diseases and Paediatrics, Stefan Żeromski Specialized Hospital in Kraków, Poland.
Introduction:
The SARS-CoV-2 pandemic has taken a heavy toll of 4 million deaths. We were all looking forward to the authorisation of safe vaccines. Soon after vaccination programmes started, the reports about anaphylaxis began to emerge. Growing anxiety has urged regulatory agencies and academic societies to issue adequate recommendations regarding patient eligibility to vaccination.
Aim Of The Study:
Observation of patients who had a history of a severe anaphylactic reaction and/or anaphylactic shock and were vaccinated against COVID-19.
Material And Methods:
A single-centre, prospective, observational study was conducted at the Department of Infectious Diseases and Paediatrics at Stefan Żeromski Specialist Hospital in Krakow, Poland. Adult patients with a history of a severe anaphylactic reaction and/or anaphylactic shock and patients without it were administered the Comirnaty vaccine by Pfizer-BioNTech or the ChAdOx1-S vaccine by AstraZeneca in a two-dose schedule at the department. The patients were then observed at the department for 60 minutes. A week after each vaccination dose, the patients were contacted by telephone in order to collect data about a late allergic reaction.
Results:
In total, 403 patients were enrolled. For the Pfizer BioNTech Comirnaty vaccine, the study group (i.e. patients with a history of severe anaphylactic reactions to various substances, other than those present in the vaccine) included 151 patients, and there were 161 controls. For the AstraZeneca ChAdOx1-S vaccine, the study group included 47 patients, and 44 patients formed the control group. Nine cases of severe anaphylactic reactions were reported: 3 in the study groups (1.5%) and 6 in the control groups (3%). Anaphylactic shock after vaccine administration occurred in one patient from the control group.
Conclusions:
COVID-19 vaccination with using Pfizer-BioNTech Comirnaty and AstraZeneca ChAdOx1-S is safe also for patients with a history of a severe anaphylactic reaction and/or anaphylactic shock. Severe anaphylactic reactions and anaphylactic shock, although rare, may also develop in patients without a prior history of allergic conditions. The Personnel od vaccination centres should be therefore trained to provide medical help. Incorrect patient exclusions delay the attainment of the goal determined for the vaccination programme.
Insights
COVID-19 vaccines from Pfizer-BioNTech and AstraZeneca are safe for individuals with a history of severe allergic reactions. Severe reactions are rare and can occur in those without prior allergies, necessitating trained staff at vaccination centers.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- The COVID-19 pandemic caused millions of deaths globally.
- Concerns about anaphylaxis following COVID-19 vaccination led to recommendations on patient eligibility.
- Anxiety surrounding vaccine safety prompted regulatory and academic responses.
Purpose of the Study:
- To observe patients with a history of severe anaphylaxis or anaphylactic shock who received COVID-19 vaccination.
- To assess the safety of COVID-19 vaccines in a high-risk allergic population.
Main Methods:
- A prospective, observational study at a single center in Poland.
- Adults with and without a history of severe anaphylaxis received Pfizer-BioNTech or AstraZeneca vaccines.
- Patients were observed for 60 minutes post-vaccination, with follow-up for late allergic reactions.
Main Results:
- 403 patients were enrolled: 198 for Pfizer-BioNTech and 91 for AstraZeneca.
- Severe anaphylactic reactions occurred in 1.5% of the study group and 3% of controls.
- Anaphylactic shock occurred in one control patient; no cases were reported in the study group for AstraZeneca.
Conclusions:
- COVID-19 vaccination with Pfizer-BioNTech and AstraZeneca is safe for patients with a history of severe anaphylaxis.
- Severe allergic reactions and anaphylactic shock are rare and can occur in individuals without prior allergy history.
- Vaccination center personnel must be trained to manage allergic reactions, and appropriate patient selection is crucial for vaccination program success.
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