Eficacia y seguridad de la vacuna COVID-19 en pacientes mayores de 18 años. Revisión Sistemática Exploratoria-Scoping Review.
DOI:
https://doi.org/10.26871/ceus.v7i1.216Palabras clave:
vacuna COVID-19, virus, eficacia, seguridad, COVID-19Resumen
Resumen
Antecedentes: el desarrollo ultrarrápido de las vacunas para el COVID-19, generó serias controversias en la evaluación de su efectividad y seguridad, pues dada su “justificada” aprobación emergente estos productos biológicos se certificaron en un tiempo récord.
Objetivo general: evaluar los parámetros de eficacia y seguridad sobre las vacunas COVID-19 en pacientes mayores de 18 años.
Metodología: revisión sistemática exploratoria-scoping review, sin metaanálisis. Se incluyeron Ensayos Cínicos Controlados (ECA), estudios de cohorte y estudios de casos y controles, publicados desde el año 2020, en idioma inglés y español, realizados en personas mayores a 18 años, referenciados en revistas cuartil 1 a 4 según el portal de Scimago. Se aplicaron descriptores en ciencias de la salud y en inglés medical subject headings, “vaccine efficacy”, “safety”, “coronavirus disease 2019 virus vaccines”, “COVID-19 vaccine”. Se aplicaron operadores boleanos and, or y not. Los resultados serán presentados en tablas personalizadas.
Resultados: Las vacunas contra el COVID-19, son eficaces especialmente en prevención de complicaciones. Los resultados indican la importancia de las dosis de refuerzo. En cuanto a la seguridad, fue valorada según la frecuencia de efectos adversos que varían entre las vacunas y los estudios. Así, la frecuencia de dolor en el lugar de la inyección varía del 61% al 88% para AstraZeneca, mientras que para Pfizer-BioNTech es del 71% en la primera dosis y del 66% en la segunda dosis. Este análisis muestra que, aunque todas las vacunas tienen efectos adversos, la mayoría son leves y temporales. Los efectos adversos graves son raros.
Palabras clave: vacuna COVID-19, virus, eficacia, seguridad, COVID-19.
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[14] Andrews N, Stowe J, Kirsebom F, Toffa S, Rickeard T, Gallagher E, et al. Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. N Engl J Med 2022;386:1532–46. https://doi.org/10.1056/NEJMoa2119451.
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[17] Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020;383:2603–15. https://doi.org/10.1056/NEJMoa2034577.
[18] Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med 2021;385:1761–73. https://doi.org/10.1056/NEJMoa2110345.
[19] Falsey AR, Sobieszczyk ME, Hirsch I, Sproule S, Robb ML, Corey L, et al. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine. N Engl J Med 2021:NEJMoa2105290. https://doi.org/10.1056/NEJMoa2105290.
[20] Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet Lond Engl 2021;397:671–81. https://doi.org/10.1016/S0140-6736(21)00234-8.
[21] Link-Gelles R, Levy ME, Natarajan K, Reese SE, Naleway AL, Grannis SJ, et al. Estimation of COVID-19 mRNA Vaccine Effectiveness and COVID-19 Illness and Severity by Vaccination Status During Omicron BA.4 and BA.5 Sublineage Periods. JAMA Netw Open 2023;6:e232598. https://doi.org/10.1001/jamanetworkopen.2023.2598.
[22] Eyre DW, Taylor D, Purver M, Chapman D, Fowler T, Pouwels KB, et al. The impact of SARS-CoV-2 vaccination on Alpha & Delta variant transmission 2021:2021.09.28.21264260.
[23] Escudero C, Prieto-Montaño P, Audicana MT. Adverse Reactions to Anti-Infective Vaccines: an Emerging Problem in the COVID-19 Era. Curr Treat Options Allergy 2022;9:250–72. https://doi.org/10.1007/s40521-022-00311-8.
[24] Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. The Lancet 2020;396:1979–93. https://doi.org/10.1016/S0140-6736(20)32466-1.
[25] Paneluisa ALA, Peralta ALJ. Efectos secundarios percibidos por la población de la vacunación contra la Covid-19. Horiz Enferm 2022:6–16. https://doi.org/10.32645/13906984.1168.
[26] Hernández-Bello J, Morales-Núñez JJ, Machado-Sulbarán AC, Díaz-Pérez SA, Torres-Hernández PC, Balcázar-Félix P, et al. Neutralizing Antibodies against SARS-CoV-2, Anti-Ad5 Antibodies, and Reactogenicity in Response to Ad5-nCoV (CanSino Biologics) Vaccine in Individuals with and without Prior SARS-CoV-2. Vaccines 2021;9:1047. https://doi.org/10.3390/vaccines9091047.
[27] Guzmán-Martínez O, Guardado K, de Guevara EL, Navarro S, Hernández C, Zenteno-Cuevas R, et al. IgG Antibodies Generation and Side Effects Caused by Ad5-nCoV Vaccine (CanSino Biologics) and BNT162b2 Vaccine (Pfizer/BioNTech) among Mexican Population. Vaccines 2021;9:999. https://doi.org/10.3390/vaccines9090999.
