Maintaining safety with SARS-CoV-2 vaccines
Open accessAbstract
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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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2034577 · Cited by 14,592 · see citing works
mRNA vaccines — a new era in vaccinology
Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D. (2018) · Nature Reviews Drug Discovery · doi:10.1038/nrd.2017.243 · Cited by 4,667 · see citing works
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Jackson, L. A., Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2022483 · Cited by 3,237 · see citing works
A global survey of potential acceptance of a COVID-19 vaccine
Lazarus, J. V., Ratzan, S. C., Palayew, A., Gostin, L. O., Larson, H. J., Rabin, K., Kimball, S., & El-Mohandes, A. (2021) · Nature Medicine · doi:10.1038/s41591-020-1124-9 · Cited by 2,904 · see citing works
SARS-CoV-2 vaccines in development
Krammer, F. (2020) · Nature · doi:10.1038/s41586-020-2798-3 · Cited by 2,098 · see citing works
Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose
Chung, C. H., Mirakhur, B., Chan, E., Le, Q.-T., Berlin, J., Morse, M., Murphy, B. A., Satinover, S. M., Hosen, J., Mauro, D., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa074943 · Cited by 1,521 · see citing works
Freeman, D. H., Loe, B. S., Chadwick, A., Vaccari, C., Waite, F., Rosebrock, L. E., Jenner, L., Petit, A., Lewandowsky, S., Vanderslott, S., et al. (2020) · Psychological Medicine · doi:10.1017/s0033291720005188 · Cited by 764 · see citing works
Chanan-Khan, A., Szebeni, J., Savay, S., Liebes, L., Rafique, N. M., Alving, C. R., & Muggia, F. M. (2003) · Annals of Oncology · doi:10.1093/annonc/mdg374 · Cited by 479 · see citing works
Stone, C. A., Liu, Y., Relling, M. V., Krantz, M. S., Pratt, A. L., Abreo, A. M., Hemler, J. A., & Phillips, E. J. (2018) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2018.12.003 · Cited by 349 · see citing works
Bochner, B. S., & Lichtenstein, L. M. (1991) · New England Journal of Medicine · doi:10.1056/nejm199106203242506 · Cited by 324 · see citing works
Dooling, K. L., McClung, N. M., Chamberland, M. E., Marin, M., Wallace, M. M., Bell, B. P., Lee, G. M., Talbot, H. K., Romero, J. R., & Oliver, S. E. (2020) · MMWR Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm6949e1 · Cited by 307 · see citing works
Diagnosis and management of anaphylaxis in precision medicine
Castells, M. (2017) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2017.06.012 · Cited by 242 · see citing works
Polyethylene Glycol–Induced Systemic Allergic Reactions (Anaphylaxis)
Sellaturay, P., Nasser, S. M., & Ewan, P. W. (2020) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2020.09.029 · Cited by 226 · see citing works
Personalized vaccinology: A review
Poland, G. A., Ovsyannikova, I. G., & Kennedy, R. B. (2017) · Vaccine · doi:10.1016/j.vaccine.2017.07.062 · Cited by 196 · see citing works
Immune‐mediated adverse reactions to vaccines
Stone, C. A., Rukasin, C. R. F., Beachkofsky, T. M., & Phillips, E. J. (2019) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.14112 · Cited by 180 · see citing works
Krantz, M. S., Liu, Y., Phillips, E. J., & Stone, C. A. (2020) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2019.12.041 · Cited by 50 · see citing works
Polyethylene glycol may be the major allergen in depot medroxy-progesterone acetate
Lu, I. N., Rutkowski, K., Kennard, L., Nakonechna, A., Mirakian, R. M., & Wagner, A. (2020) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2020.04.057 · Cited by 16 · see citing works
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Unlocking the promise of mRNA therapeutics
Rohner, E., Yang, R., Foo, K. S., Goedel, A., & Chien, K. R. (2022) · Nature Biotechnology · doi:10.1038/s41587-022-01491-z · Cited by 612 · see citing works
Nanomaterial Delivery Systems for mRNA Vaccines
Buschmann, M. D., Carrasco, M. J., Alishetty, S., Paige, M., Alameh, M. G., & Weissman, D. (2021) · Vaccines · doi:10.3390/vaccines9010065 · Cited by 582 · see citing works
“Since the emergency use approval of the Pfizer/BioNTech vaccine, there has been several observed incidences of acute anaphylaxis corresponding to 1 case in 100,000 vaccinations, which is about 10-fold the rate seen with other vaccines [170].”
