Risk factors for COVID-19 infection in people with 4th dose of bivalent mRNA vaccines in general medicine from October 2022 to February 2023
Article Sidebar
Main Article Content
Abstract
Background: Risk factors of COVID-19 infection in people vaccinated with the 4th dose of mRNA COVID-19 vaccine remain the subject of debate.
Objective: To identify risk and protective factors of COVID-19 in vaccinated people with 4th dose of bivalent mRNA vaccines.
Location: General Practitioner consultation in Toledo (Spain).
Methodology: Longitudinal and prospective study of cases and controls of adult patients with or without COVID-19 infection in vaccinated people with 4th dose of bivalent mRNA vaccines, from October 1, 2022, to February 28, 2023.
Results: Five cases of COVID-19 infections in vaccinated people with 4th dose were included, which were compared with 52 controls (with 4th dose and without COVID-19 after the booster). The risk factors for COVID-19 infection with the 4th dose were: Women (RR = 1.67), Socio-Health Care Workers (RR = 10.39; p = 0.0349), Chronic Diseases of the blood (RR = 6.9. p = 0.0322), Chronic Diseases of Endocrine (RR = 2.72. p = 0.039425), and Chronic Diseases of Circulatory system (RR = 1.87).
Conclusion: In the general practice setting in Toledo, Spain, being a socio-health care worker and having chronic diseases presumably associated with immunosuppression were statistically significant risk factors for COVID-19 infection in people vaccinated with the 4th dose of bivalent mRNA vaccines. The most exposed or immunosuppressed people continue to be at risk of becoming infected with SARS-CoV-2 despite having received the 4th dose of the mRNA COVID-19 vaccine, so other preventive methods in these groups are advisable.
Downloads
Article Details
Copyright (c) 2023 Turabian JL.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Licensing and protecting the author rights is the central aim and core of the publishing business. Peertechz dedicates itself in making it easier for people to share and build upon the work of others while maintaining consistency with the rules of copyright. Peertechz licensing terms are formulated to facilitate reuse of the manuscripts published in journals to take maximum advantage of Open Access publication and for the purpose of disseminating knowledge.
We support 'libre' open access, which defines Open Access in true terms as free of charge online access along with usage rights. The usage rights are granted through the use of specific Creative Commons license.
Peertechz accomplice with- [CC BY 4.0]
Explanation
'CC' stands for Creative Commons license. 'BY' symbolizes that users have provided attribution to the creator that the published manuscripts can be used or shared. This license allows for redistribution, commercial and non-commercial, as long as it is passed along unchanged and in whole, with credit to the author.
Please take in notification that Creative Commons user licenses are non-revocable. We recommend authors to check if their funding body requires a specific license.
With this license, the authors are allowed that after publishing with Peertechz, they can share their research by posting a free draft copy of their article to any repository or website.
'CC BY' license observance:
|
License Name |
Permission to read and download |
Permission to display in a repository |
Permission to translate |
Commercial uses of manuscript |
|
CC BY 4.0 |
Yes |
Yes |
Yes |
Yes |
The authors please note that Creative Commons license is focused on making creative works available for discovery and reuse. Creative Commons licenses provide an alternative to standard copyrights, allowing authors to specify ways that their works can be used without having to grant permission for each individual request. Others who want to reserve all of their rights under copyright law should not use CC licenses.
El-Sadr WM, Vasan A, El-Mohandes A. Facing the New Covid-19 Reality. N Engl J Med. 2023 Feb 2;388(5):385-387. doi: 10.1056/NEJMp2213920. Epub 2023 Jan 28. PMID: 36724378.
Grant R, Sacks JA, Abraham P, Chunsuttiwat S, Cohen C, Figueroa JP, Fleming T, Fine P, Goldblatt D, Hasegawa H, MacIntrye CR, Memish ZA, Miller E, Nishioka S, Sall AA, Sow S, Tomori O, Wang Y, Van Kerkhove MD, Wambo MA, Cohen HA, Mesfin S, Otieno JR, Subissi L, Briand S, Wentworth DE, Subbarao K. When to update COVID-19 vaccine composition. Nat Med. 2023 Apr;29(4):776-780. doi: 10.1038/s41591-023-02220-y. PMID: 36807683.
