Cited by 395SARS-CoV-2 and COVID-19 ResearchPharmacovigilance and Adverse Drug ReactionsVaccine Coverage and Hesitancy

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Maintaining Safety with SARS-CoV-2 Vaccines

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Castells, Mariana C., Phillips, Elizabeth J.·2021·New England Journal of Medicine

DOI 10.1056/nejmra2035343PMC PMC7787218

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Abstract

The following table lists substances, other than active ingredients (i.e., antigens), shown in the manufacturers' package insert (PI) as being contained in the final formulation of each vaccine.Substances used in the manufacture of a vaccine but not listed as contained in the final product (e.g., culture media) can be found in each PI, but are not shown on this table.Each PI, which can be found on the FDA's website (see below) contains a description of that vaccine's manufacturing process, including the amount and purpose of each substance.In most PIs, this information is found in Section 11: "Description." Please refer to the PI for a complete list of ingredients or excipients.

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“Upon the initiation of the vaccine campaigns, acute anaphylaxis was reported in the UK and the USA, with an incidence of roughly 1 in 100,000 individuals [51].”
Background
High incidence of multisystem inflammatory syndrome and other autoimmune diseases after SARS-CoV-2 infection compared to COVID-19 vaccination in children and adolescents in south central Europe
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Tanno, L. K., Bérard, F., Beaudoin, É., Didier, A. P., & Demoly, P. M. (2021) · Vaccines · doi:10.3390/vaccines9060560 · Cited by 13
“However, to date, nothing has confirmed the causes of the reactions of the two English cases [27] and 33 other American cases described since 3 January 2021 [28].”
Background
Tuning the immune response: sulfated archaeal glycolipid archaeosomes as an effective vaccine adjuvant for induction of humoral and cell-mediated immunity towards the SARS-CoV-2 Omicron variant of concern
Renner, T. M., Akache, B., Stuible, M., Rohani, N., Donates, Y. C., Deschatelets, L., Dudani, R., Harrison, B. A., Baardsnes, J., Koyuturk, I., et al. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1182556 · Cited by 13
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Hypersensitivity Reactions to Vaccines: Current Evidence and Standards for SARS-CoV-2 Vaccines
Carvalho, J. C., Cunha, F., Coutinho, I. A., Loureiro, C., Faria, E., & Todo‐Bom, A. M. (2021) · Acta Médica Portuguesa · doi:10.20344/amp.16096 · Cited by 12
A minimalist supramolecular nanovaccine forcefully propels the Tfh cell and GC B cell responses
Jia, H., Shang, Y., Cao, H., Gao, Y., Liu, J., Yang, L., Yang, C., Ren, C., Wang, Z., & Liu, J. (2022) · Chemical Engineering Journal · doi:10.1016/j.cej.2022.134782 · Cited by 13
Polyethylene Glycol Allergy and Immediate-Type Hypersensitivity Reaction to COVID-19 Vaccination: Case Report
Habran, M., Vandebotermet, M., & Schrijvers, R. (2021) · Journal of Investigational Allergology and Clinical Immunology · doi:10.18176/jiaci.0740 · Cited by 12
“A common cause has not been identified and excipients have been suggested as a more likely culprit compared with active agent [2].”
Background
Optimization of an alum-anchored clinical HIV vaccine candidate
Rodrigues, K. A., Cottrell, C. A., Steichen, J. M., Gröschel, B., Abraham, W. D., Suh, H., Agarwal, Y., Ni, K., Chang, J. Y. H., Yousefpour, P., et al. (2023) · npj Vaccines · doi:10.1038/s41541-023-00711-0 · Cited by 10
The respiratory syncytial virus vaccines are here: Implications for solid organ transplantation
Trubin, P. A., Azar, M. M., & Kotton, C. N. (2024) · American Journal of Transplantation · doi:10.1016/j.ajt.2024.02.003 · Cited by 13
Identification of cross reactive T cell responses in adenovirus based COVID 19 vaccines
Gardner, J., Abrams, S. T., Toh, C., Parker, A. L., Lovatt, C., Nicolson, P. L. R., Watson, S. P., Grice, S., Hering, L. M., Pirmohamed, M., et al. (2024) · npj Vaccines · doi:10.1038/s41541-024-00895-z · Cited by 12
“S and BNT162b2 vaccines 16,17 , with allergy to vaccine excipients cited as common cause of anaphylaxis 18 .”