BackgroundDrug allergy: A 2022 practice parameter update
Khan, D. A., Banerji, A., Blumenthal, K. G., Phillips, E. J., Solensky, R., White, A. A., Bernstein, J. A., Chu, D. K., Ellis, A. K., Golden, D. B. K., et al. (2022) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2022.08.028 · Cited by 572 · see citing works
Chen, B., Cheng, T., & Roffler, S. R. (2021) · ACS Nano · doi:10.1021/acsnano.1c05922 · Cited by 573 · see citing works
The Limitless Future of RNA Therapeutics
Damase, T. R., Sukhovershin, R. A., Boada, C., Taraballi, F., Pettigrew, R. I., & Cooke, J. P. (2021) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2021.628137 · Cited by 549 · see citing works
Shi, D., Beasock, D., Fessler, A., Szebeni, J., Ljubimova, J. Y., Afonin, K. A., & Dobrovolskaia, M. A. (2022) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.114079 · Cited by 535 · see citing works
The dawn of mRNA vaccines: the COVID-19 case
Verbeke, R., Lentacker, I., De Smedt, S. C., & Dewitte, H. (2021) · Journal of Controlled Release · doi:10.1016/j.jconrel.2021.03.043 · Cited by 504 · see citing works
Watad, ., Marco, G. D., Mahajna, H., Druyan, A., Eltity, M., Hijazi, N., Haddad, A., Elias, M., Zisman, D., Naffaa, M. E., et al. (2021) · Vaccines · doi:10.3390/vaccines9050435 · Cited by 364 · see citing works
COVID-19 in early 2021: current status and looking forward
Wang, C., Wang, Z., Wang, G., Lau, J. Y., Zhang, K., & Li, W. (2021) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-021-00527-1 · Cited by 346 · see citing works
STING agonist delivery by tumour-penetrating PEG-lipid nanodiscs primes robust anticancer immunity
Dane, E. L., Belessiotis‐Richards, A., Backlund, C. M., Wang, J., Hidaka, K., Milling, L. E., Bhagchandani, S. H., Melo, M. B., Wu, S., Li, N., et al. (2022) · Nature Materials · doi:10.1038/s41563-022-01251-z · Cited by 337 · see citing works
McDonald, I., Murray, S. M., Reynolds, C. J., Altmann, D. M., & Boyton, R. J. (2021) · npj Vaccines · doi:10.1038/s41541-021-00336-1 · Cited by 247 · see citing works
The safety of Covid-19 mRNA vaccines: a review
Anand, P., & Stahel, V. P. (2021) · Patient Safety in Surgery · doi:10.1186/s13037-021-00291-9 · Cited by 232 · see citing works
Greenhawt, M., Abrams, E. M., Shaker, M. S., Chu, D. K., Khan, D. A., Akin, C., Alqurashi, W., Arkwright, P. D., Baldwin, J. L., Ben‐Shoshan, M., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.06.006 · Cited by 204 · see citing works
“14,18,88,121 Of note, skin testing to the vaccines is not approved under any of the EUAs.”
Anti-PEG antibodies compromise the integrity of PEGylated lipid-based nanoparticles via complement
Sentí, M. E., de Jongh, C. A., Dijkxhoorn, K., Verhoef, J. J. F., Szebeni, J., Storm, G., Hack, C. E., Schiffelers, R. M., Fens, M. H. A. M., & Boross, P. (2021) · Journal of Controlled Release · doi:10.1016/j.jconrel.2021.11.042 · Cited by 202 · see citing works
Kounis, N. G., Koniari, I. C., GREGORIO, C. D., Velissaris, D., Petalas, K., Brinia, A., Assimakopoulos, S. F., Gogos, C., Kouni, S. N., Kounis, G. N., et al. (2021) · Vaccines · doi:10.3390/vaccines9030221 · Cited by 192 · see citing works
“Vaccinated subjects with very high IgE concentrations thereby respond poorly to the vaccine [69].”
BackgroundNanotechnology-based mRNA vaccines
Chen, S., Huang, X., Xue, Y., Álvarez‐Benedicto, E., Shi, Y., Chen, W., Koo, S., Siegwart, D. J., Dong, Y., & Tao, W. (2023) · Nature Reviews Methods Primers · doi:10.1038/s43586-023-00246-7 · Cited by 172 · see citing works
Szebeni, J., Storm, G., Ljubimova, J. Y., Castells, M., Phillips, E. J., Turjeman, K., Barenholz, Y., Crommelin, D. J. A., & Dobrovolskaia, M. A. (2022) · Nature Nanotechnology · doi:10.1038/s41565-022-01071-x · Cited by 168 · see citing works
Fix, O. K., Blumberg, E. A., Chang, K., Chu, J., Chung, R. T., Goacher, E. K., Hameed, B., Kaul, D. R., Kulik, L., Kwok, R. M., et al. (2021) · Hepatology · doi:10.1002/hep.31751 · Cited by 156 · see citing works
mRNA vaccine in cancer therapy: Current advance and future outlook
Li, Y., Wang, M., Peng, X., Yang, Y., Chen, Q., Liu, J., She, Q., Tan, J., Lou, C., Liao, Z., et al. (2023) · Clinical and Translational Medicine · doi:10.1002/ctm2.1384 · Cited by 152 · see citing works
Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials
Chen, M., Yuan, Y., Zhou, Y., Deng, Z., Zhao, J., Feng, F., Zou, H., & Sun, C. (2021) · Infectious Diseases of Poverty · doi:10.1186/s40249-021-00878-5 · Cited by 141 · see citing works
“Severe adverse events (SAEs) were rare, and only were reported in some volunteers as hypersensitivity, facioplegia, urticaria and anaphylactic shock [11].”
