Immunogenicity Response and Adverse Drug Reaction of Covid-19 Vaccine in Pregnancy and Lactation: Rapid Review
Main Article Content
Abstract
Vaccines have emerged as a solution to COVID-19 and have been demonstrated to be effective in preventing severe complications. However, evidence regarding their safety and immunogenicity in pregnant and lactating women remains limited. This rapid review synthesized available evidence on the immunogenicity and safety of COVID-19 vaccines during pregnancy and lactation. Article selection was conducted using PubMed, ScienceDirect, and MEDLINE from database inception until June 10, 2023, using the search strategy ("COVID-19 vaccine") AND ("Pregnancy") AND/OR ("Lactation"). Studies included English-language randomized controlled trials and clinical trials involving human subjects who received COVID-19 vaccines, and methodological quality was assessed using the Jadad and MINORS scores. Based on the 9 articles included, IgA and IgG levels increased in maternal blood and breastmilk following vaccination with mRNA, viral vector, and recombinant protein subunit vaccines, with responses varying by vaccine type, dose, and sampling time. The immunogenicity response generated by the vaccine may boost the infant immunity by transferring antibodies through the placenta and breastmilk. The results indicate that no serious vaccine-related adverse effects have been observed with COVID-19 vaccines administered during pregnancy and lactation in mothers or infants across studies.
Article Details

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
The authors retain the copyright and grant the journal the right of first publication simultaneously under the Creative Commons Attribution License. This license allows others to share the work with proper acknowledgment of authorship and initial publication in this journal. Authors are permitted and encouraged to deposit their articles in institutional repositories, on their personal websites, or in other online repositories after the article has been published in JSFK.
References
[1] Louis-Jean J, Cenat K, Njoku CV, Angelo J, Sanon D. Coronavirus (COVID-19) and racial disparities: a perspective analysis. J Racial Ethn Health Disparities. 2020;7(6):1039–45. https://doi.org/10.1007/S40615-020-00879-4
[2] Liu K, et al. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020;133(9):1025–31. https://doi.org/10.1097/CM9.0000000000000744
[3] Murakami N, et al. Therapeutic advances in COVID-19. Nat Rev Nephrol. 2023;19(1):38–52. https://doi.org/10.1038/s41581-022-00642-4
[4] World Health Organization. COVID-19 cases | WHO COVID-19 dashboard [Internet]. [cited 8 September 2024]. Available from: https://data.who.int/dashboards/covid19/cases
[5] Corrao G, et al. Persistence of protection against SARS-CoV-2 clinical outcomes up to 9 months since vaccine completion: a retrospective observational analysis in Lombardy, Italy. Lancet Infect Dis. 2022. https://doi.org/10.1016/S1473-3099(21)00813-6
[6] Katikireddi SV, et al. Two-dose ChAdOx1 nCoV-19 vaccine protection against COVID-19 hospital admissions and deaths over time: a retrospective, population-based cohort study in Scotland and Brazil. Lancet. 2022;399(10319):25–35. https://doi.org/10.1016/S0140-6736(21)02754-9
[7] Poukka E, et al. Cohort study of COVID-19 vaccine effectiveness among healthcare workers in Finland, December 2020–October 2021. Vaccine. 2022;40(5):701–5. https://doi.org/10.1016/j.vaccine.2021.12.032
[8] Suah JL, et al. Waning COVID-19 vaccine effectiveness for BNT162b2 and CoronaVac in Malaysia: an observational study. Int J Infect Dis. 2022;119:69–76. https://doi.org/10.1016/j.ijid.2022.03.028
[9] Zheutlin A, et al. Durability of protection post-primary COVID-19 vaccination in the United States. Vaccines (Basel). 2022;10(9):1458. https://doi.org/10.3390/vaccines10091458
[10] Gray KJ, et al. Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. Am J Obstet Gynecol. 2021;225(3):303.e1–303.e17. https://doi.org/10.1016/j.ajog.2021.03.023
