Mother's Pregnancy Trimester Does Not Affect the Differences of IgG SARS-COV-2 Antibody Levels in Pregnant Women after mRNA and Inactivated Coronavirus Disease 2019 Vaccination

BACKGROUND: Since pregnancy increases the risk of coronavirus disease 2019 (COVID-19) and its morbidity in pregnant women, it is necessary and recommended to prevent COVID-19 in pregnant women by vaccination such as by messenger RNA (mRNA) and inactivated vaccines. SARS-CoV-2 antibodies produced from vaccination have different results according to the type of vaccine given. The previous studies showed that IgG SARS-CoV-2 antibody levels were influenced by various factors such as gestational weeks at the time when vaccines were given. Moreover, there have been no previous studies on the effect of gestational age on quantitative IgG levels after the second dose of the vaccine especially in Indonesia during this pandemic due to some restrictions on daily activities. AIM: The aim of this study is to see the effect of giving the COVID-19 vaccine based on maternal gestational age (in trimester units) on maternal immunity (IgG SARS-CoV-2) in Dr. Hasan Sadikin General Hospital Bandung, Bandung Kiwari Hospital and Dr. Slamet Hospital, Garut. METHOD(S): This was a retrospective and cohort study by taking secondary data using consecutive sampling from the previous tests on the levels of SARS-CoV-2 IgG antibodies after two doses of inactivated vaccine and mRNA. Healthy pregnant women 14-34 weeks at the Department of Obstetrics and Gynecology, Dr. Hasan Sadikin (RSHS) Bandung, Bandung Kiwari Hospital, and Dr. Slamet Hospital for the period October 2021 to January 2022 were the target population of this study. Based on inclusion and exclusion criteria, 103 samples met the criteria. Examination of Maternal SARS-CoV-2 IgG Antibody Levels procedures was carried out using Chemiluminescent Microparticle Immunoassay. Statistical analysis was done using IBM SPSS 28.00 and p < 0.05 was considered statistically significant. RESULT(S): There was no significant difference (p = 0.236, p > 0.05) between the mean maternal age in the mRNA and inactivated vaccine groups. The mRNA and inactivated vaccine groups also had no significant difference in the gestational age category (0.70). There was a significant difference (p = 0.0001) between the levels of SARS-CoV-2 IgG antibodies after the vaccine in the mRNA and inactivated vaccine groups. There was no significant difference in the levels of SARS-CoV-2 IgG antibodies in the gestational age group after the mRNA vaccine (p = 0.426) and after the inactivated vaccine (p = 0.293). There was a significant difference (p < 0.05) in the subgroup analysis in each gestational age group (second trimester and third trimester) between SARS-CoV-2 IgG antibody levels after the mRNA vaccine compared to inactivated vaccine. DISCUSSIONS: The mRNA vaccine is based on the principle that mRNA is an intermediate messenger to be translated to an antigen after delivery to the host cell via various routes. However, inactivated vaccines contain viruses whose genetic material has been destroyed by heat, chemicals, or radiation, so they cannot infect cells and replicate but can still trigger an immune response. The administration of the vaccine in the second and third trimesters of pregnancy has the same results in increasing levels of SARS-CoV-2 IgG antibodies after mRNA and inactivated vaccination in this study. CONCLUSION(S): mRNA vaccination in pregnant women is better than inactivated vaccines based on the levels of IgG SARS-CoV-2 antibodies after vaccination. The maternal trimester of pregnancy was not a factor influencing the levels of SARS-CoV-2 IgG antibodies after either mRNA or inactivated COVID-19 vaccinations in this study.Copyright © 2023 Anita Deborah Anwar, Putri Nadhira Adinda Adriansyah, Ivan Christian Channel, Annisa Dewi Nugrahani, Febriani Febriani, Asep Surachman, Dhanny Primantara Johari Santoso, Akhmad Yogi Pramatirta, Budi Handono.

Appraisal of COVID-19 Vaccination Acceptance in the Romanian Pregnant Population.

Widespread COVID-19 vaccination is crucial for limiting the spread of SARS-CoV-2 and minimizing the risk of novel variants arising in the general population, especially in pregnant women. According to the publicly available research data, vaccination intentions vary significantly by country, with Romania among the European countries with the lowest vaccination rates. Thus, we sought to determine the scale of acceptance of the COVID-19 vaccination campaign among pregnant women in Romania, as well as the variables affecting their choices. A cross-sectional study was conducted on pregnant women referred to the Obstetrics and Gynecology Clinic of the Timisoara Municipal Emergency Hospital in Romania, where participants were asked to complete an online survey including standardized and unstandardized questionnaires indicating their willingness to receive a COVID-19 vaccine and the reasons for their willingness. Out of the 500 women who were requested to participate, there was a total of 345 validated questionnaires, with 184 vaccinated and 161 unvaccinated pregnant women. The statistically significant determinant factors for COVID-19 vaccination acceptance were the urban area of residence (OR = 0.86), having a higher level of education (OR = 0.81), the third trimester of pregnancy (OR = 0.54), trusting the government (OR = 0.83), being a frequent traveler (OR = 0.76), fearing the severity of COVID-19 (OR = 0.68), the higher availability of COVID-19 vaccines nearby (OR = 0.87), and seeing more people getting vaccinated (OR = 0.75). As there are no increased risks associated with SARS-CoV-2 immunization in pregnant women, the variables identified in this research are crucial in determining the acceptability of COVID-19 vaccines that should be addressed in this vulnerable group to increase vaccination rates.