BackgroundResultFirst-Dose mRNA COVID-19 Vaccine Allergic Reactions: Limited Role for Excipient Skin Testing
Wolfson, A. R., Robinson, L. B., Li, L., McMahon, A. E., Cogan, A. S., Fu, X., Wickner, P. G., Samarakoon, U., Saff, R. R., Blumenthal, K. G., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.06.010 · Cited by 140 · see citing works
“7) History of PEG Allergy 2 (3) 2 (3) 0 (0) Reaction History (n, %) Cutaneous Symptoms ǁ 65 (81) 51 (78) 14 (93) Lower Respiratory Symptoms ¶ 18 (23) 14 (22) 4 (27) Cardiovascular Symptoms # 11 (14) 10 (15) 1 (7) Gastrointestinal Symptoms ** 9 (11) 7 (11) 2 (13) Upper Airway Symptoms †† 6 (8) 6 (9) 0 (0) Other Symptom…”
BackgroundAlthaus, K., Mӧller, P., Uzun, G., Singh, A., Beck, A., Bettag, M., Bösmüller, H. C., Guthoff, M., Dorn, F., Petzold, G. C., et al. (2021) · Haematologica · doi:10.3324/haematol.2021.279000 · Cited by 132 · see citing works
Reactivation of Varicella Zoster Virus after Vaccination for SARS-CoV-2
Psichοgiou, M., Samarkos, M., Mikos, N., & Hatzakis, A. E. (2021) · Vaccines · doi:10.3390/vaccines9060572 · Cited by 135 · see citing works
“In addition, mRNA platform is a promising new technology and demonstration of its safety is meaningful for the development of further vaccines against viruses and tumors [41].”
BackgroundWarren, C. M., Snow, T. T., Lee, A., Shah, M. M., Heider, A., Blomkalns, A. L., Betts, B. A., Buzzanco, A. S., González, J. C., Chinthrajah, R. S., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.25524 · Cited by 132 · see citing works
“In pharmaceuticals, PEG is often conjugated to biological therapeutics to form a depot agent, and sensitivity to PEG has been linked to IgE-mediated anaphylaxis after administration of PEG-conjugated biological therapeutics.(9,10,14-16) Interestingly, severe allergic reactions to PEG have been associated with preexist…”
BackgroundInfluentialVaccines and allergic reactions: The past, the current COVID‐19 pandemic, and future perspectives
Sampath, V., Rabinowitz, G., Shah, M. M., Jain, S., Diamant, Z., Jeseňák, M., Rabin, R. L., Vieths, S., Agache, I. O., Akdiş, M., et al. (2021) · Allergy · doi:10.1111/all.14840 · Cited by 117 · see citing works
COVID-19 Vaccines: Current Understanding on Immunogenicity, Safety, and Further Considerations
He, Q., Mao, Q., Zhang, J., Bian, L., Gao, F., Wang, J., Xu, M., & Liang, Z. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.669339 · Cited by 108 · see citing works
“Severe allergic reactions have been reported after the administration of the two vaccines (89, 90).”
BackgroundHartwell, B., Melo, M., Xiao, P., Lemnios, A. A., Li, N., Chang, J. Y. H., Yu, J.-Y., Gebre, M. S., Chang, A., Maiorino, L., et al. (2022) · Science Translational Medicine · doi:10.1126/scitranslmed.abn1413 · Cited by 108 · see citing works
“Recently, some concerns have arisen from clinical studies of the SARS-CoV-2 mRNA vaccines regarding the possibility of antibody responses against PEG included in vaccine formulations, which might induce allergic reactions in human volunteers (50, 51).”
SARS-CoV-2 vaccines: a triumph of science and collaboration
Golob, J. L., Lugogo, N. L., Lauring, A. S., & Lok, A. S.-F. (2021) · JCI Insight · doi:10.1172/jci.insight.149187 · Cited by 106 · see citing works
“rare observed incidence of anaphylaxis remains unclear, as does the possible underlying etiology (49).”
BackgroundA COVID-19 Vaccine: Big Strides Come with Big Challenges
Mellet, J., & Pepper, M. S. (2021) · Vaccines · doi:10.3390/vaccines9010039 · Cited by 102 · see citing works
“Scientists speculate that these allergic reactions might be related to either the lipid or the PEG component of these vaccines [46].”
BackgroundRecent Advances in Site-Specific Lipid Nanoparticles for mRNA Delivery
Xu, X., & Xia, T. (2023) · ACS Nanoscience Au · doi:10.1021/acsnanoscienceau.2c00062 · Cited by 105 · see citing works
Multisystem inflammatory syndrome in an adult following the SARS-CoV-2 vaccine (MIS-V)
Nune, A., Iyengar, K. P., Goddard, C., & Ahmed, A. E. (2021) · BMJ Case Reports · doi:10.1136/bcr-2021-243888 · Cited by 100 · see citing works
Adverse events following COVID-19 vaccination: A systematic review and meta-analysis
Kouhpayeh, H., & Ansari, H. (2022) · International Immunopharmacology · doi:10.1016/j.intimp.2022.108906 · Cited by 99 · see citing works
“Severe adverse events (SAEs) are rare, and usually were reported in some cases as hypersensitivity, acute allergic reactions, urticaria and anaphylactic shock [41].”