Vacunas contra la COVID-19
Wong‐Chew, R. M., Ramírez, J. B. D., Carbajal, P. B., León, M. L. G., Angel-Ambrocio, A. H., Velázquez, X. V., Maldonado, L. A. C., González, Y. V., Martínez, L. M. V., Bautista, D. G., et al. (2021) · Acta Médica Grupo Ángeles · doi:10.35366/101742 · Cited by 17
Endotyping of IgE-Mediated Polyethylene Glycol and/or Polysorbate 80 Allergy
Ieven, T., Coorevits, L., Vandebotermet, M., Tuyls, S., Vanneste, H., Santy, L., Wets, D., Proost, P., Frans, G., Devolder, D., et al. (2023) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2023.06.031 · Cited by 12
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COVID‐19 vaccines and the role of other potential allergenic components different from PEG. A reply to: “Other excipients than PEG might cause serious hypersensitivity reactions in COVID‐19 vaccines”
Cabanillas, B., Akdiş, C. A., & Novak, N. (2021) · Allergy · doi:10.1111/all.14761 · Cited by 12
Lipid nanoparticle–mediated in vivo generation of panCAR immune cells for solid tumor immunotherapy
Yin, Q., Liang, X., Zhang, C., Bai, Y., Li, J., Qian, F., & Qiu, M. (2026) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.2509698123 · Cited by 12
“The LNPs contain lipid - conjugated PEG to extend the half - life, improve stability, and reduce immune system recognition (45).”
Drug-induced Anaphylaxis
Torres, M. J., Labella, M., María, R. S. D. S., Bogas, G., Salas, M. L., Fernández, T. D., Mayorga, C., & Doña, I. (2022) · Current Pharmaceutical Design · doi:10.2174/1381612829666221024154951 · Cited by 11
Skin testing with Pfizer SARS-CoV-2 vaccine and PEG 2000
Vieira, J. V. P., Marcelino, J. L. A., Ferreira, F., Farinha, S., Silva, R., Proença, M., & Tomáz, E. (2021) · Asia Pacific Allergy · doi:10.5415/apallergy.2021.11.e18 · Cited by 11
“Although evidence on the pathogenesis of severe immediate reactions to the SARS-CoV-2 vaccine is lacking, the PEG molecule has been proposed as a possible culprit for these reactions due to existing evidence of its ability to cause immunoglobulin E (IgE)-mediated anaphylaxis [4-6].”
Background
Localized and generalized urticarial allergic dermatitis secondary to SARS-CoV-2 vaccination in a series of 6 patients
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“The mRNA SARS-CoV-2 vaccines available in the United States have PEG 2000 (ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide) or its derivative polysorbate 80 in their excipients.(8) The cross-reactivity to polysorbate 80 is thought to be due to the shared chemical moiety, e(CH2CH2O)n, which has also…”
BackgroundResult
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Brown, R. B. (2021) · Medicina · doi:10.3390/medicina57080739 · Cited by 11
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Gütl, K., Raggam, R. B., & Gary, T. (2022) · Biomedicines · doi:10.3390/biomedicines10061246 · Cited by 11
“S (Johnson & Johnson/Janssen, New Brunswick, NJ, USA) are recombinant adenoviral vectors encoding SARS-CoV-2 spike glycoprotein [1].”
Background
Anaphylaxis: Advances in the Past 10 Years
Weiler, C. R., Schrijvers, R., & Golden, D. B. K. (2022) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2022.09.019 · Cited by 13
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Lee, K.-M., Lin, S., Wu, C.-J., & Kuo, R. (2023) · Biomedical Journal · doi:10.1016/j.bj.2023.01.002 · Cited by 14
“Although PEG is known to be a cause of life-threatening anaphylaxis, its correlation with adverse events following vaccination with mRNA vaccines remains to be clariﬁed [37,48,49].”
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Damodharan, K., Arumugam, G. S., Ganesan, S., Doble, M., & Thennarasu, S. (2021) · RSC Advances · doi:10.1039/d0ra09668g · Cited by 12
Linear Polyglycerol for N-terminal-selective Modification of Interleukin-4
Tully, M., Hauptstein, N., Licha, K., Meinel, L., Lühmann, T. C., & Haag, R. (2021) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2021.10.032 · Cited by 11
Sequence similarity of HSP65 of Mycobacterium bovis BCG with SARS-CoV-2 spike and nuclear proteins: may it predict an antigen-dependent immune protection of BCG against COVID-19?
Finotti, P. (2021) · Cell Stress and Chaperones · doi:10.1007/s12192-021-01244-y · Cited by 11
“…the binding of S protein to ACE2 receptor have potent neutralizing activity, being thus the focus in the development of therapeutic interventions for COVID-19 (Henderson 2020), including the currently used vaccines that incorporate S protein to elicit humoral immunity (Castells and Phillips 2020).”
Background
Success of nano-vaccines against COVID-19: a transformation in nanomedicine
Sarangi, M. K., Padhi, S. K., Rath, G., Nanda, S. S., & Yi, D. K. (2022) · Expert Review of Vaccines · doi:10.1080/14760584.2022.2148659 · Cited by 11
“may improve the efficacy or cross-neutralizing protection by reducing the required number of doses [232].”
