Critical evaluation of the safety profile of MRNA- and viral-vector-based COVID-19 vaccines: clinical and epidemiological implications

Authors

DOI:

https://doi.org/10.62452/k7dr0877

Keywords:

COVID-19 vaccines, mRNA, viral vectors,, adverse effects, pharmacovigilance

Abstract

This review critically assesses the safety profile of COVID-19 vaccines developed using messenger RNA and viral vector technologies, addressing both common and rare but clinically significant adverse events. Based on recent scientific literature and pharmacovigilance data, most reported effects are mild and self-limiting, such as fever, myalgia, and injection site pain. However, rare events like myocarditis, pericarditis, thrombosis with thrombocytopenia, and Guillain-Barré syndrome have been documented and thoroughly investigated. Despite these findings, current evidence confirms that the benefits of vaccination far outweigh the associated risks, particularly when compared to complications arising from SARS-CoV-2 infection. The review emphasizes the importance of ongoing surveillance and evidence-based public communication strategies to maintain trust in immunization programs.

Downloads

Download data is not yet available.

Author Biography

  • María Sol Nuñez-Crespo, Universidad Regional Autónoma de Los Andes. Ecuador.

     

     

References

AlShurman, B. A., Khan, A. F., Mac, C., Majeed, M., & Butt, Z. A. (2021). What demographic, social, and contextual factors influence the intention to use COVID-19 vaccines: A scoping review. International Journal of Environmental Research and Public Health, 18(17), 1–43. https://doi.org/10.3390/ijerph18179342

Álvarez Ramírez, A., Muela Campos, D., Domínguez Torres, N. I., Corral Apodaca, M. M., Montes Chavira, L. O., Nevárez Rascón, A., & Gil Reza Bravo, G. (2022). Efectos secundarios posteriores a inmunización Sinovac® contra SARS-CoV-2, en estudiantes de odontología de 20-30 años. Revista de la Asociación Dental Mexicana, 79(3), 1–7. https://doi.org/10.35366/105825

Ayati, N., Evans, S., Rasoul Zakavi, S., & Gruenewald, S. M. (2023). Comparison between viral vector and mRNA based COVID-19 vaccination in prevalence and severity of regional immune reactions, and 18F-FDG PET/CT features. Asia Ocean Journal of Nuclear Medicine and Biology, 11(1), 4–12. https://doi.org/10.22038/aojnmb.2022.63110.1443

Baden, L. R., El Sahly, H. M., Essink, B., Kotloff, K., Frey, S., Novak, R., Diemert, D., Spector, S. A., Rouphael, N., Creech, C. B., McGettigan, J., Khetan, S., Segall, N., Solis, J., Brosz, A., Fierro, C., Schwartz, H., Neuzil, K., Corey, L., … Zaks, T. (2021). Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. New England Journal of Medicine, 384(5), 1–14. https://doi.org/10.1056/nejmoa2035389

Bass, A. R., Stratton, K., Kumova, O. K., & Rosenberg, D. (Eds.). (2024). Evidence review of the adverse effects of COVID-19 vaccination and intramuscular vaccine administration. The National Academies Press.

Beatty, A. L., Peyser, N. D., Butcher, X. E., Cocohoba, J. M., Lin, F., Olgin, J. E., Pletcher, M. J., & Marcus, G. M. (2021). Analysis of COVID-19 vaccine type and adverse effects following vaccination. JAMA Network Open, 4(12), 1–13. https://doi.org/10.1001/jamanetworkopen.2021.40364

Becker, M. S., Balbuena, C., & Samudio, M. (2021). Reacciones adversas post vacunación, y eventual infección por Covid-19 en odontólogos. Revista científica ciencias de la salud, 3(2), 1–11. https://doi.org/10.53732/rccsalud/03.02.2021.85

Chohan, H. K., Jamal, A., Mubeen, M., Khan, M. U., Junaid, M., Chohan, M. K., Imran, A., Aslam, A., Anwar, A., & Hashmi, A. A. (2023). The common systemic and local adverse effects of the Sinovac COVID-19 vaccine: An observational study from Pakistan. Cureus, 15(3), 1–9. https://doi.org/10.7759/cureus.38564