[28] López-Contreras JE, Paredes-Casillas P, Morales-Romero J, Castillo-Vélez FE, Lona-Reyes JC, Bedolla-Barajas M. Incidencia y factores asociados con las reacciones adversas tras la primera dosis de la vacuna Pfizer-BioNTech en trabajadores de la salud. Cir Cir 2023;91:034–41. https://doi.org/10.24875/CIRU.21000749.
[29] Hernández RDCS, Zayas EO, Duque RR, Rodríguez AVG, Flores DMB. Síntomas adversos de la primera dosis de la vacuna AstraZeneca contra COVID-19 en adultos ecuatorianos. Rev Eugenio Espejo 2022;16:58–71. https://doi.org/10.37135/ee.04.15.07.
[30] Paredes GSC. Efectos adversos de la vacuna anticovid-19 Oxford/AstraZeneca en personal sanitario del Hospital San Isidro en Tocoa, Colón, Honduras. Innovare Rev Cienc Tecnol 2022;11:100–2. https://doi.org/10.5377/innovare.v11i2.14784.
[31] Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, et al. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis 2021;21:1654–64. https://doi.org/10.1016/S1473-3099(21)00396-0.
[2] Ugalde A, Hellmann F, Homedes N. Inequity in access to vaccines: the failure of the global response to the COVID-19 pandemic. Salud Colect 2022;18:e4190–e4190. https://doi.org/10.18294/sc.2022.4190.
[3] Ball P. The lightning-fast quest for COVID vaccines - and what it means for other diseases. Nature 2021;589:16–8. https://doi.org/10.1038/d41586-020-03626-1.
[4] Billington J, Deschamps I, Erck SC, Gerberding JL, Hanon E, Ivol S, et al. Developing Vaccines for SARS-CoV-2 and Future Epidemics and Pandemics: Applying Lessons from Past Outbreaks. Health Secur 2020;18:241–9. https://doi.org/10.1089/hs.2020.0043.
[5] Janssen Biotech, Inc. Vaccines and Related Biological Products Advisory Committee Meeting February 26, 202 n.d. https://www.fda.gov/media/146217/download.
[6] Prüβ BM. Current State of the First COVID-19 Vaccines. Vaccines 2021;9:30. https://doi.org/10.3390/vaccines9010030.
[7] Castelo-Rivas WP, Carrión-Cevallos KJ, Ramírez-Cedeño KJ, Tipanluisa-Cajilema SA. Reacciones adversas en personas vacunadas contra la COVID-19 pertenecientes al Recinto Umpechico, Ecuador. Rev Inf Científica 2022;101. http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S1028-99332022000400010&lng=es&nrm=iso&tlng=es.
[8] Al Khames Aga QA, Alkhaffaf WH, Hatem TH, Nassir KF, Batineh Y, Dahham AT, et al. Safety of COVID-19 vaccines. J Med Virol 2021;93:6588–94. https://doi.org/10.1002/jmv.27214.
[9] Ahmed SH, Waseem S, Shaikh TG, Qadir NA, Siddiqui SA, Ullah I, et al. SARS-CoV-2 vaccine-associated-tinnitus: A review. Ann Med Surg 2022;75. https://doi.org/10.1016/j.amsu.2022.103293.
[10] Graña C, Ghosn L, Evrenoglou T, Jarde A, Minozzi S, Bergman H, et al. Efficacy and safety of COVID‐19 vaccines. Cochrane Database Syst Rev 2022. https://doi.org/10.1002/14651858.CD015477.
[11] Eyre DW, Taylor D, Purver M, Chapman D, Fowler T, Pouwels KB, et al. The impact of SARS-CoV-2 vaccination on Alpha & Delta variant transmission 2021:2021.09.28.21264260. https://doi.org/10.1101/2021.09.28.21264260.
[12] Duong D. Alpha, Beta, Delta, Gamma: What’s important to know about SARS-CoV-2 variants of concern? CMAJ Can Med Assoc J 2021;193:E1059–60. https://doi.org/10.1503/cmaj.1095949.
[13] Chemaitelly H, Tang P, Hasan MR, AlMukdad S, Yassine HM, Benslimane FM, et al. Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar. N Engl J Med 2021;385:e83. https://doi.org/10.1056/NEJMoa2114114.
[14] Andrews N, Stowe J, Kirsebom F, Toffa S, Rickeard T, Gallagher E, et al. Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. N Engl J Med 2022;386:1532–46. https://doi.org/10.1056/NEJMoa2119451.
[15] Haas EJ, Angulo FJ, McLaughlin JM, Anis E, Singer SR, Khan F, et al. Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data. The Lancet 2021;397:1819–29. https://doi.org/10.1016/S0140-6736(21)00947-8.