The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination.

Clinical trials for COVID-19 vaccines initially excluded pregnant women due to safety concerns, and when the vaccines were authorized for emergency use, they were not recommended for this population. However, observational studies discovered that pregnant women infected with COVID-19 have higher risks of negative pregnancy and delivery outcomes compared to non-pregnant women, raising the question of the risks-benefits of administering COVID-19 vaccines to pregnant women. By mid-2021, there was general consensus on the relative safety of COVID-19 vaccination during pregnancy; therefore, it is critical to investigate the safety issues related to these vaccines, considering the increasing acceptance among pregnant women. To address these concerns, we developed a research project to study the short-term effects and outcomes of COVID-19 vaccination during the first trimester of pregnancy. Our research followed an observational retrospective design for 12 months from the beginning of the vaccination campaign, and included 124 cases of spontaneous abortions and 927 ongoing pregnancies. The odds of spontaneous abortion were non-significant for both versions of the mRNA vaccine (Pfizer BNT162b2 AOR = 1.04, CI = 0.91-1.12; Moderna mRNA-1273 AOR = 1.02, CI = 0.89-1.08). Overall, our data indicated that the risk of spontaneous abortion after mRNA COVID-19 immunization during the first trimester of pregnancy is commensurate with the predicted risk in non-vaccinated pregnant women. These findings contribute to the growing body of information regarding the safety of mRNA COVID-19 vaccination during pregnancy.

Determinants of COVID-19 Vaccination Hesitancy among Romanian Pregnant Women.

Universal COVID-19 immunization is seen as a critical approach for limiting the spread of SARS-CoV-2 and reducing the danger of new variations emerging in the general population, especially in pregnant women. The literature and accessible research data indicate that vaccination intentions vary greatly by country, with Romania ranking among the European nations with the lowest vaccination rates. Thus, we aimed to investigate the prevalence and extent of COVID-19 vaccine hesitancy among pregnant women in Romania and the factors influencing their decision. A cross-sectional study was conducted on pregnant women referred to the Obstetrics and Gynecology Clinic of the Timisoara Municipal Emergency Hospital in Romania. Participants were asked to complete the validated VAX scale about vaccine hesitancy and to report their willingness to receive a COVID-19 vaccine and their reasons for hesitancy. The group of 184 pregnant women who completed the survey recorded significantly more hesitant respondents than the non-pregnant group with 161 respondents (52.2% vs. 40.3%). They had significantly higher average scores in all VAX scale subsections, while 78.1% of them gave credits to social media for their COVID-19 vaccination decision, compared with 63.0% of non-pregnant women. The independent risk factors for hesitancy were determined as not being afraid of COVID-19 OR = 1.89, below-average income OR = 2.06, trusting social media rumors OR = 2.38, not believing in SARS-CoV-2 existence OR = 2.67, and being a vaccination non-believer OR = 3.15. We advocate for pregnant women to get vaccinated against COVID-19 and for the development of targeted campaigns to address the factors of hesitation. This research emphasizes the critical need for delivering the COVID-19 immunization to the whole community, including pregnant women who may have vaccine-related concerns.

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

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.

Early exploration of COVID-19 vaccination safety and effectiveness during pregnancy: interim descriptive data from a prospective observational study.

OBJECTIVE: During December 2020, a massive vaccination program was introduced in our country. The Pfizer-BioNTech, BNT162b2 vaccine was first offered exclusively to high-risk population, such as medical personnel (including pregnant women). In this study we compare short term outcomes in vaccinated vs. non-vaccinated pregnant women. METHODS: In this prospective observational cohort study, vaccinated and non-vaccinated pregnant women were recruited using an online Google forms questionnaire targeting medical groups on Facebook and WhatsApp. A second questionnaire was sent one month after the first one for interim analysis. Our primary outcome was composite complications in vaccinated and non-vaccinated groups, considered any of the following: vaginal bleeding, pregnancy loss, hypertension, gestational diabetes, and preterm birth. Secondary outcomes included: vaccine side effects, diagnosis of COVID-19 since the last questionnaire, prevalence of vaccinated participants, and reasons for refusal to be vaccinated. RESULTS: Overall, 432 women answered the first questionnaire, of which 326 responses were received to the second questionnaire. Vaccination rate increased from 25.5% to 62% within a month. Maternal age, gestational age at enrollment, nulliparity and number of children were similar in both groups. The rate of composite pregnancy complications was similar between vaccinated and non-vaccinated group (15.8% vs 20.1%, p = 0.37), respectively. The risk for COVID-19 infection was significantly lower in the vaccinated group (1.5% vs 6.5%, p = 0.024, Odds Ratio: 4.5, 95% confidence interval 1.19-17.6). CONCLUSIONS: mRNA vaccine during pregnancy does not seem to increase the rate of pregnancy complications and is effective in prevention of COVID-19 infection.