Galeano, R., Antúnez, K., Chamorro, O. N., Recalde, D., López, R., Kallsen, J., & Ocampos, S. (2023). Efectos adversos a las vacunas contra la COVID-19 en Paraguay en el 2021. Revista científica Ciencias De La Salud, 5, 1–6. https://doi.org/10.53732/rccsalud/2023.e5102

Gao, J., Feng, L., Li, Y., Lowe, S., Guo, Z., Bentley, R., Xie, C., Wu, B., Xie, P., Xia, W., Ma, S., Liu, H., Guo, X., Uy, J. P. N., Zhou, Q., Wazir, H., & Sun, C. (2023). A systematic review and meta-analysis of the association between SARS-CoV-2 vaccination and myocarditis or pericarditis. American Journal of Preventive Medicine, 64(2), 1–10. https://doi.org/10.1016/j.amepre.2022.09.002

Garrochamba Peñafiel, B. D., & Abad Macas, S. V. (2024). Eventos adversos atribuibles a la vacuna AstraZeneca en pacientes inmunizados contra la COVID-19. LATAM Revista Latinoamericana de Ciencias Sociales y Humanidades, 5(5), 1–12. https://doi.org/10.56712/latam.v5i5.2668

González Macias, M. G. (2022). Efectos adversos: Vacuna AstraZeneca en jóvenes de 18 a 29 años en Juchipila, Zac. 5, 1–10. https://doi.org/10.60568/eic.v4i1.1556

Hui, A.-M., Li, J., Zhu, L., Tang, R., Ye, H., Lin, M., Mei, L., Lei, G., Wang, X., Peng, F., Wu, Z., Guo, X., Shi, Y., Pan, H., Zhu, J., Song, Z., Qiu, J., Wang, W., Zhen, J., Ozhelva, O., … Zhu, F. (2022). Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial. Lancet Regional Health – Western Pacific, 29, 100586. https://doi.org/10.1016/j.lanwpc.2022.100586

Krumholz, H. M., Wu, Y., Sawano, M., Shah, R., Zhou, T., Arun, A. S., Khosla, P., Kaleem, S., Vashist, A., Bhattacharjee, B., Ding, Q., Lu, Y., Caraballo, C., Warner, F., Huang, C., Herrin, J., Putrino, D., Hertz, D., Dressen, B., & Iwasaki, A. (2023). Post-vaccination syndrome: A descriptive analysis of reported symptoms and patient experiences after Covid-19 immunization. medRxiv, 1–32. https://doi.org/10.1101/2023.11.09.23298266

Lamb, C., Owens, C., Gamboa, W., & Lopez-Yunez, A. (2023). Evaluating Johnson and Johnson COVID-19 Vaccination Outcomes in a Low-Income Hispanic Population. Vaccines, 11(1), 148. https://doi.org/10.3390/vaccines11010148

Li, M., Wang, H., Tian, L., Pang, Z., Yang, Q., Huang, T., Fan, J., Song, L., Tong, Y., & Fan, H. (2022). COVID-19 vaccine development: Milestones, lessons and prospects. Signal Transduction and Targeted Therapy, 7(1), 1–32. https://doi.org/10.1038/s41392-022-00996-y

Medeiros, K. S., Costa, A. P. F., Sarmento, A. C. A., Freitas, C. L., & Gonçalves, A. K. (2022). Side effects of COVID-19 vaccines: A systematic review and meta-analysis protocol of randomised trials. BMJ Open, 12(2), e050278. http://dx.doi.org/10.1136/bmjopen-2021-050278

Mevorach, D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., Olsha-Castell, S., Arad, D., Hasin, T., Levi, N., Asleh, R., Amir, O., Meir, K., Cohen, D., Dichtiar, R., Novick, D., Hershkovitz, Y., Dagan, R., Leitersdorf, I., … Alroy-Preis, S. (2021). Myocarditis after BNT162b2 mRNA vaccine against Covid-19 in Israel. New England Journal of Medicine, 385(23), 1–10. https://doi.org/10.1056/nejmoa2109730