InfluentialKrantz, M. S., Kwah, J. H., Stone, C. A., Phillips, E. J., Ortega, G., Banerji, A., & Blumenthal, K. G. (2021) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2021.3779 · Cited by 98 · see citing works
Current and future nanoparticle vaccines for COVID-19
Vu, M. N., Kelly, H. G., Kent, S. J., & Wheatley, A. K. (2021) · EBioMedicine · doi:10.1016/j.ebiom.2021.103699 · Cited by 97 · see citing works
“This phenomenon also raises safety concerns to other PEG derivatives such as polysorbates which are formulated with other nanoparticle vaccines, for examples S protein-micelle vaccines manufactured by Novavax [82].”
Troelnikov, A., Perkins, G. B., Yuson, C., Ahamdie, A., Balouch, S., Hurtado, P. R., & Hissaria, P. (2021) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2021.04.032 · Cited by 95 · see citing works
Krzywicka, K., Heldner, M. R., van Kammen, M. S., van Haaps, T. F., Hiltunen, S., Silvis, S. M., Levi, M. M., Hovinga, J. A. K., Jood, K., Lindgren, E., et al. (2021) · European Journal of Neurology · doi:10.1111/ene.15029 · Cited by 95 · see citing works
“Using the EMA pharmacovigilance database and pre-COVID-19 CVST cases as a historical control group, we found that CVST reported after ChAdOx1 nCov-19 vaccination: (1) was notified more frequently than after the BNT162b2 and mRNA-1273 vaccines; (2) was associated in approximately half of patients with thrombocytopenia,…”
Chen, W.-A., Chang, D.-Y., Chen, B., Lin, Y., Barenholz, Y., & Roffler, S. R. (2023) · ACS Nano · doi:10.1021/acsnano.2c12193 · Cited by 98 · see citing works
Shavit, R., Segal, R. M., Kidon, M. I., Offengenden, I., Yahia, S. H., Machnes‐Maayan, D., Lifshitz, Y., Niznik, S., Frizinsky, S., Deutch, M., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.22255 · Cited by 93 · see citing works
Carreño, J. M., Singh, G., Tcheou, J., Srivastava, K., Gleason, C., Muramatsu, H., Desai, P., Aberg, J. A., Miller, R. L., PARIS study group, et al. (2022) · Vaccine · doi:10.1016/j.vaccine.2022.08.024 · Cited by 92 · see citing works
“Furthermore, it has been suggested that certain components of the mRNA 82 vaccine formulations might be involved in the development of some of the adverse reactions 83 observed, including anaphylaxis (2, 9).”
BackgroundCaballero, M. L., Krantz, M. S., Quirce, S., Phillips, E. J., & Stone, C. A. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.03.002 · Cited by 91 · see citing works
Allergy to COVID-19 vaccines: A current update
Cabanillas, B., & Novak, N. (2021) · Allergology International · doi:10.1016/j.alit.2021.04.003 · Cited by 90 · see citing works
Factors Associated With COVID‐19 Disease Severity in US Children and Adolescents
Antoon, J. W., Grijalva, C. G., Thurm, C. W., Richardson, T., Spaulding, A. B., Teufel, R. J., Reyes, M. A., Shah, S. S., Burns, J. E., Kenyon, C. C., et al. (2021) · Journal of Hospital Medicine · doi:10.12788/jhm.3689 · Cited by 88 · see citing works
Cutaneous Adverse Reactions Associated with SARS-CoV-2 Vaccines
Bellinato, F., Maurelli, M., Gisondi, P., & Girolomoni, G. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10225344 · Cited by 88 · see citing works
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BackgroundAllergies and COVID‐19 vaccines: An ENDA/EAACI Position paper
Barbaud, A. M., Garvey, L. H., Arcolacı, A., Brockow, K., Mori, F., Mayorga, C., Bonadonna, P., Atanasković‐Marković, M., Moral, L., Zanoni, G., et al. (2022) · Allergy · doi:10.1111/all.15241 · Cited by 88 · see citing works
“2022;77:2292–2312.wileyonlinelibrary.com/journal/all Received: 13 September 2021 | Revised: 17 December 2021 | Accepted: 3 January 2022 DOI: 10.1111/all.15241 E A A C I P O S I T I O N P A P E R Allergies and COVID- 19 vaccines: An ENDA/EAACI Position paper Annick Barbaud1 | Lene Heise Garvey2,3 | Alessandra Arcolaci4…”
BackgroundInfluentialEfficacy and Safety of COVID-19 Vaccines in Phase III Trials: A Meta-Analysis
Cheng, H., Peng, Z., Luo, W., Si, S., Mo, M., Zhou, H., Xin, X., Liu, H., & Yu, Y. (2021) · Vaccines · doi:10.3390/vaccines9060582 · Cited by 87 · see citing works
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BackgroundPEG That Reaction: A Case Series of Allergy to Polyethylene Glycol
Cox, F., Khalib, K., & Conlon, N. P. (2021) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1824 · Cited by 84 · see citing works
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Patrizio, A., Ferrari, S. M., Antonelli, A., & Fallahi, P. (2021) · Journal of Autoimmunity · doi:10.1016/j.jaut.2021.102738 · Cited by 83 · see citing works
“The widespread use of mRNA vaccines against SARS-CoV-2 has quickly revealed their possible side effects such as fever, fatigue, headache, muscle and joint pain or anaphylaxis [1].”