Callaway E. COVID 'variant soup' is making winter surges hard to predict. Nature. 2022 Nov;611(7935):213-214. doi: 10.1038/d41586-022-03445-6. PMID: 36307585.
Khoury DS, Docken SS, Subbarao K, Kent SJ, Davenport MP, Cromer D. Predicting the efficacy of variant-modified COVID-19 vaccine boosters. Nat Med. 2023 Mar;29(3):574-578. doi: 10.1038/s41591-023-02228-4. Epub 2023 Mar 2. PMID: 36864253.
Lin DY, Xu Y, Gu Y, Zeng D, Sunny SK, Moore Z. Durability of Bivalent Boosters against Omicron Subvariants. N Engl J Med. 2023 May 11;388(19):1818-1820. doi: 10.1056/NEJMc2302462. Epub 2023 Apr 12. PMID: 37043647; PMCID: PMC10120009.
European Medicines Agency (2022) ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines. News 06/09/2022. https://www.ema.europa.eu/en/news/ecdc-ema-statement-booster-vaccination-omicron-adapted-bivalent-covid-19-vaccines
Jiménez AL. Portfolio of omicron-adapted vaccines expands: how does each one work? The EMA has already recommended the authorization of the vaccines against COVID-19 adapted from Comirnaty Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5. 2022; https://www.consalud.es/pacientes/especial-coronavirus/como-funcionan-vacunas-adaptadas_120131_102.html
Kingsley T. UK 'blind' to new immune-evasive Covid variants creating 'perfect storm' for devastating wave. The Independent; 2022; https://webcache.googleusercontent.com/search?q=cache:kZEI2MAHtYQJ:https://www.independent.co.uk/news/health/uk-covid-variant-omicron-new-wave-b2183934.html&cd=2&hl=es&ct=clnk&gl=es
Chalkias S, Harper C, Vrbicky K, Walsh SR, Essink B, Brosz A, McGhee N, Tomassini JE, Chen X, Chang Y, Sutherland A, Montefiori DC, Girard B, Edwards DK, Feng J, Zhou H, Baden LR, Miller JM, Das R. A Bivalent Omicron-Containing Booster Vaccine against Covid-19. N Engl J Med. 2022 Oct 6;387(14):1279-1291. doi: 10.1056/NEJMoa2208343. Epub 2022 Sep 16. PMID: 36112399; PMCID: PMC9511634.
Loewy MA. COVID-19: the weekly summary (September 30 to October 6, 2022). Medscape. (2022) https://espanol.medscape.com/verarticulo/5909795?src=mkm_ret_221009_mscpmrk-ES_ExcNews&uac=327178AR&impID=4719707&faf=1
Wang Q, Bowen A, Valdez R, Gherasim C, Gordon A, Liu L, Ho DD. Antibody Response to Omicron BA.4-BA.5 Bivalent Booster. N Engl J Med. 2023 Feb 9;388(6):567-569. doi: 10.1056/NEJMc2213907. Epub 2023 Jan 11. PMID: 36630643; PMCID: PMC9847504.
Collier AY, Miller J, Hachmann NP, McMahan K, Liu J, Bondzie EA, Gallup L, Rowe M, Schonberg E, Thai S, Barrett J, Borducchi EN, Bouffard E, Jacob-Dolan C, Mazurek CR, Mutoni A, Powers O, Sciacca M, Surve N, VanWyk H, Wu C, Barouch DH. Immunogenicity of BA.5 Bivalent mRNA Vaccine Boosters. N Engl J Med. 2023 Feb 9;388(6):565-567. doi: 10.1056/NEJMc2213948. Epub 2023 Jan 11. PMID: 36630611; PMCID: PMC9847505.
Marks PW, Califf RM. Bivalent Covid-19 Vaccines. N Engl J Med. 2023 Mar 23;388(12):1151. doi: 10.1056/NEJMc2301323. Epub 2023 Mar 1. PMID: 36856582.
