Safety of third SARS-CoV-2 vaccine (booster dose) during pregnancy

Dick, Aharon; Rosenbloom, Joshua I.; Karavani, Gilad; Gutman-Ido, Einat; Lessans, Naama; Chill, Henry H.

doi:10.1016/j.ajogmf.2022.100637

Cited by 23 publications

(41 citation statements)

References 15 publications

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“…Our finding of significantly lower rates of local rash/pain/swelling in the third vaccine group contrasts with findings in other studies that compared adverse effects in the second versus third dose of vaccine. These studies have reported similar rates of all adverse effects after the second and third vaccine doses, both in the general population and among pregnant women [ 16 , 17 ].…”

Section: Discussionmentioning

confidence: 98%

Early Adverse Events and Immune Response Following Second and Third COVID-19 Vaccination in Pregnancy

Toussia-Cohen

Yinon

Peretz-Machluf

et al. 2022

JCM

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(1) Background: The adverse-effect profile and short-term obstetric and neonatal outcomes among pregnant women who were vaccinated with the BNT162b2 vaccine at any stage of pregnancy do not indicate any safety concerns. The vaccine is effective in generating a humoral immune response in pregnant women. (2) Objective: To determine the vaccine-induced immunity and adverse events associated with the third (booster) dose of the BNT162b2 vaccine compared to the first and second dose of the vaccine among pregnant women. (3) Study design: A prospective cohort study in a tertiary referral center comparing pregnant women who were vaccinated by the first and second dose of the BNT162b2 (Pfizer/BioNTech) vaccine to pregnant women vaccinated by a third (booster) dose, between January and November 2021. A digital questionnaire regarding adverse events was filled by both groups 2–4 weeks after vaccination. Blood samples were collected and tested for SARS-COV-2 IgG antibodies 28–32 days after the administration of the second or third BNT162b2 dose. (4) Results: Seventy-eight pregnant women who received the first and second doses of the vaccine were compared to eighty-four pregnant women who received the third dose of the vaccine. In terms of adverse events following vaccination, local rash/pain/swelling (93.6% vs. 72.6%, p < 0.001) was significantly less common after the third vaccination compared to after the second vaccination. Other adverse events, including early obstetric complications, did not differ between the two groups. SARS-CoV-2 IgG serum levels 28–32 days after the vaccination were significantly higher after the third vaccination compared to the second vaccination (1333.75 vs. 2177.93, respectively, p < 0.001). (5) Conclusion: This study confirms the safety regarding early adverse events and immunogenicity, and the lack of early obstetric complications of the BNT162b2 second- and third-dose vaccine in pregnant women. The third (booster) dose is effective in generating a stronger humoral immune response in pregnant women compared with the second dose.

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Section: Discussionmentioning

confidence: 98%

Early Adverse Events and Immune Response Following Second and Third COVID-19 Vaccination in Pregnancy

Toussia-Cohen

Yinon

Peretz-Machluf

et al. 2022

JCM

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“…In a recent systematic review and meta-analysis who evaluated the neonate’s outcome, two doses of the vaccine were observed to be protective against NICU admissions [ 27 ]. In the study of Dick et al who examined some neonate’s outcomes of women who received the third booster dose, the rates of Umbilical artery pH<7.1 was significantly lower among the third doses group compared to unvaccinated women [ 28 ]. This interesting finding, obviously this is not due to the protection towards Covid-19 since all groups did not develop Covid-19 infection.…”

Section: Discussionmentioning

confidence: 99%

Covid-19 third vaccination during pregnancy: maternal and neonatal outcomes—a retrospective study

Rottenstreich

Rotem

Wiener-Well

et al. 2022

Arch Gynecol Obstet

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Purpose To evaluate the impact of Covid-19 (Pfizer-BioNTech BNT162b2) third booster dose vaccination during pregnancy on maternal and neonatal outcomes. Methods This is a multicenter, retrospective computerized database study. Parturients who delivered in Israel between August and December 2021 with full records of Covid-19 disease and vaccination status were included. Those who received third booster during pregnancy were compared to those who received two doses of vaccine during pregnancy and to unvaccinated parturients. Various adverse maternal and neonatal outcomes were evaluated. Parturients who were previously positive with Covid-19 PCR swabs during pregnancy or before pregnancy were excluded. Univariate analysis was followed by multivariate analysis. Results A total of 2583 women were included in the analysis; 626 received the third booster dose of the BNT162b2 Covid-19 vaccine, 1094 received two doses of the vaccine, and 863 unvaccinated women. Maternal and neonatal outcomes were comparable between the study groups. An adjusted multivariable logistic regression analysis demonstrated that receiving the third booster was not associated with an increase in neither composite adverse maternal or neonatal outcome (aOR 0.9; 95% CI [0.65–1.22], p = 0.47; aOR 0.7; 95% CI [0.53–1.035], p = 0.09, respectively) when compared to those who received two doses of the vaccine. However, administration of the third booster dose during pregnancy was associated with a reduced composite adverse neonatal outcome when compared to unvaccinated women (aOR 0.6; 95% CI [0.42–0.86], p = 0.01). Conclusion Receiving the third booster dose of the BNT162b2 Covid-19 vaccine during pregnancy is not associated with an increased risk of any adverse maternal outcomes and may be beneficial for the neonates.

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“…In Israel, 294 pregnant women who received three doses of mRNA vaccines had similar rates of preterm and SGA births compared to women who were unvaccinated (N = 3368) or had only received two doses (N = 2854). There was, however, a higher rate of post-partum hemorrhage in those who received three doses (9.5%) than in the unvaccinated (3.2%) or double-vaccinated (3.5%) groups [91]. Although the underlying potential mechanism for this difference is unknown, the safety of additional vaccine doses beyond the initial two-dose schedule warrants further study.…”

Section: Discussionmentioning

confidence: 93%

“…Three studies published to date suggest that an mRNA vaccine administered as a third dose is in principle safe and induces a robust IgG response in the mother that is transferred to the newborn [55,91,92]. In Israel, 294 pregnant women who received three doses of mRNA vaccines had similar rates of preterm and SGA births compared to women who were unvaccinated (N = 3368) or had only received two doses (N = 2854).…”

Section: Discussionmentioning

confidence: 99%