BackgroundNanomaterial-encapsulated STING agonists for immune modulation in cancer therapy
Chen, X., Xu, Z., Li, T., Thakur, A., Wen, Y., Zhang, K., Liu, Y., Liang, Q., Liu, W., Qin, J., et al. (2024) · Biomarker Research · doi:10.1186/s40364-023-00551-z · Cited by 83 · see citing works
“However, using PEGylated NPs raises potential concerns about preexisting anti-PEG responses, such as allergic reactions, alerting developers to the side effects of exogenous modification on nanocarriers [94].”
BackgroundSchramm, R., Costard‐Jäckle, A., Rivinius, R., Fischer, B., Muller, B. Z., Boeken, U., Haneya, A., Provazník, Z., Knabbe, C., & Gummert, J. F. (2021) · Clinical Research in Cardiology · doi:10.1007/s00392-021-01880-5 · Cited by 79 · see citing works
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Mu, Z., Haynes, B. F., & Cain, D. W. (2021) · Vaccines · doi:10.3390/vaccines9020134 · Cited by 80 · see citing works
Striving for Uniformity: A Review on Advances and Challenges To Achieve Uniform Polyethylene Glycol
Bento, C., Katz, M., Santos, M. M. M., & Afonso, C. A. M. (2024) · Organic Process Research & Development · doi:10.1021/acs.oprd.3c00428 · Cited by 81 · see citing works
Haabeth, O., Lohmeyer, J., Sallets, A., Blake, T. R., Sagiv-Barfi, I., Czerwinski, D., McCarthy, B. G., Powell, A. E., Wender, P., Waymouth, R., et al. (2021) · bioRxiv · doi:10.1021/acscentsci.1c00361 · Cited by 61 · see citing works
Enhancing therapeutic performance of personalized cancer vaccine via delivery vectors
Ye, T., Li, F., Ma, G., & Wei, W. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.113927 · Cited by 73 · see citing works
Zhang, R., Shao, S., Piao, Y., Xiang, J., Wei, X., Zhang, Z., Zhou, Z., Tang, J., Qiu, N., Xu, X., et al. (2023) · Advanced Materials · doi:10.1002/adma.202303614 · Cited by 71 · see citing works
Straight to the point: targeted mRNA-delivery to immune cells for improved vaccine design
Clemente, B., Denis, M., Silveira, C. P., Schiavetti, F., Brazzoli, M., & Stranges, D. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1294929 · Cited by 67 · see citing works
“Another aspect that is highly relevant for patient compliance is the emergence of side effects, such as injection site pain, fever, fatigue, headache and diarrhea following mRNA vaccination (13).”
BackgroundBeyond Lipids: Exploring Advances in Polymeric Gene Delivery in the Lipid Nanoparticles Era
Jogdeo, C. M., Siddhanta, K., Das, A., Ding, L., Panja, S., Kumari, N., & Oupický, D. (2024) · Advanced Materials · doi:10.1002/adma.202404608 · Cited by 72 · see citing works
COVID ‐19: vaccination problems
Brüssow, H. (2021) · Environmental Microbiology · doi:10.1111/1462-2920.15549 · Cited by 66 · see citing works
“It is currently unknown whether for these subjects the adenovirus vectored vaccine which is formulated with polysorbate 80, a nonionic surfactant and emulsifier that has a structure similar to PEG, is an alternative (Castells and Phillips, 2021).”
