Abstract
Allergic reactions among some individuals who received the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine discourage patients with allergic conditions from receiving this vaccine and physicians from recommending the vaccine. To describe the assessment and immunization of highly allergic individuals with the BNT162b2 vaccine. In a prospective cohort study from December 27, 2020, to February 22, 2021, 8102 patients with allergies who applied to the COVID 19 vaccine referral center at the Sheba Medical Center underwent risk assessment using an algorithm that included a detailed questionnaire. High-risk patients (n = 429) were considered "highly allergic" and were immunized under medical supervision. Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Allergic and anaphylactic reactions after the first and second doses of BNT162b2 vaccine among highly allergic patients. Of the 429 individuals who applied to the COVID-19 referral center and were defined as highly allergic, 304 (70.9%) were women and the mean (SD) age was 52 (16) years. This highly allergic group was referred to receive immunization under medical supervision. After the first dose of the BNT162b2 vaccine, 420 patients (97.9%) had no immediate allergic event, 6 (1.4%) developed minor allergic responses, and 3 (0.7%) had anaphylactic reactions. During the study period, 218 highly allergic patients (50.8%) received the second BNT162b2 vaccine dose, of which 214 (98.2%) had no allergic reactions and 4 patients (1.8%) had minor allergic reactions. Other immediate and late reactions were comparable with those seen in the general population, except for delayed itch and skin eruption, which were more common among allergic patients. The rate of allergic reactions to BNT162b2 vaccine, is higher among patients with allergies, particularly among a subgroup with a history of high-risk allergies. This study suggests that most patients with a history of allergic diseases and, particularly, highly allergic patients can be safely immunized by using an algorithm that can be implemented in different medical facilities and includes a referral center, a risk assessment questionnaire, and a setting for immunization under medical supervision of highly allergic patients. Further studies are required to define more specific risk factors for allergic reactions to the BNT162b2 vaccine.
Highlights
The COVID-19 pandemic has medical, economic, and many other global consequences
Of the 429 individuals who applied to the COVID-19 referral center and were defined as highly allergic, 304 (70.9%) were women and the mean (SD) age was 52 (16) years
This study suggests that most patients with a history of allergic diseases and, highly allergic patients can be safely immunized by using an algorithm that can be implemented in different medical facilities and includes a referral center, a risk assessment questionnaire, and a setting for immunization under medical supervision of highly allergic patients
Summary
The COVID-19 pandemic has medical, economic, and many other global consequences. Immunization of most of the population seems to be the main tool to prevent morbidity and mortality and to facilitate a return to normalcy. In December 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and the Moderna COVID-19 vaccine (mRNA-1273), each administered as 2 doses separated by 21 and 28 days, respectively.[1,2] Both vaccines are composed of a nanoparticle-encapsulated lipid, nucleosidemodified messenger RNA (mRNA) that encodes the SARS-CoV-2 spike glycoprotein. Both vaccines were found to be approximately 95% effective in preventing COVID-19. Adverse events included mostly pain at the injection site, fatigue, and headache.[3,4] several obstacles have occurred on the path of this global immunization program, one of which is the risk of allergic reactions to these vaccines.[5,6,7]
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