Paredes-Larrea, A., & Ayala-Godoy, G. F. (2024). Reacciones adversas de las vacunas contra el SARS COV 2 en personales de salud, primer semestre del año 2021. Revista del Instituto de Medicina Tropical, 19(1), 21–26. http://dx.doi.org/10.18004/imt/2024.19.1.21

Rahman, M., Masum, H. U., Wajed, S., & Talukder, A. (2022). A comprehensive review on COVID-19 vaccines: Development, effectiveness, adverse effects, distribution and challenges. Virusdisease, 33(1), 1–22. https://doi.org/10.1007/s13337-022-00755-1

Saeteros Hernández, R. D. C., Ortiz Zayas, E., Rodríguez Duque, R., Granizo Rodríguez, A. V., & Baquerizo Flores, D. M. (2022). Síntomas adversos de la primera dosis de la vacuna AstraZeneca contra COVID-19 en adultos ecuatorianos. Revista Eugenio Espejo, 16(3), 58–71. https://doi.org/10.37135/ee.04.15.07

Santangelo, O. E., Provenzano, S., Di Martino, G., & Ferrara, P. (2024). COVID-19 vaccination and public health: Addressing global, regional, and within-country inequalities. Vaccines (Basel), 12(8), 1–16. https://doi.org/10.3390/vaccines12080885

Schreckenberg, R., Woitasky, N., Itani, N., Czech, L., Ferdinandy, P., & Schulz, R. (2024). Cardiac side effects of RNA-based SARS-CoV-2 vaccines: Hidden cardiotoxic effects of mRNA-1273 and BNT162b2 on ventricular myocyte function and structure. British Journal of Pharmacology, 181(3), 1–17. https://doi.org/10.1111/bph.16262

Syed, A. S., Sultana, S., Begum, A., Nadeem, K., Ara, J., Askarey, S. H., Siddiqui, A. A., Anwar, A., & Hashmi, A. A. (2023). Severity of adverse effects of Sinovac COVID-19 vaccine in postmenopausal women: A multicenter experience from Pakistan. Cureus, 15(7), 1–10. https://doi.org/10.7759/cureus.46682

Tito Pineda, A. P., Ipiales Ayala, A. V., Tapia Paguay, M. X., & López Aguilar, E. C. (2023). Vacuna COVID-19 y efectos adversos posvacunación en personal de enfermería. Horizontes de Enfermería, 13, 1–12. https://doi.org/10.32645/13906984.1228

Van den Ouweland, F., Charpentier, N., Türeci, Ö., Rizzi, R., Mensa, F. J., Lindemann, C., & Pather, S. (2024). Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data. Human Vaccines & Immunotherapeutics, 20(1). https://doi.org/10.1080/21645515.2024.2315659

Whitehead, H. S., French, C. E., Caldwell, D. M., Letley, L., & Mounier-Jack, S. (2023). A systematic review of communication interventions for countering vaccine misinformation. Vaccine, 41(5), 1018–1034. http://dx.doi.org/10.1016/j.vaccine.2022.12.05

Yasmin, F., Najeeb, H., Naeem, U., Moeed, A., Atif, A. R., Asghar, M. S., Nimri, N., Saleem, M., Bandyopadhyay, D., Krittanawong, C., Eljack, M. M. F., Tahir, M. J., & Waqar, F. (2023). Adverse events following COVID‐19 mRNA vaccines: A systematic review of cardiovascular complication, thrombosis, and thrombocytopenia. Immun Inflamm Dis, 11(3), 1–10. https://doi.org/10.1002/iid3.807

Downloads

Published

2025-09-20

How to Cite

Nuñez-Crespo, M. S. ., Carrasco-Guano, E. F. ., Loor-Flores, M. E. ., & Culqui-Molina, W. P. . (2025). Critical evaluation of the safety profile of MRNA- and viral-vector-based COVID-19 vaccines: clinical and epidemiological implications. Revista Metropolitana De Ciencias Aplicadas, 8(4), 163-176. https://doi.org/10.62452/k7dr0877