BackgroundMcMurry, R., Lenehan, P. J., Awasthi, S., Silvert, E., Puranik, A., Pawlowski, C., Venkatakrishnan, A., Anand, P., Agarwal, V., O’Horo, J. C., et al. (2021) · Med · doi:10.1016/j.medj.2021.06.006 · Cited by 65 · see citing works
“Notably, these rates of adverse effects documented in EHR notes were markedly lower than the rates of adverse effects observed in clinical trials (e.g., fatigue [63%–70%], myalgia [38%–62%], arthralgia [24%–46%], fever [14%–16%], and ery-thema [10%–15”
Kim, M. S., Jung, S. Y., Ahn, J. G., Park, S.-J., Shoenfeld, Y., Kronbichler, A., Koyanagi, A., Dragioti, E., Tizaoui, K., Hong, S. H., et al. (2021) · Journal of Medical Virology · doi:10.1002/jmv.27424 · Cited by 67 · see citing works
“2,3,6 Although the safety profiles of mRNA vaccines have been evaluated in serial clinical trials, 4,5,7 concerns remain as the safety evaluations in clinical trials were limited to relatively healthy people, excluding vulnerable populations such as children, pregnant women, and individuals with…”
BackgroundCOVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network
Ludwig, H., Sonneveld, P., Facon, T. T. F., Miguel, J. F. S., Avet‐Loiseau, H., Mohty, M., Mateos, M.-V., Moreau, P., Cavo, M., Pawlyn, C., et al. (2021) · The Lancet Haematology · doi:10.1016/s2352-3026(21)00278-7 · Cited by 65 · see citing works
McSweeney, M. D., Mohan, M., Commins, S. P., & Lai, S. K. (2021) · Frontiers in Allergy · doi:10.3389/falgy.2021.715844 · Cited by 64 · see citing works
Alhumaid, S., Mutair, A. S. A., Alawi, Z. A., Rabaan, A. A., Tirupathi, R., Alomari, M. A., Alshakhes, A. S., Alshawi, A. M., Ahmed, G. Y., Almusabeh, H. M., et al. (2021) · Allergy Asthma and Clinical Immunology · doi:10.1186/s13223-021-00613-7 · Cited by 62 · see citing works
Gounant, V., Ferré, V. M., Soussi, G., Charpentier, C., Flament, H., Houhou‐Fidouh, N., Collin, G., Namour, C., Assoun, S., Bizot, A., et al. (2021) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2021.10.015 · Cited by 61 · see citing works
“After blood sampling and vaccine injection, patients were followed up for 15 minutes under medical surveillance.(27) This study was approved by the ParisNorth institutional review board (number 00006477, approval N CER-2021-72).”
Safety of COVID-19 vaccination in patients with polyethylene glycol allergy: A case series
Picard, M., Drolet, J., Masse, M.-S., Filion, C. A., ALMuhizi, F., Fein, M. N., Copaescu, A. M., Isabwe, G. A. C., Blaquière, M., & Primeau, M.-N. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.11.021 · Cited by 59 · see citing works
Dézsi, L., Mészáros, T., Kozma, G. T., H-Velkei, M., Oláh, C. Z., Szabó, M., Patkó, Z., Fülöp, T., Hennies, M., Szebeni, M., et al. (2022) · GeroScience · doi:10.1007/s11357-021-00495-y · Cited by 58 · see citing works
Baki, A., Remmo, A., Löwa, N., Wiekhorst, F., & Bleul, R. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22126235 · Cited by 57 · see citing works
“However, it is frequently reported that PEG can lead to pseudo allergic reactions in clinical applications and can provoke IgE-mediated reactions and recurrent anaphylaxis [65,66].”
BackgroundInnovative Nanomedicine Delivery: Targeting Tumor Microenvironment to Defeat Drug Resistance
Meng, W., Huang, L., Guo, J., Xin, Q., Liu, J., & Hu, Y. (2024) · Pharmaceutics · doi:10.3390/pharmaceutics16121549 · Cited by 61 · see citing works
“Immune and allergic reactions triggered by nanomedicine delivery systems are another safety issue to be considered [149].”
Huang, Y., Zhang, Z., & Zhou, Y. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.1053617 · Cited by 55 · see citing works
“But some patients may not be suitable for vaccination due to a severe allergic reaction or may fail to mount a protective immune response through vaccines (7, 8).”
BackgroundPark, J. K., Lee, E. B., Shin, K., Sung, Y., Kim, T., Kwon, S., Lee, M. S., Hong, S., Choi, B. Y., Lee, S., et al. (2021) · Journal of Korean Medical Science · doi:10.3346/jkms.2021.36.e95 · Cited by 53 · see citing works
Ossato, A., Tessari, R., Trabucchi, C., Zuppini, T., Realdon, N., & Marchesini, F. (2021) · European Journal of Hospital Pharmacy · doi:10.1136/ejhpharm-2021-002933 · Cited by 54 · see citing works
Zakarya, K. D., Бекболатович, К. Л., Orynbayev, M. B., Abduraimov, Y. O., Sultankulova, K. T., Kassenov, M., Sarsenbayeva, G., Кулмагамбетов, И. Р., Davlyatshin, T. I., Sergeeva, M. V., et al. (2021) · EClinicalMedicine · doi:10.1016/j.eclinm.2021.101078 · Cited by 53 · see citing works
“Between the vaccine and placebo groups, no statistically significant difference has been shown in the level of total serum IgE antibodies which are known as specific triggers of allergic reactions [12].”
