Reactogenicity Study of mRNA Vaccines Against COVID-19
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Keywords

SARS-CoV-2; COVID-19-vaccination; mRNA vaccines; adverse reactions; health care workers

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1.
Inglés Torruella J, Gil Soto RM, Sabaté Aguila E, García Grau M, Pons Boronat N, Rubio Civit A, Bandera Baez M, Moreno Martin G. Reactogenicity Study of mRNA Vaccines Against COVID-19. Arch Prev Riesgos Labor [Internet]. 2023 Apr. 15 [cited 2024 May 17];26(2):106-2. Available from: https://www.archivosdeprevencion.eu/index.php/aprl/article/view/265

Abstract

Objective: To compare the reactogenicity between the types of mRNA Commirnaty® (Pfizer) and Spikevax® (Moderna) vaccines against COVID-19 in a healthcare population.

Methods: Cross sectional study of short-term adverse effects and their consequences (sick leave, limitations of daily life, etc.) after the administration of the first and second doses of both vaccines in professionals and students of a health institution. A questionnaire on symptoms and their consequences was administered seven days after each vaccination dose. The prevalence and 95% confidence interval (95%CI) were calculated. Differences between vaccines were quantified using the odds ratio (OR) and its 95%CI.

Results: The questionnaire was completed by 1924 and 1170 healthcare providers (response rates 62.2% and 39.1%) after the first and second doses, respectively, of the Commirnaty® vaccine, and 410 (56.0%) and 107 (15.0%) of Spikevax®. After the first dose of Comirnaty®, 67.4% presented some adverse effect, and 76.1% for Spikevax® (OR 1.5 95%CI 1.2-1.9). In general, women and young people showed greater reactogenicity and differences between vaccines. Consequences of adverse effects were more frequent for Spikevax®. The reactogenicity was higher after the second than the first dose, for both vaccines (Comirnaty®: 67.4% vs. 75.6%; Spikevax®: 76.1% vs. 87.9%.

Conclusions: The greater reactogenicity and its consequences, for the first and second dose of the Spikevax® vaccine compared to Comirnaty®, and of the second dose compared to the first dose of both vaccines, provides useful knowledge for planning vaccination against COVID-19 campaigns in healthcare settings.

https://doi.org/10.12961/aprl.2022.26.02.02
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References

Centro de Coordinación de Alertas y Emergencias Sanitarias. Actualización nº 630. Enfermedad por el coronavirus (COVID-19). 02.09.2022. [En línea] 02 de Setiembre de 2022. https://www.sanidad.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/documentos/Actualizacion_630_COVID-19.pdf .

Parés-Badell O, Martínez-Gómez X, Pinós L, Borras-Bermejo B, Uriona S, Otero-Romero S, et al. Local and Systemic Adverse Reactions to mRNA COVID-19 Vaccines Comparing Two Vaccine Types and Occurrence of Previous COVID-19 Infection. Vaccines. 2021;9:1463. doi: 10.3390/vaccines9121463

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al.; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403-416. doi: 10.1056/NEJMoa2035389

World Health Organization. COVID-19 vaccine tracker and landscape. [Online] September 2022. [Cited: September 02, 2022.] https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines .

Ministerio de Sanidad. Centro de Coordinación de Alertas y Emergencias Sanitarias . Información Científica-Técnica: Información sobre la inmunidad frente a COVID-19 . Centro de Coordinación de Alertas y Emergencias Sanitarias , Dirección General de Salud Pública. 15/10/2021. Informe Científico-Técnico. https://www.sanidad.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/documentos/20211015_INMUNIDAD_y_VACUNAS.pdf

World Health Organization. Coronavirus disease (COVID-19): Vaccines. [Online] May 17, 2022. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-(covid-19)-vaccines .

Ministerio de Sanidad. Estrategia de vacunación COVID-19 en España. [En línea] [Citado el: 07 de Octubre de 2022.] https://www.sanidad.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/vacunaCovid19.htm .

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al.; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615. doi: 10.1056/NEJMoa2034577

Parés-Badell O, Zules-Oña R, Armadans L, Pinós L, Borrás-Bermejo B, Otero S, et al. Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination. Vaccines (Basel). 2022;10(8):1217. doi: 10.3390/vaccines10081217

Ministerio de Sanidad. Centro de Coordinación de Alertas y Emergéncias Sanitarias. Información Científica-Técnica: Parámetros Epidemiológicos. Centro de Coordinación de Alertas y Emergéncias Sanitarias, Dirección General de Salud Pública, Calidad e Innovación. 13/01/2022. pág. 27. https://www.sanidad.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/documentos/20220113_EPIDEMIOLOGIA.pdf

Ministerio de Sanidad. Vacuna Covid-19. [En línea] [Citado el: 04 de Septiembre de 2022.] https://www.sanidad.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/vacunaCovid19.htm .

Red Nacional de Vigiláncia Epidemiológica. Seguimiento de la efectividad de la vacunación frente a hospitalización y fallecimiento por COVID19 en Informe de España. [En línea] Julio de 2022. https://www.isciii.es/QueHacemos/Servicios/VigilanciaSaludPublicaRENAVE/EnfermedadesTransmisibles/Documents/INFORMES/Informes%20COVID-19/Otros_Informes_COVID-19/Informes_Periodicos_Seguimiento_Vacunación_COVID-19/Informe%20vacunas_CNE_2207_Julio.pdf .