Background
Adverse Events of COVID-19 Vaccination among the Saudi Population: A Systematic Review and Meta-Analysis
Alhossan, A., Alsaran, A. K., Almahmudi, A. H., Aljohani, Z. S., Albishi, M. R., & Almutairi, A. K. (2022) · Vaccines · doi:10.3390/vaccines10122089 · Cited by 10
“Vaccineinduced anaphylaxis was almost 10 times more common with Pfizer-BioNTech and Moderna than earlier vaccinations [45].”
BackgroundMethod
Association of death or illness from COVID-19 among family and friends on vaccine uptake within four months of the Emergency Use Authorization. Findings from a national survey in the United States
Kalra, S., Kalra, D., Grafova, I. B., Rubin, J. S., Monheit, A. C., Cantor, J. C., Duberstein, P. R., & Bhuyan, S. S. (2023) · Vaccine · doi:10.1016/j.vaccine.2023.01.024 · Cited by 10
“Food and Drug Administration (FDA) issued emergency use authorization (EUA) for Pfizer BioNTech and Moderna mRNA vaccines in December 2020 [4].”
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Lim, X. R., Chan, G. Y. L., Tan, J. W. L., Ng, C. Y. L., Chua, C. G., Tan, G. B., Chan, S. S. W., Ong, K. H., Tan, Y. C. R. S., Tan, S. H. Z., et al. (2023) · Vaccines · doi:10.3390/vaccines11061020 · Cited by 11
The E484K Substitution in a SARS-CoV-2 Spike Protein Subunit Vaccine Resulted in Limited Cross-Reactive Neutralizing Antibody Responses in Mice
Hu, L., Xu, Y., Wu, L., Feng, J., Zhang, L., Tang, Y., Zhao, X., Mai, R., Chen, L., Mei, L., et al. (2022) · Viruses · doi:10.3390/v14050854 · Cited by 11
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Background
COVID-19 and preventive strategy.
Krittanawong, C., Maitra, N. S., Kumar, A., Hahn, J., Wang, Z., Carrasco, D., Zhang, H. J., Sun, T., Jneid, H. M., & Virani, S. S. (2022) · PubMed Central · Cited by 10
Spleen‐Targeted mRNA Nanoparticles for Modulating B Cell Hyperactivation in Rheumatoid Arthritis Therapy
Liu, Y., Zhang, R., Qiu, N., Wang, S., Chen, J., Xu, X., Xiang, J., & Shen, Y. (2024) · Advanced Functional Materials · doi:10.1002/adfm.202417101 · Cited by 9
SARS-CoV-2 vaccination does not induce relapses of patients with inflammatory bowel disease
Elkharsawi, A. R., von Arnim, U., Schmelz, R., Sander, C., Stallmach, A., Teich, N., Walldorf, J., & Reuken, P. A. (2022) · Zeitschrift für Gastroenterologie · doi:10.1055/a-1710-3861 · Cited by 9
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Structural and Phylogenetic Analysis of SARS-CoV-2 Spike Glycoprotein from the Most Widespread Variants
Caputo, E., & Mandrich, L. (2022) · Life · doi:10.3390/life12081245 · Cited by 9
“The response to the pandemic was the development of vaccines in less than one year; in fact, starting from December 2020, five vaccines have been licensed and used [1,2].”
Realizing time-staggered expression of nucleic acid-encoded proteins by co-delivery of messenger RNA and plasmid DNA on a single nanocarrier
Nasr, S. S., Paul, P., Loretz, B., & Lehr, C. (2024) · Drug Delivery and Translational Research · doi:10.1007/s13346-024-01668-w · Cited by 9
“Following the outbreak of the COVID-19 pandemic, the approval of mRNA-based vaccines and their mass administration with high efficiency [1–3] and safety margin in the general population [4–7], is currently accelerating the advancement of nucleic acid (NA) based therapeutic [8].”
Influential
Prolonged Anaphylaxis to Pfizer Coronavirus Disease 2019 Vaccine: A Case Report and Mechanism of Action
Frank, A., Radparvar, S., Manasia, A. R., Bassily‐Marcus, A., & Kohli-Seth, R. D. (2021) · Critical Care Explorations · doi:10.1097/cce.0000000000000397 · Cited by 9
“In general, anaphylactic reactions to vaccines are rare, approximately one per one million doses (5).”
Background
Efficacy of a rational algorithm to assess allergy risk in patients receiving the BNT162b2 vaccine
Yacoub, M., Cucca, V., Asperti, C., Ramirez, G. A., Della‐Torre, E., Moro, M., Zandalasini, C., Napoli, D. D., Ambrosio, A. G., Signorelli, C., et al. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.09.048 · Cited by 9
Basophil Activation Test with Different Polyethylene Glycols in Patients with Suspected PEG Hypersensitivity Reactions
Vespa, S., Biondo, P. D., Simeone, P., Cavallucci, E., Catitti, G., Auciello, R., Bellis, D. D., Altomare, I., Pierdomenico, L., Canonico, B., et al. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms232314592 · Cited by 9
“in a short time, of new vaccines to prevent SARS-CoV-2 infection was one of the most relevant scientific landmark achievements in this context [2,3].”
