tetano
Editor, Senior Moderator
Vaccine
. 2025 May 1:56:127194.
doi: 10.1016/j.vaccine.2025.127194. Online ahead of print. Short-term side effects following COVID-19 vaccination in pregnancies complicated by autoimmune inflammatory rheumatic diseases: A prospective cohort study
Shunya Kaneshita[SUP] 1 [/SUP], Christina D Chambers[SUP] 2 [/SUP], Diana Johnson[SUP] 3 [/SUP], Arthur Kavanaugh[SUP] 4 [/SUP], Richard Garfein[SUP] 5 [/SUP], Gretchen Bandoli[SUP] 2 [/SUP]
Affiliations
Background: Pregnant women are at higher risk for severe Coronavirus disease 2019 (COVID-19) infection, leading the Centers for Disease Control and Prevention to recommend vaccination. However, the frequency of vaccine side effects in pregnant women with autoimmune inflammatory rheumatic diseases (AIIRD) remains unknown. We investigated the frequencies of short-term (≤ 7 days) adverse reactions following the initial COVID-19 vaccination ever received by pregnant women with AIIRD.
Methods: A descriptive analysis of the incidence of side effects following the COVID-19 vaccination in pregnant women with AIIRD was conducted utilizing data from the MotherToBaby Study registry, a prospective cohort study designed to assess the safety of drug and vaccine exposure during pregnancy. This study enrolled pregnant women living in the United States or Canada between January 2021 and September 2022.
Results: Of 1413 participants who received dose 1 of the COVID-19 vaccine in pregnancy, 79 had AIIRD. There was no large difference in the total number of adverse reactions between pregnant women with and without AIIRD (β = -0.01, 95 % Confidence Interval [CI]: -0.17, 0.17). Pregnant women with higher Health Assessment Questionnaire Disability Index (HAQ-DI) in AIIRD had a higher total number of systemic reactions (β = 0.56, 95 % CI: 0.04, 1.10) than those with lower HAQ-DI, although the total number of adverse reactions was not different (β = 0.27, 95 % CI: -0.08, 0.62).
Conclusions: We found no difference in the frequency of COVID-19 vaccine-related side effects between pregnant women with and without AIIRD. Patients with AIIRD who have higher levels of functional impairment may have a slightly higher frequency of short-term adverse effects. The results of this assessment may help provide information for pregnant women with AIIRD regarding COVID-19 vaccination.
Keywords: Autoimmune inflammatory rheumatic diseases; COVID-19 vaccine; Pregnant women; Side effects.
. 2025 May 1:56:127194.
doi: 10.1016/j.vaccine.2025.127194. Online ahead of print. Short-term side effects following COVID-19 vaccination in pregnancies complicated by autoimmune inflammatory rheumatic diseases: A prospective cohort study
Shunya Kaneshita[SUP] 1 [/SUP], Christina D Chambers[SUP] 2 [/SUP], Diana Johnson[SUP] 3 [/SUP], Arthur Kavanaugh[SUP] 4 [/SUP], Richard Garfein[SUP] 5 [/SUP], Gretchen Bandoli[SUP] 2 [/SUP]
Affiliations
- PMID: 40315794
- DOI: 10.1016/j.vaccine.2025.127194
Background: Pregnant women are at higher risk for severe Coronavirus disease 2019 (COVID-19) infection, leading the Centers for Disease Control and Prevention to recommend vaccination. However, the frequency of vaccine side effects in pregnant women with autoimmune inflammatory rheumatic diseases (AIIRD) remains unknown. We investigated the frequencies of short-term (≤ 7 days) adverse reactions following the initial COVID-19 vaccination ever received by pregnant women with AIIRD.
Methods: A descriptive analysis of the incidence of side effects following the COVID-19 vaccination in pregnant women with AIIRD was conducted utilizing data from the MotherToBaby Study registry, a prospective cohort study designed to assess the safety of drug and vaccine exposure during pregnancy. This study enrolled pregnant women living in the United States or Canada between January 2021 and September 2022.
Results: Of 1413 participants who received dose 1 of the COVID-19 vaccine in pregnancy, 79 had AIIRD. There was no large difference in the total number of adverse reactions between pregnant women with and without AIIRD (β = -0.01, 95 % Confidence Interval [CI]: -0.17, 0.17). Pregnant women with higher Health Assessment Questionnaire Disability Index (HAQ-DI) in AIIRD had a higher total number of systemic reactions (β = 0.56, 95 % CI: 0.04, 1.10) than those with lower HAQ-DI, although the total number of adverse reactions was not different (β = 0.27, 95 % CI: -0.08, 0.62).
Conclusions: We found no difference in the frequency of COVID-19 vaccine-related side effects between pregnant women with and without AIIRD. Patients with AIIRD who have higher levels of functional impairment may have a slightly higher frequency of short-term adverse effects. The results of this assessment may help provide information for pregnant women with AIIRD regarding COVID-19 vaccination.
Keywords: Autoimmune inflammatory rheumatic diseases; COVID-19 vaccine; Pregnant women; Side effects.