tetano
Editor, Senior Moderator
J Allergy Clin Immunol
. 2024 Mar 7:S0091-6749(24)00236-7.
doi: 10.1016/j.jaci.2024.03.001. Online ahead of print. "A randomized double-blinded trial to assess recurrence of systemic allergic reactions following COVID-19 mRNA vaccination"
Muhammad B Khalid[SUP] 1 [/SUP], Ellen Zektser[SUP] 1 [/SUP], Eric Chu[SUP] 2 [/SUP], Min Li[SUP] 1 [/SUP], Joanna Utoh[SUP] 1 [/SUP], Patrick Ryan[SUP] 3 [/SUP], Hanna S Loving[SUP] 4 [/SUP], Roa Harb[SUP] 4 [/SUP], Robbie Kattappuram[SUP] 5 [/SUP], Lindsay Chatman[SUP] 1 [/SUP], Stella Hartono[SUP] 1 [/SUP], Estefania Claudio-Etienne[SUP] 1 [/SUP], Guangping Sun[SUP] 1 [/SUP], Edward P Feener[SUP] 6 [/SUP], Zhongbo Li[SUP] 7 [/SUP], Samuel K Lai[SUP] 7 [/SUP], Quang Le[SUP] 8 [/SUP], Lawrence B Schwartz[SUP] 8 [/SUP], Jonathan J Lyons[SUP] 9 [/SUP], Hirsh Komarow[SUP] 10 [/SUP], Zhao-Hua Zhou[SUP] 11 [/SUP], Haniya Raza[SUP] 3 [/SUP], Maryland Pao[SUP] 3 [/SUP], Karen Laky[SUP] 1 [/SUP], Steven M Holland[SUP] 12 [/SUP], Erica Brittain[SUP] 13 [/SUP], Pamela A Frischmeyer-Guerrerio[SUP] 14 [/SUP]
Affiliations
Background: Systemic allergic reactions (sARs) following coronavirus disease-2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than traditional vaccines.
Objective: We aimed to evaluate the safety of revaccination in these individuals and to interrogate mechanisms underlying these reactions.
Methods: In this randomized, double-blinded, phase 2 trial, individuals 16-69 years who previously reported a convincing sAR to their first dose of COVID-19 mRNA vaccine were randomly assigned to receive second dose of BNT162b2 (Pfizer-BioNTech; Comirnaty®) vaccine and placebo on consecutive days in a blinded, 1:1 cross-over fashion at the National Institutes of Health (NIH). Five months later, an open-label BNT162b2 booster was offered if the second dose did not result in severe sAR. None of the participants received the mRNA-1273 (Moderna; Spikevax®) vaccine during the study. The primary endpoint was recurrence of sAR following second dose and booster vaccination; exploratory endpoints included biomarker measurements.
Results: Of 111 screened individuals, 18 were randomized to receive study interventions. Eight received BNT162b2 second dose followed by placebo; eight received placebo followed by BNT162b2 second dose; two withdrew before receiving any study intervention. All 16 received the booster dose. Following second dose and booster vaccination, sARs recurred in two subjects (12.5%, 95% CI 1.6-38.3). No sAR occurred after placebo. An anaphylaxis mimic, immunization stress-related response (ISRR), occurred more commonly than sARs following both vaccine and placebo and was associated with higher pre-dose anxiety scores, paresthesias, and distinct vital sign and biomarker changes.
Conclusion: Our findings support revaccination of individuals who report sARs to COVID-19 mRNA vaccines. Distinct clinical and laboratory features may distinguish sARs from ISRRs.
Keywords: Allergic reaction; Anaphylaxis; COVID-19; ISRR; Immunization Stress-Related Response; PEG; Vaccine; mRNA.
. 2024 Mar 7:S0091-6749(24)00236-7.
doi: 10.1016/j.jaci.2024.03.001. Online ahead of print. "A randomized double-blinded trial to assess recurrence of systemic allergic reactions following COVID-19 mRNA vaccination"
Muhammad B Khalid[SUP] 1 [/SUP], Ellen Zektser[SUP] 1 [/SUP], Eric Chu[SUP] 2 [/SUP], Min Li[SUP] 1 [/SUP], Joanna Utoh[SUP] 1 [/SUP], Patrick Ryan[SUP] 3 [/SUP], Hanna S Loving[SUP] 4 [/SUP], Roa Harb[SUP] 4 [/SUP], Robbie Kattappuram[SUP] 5 [/SUP], Lindsay Chatman[SUP] 1 [/SUP], Stella Hartono[SUP] 1 [/SUP], Estefania Claudio-Etienne[SUP] 1 [/SUP], Guangping Sun[SUP] 1 [/SUP], Edward P Feener[SUP] 6 [/SUP], Zhongbo Li[SUP] 7 [/SUP], Samuel K Lai[SUP] 7 [/SUP], Quang Le[SUP] 8 [/SUP], Lawrence B Schwartz[SUP] 8 [/SUP], Jonathan J Lyons[SUP] 9 [/SUP], Hirsh Komarow[SUP] 10 [/SUP], Zhao-Hua Zhou[SUP] 11 [/SUP], Haniya Raza[SUP] 3 [/SUP], Maryland Pao[SUP] 3 [/SUP], Karen Laky[SUP] 1 [/SUP], Steven M Holland[SUP] 12 [/SUP], Erica Brittain[SUP] 13 [/SUP], Pamela A Frischmeyer-Guerrerio[SUP] 14 [/SUP]
Affiliations
- PMID: 38460680
- DOI: 10.1016/j.jaci.2024.03.001
Background: Systemic allergic reactions (sARs) following coronavirus disease-2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than traditional vaccines.
Objective: We aimed to evaluate the safety of revaccination in these individuals and to interrogate mechanisms underlying these reactions.
Methods: In this randomized, double-blinded, phase 2 trial, individuals 16-69 years who previously reported a convincing sAR to their first dose of COVID-19 mRNA vaccine were randomly assigned to receive second dose of BNT162b2 (Pfizer-BioNTech; Comirnaty®) vaccine and placebo on consecutive days in a blinded, 1:1 cross-over fashion at the National Institutes of Health (NIH). Five months later, an open-label BNT162b2 booster was offered if the second dose did not result in severe sAR. None of the participants received the mRNA-1273 (Moderna; Spikevax®) vaccine during the study. The primary endpoint was recurrence of sAR following second dose and booster vaccination; exploratory endpoints included biomarker measurements.
Results: Of 111 screened individuals, 18 were randomized to receive study interventions. Eight received BNT162b2 second dose followed by placebo; eight received placebo followed by BNT162b2 second dose; two withdrew before receiving any study intervention. All 16 received the booster dose. Following second dose and booster vaccination, sARs recurred in two subjects (12.5%, 95% CI 1.6-38.3). No sAR occurred after placebo. An anaphylaxis mimic, immunization stress-related response (ISRR), occurred more commonly than sARs following both vaccine and placebo and was associated with higher pre-dose anxiety scores, paresthesias, and distinct vital sign and biomarker changes.
Conclusion: Our findings support revaccination of individuals who report sARs to COVID-19 mRNA vaccines. Distinct clinical and laboratory features may distinguish sARs from ISRRs.
Keywords: Allergic reaction; Anaphylaxis; COVID-19; ISRR; Immunization Stress-Related Response; PEG; Vaccine; mRNA.