Offit PA. Bivalent Covid-19 Vaccines - A Cautionary Tale. N Engl J Med. 2023 Feb 9;388(6):481-483. doi: 10.1056/NEJMp2215780. Epub 2023 Jan 11. PMID: 36630616.
Zou J, Kurhade C, Patel S, Kitchin N, Tompkins K, Cutler M, Cooper D, Yang Q, Cai H, Muik A, Zhang Y, Lee DY, Şahin U, Anderson AS, Gruber WC, Xie X, Swanson KA, Shi PY. Neutralization of BA.4-BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine. N Engl J Med. 2023 Mar 2;388(9):854-857. doi: 10.1056/NEJMc2214916. Epub 2023 Jan 25. PMID: 36734885; PMCID: PMC9891359.
Cohen C, Pulliam J. COVID-19 infection, reinfection, and the transition to endemicity. Lancet. 2023 Mar 11;401(10379):798-800. doi: 10.1016/S0140-6736(22)02634-4. Epub 2023 Feb 16. PMID: 36930672; PMCID: PMC9934854.
Rey Calero J. Epidemiological method and community health. Madrid: Interamericana. McGraw-Hill. 1989.
Consejo interterritorial de salud. (2022) Comirnaty Bivalente, Original/Omicron BA.4-5 (COVID-19 mRNA Vaccine, Pfizer-BioNTech) Technical Guide. https://www.sanidad.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/covid19/Guias_Tecnicas/docs/Guia_Tecnica_COMIRNATY_bivalente.pdf
Lin DY, Xu Y, Gu Y, Zeng D, Wheeler B, Young H, Sunny SK, Moore Z. Effectiveness of Bivalent Boosters against Severe Omicron Infection. N Engl J Med. 2023 Feb 23;388(8):764-766. doi: 10.1056/NEJMc2215471. Epub 2023 Jan 25. PMID: 36734847; PMCID: PMC9933929.
Consejo Interterritorial. Update of the vaccination recommendations against COVID-19 for autumn-winter in Spain Approved by the Public Health Commission on December 15, 2022. Prepared by the Report on the Vaccination Program and Registry. 2022. https://www.sanidad.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/covid19/docs/Recomendaciones_vacunacion_Otono_Invierno_Covid.pdf
Ministerio de Sanidad. COVID-19 early detection, surveillance and control strategy. 2021; https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/documentos/COVID19_Estrategia_vigilancia_y_control_e_indicadores.pdf
Strauss AL. Chronic illness and the quality of life. St Louis: The C.V. Mosby Company. 1984.
WHO. International Statistical Classification of Diseases and Health-Related Problems. ICD-10 Version: 2019. https://icd.who.int/browse10/2019/en
Turabian JL. Family Genogram in General Medicine: A Soft Technology that can be Strong. An Update. Res Med Eng Sci. 2017; 3(1). http://crimsonpublishers.com/rmes/pdf/RMES.000551.pdf
Russell LT. Capturing Family Complexity in Family Nursing Research and Practice. J Fam Nurs. 2020; 26(4):287-93. https://journals.sagepub.com/doi/10.1177/1074840720965396
Pan-Hispanic Dictionary of Legal Spanish (2022) [Ethnic minority]. https://dpej.rae.es/lema/minor%C3%ADa-%C3%A9tnica
Open Source Epidemiologic Statistics for Public Health. http://www.openepi.com/SampleSize/SSCC.htm
Turabian JL. An ostrich strategy for covid-19 is too risky. BMJ. 2022 May 3;377:o1112. doi: 10.1136/bmj.o1112. PMID: 35504630.
Atlas España. The new vaccination campaign for the fourth dose of Covid19 starts throughout Spain. 2022; ABC; 25/09. https://www.abc.es/espana/arranca-espana-nueva-campana-vacunacion-cuarta-dosis-20220925183607-vi.html
CDC. Stay Up to Date with COVID-19 Vaccines Including Boosters. 2022. Updated Sept. 8, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fbooster-shot.html
Davis-Gardner ME, Lai L, Wali B, Samaha H, Solis D, Lee M, Porter-Morrison A, Hentenaar IT, Yamamoto F, Godbole S, Liu Y, Douek DC, Lee FE, Rouphael N, Moreno A, Pinsky BA, Suthar MS. Neutralization against BA.2.75.2, BQ.1.1, and XBB from mRNA Bivalent Booster. N Engl J Med. 2023 Jan 12;388(2):183-185. doi: 10.1056/NEJMc2214293. Epub 2022 Dec 21. PMID: 36546661; PMCID: PMC9812288.