Background
Second dose of COVID‐19 vaccination in immediate reactions to the first BNT162b2
Duque, J. S. R., Leung, D., Au, E. Y. L., & Lau, Y. (2021) · Pediatric Allergy and Immunology · doi:10.1111/pai.13683 · Cited by 9
Engineering Materials and Devices for the Prevention, Diagnosis, and Treatment of COVID-19 and Infectious Diseases
Soto, J., Linsley, C. S., Song, Y., Chen, B., Fang, J., Neyyan, J., Davila, R., Lee, B. S., Wu, B. M., & Li, S. (2023) · Nanomaterials · doi:10.3390/nano13172455 · Cited by 9
Significance of VLPs in Vlp-circRNA vaccines: a vaccine candidate or delivery vehicle?
Gupta, R., Arora, K., Arora, N. M., & Kundu, P. K. (2024) · RNA Biology · doi:10.1080/15476286.2024.2399307 · Cited by 11
Nucleic Acids as Biotools at the Interface between Chemistry and Nanomedicine in the COVID-19 Era
Borbone, N., Piccialli, I., Falanga, A. P., Piccialli, V., Roviello, G. N., & Oliviero, G. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23084359 · Cited by 9
“However, despite the mass immunization campaign [11,12] and the efforts of pharmaceutical companies and the scientific community to devise effective therapies via new drug development [13,14], drug repurposing [15,16], herbal medicine [17–21] and other recently proposed approaches [22–26], SARS-CoV-2 and other human c…”
Background
Evaluation of Patients with Vaccine Allergies Prior to mRNA-Based COVID-19 Vaccination
Lim, X. R., Tan, J. W. L., Chan, G. Y. L., Hou, J., Xie, L., Goh, V. H. L., Boon, J., Lee, S. S. M., Teo, C. M., Tan, S. C., et al. (2022) · Vaccines · doi:10.3390/vaccines10071025 · Cited by 8
“Since the rollout of the vaccinations worldwide, reports of severe hypersensitivity reactions post mRNA vaccinations surfaced, prompting various clinical immunology/allergy expert panels and professional bodies to issue guidance or recommendations that those with a history of an immediate allergic reaction to other va…”
Background
COVID-19 Vaccine Hesitancy: The Perils of Peddling Science by Social Media and the Lay Press
Thorakkattil, S. A., Abdulsalim, S., Karattuthodi, M. S., Unnikrishnan, M. K., Rashid, M., & Thunga, G. (2022) · Vaccines · doi:10.3390/vaccines10071059 · Cited by 8
“The WHO recommends that all nations should investigate serious AEFIs [43].”
Background
Polymyalgia rheumatica and polymyalgia-like syndromes as adverse events following COVID-19 vaccines: working notes from a narrative review of published literature
Manzo, C., Castagna, A., & Isetta, M. (2022) · Reumatologia/Rheumatology · doi:10.5114/reum.2022.115665 · Cited by 8
“Similarly, polysorbate 80 is an excipient used in the preparation of ChAdOx1-S vaccine whose ability to trigger an ASIA syndrome is still to be proven [50].”
Background
Allergic Reactions to COVID-19 Vaccination in High-Risk Allergic Patients: The Experience of Trieste University Hospital (North-Eastern Italy)
Filon, F. L., Lazzarato, I., Patriarca, E., Iavernig, T., Peratoner, A., Perri, G., Ponis, G., Rocco, G., & Cegolon, L. (2022) · Vaccines · doi:10.3390/vaccines10101616 · Cited by 8
“7 cases per million doses in a greater population of vaccinees [5], a estimate 5–10 times higher than that reported for other non-COVID-19 vaccines [6].”
Result
Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study
Bareiß, A., Uzun, G., Mikus, M., Becker, M., Althaus, K., Schneiderhan‐Marra, N., Fürstberger, A., Schwab, J. D., Kestler, H. A., Holderried, M., et al. (2022) · Viruses · doi:10.3390/v15010065 · Cited by 8
“Most of the reported side effects usually diminish in a few days, however, on rare occasions, severe side effects such as anaphylaxis [16] and thrombotic events were reported [17,18].”
Background
Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study
Alkhalifah, J. M., Seraihi, A. A., Al‐Tawfiq, J. A., Alshehri, B. F., Alhaluli, A. H., Alsulais, N. M., Alessa, M. M., Seddiq, W., Aljeri, T., Qahtani, M. H., et al. (2023) · Frontiers in Public Health · doi:10.3389/fpubh.2023.1043696 · Cited by 9
“Post-vaccination adverse events (AEs) reporting and safety monitoring are recommended by multiple institutions worldwide, especially during a pandemic (2).”
