COVID-19 infection imposes a risk for pregnant individuals and may lead to adverse maternal and obstetric outcomes. This is a retrospective cohort study of all women giving birth between March and July 2021 at a single tertiary center. Obstetric and neonatal outcomes were compared between vaccinated and non-vaccinated pregnant women with singleton pregnancies. Women with prior COVID-19 infection, multiple gestations and stillbirth were excluded from the study. Of 4708 women who delivered during the study period, 3700 met the eligibility criteria, of whom 3240 were vaccinated during pregnancy. Compared with the non-vaccinated group, the vaccinated group was characterized by a lower rate of smoking (3.70% vs 6.67%, p = 0.0028), whereasother maternal characteristics were not significantly different. Multivariable analysis demonstrated that COVID-19 mRNA vaccination was not significantly associated with increased risk of preterm birth as well as other adverse obstetric outcomes including hypertensive diseases of pregnancy, cesarean delivery and small for gestational age. However, a significantly lower risk for meconium-stained amniotic fluid was observed among the vaccinated group (adjusted odds ratio 0.63; 95% confidence interval, 0.46–0.86, p = 0.0039). Moreover, the vaccine was not significantly associated with increased risk of neonatal adverse outcomes including respiratory complications and NICU hospitalization. In conclusion, BNT162b2 messenger RNA vaccination during pregnancy was not associated with an increased rate of adverse obstetric and neonatal outcomes. Therefore, in view of its safety on one hand, and the risk associated with COVID-19 disease in pregnancy on the other hand, BNT 162b2 COVID-19 vaccine should be recommended for pregnant women.
(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.
Pregnant women with coronavirus disease 2019 have been shown to be at increased risk of severe maternal outcome 1 and are recommended to get vaccinated with the first and second doses of the BNT162b2 vaccine, which has shown encouraging results in terms of its safety and effectiveness in pregnancy 2,3 . The administration of a third (booster) dose of the BNT162b2 vaccine following the emergence of the B.1.617.2 (Delta) variant has proved to be effective in lowering rates of confirmed infection, severe illness and COVID-19-related death 4 and is, therefore, also recommended for pregnant women. We report on the adverse events and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) serum levels in pregnant women who received the third dose of the BNT162b2 vaccine.This was a prospective cohort study between August and November 2021 of pregnant women who received the third dose of the BNT162b2 vaccine and were matched by age in a 1:1 ratio to a control group of non-pregnant women who received the third dose of the vaccine during the same time period. All women had received two doses of BNT162b2 vaccine at least 5 months earlier. Blood samples were collected and tested for SARS-CoV-2 IgG antibodies (in binding antibody unit (BAU)/mL) before and 33 ± 3 days after the administration of the third BNT162b2 dose. Women with medical conditions,
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