[16] McMenamin ME, Nealon J, Lin Y, Wong JY, Cheung JK, Lau EHY, et al. Vaccine effectiveness of one, two, and three doses of BNT162b2 and CoronaVac against COVID-19 in Hong Kong: a population-based observational study. Lancet Infect Dis 2022;22:1435–43. https://doi.org/10.1016/S1473-3099(22)00345-0.
[17] Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020;383:2603–15. https://doi.org/10.1056/NEJMoa2034577.
[18] Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med 2021;385:1761–73. https://doi.org/10.1056/NEJMoa2110345.
[19] Falsey AR, Sobieszczyk ME, Hirsch I, Sproule S, Robb ML, Corey L, et al. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine. N Engl J Med 2021:NEJMoa2105290. https://doi.org/10.1056/NEJMoa2105290.
[20] Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet Lond Engl 2021;397:671–81. https://doi.org/10.1016/S0140-6736(21)00234-8.
[21] Link-Gelles R, Levy ME, Natarajan K, Reese SE, Naleway AL, Grannis SJ, et al. Estimation of COVID-19 mRNA Vaccine Effectiveness and COVID-19 Illness and Severity by Vaccination Status During Omicron BA.4 and BA.5 Sublineage Periods. JAMA Netw Open 2023;6:e232598. https://doi.org/10.1001/jamanetworkopen.2023.2598.
[22] Eyre DW, Taylor D, Purver M, Chapman D, Fowler T, Pouwels KB, et al. The impact of SARS-CoV-2 vaccination on Alpha & Delta variant transmission 2021:2021.09.28.21264260.
[23] Escudero C, Prieto-Montaño P, Audicana MT. Adverse Reactions to Anti-Infective Vaccines: an Emerging Problem in the COVID-19 Era. Curr Treat Options Allergy 2022;9:250–72. https://doi.org/10.1007/s40521-022-00311-8.
[24] Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. The Lancet 2020;396:1979–93. https://doi.org/10.1016/S0140-6736(20)32466-1.
[25] Paneluisa ALA, Peralta ALJ. Efectos secundarios percibidos por la población de la vacunación contra la Covid-19. Horiz Enferm 2022:6–16. https://doi.org/10.32645/13906984.1168.
[26] Hernández-Bello J, Morales-Núñez JJ, Machado-Sulbarán AC, Díaz-Pérez SA, Torres-Hernández PC, Balcázar-Félix P, et al. Neutralizing Antibodies against SARS-CoV-2, Anti-Ad5 Antibodies, and Reactogenicity in Response to Ad5-nCoV (CanSino Biologics) Vaccine in Individuals with and without Prior SARS-CoV-2. Vaccines 2021;9:1047. https://doi.org/10.3390/vaccines9091047.
[27] Guzmán-Martínez O, Guardado K, de Guevara EL, Navarro S, Hernández C, Zenteno-Cuevas R, et al. IgG Antibodies Generation and Side Effects Caused by Ad5-nCoV Vaccine (CanSino Biologics) and BNT162b2 Vaccine (Pfizer/BioNTech) among Mexican Population. Vaccines 2021;9:999. https://doi.org/10.3390/vaccines9090999.
[28] López-Contreras JE, Paredes-Casillas P, Morales-Romero J, Castillo-Vélez FE, Lona-Reyes JC, Bedolla-Barajas M. Incidencia y factores asociados con las reacciones adversas tras la primera dosis de la vacuna Pfizer-BioNTech en trabajadores de la salud. Cir Cir 2023;91:034–41. https://doi.org/10.24875/CIRU.21000749.
[29] Hernández RDCS, Zayas EO, Duque RR, Rodríguez AVG, Flores DMB. Síntomas adversos de la primera dosis de la vacuna AstraZeneca contra COVID-19 en adultos ecuatorianos. Rev Eugenio Espejo 2022;16:58–71. https://doi.org/10.37135/ee.04.15.07.
[30] Paredes GSC. Efectos adversos de la vacuna anticovid-19 Oxford/AstraZeneca en personal sanitario del Hospital San Isidro en Tocoa, Colón, Honduras. Innovare Rev Cienc Tecnol 2022;11:100–2. https://doi.org/10.5377/innovare.v11i2.14784.
[31] Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, et al. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis 2021;21:1654–64. https://doi.org/10.1016/S1473-3099(21)00396-0.
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Publicado
2026-04-25
Cómo citar
Garzón Orellana, P. A., Encalada Torres, L. E., Molina Matute, M. F., & Picón Saavedra, S. (2026). Eficacia y seguridad de la vacuna COVID-19 en pacientes mayores de 18 años. Revisión Sistemática Exploratoria-Scoping Review. Revista CEUS, 7(1). https://doi.org/10.26871/ceus.v7i1.216
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Derechos de autor 2026 Paul Armando Garzón Orellana, Lorena Esperanza Encalada Torres, Marcos Fernando Molina Matute, Santiago Picón Saavedra
Esta obra está bajo una licencia internacional Creative Commons Atribución 4.0.