Background
Answers to burning questions for clinical allergologists related to the new COVID-19 vaccines
Altrichter, S., Wöhrl, S., Horak, F., Idzko, M., Jordakieva, G., Untersmayr, E., Szépfalusi, Z., Zieglmayer, P. U., Jensen‐Jarolim, E., Wiedermann, U., et al. (2021) · Allergo Journal International · doi:10.1007/s40629-021-00177-3 · Cited by 8
Safety of BNT162b2 mRNA COVID-19 vaccine in patients with mast cell disorders
Rosman, Y., Lavi, N., Meir‐Shafrir, K., Lachover‐Roth, I., Cohen‐Engler, A., Mekori, Y. A., & Confino‐Cohen, R. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.06.032 · Cited by 8
“Since the initial report from the United Kingdom regarding anaphylaxis after the PBTV, several more cases have been reported.(4) In the real-world setting, the incidence of anaphylaxis associated with the PBTV appears to be 10 times higher than that reported with all previous vaccines.”
Background
Cellular and humoral responses to SARS-CoV-2 vaccination in immunosuppressed patients
Mohanraj, D., Baldwin, S., Singh, S., Gordon, A., & Whitelegg, A. M. E. (2022) · Cellular Immunology · doi:10.1016/j.cellimm.2022.104501 · Cited by 10
COVID‐19 vaccines and anaphylaxis—evaluation with skin prick testing, basophil activation test and Immunoglobulin E
Csuth, Á., Nopp, A., Storsæter, J., Nilsson, L. J., & Jenmalm, M. C. (2022) · Clinical & Experimental Allergy · doi:10.1111/cea.14143 · Cited by 8
Case Report: A case of multisystem inflammatory syndrome in an 11-year-old female after COVID-19 inactivated vaccine
Saeed, S., Cao, J., Xu, J., Zhang, Y., Zheng, X., Jiang, L., Jiang, C., & Zhang, X. (2023) · Frontiers in Pediatrics · doi:10.3389/fped.2023.1068301 · Cited by 8
“Adverse reactions often begin within three days of vaccination and resolve within a few days (8, 9).”
Background
Delving Into COVID-19 Vaccination–Induced Anaphylaxis: Are mRNA Vaccines Safe in Mast Cell Disorders?
Rama, T. A., & Álvarez-Twose, I. (2021) · Journal of Investigational Allergology and Clinical Immunology · doi:10.18176/jiaci.0680 · Cited by 8
Durable protective efficiency provide by mRNA vaccines require robust immune memory to antigens and weak immune memory to lipid nanoparticles
Tang, X., Zhang, J., Sui, D., Xu, Z., Yang, Q., Wang, T., Li, X., Liu, X., Deng, Y., & Song, Y. (2024) · Materials Today Bio · doi:10.1016/j.mtbio.2024.100988 · Cited by 7
“Studies have suggested that the side effects of mRNA vaccines are related to anti-PEG antibodies [35,36], and we detected anti-PEG antibodies in mouse serum using ELISA.”
Method
Asymmetrical branched PEG-modified liposomes evade anti-PEG antibody recognition to abolish accelerated blood clearance and amplify tumor drug accumulation
Zhang, K., Li, M., Sui, D., Zhao, J., She, Z., Ding, K., Shang, X., Du, Z., Wang, N., Lu, Y., et al. (2025) · Nanoscale · doi:10.1039/d5nr01680k · Cited by 7
Adverse Events and Safety of SARS-CoV-2 Vaccines: What’s New and What’s Next
Corey, K. B., Koo, G., & Phillips, E. J. (2022) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2022.04.035 · Cited by 9
“In addition, fortunately, and contrary to much anxiety in the general population about serious vaccine adverse events appearing years later, past experience has told us that vaccine-related adverse reactions are unlikely to occur more than 2 months following initial vaccination.(6,22,100) Reassuringly, the reactions d…”
A case of coronavirus disease 2019 messenger RNA vaccine tolerance and immune response despite presence of anti-polyethylene glycol antibodies
Corey, K. B., Koo, G., Stone, C. A., Kroop, S. F., Fissell, W. H., Kozlowski, S., Zhou, Z., & Phillips, E. J. (2022) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2022.05.013 · Cited by 7
Prolonged Diarrhea Following COVID-19 Vaccination: A Case Report and Literature Review
Akaishi, T., Takahashi, T., Sato, S., Jin, X., Masamune, A., & Ishii, T. (2022) · The Tohoku Journal of Experimental Medicine · doi:10.1620/tjem.2022.j043 · Cited by 7
Pulmonary embolism with junctional tachycardia: A serious complication after COVID-19 vaccination
Miri, C., Bouchlarhem, A., Boulouiz, S., Ouafi, N. E., & Bazid, Z. (2022) · Annals of Medicine and Surgery · doi:10.1016/j.amsu.2022.103983 · Cited by 7
“COVID-19 vaccines were developed as a result of coordinated global efforts, they were intended for public administration and are now widely available [1].”
