Short-term Reactions Among Pregnant and Lactating Individuals in the First Wave of the COVID-19 Vaccine Rollout

Kachikis, Alisa; Englund, Janet A.; Singleton, Michael; Covelli, Isabela; Drake, Alison L.; Eckert, Linda O.

doi:10.1001/jamanetworkopen.2021.21310

Cited by 66 publications

(97 citation statements)

References 2 publications

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“…Additional findings and similar data were recently reported by other studies investigating the topic of COVID-19 vaccination in pregnant women [15,19]. The safety profile of BNT162b2 was described as insignificantly different after pregnant women were found to have equal rates of rash, fever, and fatigability after immunization as non-pregnant women [20,21]. Myalgia, arthralgia, and headache were significantly less common in pregnant women following each dose.…”

Section: Discussionsupporting

confidence: 87%

Immunogenicity Following Administration of BNT162b2 and Ad26.COV2.S COVID-19 Vaccines in the Pregnant Population during the Third Trimester

Citu

Cîtu

Gorun

et al. 2022

Viruses

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Globally, COVID-19 vaccines are currently being used to prevent transmission and to reduce morbidity and death associated with SARS-CoV-2 infection. Current research reveals that vaccines such as BNT162b2 and Ad26.COV2.S are highly immunogenic and have high short-term effectiveness for most of the known viral variants. Clinical trials showed satisfying results in the general population, but the reluctance in testing and vaccinating pregnant women left this category with little evidence regarding the safety, efficacy, and immunogenicity following COVID-19 vaccination. With the worldwide incidence of COVID-19 remaining high and the possibility of new transmissible SARS-CoV-2 mutations, data on vaccination effectiveness and antibody dynamics in pregnant patients are critical for determining the need for special care or further booster doses. An observational study was developed to evaluate pregnant women receiving the complete COVID-19 vaccination scheme using the BNT162b2 and Ad26.COV2.S, and determine pregnancy-related outcomes in the mothers and their newborns, as well as determining adverse events after vaccination and immunogenicity of vaccines during four months. There were no abnormal findings in pregnancy and newborn characteristics comparing vaccinated versus unvaccinated pregnant women. COVID-19 seropositive pregnant women had significantly higher spike antibody titers than seronegative patients with similar characteristics, although they were more likely to develop fever and lymphadenopathy following vaccination. The same group of pregnant women showed no statistically significant differences in antibody titers during a 4-month period when compared with case-matched non-pregnant women. The BNT162b2 and Ad26.COV2.S vaccines are safe to administer during the third trimester of pregnancy, while their safety, efficacy, and immunogenicity remain similar to those of the general population.

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Section: Discussionsupporting

confidence: 87%

Immunogenicity Following Administration of BNT162b2 and Ad26.COV2.S COVID-19 Vaccines in the Pregnant Population during the Third Trimester

Citu

Cîtu

Gorun

et al. 2022

Viruses

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“…The limitation of COVID-19 vaccines' safety evidence has resulted from the initial exclusion of PLW from the development trials; therefore, the obstetric societies have been calling upon manufacturers to include PLW in their vaccine trials in order to have reliable evidence on the potential/theoretical risks of vaccines, especially for fetuses and babies [61][62][63][64][65]. The post-marketing studies (phase IV) yielded no differences between pregnant and non-pregnant women regarding post-vaccination side effects' prevalence or intensity [66][67][68]. Therefore, independent post-marketing studies of COVID-19 vaccines are believed to provide critical evidence to guide the public to make informed decisions [69][70][71][72][73][74][75][76].…”

Section: Discussionmentioning

confidence: 99%

COVID-19 Vaccine Acceptance of Pregnant and Lactating Women (PLW) in Czechia: An Analytical Cross-Sectional Study