[11] Duarte G, et al. Perspectives on administration of COVID-19 vaccine to pregnant and lactating women: a challenge for low- and middle-income countries. AJOG Glob Rep. 2021;1(4):100020. https://doi.org/10.1016/j.xagr.2021.100020
[12] Jadad AR, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12. https://doi.org/10.1016/0197-2456(95)00134-4
[13] Pradipta IS, Houtsma D, van Boven JFM, Alffenaar JWC, Hak E. Interventions to improve medication adherence in tuberculosis patients: a systematic review of randomized controlled studies. NPJ Prim Care Respir Med. 2020;30(1). https://doi.org/10.1038/s41533-020-0179-x
[14] Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73(9):712–6. https://doi.org/10.1046/j.1445-2197.2003.02748.x
[15] Lamb YN. BNT162b2 mRNA COVID-19 vaccine: first approval. Drugs. 2021;81(4):495–501. https://doi.org/10.1007/s40265-021-01480-7
[16] Baden LR, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403–16. https://doi.org/10.1056/NEJMoa2035389
[17] Voysey M, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99–111. https://doi.org/10.1016/S0140-6736(20)32661-1
[18] Más-Bermejo PI, et al. Cuban Abdala vaccine: effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba: a cohort study. Lancet Reg Health Am. 2022;16:100366. https://doi.org/10.1016/j.lana.2022.100366
[19] Sterlin D, Malaussena A, Gorochov G. IgA dominates the early neutralizing antibody response to SARS-CoV-2 virus. Med Sci (Paris). 2021;37(11):968–70. https://doi.org/10.1051/medsci/2021154
[20] Atyeo C, et al. COVID-19 booster dose induces robust antibody response in pregnant, lactating, and nonpregnant women. Am J Obstet Gynecol. 2023;228(1):68.e1–68.e12. https://doi.org/10.1016/j.ajog.2022.07.014
[21] Bäuerl C, et al. Assessment of SARS-CoV-2 neutralizing antibody titers in breastmilk from convalescent and vaccinated mothers. iScience. 2023;26(6):106802. https://doi.org/10.1016/j.isci.2023.106802
[22] Charepe N, et al. COVID-19 mRNA vaccine and antibody response in lactating women: a prospective cohort study. BMC Pregnancy Childbirth. 2021;21(1):757. https://doi.org/10.1186/s12884-021-04051-6
[23] Golan Y, et al. COVID-19 mRNA vaccination in lactation: assessment of adverse events and vaccine-related antibodies in mother–infant dyads. Front Immunol. 2021;12:777103. https://doi.org/10.3389/fimmu.2021.777103
[24] Juncker HG, et al. Comparing the human milk antibody response after vaccination with four COVID-19 vaccines: a prospective, longitudinal cohort study in the Netherlands. EClinicalMedicine. 2022;47:101393. https://doi.org/10.1016/j.eclinm.2022.101393
[25] Pérez-Bernal M, et al. SARS-CoV-2 spike RBD-specific IgA and IgG antibodies in breast milk after vaccination with the protein subunit vaccine Abdala. Infect Med. 2022;1(4):253–61. https://doi.org/10.1016/j.imj.2022.11.001
[26] Ricciardi A, et al. Serum and breastmilk SARS-CoV-2-specific antibodies following BNT162b2 vaccine: prolonged protection from SARS-CoV-2 in newborns and older children. Int J Infect Dis. 2022;122:905. https://doi.org/10.1016/j.ijid.2022.06.055
[27] Gonçalves J, et al. Secretory IgA and T cells targeting SARS-CoV-2 spike protein are transferred to the breastmilk upon mRNA vaccination. Cell Rep Med. 2021;2(12):100468. https://doi.org/10.1016/j.xcrm.2021.100468
[28] Lee Y, et al. SARS-CoV-2 mRNA vaccine induced higher antibody affinity and IgG titers against variants of concern in post-partum vs non-post-partum women. EBioMedicine. 2022;77:103940. https://doi.org/10.1016/j.ebiom.2022.103940
[29] Atyeo C, Alter G. The multifaceted roles of breast milk antibodies. Cell. 2021;184(6):1486–99. https://doi.org/10.1016/j.cell.2021.02.031
[30] McGuire TM. Drugs affecting milk supply during lactation. Aust Prescr. 2018;41(1):7–9. https://doi.org/10.18773/austprescr.2018.002
[31] Pillay J, Davis TJ. Physiology, lactation [Internet]. StatPearls. 2023 [cited 8 September 2024]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499981/