Consejo Interterritorial. Sistema Nacional de Salud. COMIRNATY 30 ?g/dosis (Vacuna COVID-19 ARNm, PfizerBioNTech). 5 de Abril de 2022, págs. 1-17. https://www.sanidad.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/covid19/Guias_Tecnicas/docs/Guia_Tecnica_COMIRNATY.pdf

Consejo Interterritorial. Sistema Nacional de Salud. SPIKEVAX (Vacuna COVID-19 ARNm, Moderna). 5 de Abril de 2022, págs. 1-16. https://www.sanidad.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/covid19/Guias_Tecnicas/docs/Guia_Tecnica_vacuna_Moderna.pdf

Mathioudakis AG, Ghrew M, Ustianowski A, Ahmad S, Borrow R, Papavasileiou LP, et al. Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey. Life (Basel). 2021;11(3):249. doi: 10.3390/life11030249

Centers for Disease Control and Prevention. Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse Events. [Online] [Cited: October 07, 2022.] https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html .

Centers for Disease Control and Prevention. The Moderna COVID-19 Vaccine’s Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events. [Online] [Cited: October 07, 2022.] https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html .

Bae S, Lee YW, Lim SY, Lee JH, Lim JS, Lee S, et al. Adverse Reactions Following the First Dose of ChAdOx1 nCoV-19 Vaccine and BNT162b2 Vaccine for Healthcare Workers in South Korea. J Korean Med Sci. 2021;36(17):e115. doi: 10.3346/jkms.2021.36.e115

Palomo-Palomo C, Guerra-Estévez D, Parrado-González A, Estaire-Gutiérrez J, Reyes-Malia M, Romero-Alonso MM. Reactogenicity of the BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19 in workers of a tertiary hospital. Farm Hosp. 2022;46(3):152-6. doi: 10.7399/fh.13047

Kremsner PG, Ahuad Guerrero RA, Arana-Arri E, Aroca Martinez GJ, Bonten M, Chandler R; HERALD study group. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial. The Lancet Infectious Diseases. 2022;22(3):329-340. doi:10.1016/S1473-3099(21)00677-0

Kadali RAK, Janagama R, Peruru S, Malayala SV. Side effects of BNT162b2 mRNA COVID-19 vaccine: A randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers. Int J Infect Dis. 2021;106:376-381. doi: 10.1016/j.ijid.2021.04.047

Powell AA, Power L, Westrop S, McOwat K, Campbell H, Simmons R, et al. Real-world data shows increased reactogenicity in adults after heterologous compared to homologous prime-boost COVID-19 vaccination, March-June 2021, England. Euro Surveill. 2021;26(28):2100634. doi: 10.2807/1560-7917.ES.2021.26.28.2100634

Ascaso-Del-Rio A, García-Pérez J, Pérez-Olmeda M, Arana-Arri E, Vergara I, Pérez-Ingidua C, et al; RescueVac study Group. Immune response and reactogenicity after immunization with two-doses of an experimental COVID-19 vaccine (CVnCOV) followed by a third-fourth shot with a standard mRNA vaccine (BNT162b2): RescueVacs multicenter cohort study. EClinicalMedicine. 2022;51:101542. doi: 10.1016/j.eclinm.2022.101542

Warkentin L, Zeschick N, Kühlein T, Steininger P, Überla K, Kaiser I, et al. Reactogenicity after heterologous and homologous COVID-19 prime-boost vaccination regimens: descriptive interim results of a comparative observational cohort study. BMC Infect Dis. 2022;22(1):504. doi: 10.1186/s12879-022-07443-x

Okumura K, Hara A, Inada I, Sugiyama D, Hoshino T, Yakoh T, et al. Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University. Vaccines (Basel). 2022;10(9):1461. doi: 10.3390/vaccines10091461

Tré-Hardy M, Cupaiolo R, Papleux E, Wilmet A, Horeanga A, Antoine-Moussiaux T, et al. Reactogenicity, safety and antibody response, after one and two doses of mRNA-1273 in seronegative and seropositive healthcare workers. J Infect. 2021;83(2):237-279. doi: 10.1016/j.jinf.2021.03.025

Krammer, F, Srivastava, K and Simon, V. Robust spike antibody responses and increased reactogenicity in seropositive individuals after a 1 single dose of SARS-CoV-2 mRNA vaccine. medRxiv. 2021. doi: 10.1101/2021.01.29.21250653 .

Raw RK, Kelly CA, Rees J, Wroe C, Chadwick DR. Previous COVID-19 infection, but not Long-COVID, is associated with increased adverse events following BNT162b2/Pfizer vaccination. J Infect. 2021;83(3):381-412. doi: 10.1016/j.jinf.2021.05.035

Kadali RAK, Janagama R, Peruru S, Gajula V, Madathala RR, Chennaiahgari N, Malayala SV. Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: A randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms. J Med Virol. 2021;93(7):4420-4429. doi: 10.1002/jmv.26996

Abara WE, Gee J, Delorey M, Tun Y, Mu Y, Shay DK, Shimabukuro T. Expected Rates of Select Adverse Events After Immunization for Coronavirus Disease 2019 Vaccine Safety Monitoring. J Infect Dis. 2022;225(9):1569-1574. doi: 10.1093/infdis/jiab628

Hause AM, Zhang B, Yue X, Marquez P, Myers TR, Parker C, et al. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US. JAMA Netw Open. 2022;5(7):e2222241. doi: 10.1001/jamanetworkopen.2022.22241

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Copyright (c) 2023 Joan Inglés Torruella, Rosa Maria Gil Soto, Esther Sabaté Aguila, Mercé García Grau, Nina Pons Boronat, Adelaida Rubio Civit, Miriam Bandera Baez, Gustavo Moreno Martin

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