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2. Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach.

Author

Greenhawt, Matthew, Dribin, Timothy, Abrams, Elissa, Shaker, Marcus, Chu, Derek, Golden, David, Akin, Cem, Anagnostou, Akterini, ALMuhizi, Faisal, Alqurashi, Waleed, Arkwright, Peter, Baldwin, James, Banerji, Aleena, Bégin, Philippe, Ben-Shoshan, Moshe, Bernstein, Jonathan, Bingemann, Theresa, Bindslev-Jensen, Carsten, Blumenthal, Kim, Byrne, Aideen, Cahill, Julia, Cameron, Scott, Campbell, Dianne, Campbell, Ronna, Cavender, Michael, Chan, Edmond, Chinthrajah, Sharon, Comberiati, Pasquale, Eastman, Jacqueline, Ellis, Anne, Fleischer, David, Fox, Adam, Frischmeyer-Guerrerio, Pamela, Gagnon, Remi, Garvey, Lene, Grayson, Mitchell, Isabwe, Ghislaine, Hartog, Nicholas, Hendron, David, Horner, Caroline, Hourihane, Johnathan, Iglesia, Edward, Kan, Manstein, Kaplan, Blanka, Katelaris, Constance, Kim, Harold, Kelso, John, Khan, David, Lang, David, Ledford, Dennis, Levin, Michael, Lieberman, Jay, Loh, Richard, Mack, Douglas, Mazer, Bruce, Mody, Ketan, Mosnaim, Gisele, Munblit, Daniel, Mustafa, S, Nanda, Anil, Nathan, Richard, Oppenheimer, John, Otani, Iris, Park, Miguel, Pawankar, Ruby, Perrett, Kirsten, Peter, Jonny, Phillips, Elizabeth, Picard, Matthieu, Pitlick, Mitchell, Ramsey, Allison, Rasmussen, Trine, Rathkopf, Melinda, Reddy, Hari, Robertson, Kara, Rodriguez Del Rio, Pablo, Sample, Stephen, Sheshadri, Ajay, Sheik, Javed, Sindher, Sayantani, Spergel, Jonathan, Stone, Cosby, Stukus, David, Tang, Mimi, Tracy, James, Turner, Paul, Vander Leek, Timothy, Wallace, Dana, Wang, Julie, Wasserman, Susan, Weldon, David, Wolfson, Anna, Worm, Margitta, and Yacoub, Mona-Rita

Subjects
COVID-19, SARS-CoV-2, allergic reactions, anaphylaxis, mRNA COVID-19 vaccine, polyethylene glycol, polysorbate 80, repeat allergic reactions, skin testing, vaccination, Humans, COVID-19 Vaccines, GRADE Approach, Consensus, Vaccine Excipients, COVID-19, Hypersensitivity, Immediate, Anaphylaxis, Excipients
Abstract

This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

Published
2023

9. Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent

Author

Mack, Douglas P., Dribin, Timothy E., Turner, Paul J., Wasserman, Richard L., Hanna, Mariam A., Shaker, Marcus, Tang, Mimi L.K., Rodríguez del Río, Pablo, Sobolewski, Brad, Abrams, Elissa M., Anagnostou, Aikaterini, Arasi, Stefania, Bajowala, Sakina, Bégin, Philippe, Cameron, Scott B., Chan, Edmond S., Chinthrajah, Sharon, Clark, Andrew T., Detjen, Paul, du Toit, George, Ebisawa, Motohiro, Elizur, Arnon, Factor, Jeffrey M., Greiwe, Justin, O’B Hourihane, Jonathan, Hughes, Sarah W., Jones, Douglas H., Muraro, Antonella, Nowak-Wegrzyn, Anna, Patel, Nandinee B., Scurlock, Amy M., Shah, Atul N., Sindher, Sayantani B., Tilles, Stephen, Vickery, Brian P., Wang, Julie, Windom, Hugh H., and Greenhawt, Matthew

Published
2024
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17. Managing food allergy: GA2LEN guideline 2022