Doheny K. What's Next for COVID? Here's What to Know. Medscape. 2023. Jan 03. https://www.medscape.com/viewarticle/986429?src=wnl_recnlnew1_ous_230105_MSCPEDIT_&uac=327178AR&impID=5062591#vp_%3Cfont%20style=%22vertical-align:%20inherit;%22%3E%3Cfont%20style=%22vertical-align:%20inherit;%22%3E1%20%3C/font%3E%3C/font%3E
Winokur P, Gayed J, Fitz-Patrick D, Thomas SJ, Diya O, Lockhart S, Xu X, Zhang Y, Bangad V, Schwartz HI, Denham D, Cardona JF, Usdan L, Ginis J, Mensa FJ, Zou J, Xie X, Shi PY, Lu C, Buitrago S, Scully IL, Cooper D, Koury K, Jansen KU, Türeci Ö, Şahin U, Swanson KA, Gruber WC, Kitchin N; C4591031 Clinical Trial Group. Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years. N Engl J Med. 2023 Jan 19;388(3):214-227. doi: 10.1056/NEJMoa2213082. PMID: 36652353; PMCID: PMC9933930.
Mahase E. Covid-19: Booster vaccines rolled out as hospital admissions rise. BMJ. 2022 Oct 14;379:o2484. doi: 10.1136/bmj.o2484. PMID: 36241204.
Vogel G. Omicron booster shots are coming—with lots of questions. COVID-19 vaccines get their first update since the pandemic began. Here's what you need to know about them. Science. 2022. https://www.science.org/content/article/omicron-booster-shots-are-coming-lots-questions
Willyard C (2023) How quickly does COVID immunity fade? What scientists know. Vaccination, infection with SARS-CoV-2 and a combination of both provide varying degrees of protection. Nature; 02 February. https://doi.org/10.1038/d41586-023-00124-y
Sahly ElH, Glück T, Sakoulas G. Vaccine Effectiveness Against SARS-CoV-2 Variants, Revisited. NEJM Journal Watch; November 2. 2022. https://www.jwatch.org/na55378/2022/11/02/vaccine-effectiveness-against-sars-cov-2-variants?query=etoc_jwid&jwd=000012293400&jspc=GP&cid=DM1624666_Non_Subscriber&bid=1243657113
Roa R. The second booster dose protects well at 6 months. La biblioteca de Springfield. 2022. https://rubenroa.blogspot.com/2022/11/la-segunda-dosis-de-refuerzo-protege.html
Roa R. Fourth dose of Covid-19 vaccine. La biblioteca de Springfield. 2022. https://rubenroa.blogspot.com/2022/09/cuarta-dosis-de-vacuna-covid-19.html
Adams K, Rhoads JP, Surie D, Gaglani M, Ginde AA, McNeal T, Talbot HK, Casey JD, Zepeski A, Shapiro NI, Gibbs KW, Files DC, Hager DN, Frosch AE, Exline MC, Mohamed A, Johnson NJ, Steingrub JS, Peltan ID, Brown SM, Martin ET, Lauring AS, Khan A, Busse LW, Duggal A, Wilson JG, Chang SY, Mallow C, Kwon JH, Chappell JD, Halasa N, Grijalva CG, Lindsell CJ, Lester SN, Thornburg NJ, Park S, McMorrow ML, Patel MM, Tenforde MW, Self WH; Influenza and other Viruses in the AcutelY ill (IVY) Network. Vaccine effectiveness of primary series and booster doses against covid-19 associated hospital admissions in the United States: living test negative design study. BMJ. 2022 Oct 11;379:e072065. doi: 10.1136/bmj-2022-072065. PMID: 36220174; PMCID: PMC9551237.