BackgroundQi, Y., Li, J.-R., Nie, Q., Gao, M., Yang, Q.-H., Li, Z.-M., Li, Q., Han, S., Ding, J., Li, Y.-Q., et al. (2021) · Biomaterials · doi:10.1016/j.biomaterials.2021.120952 · Cited by 45 · see citing works
Shin, K., Suh, H., Grundler, J., Lynn, A. Y., Pothupitiya, J. U., Moscato, Z. M., Reschke, M., Bracaglia, L. G., Piotrowski-Daspit, A. S., & Saltzman, W. M. (2022) · Biomaterials · doi:10.1016/j.biomaterials.2022.121676 · Cited by 49 · see citing works
Shimizu, J., Sasaki, T., Koketsu, R., Morita, R., Yoshimura, Y., Murakami, A., Saito, Y., Kusunoki, T., Samune, Y., Nakayama, E. E., et al. (2022) · Scientific Reports · doi:10.1038/s41598-022-19993-w · Cited by 48 · see citing works
Vaccine allergy: evidence to consider for COVID-19 vaccines
Nilsson, L. E., Csuth, Á., Storsæter, J., Garvey, L. H., & Jenmalm, M. C. (2021) · Current Opinion in Allergy and Clinical Immunology · doi:10.1097/aci.0000000000000762 · Cited by 48 · see citing works
Liao, Y., Li, Y., Pei, R., Fang, X. D., Zeng, P., Fan, R., Ou, Z., Deng, J., Zhou, J., Guan, W., et al. (2021) · Emerging Microbes & Infections · doi:10.1080/22221751.2021.1951126 · Cited by 48 · see citing works
“Recombinant protein vaccines have relatively safe profiles, because this kind of vaccines does not require lipidated PEG to form nanoparticles for delivery, or the adenovirus vectors for viral gene packaging, given that a number of AEs and SAEs present a strong correlation with lipid-PEG formulation and adenovirus vec…”
BackgroundPfizer-BioNTech COVID-19 Vaccine Tolerance in Allergic versus Non-Allergic Individuals
Nittner‐Marszalska, M., Rosiek‐Biegus, M., Kopeć, A., Pawłowicz, R., Kosińska, M., Łata, A., & Szenborn, L. (2021) · Vaccines · doi:10.3390/vaccines9060553 · Cited by 47 · see citing works
Duong, T. V., Lin, C.-Y., Chen, S., Huang, Y., Okan, O., Dadaczynski, K., & Lai, C.-F. (2021) · Vaccines · doi:10.3390/vaccines9090985 · Cited by 50 · see citing works
Özer, İ., Pitoc, G. A., Layzer, J. M., Moreno, A., Olson, L. B., Layzer, K. D., Hucknall, A., Sullenger, B. A., & Chilkoti, A. (2022) · Advanced Materials · doi:10.1002/adma.202107852 · Cited by 45 · see citing works
Chen, L., Qu, J., Kalyani, F. S., Zhang, Q., Fan, L., Fang, Y., Li, Y., & Xiang, C. (2022) · Cellular and Molecular Life Sciences · doi:10.1007/s00018-021-04096-y · Cited by 45 · see citing works
Wong, C. K. H., Lau, K. T. K., Xiong, X., Au, I. C. H., Lai, F. T. T., Wan, E. Y. F., Chui, C. S. L., Li, X., Chan, E. W., Gao, L., et al. (2022) · PLoS Medicine · doi:10.1371/journal.pmed.1004018 · Cited by 45 · see citing works
“Consistent with previous observations that anaphylaxis was clinically manifested more frequently after the first dose of either vaccine [57,59], it remains to be determined if these events would be considered anaphylaxis with previous sensitization to specific components of the vaccines, or anaphylactoid reactions occ…”
ResultAkache, B., Renner, T. M., Tran, A., Deschatelets, L., Dudani, R., Harrison, B. A., Duque, D., Haukenfrers, J., Rossotti, M. A., Gaudreault, F., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-01363-7 · Cited by 41 · see citing works
Maintaining Safety with SARS-CoV-2 Vaccines
Rolla, G., Brussino, L., & Badiu, I. (2021) · New England Journal of Medicine · doi:10.1056/nejmc2100766 · Cited by 44 · see citing works
Michos, A. G., Tatsi, E., Filippatos, F., Dellis, C., Koukou, D., Efthymiou, V., Kastrinelli, E., Mantzou, A., & Syriopoulou, V. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.07.067 · Cited by 43 · see citing works
“It is important after the emergent authorization of COVID-19 vaccines, to maintain public confidence for the safety of immunization with post-vaccination surveillance and documentation of AEs, to achieve high immunization coverage [18,19].”
Deaths associated with newly launched SARS-CoV-2 vaccination (Comirnaty®)
Edler, C., Klein, A., Schröder, A. S., Sperhake, J., & Ondruschka, B. (2021) · Legal Medicine · doi:10.1016/j.legalmed.2021.101895 · Cited by 42 · see citing works
“2 reactions up to anaphylactic shock were reported [6].”
Bonadonna, P., Brockow, K., Niedoszytko, M., Elberink, H. O., Akin, C., Nedoszytko, B., Butterfield, J. H., Álvarez‐Twöse, I., Sotlar, K., Schwaab, J., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.03.041 · Cited by 41 · see citing works
“Severe allergic reactions to the previous dose of mRNA COVID-19 vaccines, to any of its components, including polyethylene glycol and potentially cross-reacting polysorbate, are contraindications for vaccination.(24) Recent data on 2 health care workers with cutaneous and systemic mastocytosis who had a history of pri…”
Anaphylaxis associated with the mRNA COVID-19 vaccines: Approach to allergy investigation
Turk, V. E. (2021) · Clinical Immunology · doi:10.1016/j.clim.2021.108748 · Cited by 40 · see citing works
“Given the evidence for both IgE-mediated and non-IgE-mediated mechanisms, further research is needed to explore the possibility of their coexistence in PEG-associated anaphylaxis [29,30].”