Author

Bansal, Priya, Berni–Canani, Roberto, Blumchen, Katharina, Bonertz, Andreas, Bourgoin-Heck, Melisande, Ceylon, Ozlem, Divaret-Chauveau, Amandine, Fleischer, David, Gomez, Maximiliano, Groetch, Marion, Hernandez, Domingo Barber, Hjorth, Betina, Hussey, Lydia Collins, Knulst, André C., Leung, Agnes, Mack, Douglas, Mahler, Vera, Mori, Francesca, Namazova-Baranova, Leyla, Palosuo, Kati, Parisi, Claudio Alberto Salvador, Pastorino, Antonio Carlos, Rudzeviciene, Odilija, Said, Maria, Sawiec, Piotr, Sicherer, Scott, Sato, Sakura, Zubchenko, Svitlana, Muraro, Antonella, de Silva, Debra, Halken, Susanne, Worm, Margitta, Khaleva, Ekaterina, Arasi, Stefania, Dunn-Galvin, Audrey, Nwaru, Bright I., De Jong, Nicolette W., Rodríguez Del Río, Pablo, Turner, Paul J., Smith, Pete, Begin, Philippe, Angier, Elizabeth, Arshad, Hasan, Ballmer-Weber, Barbara, Beyer, Kirsten, Bindslev-Jensen, Carsten, Cianferoni, Antonella, Demoulin, Céline, Deschildre, Antoine, Ebisawa, Motohiro, Fernandez-Rivas, Maria Montserrat, Fiocchi, Alessandro, Flokstra-de Blok, Bertine, Gerdts, Jennifer, Gradman, Josefine, Grimshaw, Kate, Jones, Carla, Lau, Susanne, Loh, Richard, Alvaro Lozano, Montserrat, Makela, Mika, Marchisotto, Mary Jane, Meyer, Rosan, Mills, Clare, Nilsson, Caroline, Nowak-Wegrzyn, Anna, Nurmatov, Ulugbek, Pajno, Giovanni, Podestà, Marcia, Poulsen, Lars K., Sampson, Hugh A., Sanchez, Angel, Schnadt, Sabine, Szajewska, Hania, Van Ree, Ronald, Venter, Carina, Vlieg-Boerstra, Berber, Warner, Amena, Wong, Gary, Wood, Robert, Zuberbier, Torsten, and Roberts, Graham

Published
2022
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19. Incidence of Surgically Managed Post-Tonsillectomy Hemorrhage Associated With NSAID Prescribing for Postoperative Pain Management.

Author

Jacobson, Andrew, Mack, Douglas, Herrera, Germaine, Bowe, Sarah N, Highland, Krista B, and Patzkowski, Michael S

Subjects
*POSTOPERATIVE pain treatment, *HOSPITAL care of children, *CHILD patients, *CHILDREN'S hospitals, *ANTI-inflammatory agents, *TONSILLITIS, *TONSILLECTOMY
Abstract

Introduction Tonsillectomy ranks high among the most common pediatric surgical procedures in the United States. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, are routinely prescribed to manage post-tonsillectomy pain, but may carry the risk of hemorrhage. Materials and Methods This retrospective, longitudinal, secondary-data analysis study compared the incidence of surgically managed post-tonsillectomy hemorrhage (sPTH) in pediatric patients prescribed ibuprofen at Brooke Army Medical Center (BAMC) after tonsillectomy compared to a similar cohort of pediatric patients at the Children's Hospital of Philadelphia (CHOP) not prescribed ibuprofen. Additional regression analysis examined predictors of sPTH at BAMC. Results The odds of sPTH was lower in patients who were prescribed ibuprofen at BAMC, relative to patients who were not at CHOP (OR 0.57, 95% CI, 0.37, 0.87; P  < 0.01). In a generalized linear model evaluating BAMC patient data, there was a lack of a relationship between reason for tonsillectomy (tonsillitis versus tonsillar obstruction), primary procedure (tonsillectomy-only versus tonsillectomy with adenoidectomy), and presence of a co-occurring procedure. Conclusions Post-tonsillectomy ibuprofen prescribing practices were not associated with an elevated risk of sPTH, relative to patients at CHOP not exposed to ibuprofen. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Core Outcome Set for IgE ‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘ COMFA ’

Author

Demidova, Anastasia, Drewitz, Karl Philipp, Kimkool, Parisut, Banjanin, Nikolina, Barzylovich, Vladyslava, Botjes, Erna, Capper, India, Castor, Mary Anne R., Comberiati, Pasquale, Cook, Emma E., Costa, Joana, Chu, Derek K., Epstein, Michelle M., Galvin, Audrey Dunn, Giovannini, Mattia, Girard, Frédéric, Golding, Michael A., Greenhawt, Matthew, Ierodiakonou, Despo, Jones, Christina J., Khaleva, Ekaterina, Knibb, Rebecca C., Macit‐Çelebi, Melahat Sedanur, Mack, Douglas P., Mafra, Isabel, Marchisotto, Mary Jane, Mijakoski, Dragan, Nekliudov, Nikita, Özdemir, Cevdet, Patel, Nandinee, Pazukhina, Ekaterina, Protudjer, Jennifer L. P., Rodríguez del Rio, Pablo, Roomet, Jelena, Sammut, Patrick, Schoos, Ann‐Marie Malby, Schopfer, Anita Fossaluzza, Schultz, Fallon, Seylanova, Nina, Skypala, Isabel, Sørensen, Martin, Stoleski, Sasho, Stylianou, Eva, Upton, Julia, van de Veen, Willem, Genuneit, Jon, Boyle, Robert J., Apfelbacher, Christian, Munblit, Daniel, Adel‐Patient, Karine, Demidova, Anastasia, Drewitz, Karl Philipp, Kimkool, Parisut, Banjanin, Nikolina, Barzylovich, Vladyslava, Botjes, Erna, Capper, India, Castor, Mary Anne R., Comberiati, Pasquale, Cook, Emma E., Costa, Joana, Chu, Derek K., Epstein, Michelle M., Galvin, Audrey Dunn, Giovannini, Mattia, Girard, Frédéric, Golding, Michael A., Greenhawt, Matthew, Ierodiakonou, Despo, Jones, Christina J., Khaleva, Ekaterina, Knibb, Rebecca C., Macit‐Çelebi, Melahat Sedanur, Mack, Douglas P., Mafra, Isabel, Marchisotto, Mary Jane, Mijakoski, Dragan, Nekliudov, Nikita, Özdemir, Cevdet, Patel, Nandinee, Pazukhina, Ekaterina, Protudjer, Jennifer L. P., Rodríguez del Rio, Pablo, Roomet, Jelena, Sammut, Patrick, Schoos, Ann‐Marie Malby, Schopfer, Anita Fossaluzza, Schultz, Fallon, Seylanova, Nina, Skypala, Isabel, Sørensen, Martin, Stoleski, Sasho, Stylianou, Eva, Upton, Julia, van de Veen, Willem, Genuneit, Jon, Boyle, Robert J., Apfelbacher, Christian, Munblit, Daniel, and Adel‐Patient, Karine

Abstract

Background: IgE‐mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. Methods: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two‐round online‐modified Delphi process followed by hybrid consensus meeting to finalize the COS. Results: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in‐person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, ‘allergic symptoms’ and ‘quality of life’ achieved consensus for inclusion as ‘core’ outcomes. Conclusion: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.

Published
2024

29. Managing Food Allergy in Schools During the COVID-19 Pandemic

Author

Greenhawt, Matthew, Shaker, Marcus, Stukus, David R., Fleischer, David M., Hourihane, Jonathan, Tang, Mimi L.K., Abrams, Elissa M., Wang, Julie, Bingemann, Theresa A., Chan, Edmond S., Lieberman, Jay, Sampson, Hugh A., Bock, S. Allan, Young, Michael C., Waserman, Susan, and Mack, Douglas P.

Published
2020
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32. Food sensitization and cardiovascular mortality: An intriguing association in need of further study

Author

Shaker, Marcus, primary, Abrams, Elissa M., additional, Oppenheimer, John, additional, Anagnostou, Aikaterini, additional, Codispoti, Christopher D., additional, Golden, David B.K., additional, Greenhawt, Matthew, additional, Stukus, David, additional, Moore- Clingenpeel, Melissa, additional, Hughes, Sarah W., additional, Mack, Douglas P., additional, Mustafa, S. Shahzad, additional, and Lang, David M., additional

Published
2024
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50. Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management:A GRADE assessment and international consensus approach