Riad

Jouzová

Üstün

et al. 2021

IJERPH

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Pregnant and lactating women (PLW) represent a particular population subset with increased susceptibility for COVID-19 morbidity and mortality, even though the evidence about the safety and efficacy of COVID-19 vaccines was delayed due to their initial exclusion from development trials. This unclear situation could have led to increased COVID-19 vaccine hesitancy levels among PLW; therefore, this study aimed to evaluate the attitudes of Czech PLW towards COVID-19 vaccines and the determinants of their attitudes. An analytical cross-sectional survey-based study was carried out in the University Hospital Brno (South Moravia, Czechia) between August and October 2021. The study utilised a self-administered questionnaire (SAQ) adapted from previous instruments used for the same purpose. The SAQ included closed-ended items covering demographic characteristics, clinical and obstetric characteristics, attitudes towards COVID-19 vaccination, and potential psychosocial predictors of vaccine acceptance. Out of the 362 included participants, 278 were pregnant (PW) and 84 were lactating women (LW). The overall COVID-19 vaccine acceptance (immediate and delayed) level was substantially high (70.2%), with a significant difference between PW (76.6%) and LW (48.8%). Out of the 70.2% who agreed to receive the vaccine, 3.6% indicated immediate acceptance, and 66.6% indicated delayed acceptance. Only 13.3% of the participants indicated their acceptance of their physician’s vaccination recommendation during pregnancy or while lactating, and 62.2% were against it. Our results agreed with the recent studies that revealed that PW tended to have a high level of COVID-19 vaccine acceptance, and they were also inclined to resist professional recommendations because they predominantly preferred to delay their vaccination. The pregnancy trimester, education level, employment status, and previous live births were significant determinants for COVID-19 vaccine acceptance. The most commonly preferred vaccine type was mRNA-based vaccines, followed by viral vector-based and inactivated virus vaccines. The first top priority of PLW was vaccine safety for their children, followed by vaccine safety for the PLW and vaccine effectiveness. Regarding psychosocial predictors, media/social media, trust in the government, the pharmaceutical industry, and healthcare professionals, partners, and a positive risk-benefit ratio were significant promoters for COVID-19 vaccine acceptance. Findings from this study suggest that promotional interventions targeting PLW should use web platforms and focus on vaccine safety evidence, the expected benefits of vaccines and potential harms of the infection.

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“…Eleven of the 32 (34%) studies (Figure 2) discussed COVID-19 vaccination-related side effects in pregnant people, [18][19][20][21][22][23] pregnancy outcomes (gestational hypertension, pre-eclampsia, thromboembolism, placental injuries, miscarriage, and stillbirth), 19,[24][25][26][27][28] and neonatal outcomes (preterm birth, congenital anomalies, small size for gestational age, neonatal ICU admission, and neonatal death). 19,[27][28][29] Included studies that evaluated pregnancy and neonatal outcomes following COVID-19 vaccination did not demonstrate harmful effects with respect to pregnancy, 19,24,25,26,27,28 fetal development, 19,27,28 or neonatal outcomes.…”

Section: Covid-19 Vaccine Safetymentioning

confidence: 99%

“…19,27,28 Other neonatal outcomes including preterm birth (9.40%, 5.90%), 19,27,29 congenital anomalies (2.20%, 1.20%), 19,27 small size for gestational age (3.20%, 12.20%), 19,27,29 and neonatal ICU admission (0.70%, 15.30%) 27,28 following COVID-19 vaccination were similar to the expected rate of neonatal outcomes in the unvaccinated population. [32][33][34][35][36] Side-effects reported in pregnant people were similar to the general population, and the most common side-effects included injection-site pain, [18][19][20] injection-site soreness, 20,21 fevers or chills, [18][19][20][21]23 fatigue, 18,20 and itching. 20 Immune thrombocytopenia (ITP) was reported in a case study.…”

Section: Covid-19 Vaccine Safetymentioning

confidence: 99%

COVID-19 vaccination among pregnant people in the United States: a systematic review

Rawal

TACKETT

Stone

et al. 2022

American Journal of Obstetrics & Gynecology MFM

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Short-term Reactions Among Pregnant and Lactating Individuals in the First Wave of the COVID-19 Vaccine Rollout

Abstract: This cohort study investigates short-term reactions associated with COVID-19 vaccines among pregnant and lactating individuals vs individuals neither pregnant nor lactating but planning pregnancy.

Cited by 66 publications

References 2 publications

Immunogenicity Following Administration of BNT162b2 and Ad26.COV2.S COVID-19 Vaccines in the Pregnant Population during the Third Trimester

Immunogenicity Following Administration of BNT162b2 and Ad26.COV2.S COVID-19 Vaccines in the Pregnant Population during the Third Trimester

COVID-19 Vaccine Acceptance of Pregnant and Lactating Women (PLW) in Czechia: An Analytical Cross-Sectional Study

COVID-19 vaccination among pregnant people in the United States: a systematic review

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