Loewy MA. COVID-19: the weekly roundup. February 10-16, 2023. Medscape 17 de feb. 2023. https://espanol.medscape.com/verarticulo/5910436?ecd=mkm_ret_230218_mscpmrk-ES_ExcNews&uac=327178AR&impID=5173986&faf=1
Loewy MA. COVID-19: the weekly summary (January 6-12, 2023). Medscape 13 de enero. 2023. https://espanol.medscape.com/verarticulo/5910270?src=mkm_ret_230116_mscpmrk-ES_ExcNews&uac=327178AR&impID=5089349&faf=1
Regev-Yochay G, Gonen T, Gilboa M, Mandelboim M, Indenbaum V, Amit S, Meltzer L, Asraf K, Cohen C, Fluss R, Biber A, Nemet I, Kliker L, Joseph G, Doolman R, Mendelson E, Freedman LS, Harats D, Kreiss Y, Lustig Y. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron. N Engl J Med. 2022 Apr 7;386(14):1377-1380. doi: 10.1056/NEJMc2202542. Epub 2022 Mar 16. PMID: 35297591; PMCID: PMC9006792.
Mallapaty S. Fourth dose of COVID vaccine offers only slight boost against Omicron infection. Nature. 2022 Feb 23. doi: 10.1038/d41586-022-00486-9. Epub ahead of print. PMID: 35197600.
Jiménez AL. Is a fourth dose of the vaccine necessary in healthcare professionals?. Consalud.es; 21.03. 2022. https://www.consalud.es/pacientes/especial-coronavirus/es-necesaria-cuarta-dosis-vacuna-profesionales-sanitarios_111849_102.html
Bueno MV, Chase JD. Gender Differences in Adverse Psychosocial Outcomes among Family Caregivers: A Systematic Review. West J Nurs Res. 2023 Jan;45(1):78-92. doi: 10.1177/01939459221099672. Epub 2022 May 25. PMID: 35614567.
Turabian JL. Sex and Gender Bio-psychosocial Differences in Coronavirus Disease 2019 (Covid-19): Men have more Biological Problems, but Women Suffer more Long-Term Serious Psychosocial Consequences and with more Implications for Population. J Women's Health Care. 2020. 9:487. https://www.longdom.org/open-access/sex-and-gender-biopsychosocial-differences-in-coronavirus-disease-2019-covid19-men-have-more-biological-problems-but-wom.pdf
Wenham C, Smith J, Davies SE, Feng H, Grépin KA, Harman S, Herten-Crabb A, Morgan R. Women are most affected by pandemics - lessons from past outbreaks. Nature. 2020 Jul;583(7815):194-198. doi: 10.1038/d41586-020-02006-z. PMID: 32641809.
Loewy MA. Pan American Health Organization: COVID-19 disproportionately affects women. Medscape; 19 de mayo. 2020. https://espanol.medscape.com/verarticulo/5905441?src=mkm_latmkt_200521_mscmrk_escoronavirus_nl&uac=327178AR&impID=2388598&faf=1
Guidry CA, Beyene RT, Watson CM, Sawyer RG, Chollet-Hinton L, Simpson SQ, Atchison L, Derickson M, Cooper LC, Pennington GP 2nd, VandenBerg S, Halimeh BN, O'Dell JC. Trial of antibiotic restraint in presumed pneumonia: A Surgical Infection Society multicenter pilot. J Trauma Acute Care Surg. 2023 Feb 1;94(2):232-240. doi: 10.1097/TA.0000000000003839. Epub 2022 Nov 18. PMID: 36534474.
Qu P, Faraone JN, Evans JP, Zheng YM, Yu L, Ma Q, Carlin C, Lozanski G, Saif LJ, Oltz EM, Gumina RJ, Liu SL. Durability of Booster mRNA Vaccine against SARS-CoV-2 BA.2.12.1, BA.4, and BA.5 Subvariants. N Engl J Med. 2022 Oct 6;387(14):1329-1331. doi: 10.1056/NEJMc2210546. Epub 2022 Sep 7. PMID: 36069925; PMCID: PMC9511629.