Author

Greenhawt, Matthew, Dribin, Timothy E., Abrams, Elissa M., Shaker, Marcus, Chu, Derek K., Golden, David B.K., Akin, Cem, Anagnostou, Akterini, ALMuhizi, Faisal, Alqurashi, Waleed, Arkwright, Peter, Baldwin, James L., Banerji, Aleena, Bégin, Philippe, Ben-Shoshan, Moshe, Bernstein, Jonathan, Bingemann, Theresa A., Bindslev-Jensen, Carsten, Blumenthal, Kim, Byrne, Aideen, Cahill, Julia, Cameron, Scott, Campbell, Dianne, Campbell, Ronna, Cavender, Michael, Chan, Edmond S., Chinthrajah, Sharon, Comberiati, Pasquale, Eastman, Jacqueline J., Ellis, Anne K., Fleischer, David M., Fox, Adam, Frischmeyer-Guerrerio, Pamela A., Gagnon, Remi, Garvey, Lene H., Grayson, Mitchell H., Isabwe, Ghislaine Annie Clarisse, Hartog, Nicholas, Hendron, David, Horner, Caroline C., Hourihane, Johnathan O.B., Iglesia, Edward, Kan, Manstein, Kaplan, Blanka, Katelaris, Constance H., Kim, Harold, Kelso, John M., Khan, David A., Lang, David, Ledford, Dennis, Levin, Michael, Lieberman, Jay A., Loh, Richard, Mack, Douglas P., Mazer, Bruce, Mody, Ketan, Mosnaim, Gisele, Munblit, Daniel, Mustafa, S. Shahzad, Nanda, Anil, Nathan, Richard, Oppenheimer, John, Otani, Iris M., Park, Miguel, Pawankar, Ruby, Perrett, Kirsten P., Peter, Jonny, Phillips, Elizabeth J., Picard, Matthieu, Pitlick, Mitchell, Ramsey, Allison, Rasmussen, Trine Holm, Rathkopf, Melinda M., Reddy, Hari, Robertson, Kara, Rodriguez del Rio, Pablo, Sample, Stephen, Sheshadri, Ajay, Sheik, Javed, Sindher, Sayantani B., Spergel, Jonathan M., Stone, Cosby A., Stukus, David, Tang, Mimi L.K., Tracy, James M., Turner, Paul J., Vander Leek, Timothy K., Wallace, Dana V., Wang, Julie, Wasserman, Susan, Weldon, David, Wolfson, Anna R., Worm, Margitta, Yacoub, Mona Rita, Greenhawt, Matthew, Dribin, Timothy E., Abrams, Elissa M., Shaker, Marcus, Chu, Derek K., Golden, David B.K., Akin, Cem, Anagnostou, Akterini, ALMuhizi, Faisal, Alqurashi, Waleed, Arkwright, Peter, Baldwin, James L., Banerji, Aleena, Bégin, Philippe, Ben-Shoshan, Moshe, Bernstein, Jonathan, Bingemann, Theresa A., Bindslev-Jensen, Carsten, Blumenthal, Kim, Byrne, Aideen, Cahill, Julia, Cameron, Scott, Campbell, Dianne, Campbell, Ronna, Cavender, Michael, Chan, Edmond S., Chinthrajah, Sharon, Comberiati, Pasquale, Eastman, Jacqueline J., Ellis, Anne K., Fleischer, David M., Fox, Adam, Frischmeyer-Guerrerio, Pamela A., Gagnon, Remi, Garvey, Lene H., Grayson, Mitchell H., Isabwe, Ghislaine Annie Clarisse, Hartog, Nicholas, Hendron, David, Horner, Caroline C., Hourihane, Johnathan O.B., Iglesia, Edward, Kan, Manstein, Kaplan, Blanka, Katelaris, Constance H., Kim, Harold, Kelso, John M., Khan, David A., Lang, David, Ledford, Dennis, Levin, Michael, Lieberman, Jay A., Loh, Richard, Mack, Douglas P., Mazer, Bruce, Mody, Ketan, Mosnaim, Gisele, Munblit, Daniel, Mustafa, S. Shahzad, Nanda, Anil, Nathan, Richard, Oppenheimer, John, Otani, Iris M., Park, Miguel, Pawankar, Ruby, Perrett, Kirsten P., Peter, Jonny, Phillips, Elizabeth J., Picard, Matthieu, Pitlick, Mitchell, Ramsey, Allison, Rasmussen, Trine Holm, Rathkopf, Melinda M., Reddy, Hari, Robertson, Kara, Rodriguez del Rio, Pablo, Sample, Stephen, Sheshadri, Ajay, Sheik, Javed, Sindher, Sayantani B., Spergel, Jonathan M., Stone, Cosby A., Stukus, David, Tang, Mimi L.K., Tracy, James M., Turner, Paul J., Vander Leek, Timothy K., Wallace, Dana V., Wang, Julie, Wasserman, Susan, Weldon, David, Wolfson, Anna R., Worm, Margitta, and Yacoub, Mona Rita

Abstract

This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

Published
2023

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