Ferretti, F., Cannatelli, R., Benucci, M., Carmagnola, S., Clementi, E., Danelli, P., Dilillo, D., Fiorina, P., Galli, M., Gallieni, M., et al. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.656362 · Cited by 39 · see citing works
“Of course, it is recommended by FDA to have adequate medical equipment immediately available to manage a potential allergic reaction after the administration (8, 9).”
BackgroundRama, T. A., Moreira, A. M., & Castells, M. (2021) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2021.01.004 · Cited by 39 · see citing works
Yu, X., Li, H., Dong, C., Qi, S., Yang, K., Bai, B., Peng, K., Buljan, M., Lin, X., Liu, Z., et al. (2023) · ACS Nano · doi:10.1021/acsnano.3c07932 · Cited by 39 · see citing works
Zhang, B., Wang, C., Guo, M., Zhu, F., Yu, Z., Zhang, W., Li, W., Zhang, Y., & Tian, W. (2024) · ACS Nano · doi:10.1021/acsnano.4c07690 · Cited by 39 · see citing works
Alhumaid, S., Rabaan, A. A., Dhama, K., Yong, S. J., Nainu, F., Hajissa, K., Dossary, N. A., Alajmi, K. K., Saggar, A. E. A., Alharbi, F. A., et al. (2022) · Vaccines · doi:10.3390/vaccines10081289 · Cited by 39 · see citing works
“Maintenance of vaccine safety requires a proactive approach to maintain public confidence and reduce vaccine hesitancy [1,2].”
BackgroundPostbiotics as potential promising tools for SARS-CoV-2 disease adjuvant therapy
Khani, N., Soleimani, R. A., Noorkhajavi, G., Soleimani, A. A., Abbasi, A., & Rad, A. H. (2022) · Journal of Applied Microbiology · doi:10.1111/jam.15457 · Cited by 39 · see citing works
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management
Luxi, N., Giovanazzi, A., Arcolacı, A., Bonadonna, P., Crivellaro, M., Cutroneo, P. M., Ferrajolo, C., Furci, F., Guidolin, L., Moretti, U., et al. (2022) · BioDrugs · doi:10.1007/s40259-022-00536-8 · Cited by 37 · see citing works
“However, severe allergic reactions have been reported since the beginning of the vaccination campaign [28, 29], which suggests a higher rate of anaphylaxis due to the COVD-19 vaccine in comparison with other marketed vaccines.”
Liquid Chromatography Methods for Analysis of mRNA Poly(A) Tail Length and Heterogeneity
Gilár, M., Doneanu, C. E., & Gaye, M. M. (2023) · Analytical Chemistry · doi:10.1021/acs.analchem.3c02552 · Cited by 37 · see citing works
Programmable manipulation of oligonucleotide–albumin interaction for elongated circulation time
Cai, Y., Zhao, H., Sun, Y., Wang, C., Geng, X., Wang, R., Tang, L., Han, D., Liu, J., & Tan, W. (2022) · Nucleic Acids Research · doi:10.1093/nar/gkac156 · Cited by 37 · see citing works
“It was recently observed that the nanoparticles and polymers (polyethylene glycol, PEG) may trigger severe allergic reactions using the approved mRNA vaccine against COVID-19 (25).”
Li, Z., Liu, S., Li, F., Li, Y., Li, Y., Peng, P., Li, S., Li, H., & Liu, T. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.965971 · Cited by 37 · see citing works
“Theoretically, these discrepancies may be attributed to differences in the strength of the immune responses to various vaccines (86, 88, 89), as corroborated by this review’s efficacy and”
ResultAseptic meningitis after vaccination of the BNT162b2 mRNA COVID-19 vaccine
Saito, K., Shimizu, T., Suzuki‐Inoue, K., Ishida, T., & Wada, Y. (2021) · Neurological Sciences · doi:10.1007/s10072-021-05543-1 · Cited by 36 · see citing works
Labella, M., Céspedes, J. A., Doña, I., Shamji, M. H., Agache, I. O., Mayorga, C., & Torres, M. J. (2021) · Allergy · doi:10.1111/all.15148 · Cited by 36 · see citing works
A Case of Multisystem Inflammatory Syndrome in a 12-Year-old Male After COVID-19 mRNA Vaccine
Yalçınkaya, R., Öz, F. N., Polat, M., Uçan, B., Teke, T. A., Kaman, A., Özdem, S., Şen, Z. S., Cinni, R. G., & Tanir, G. (2021) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000003432 · Cited by 36 · see citing works
- Authors
- Castells, M. C., & Phillips, E. J.
- Affiliations
- Brigham and Women's Hospital (US)
- Corresponding author
- Castells, Mariana C.
- 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
- 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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