Biphasic anaphylaxis after first dose of messenger RNA coronavirus disease 2019 vaccine with positive polysorbate 80 skin testing result
Pitlick, M. M., Park, M. A., Gonzalez‐Estrada, A., & Chiarella, S. E. (2021) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2021.07.020 · Cited by 7
“Immunoglobulin E and non −immunoglobulin E-mediated mechanisms are implicated in polysorbate and PEG reactions.(7) Expert opinion suggests an algorithm using nonirritating concentrations for PEG and polysorbate testing in the evaluation of patients with possible anaphylaxis to the mRNA COVID-19 vaccines.”
An Exploration of the Universal and Switchable RAFT-Mediated Synthesis of Poly(styrene-alt-maleic acid)-b-poly(N-vinylpyrrolidone) Block Copolymers
Ball, L. E., Smith, M., Pfukwa, R., & Klumperman, B. (2025) · Macromolecules · doi:10.1021/acs.macromol.4c02741 · Cited by 6
Allergic Reactions After COVID-19 Vaccination—Putting Risk Into Perspective
Phillips, E. J. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.22326 · Cited by 6
Allergic reactions to the Ad26.COV2.S vaccine in South Africa
Peter, J., Day, C., Takuva, S. G., Takalani, A., Engelbrecht, I., Garrett, N., Goga, A. E., Louw, V. J., Opie, J., Jacobson, B. F., et al. (2021) · Journal of Allergy and Clinical Immunology Global · doi:10.1016/j.jacig.2021.12.002 · Cited by 6
“Sex: female, n (%) 91 (85) 21 (88) 57 (83) 60 (86) Age (y), median (IQR) 38 (28-45) 38 (29-52) 37 (27-43) 39 (28-46) Time to reaction (h), median (IQR) 24 (6-96) 0.”
Background
L'anaphylaxie et les vaccins COVID-19
Castells, M., Demoly, P. M., & Tanno, L. K. (2021) · Revue française d'allergologie · doi:10.1016/s1877-0320(21)00439-5 · Cited by 6
Covid-19 pandemic: Perspectives on management
Gathiram, P., Moodley, J., & Khaliq, O. P. (2021) · Journal of Reproductive Immunology · doi:10.1016/j.jri.2021.103344 · Cited by 6
Nonviral vector system for cancer immunogene therapy
Nie, W., Chen, J., Wang, B., & Gao, X. (2022) · MedComm – Biomaterials and Applications · doi:10.1002/mba2.10 · Cited by 6
The COVID-19 Vaccine Landscape: What a Rheumatologist Needs to Know
Bechman, K., Dey, M., Yates, M., Bukhari, M. A. S., Winthrop, K. L., & Galloway, J. B. (2021) · The Journal of Rheumatology · doi:10.3899/jrheum.210106 · Cited by 6
“17 This may relate to the polyethylene glycol (PEG) ingredient, also in the Moderna vaccine.”
Background
COVID-19 vaccines: challenges and solutions
Afshar, Z. M., Babazadeh, A., Janbakhsh, A., Afsharian, M., & Ebrahimpour, S. (2022) · Minerva Respiratory Medicine · doi:10.23736/s2784-8477.21.01921-0 · Cited by 5
Discovery in polyethylene glycol immunogenicity: The characteristic of intergenerational inheritance of anti-polyethylene glycol IgG
Gao, X., Yan, X., Wang, R., Li, C., Qiu, Q., Liu, M., Tang, X., Yan, N. J., Li, J., Song, Y., et al. (2022) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2022.01.008 · Cited by 5
Axillary lymph node imaging in mRNA, vector-based, and mix-and-match COVID-19 vaccine recipients: ultrasound features
Rouilleault, A. C. I., Soriano, I., Elizalde, A., Quan, P. L., Fernández‐Montero, A., Sobrido, C., & Pina, L. (2022) · European Radiology · doi:10.1007/s00330-022-08846-9 · Cited by 5
Characterizing Responses to COVID-19 Vaccine Promotion on TikTok
Southwick, L., Francisco, A., Bradley, M., Klinger, E. V., & Guntuku, S. C. (2022) · American Journal of Health Promotion · doi:10.1177/08901171221141974 · Cited by 5
“Vaccines against the severe acute respiratory syndrome coronavirus (SARS-CoV-2) that causes COVID-19 are essential for population-level health and safety.(1) Since December 2020, four COVID-19 vaccines have received U.”
Background
In Vitro Antibody-Dependent Enhancement of SARS-CoV-2 Infection Could Be Abolished by Adding Human IgG
Wang, X., Li, M., Lu, P., Li, C., Zhao, C., Zhao, X., Qiao, R., Cui, Y., Chen, Y., Li, J., et al. (2023) · Pathogens · doi:10.3390/pathogens12091108 · Cited by 5
Polysorbate 80-containing ionizable lipid nanoparticles for mRNA delivery
Tang, X., Ding, S., Yang, S., Cheng, Y., Liu, H., Chen, K., & Han, X. (2024) · Biomaterials Science · doi:10.1039/d4bm00523f · Cited by 5
A study on the side effects caused by the Pfizer/BioNTech COVID-19 vaccine: Focus on IgG antibodies and serological biomarkers
Ali, K. M., Rashid, P. M. A., Ali, K. M., Mahmood, K. I., & Rostam, H. M. (2024) · Central European Journal of Immunology · doi:10.5114/ceji.2024.136382 · Cited by 5
Detection of PEG-specific antibodies in SARS-CoV-2 positive and negative sera with implications for autoimmune reactivity
Vojdani, A., & Vojdani, E. (2025) · Scientific Reports · doi:10.1038/s41598-025-17777-6 · Cited by 3
Health Technology Assessment of mRNA Vaccines: Clinical, Economic, and Public Health Implications
Genovese, G., Rizzo, C. E., & Genovese, C. (2025) · Vaccines · doi:10.3390/vaccines13101045 · Cited by 4
Membrane-Camouflaged Biomimetic Nanoparticles for Effective Ischemic Stroke Therapeutics? A Comprehensive Review of the Literature
Cheng, F., Wang, J., & Sun, F. (2025) · International Journal of Nanomedicine · doi:10.2147/ijn.s563061 · Cited by 6
“40,41 In contrast, NPs coated with natural cell membranes carry specific membrane proteins or engineered membrane components on their surfaces, which can endow CMC@NPs with unique biomimetic functions and serve as the molecular basis for their interactions with biological systems (Table 2).”
Exploring the impact of lipid nanoparticles on protein stability and cellular proteostasis
Gao, Z., Jing, B., Wang, Y., Wan, W., Dong, X., & Liu, Y. (2024) · Journal of Colloid and Interface Science · doi:10.1016/j.jcis.2024.08.146 · Cited by 4
Novel polymersomes based on Poly(2-methyl-2-oxazoline) polymers with excellent pharmacokinetic behavior and antitumor effect by modulating dynamic protein corona
Cai, Z., Fu, F., Zhu, S., Wu, J., Han, X., Jiang, S., Qian, Z., & Wang, C. (2025) · Chemical Engineering Journal · doi:10.1016/j.cej.2025.162443 · Cited by 4
COVID-19 vaccination: Recommendations for management of patients with allergy or immune-based diseases
Peter, J. (2021) · South African Medical Journal · doi:10.7196/samj.2021.v111i4.15576 · Cited by 5
“[8] The likely inciting allergen in the two mRNA COVID-19 vaccines developed by PfizerBioNtech and Moderna is the polyethylene glycol (PEG) lipid conjugate that helps to provide a hydrophilic layer to prolong the half-life.”
BackgroundInfluential
COVID-19 Vaccination in Patients With Inflammatory Bowel Disease and History of Reaction to Injectable Therapies
Squire, J. D., Gonzalez‐Estrada, A., Caldera, F., & Farraye, F. A. (2021) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izab094 · Cited by 4
Spatiotemporal tracking of the transport of RNA nano-drugs: from transmembrane to intracellular delivery
Pang, X., Zhang, Q., Li, S., Zhao, J., Cai, M., Wang, H., Xu, H., Yang, G., & Shan, Y. (2022) · Nanoscale · doi:10.1039/d2nr00988a · Cited by 4
COVID vaccination can be performed in patients with a history of allergic reactions to the vaccines or their components: experience from a specialist clinic in South Australia
Tunbridge, M. J., Perkins, G. B., Lee, M., Salehi, T., Ryoo, D., Kette, F. E., Smith, W., Gold, M., Le, T. A., Yuson, C., et al. (2022) · Internal Medicine Journal · doi:10.1111/imj.15888 · Cited by 4
Taxanes Hypersensitivity is not a risk factor for severe reactions to SARS-Cov-2 vaccines
Cortellini, G., Raiteri, A., Biagioni, B., Liberati, S., Lippolis, D., Cortellini, G., & Piscaglia, F. (2022) · European Annals of Allergy and Clinical Immunology · doi:10.23822/eurannaci.1764-1489.265 · Cited by 4
Pyoderma Gangrenosum Triggered by COVID-19 Vaccination in a Patient with Ulcerative Colitis: A Case Report
Kim, Y., Shim, H., Jeong, H., & Park, Y. (2022) · The International Journal of Lower Extremity Wounds · doi:10.1177/15347346221141173 · Cited by 4
The usability of testing skin reaction applying skin prick tests with Comirnaty (Pfizer, USA) vaccine in detecting the risk of developing post-vaccination immediate hypersensitivity response (anaphylaxis) after administration of this vaccine
Gulas, E., Bant, A., Kruszewski, J., Betiuk, B., Niedoszytko, M., & Chciałowski, A. (2023) · Advances in Dermatology and Allergology · doi:10.5114/ada.2023.131860 · Cited by 4
“Severe allergic reactions occur statistically with a frequency of about 1 case per million administrations of the medical product [1].”
Background
How Do We Move Type 1 Diabetes Immunotherapies Forward During the Current COVID-19 Pandemic?
Haller, M. J., Jacobsen, L. M., Posgai, A. L., & Schatz, D. (2021) · Diabetes · doi:10.2337/dbi20-0045 · Cited by 4
“Timing of COVID-19 Vaccination December 2020 simultaneously saw the widespread circulation of more transmissible SARS-CoV-2 variants (57) along with the worldwide commencement of mass immunization against COVID-19 (58).”
Background
What gastroenterologists should know about SARS–CoV 2 vaccine: World Endoscopy Organization perspective
Spadaccini, M., Canziani, L. M., Aghemo, A., Lleò, A., Maselli, R., Anderloni, A. A., Carrara, S., Fugazza, A., Pellegatta, G., Galtieri, P. A., et al. (2021) · United European Gastroenterology Journal · doi:10.1002/ueg2.12103 · Cited by 3
New-onset and relapsing glomerular diseases related to COVID-19 vaccination
Liu, F., Feng, C., Mao, J., & Fu, H.-D. (2021) · Journal of Zhejiang University (Medical Sciences) · doi:10.3724/zdxbyxb-2021-0156 · Cited by 4
Case Report: Subacute thyroiditis after receiving inactivated SARS-CoV-2 vaccine (BBIBP-CorV)
Pi, L., Lin, J., Zheng, Y. Y., Wang, Z., & Zhou, Z. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.918721 · Cited by 4
“At present, almost all researchers focused mainly on nonspecific adverse events for SARS-CoV-2 vaccines (29), but less attention was placed on specific diseases, which were presented only in rare case reports, such as subacute thyroiditis (11, 30, 31), hypophysitis (32), autoimmune hepatitis (33), granulomatous”
Background
Analysis of Adverse Effects of COVID-19 Vaccines Experienced by Healthcare Workers at Guizhou Provincial Staff Hospital, China
Wei, Y., Wang, Y., Liu, L., Zha, Y., Yang, Y., Wang, Y., Roberts, N., & Li, Y. (2022) · Vaccines · doi:10.3390/vaccines10091449 · Cited by 4
Safety and Considerations of the COVID-19 Vaccine Massive Deployment
Li, J., Song, M., Guo, D., & Yi, Y. (2021) · Virologica Sinica · doi:10.1007/s12250-021-00408-5 · Cited by 4
“The data collected from mass vaccination with mRNA1273 and BNT162b2 indicate the anaphylactic rate is around 1/100000, higher than that of common vaccines (Castells and Phillips 2021).”
Background
Serological testing for SARS-CoV-2 antibodies in clinical practice: a comparative diagnostic accuracy studyPreprint
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Vaccine side effects after vaccination against COVID-19 in employees at an University Hospital in Austria
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Hypersensitivity to Excipients in Drugs: An EAACI Position Paper
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Pre-intervention with intravenous immunoglobulin reverses the immunogenic clearance of PEGylated nanomedicines
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Authors: Castells, M. C., & Phillips, E. J.
Affiliations: Brigham and Women's Hospital (US)
Corresponding author: Castells, Mariana C.
ORCID: Castells, Mariana C.
Phillips, Elizabeth J.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2021-02-18
Volume: 384
Issue: 7
Pages: 643-649
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmra2035343
PMC: PMC7787218
OpenAlex: W3115737775
Cited by: 395
References: 17
Citations by year: 2026: 10 · 2025: 15 · 2024: 24 · 2023: 42 · 2022: 114 · 2021: 189
FWCI: 11.32
Type: journal article
Language: en
Open access: green
europepmc.org
Locations: New England Journal of Medicine (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords: COVID-19 vaccines, vaccine excipients, vaccine ingredients, package inserts, vaccine safety, vaccine production
MeSH terms: COVID-19, COVID-19 Vaccines, mRNA Vaccines, Anaphylaxis, Humans, Vaccines, Synthetic, Viral Vaccines

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Maintaining Safety with SARS-CoV-2 Vaccines

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