Systematic review of the safety, immunogenicity, and effectiveness of COVID-19 vaccines in pregnant and lactating individuals and their infants.

Background and Objectives: Pregnant women are more likely to develop a more severe course of COVID-19 than their non-pregnant peers. There are many arguments for the safety and efficacy of COVID-19 vaccines in pregnant women. The aim of this study is to conduct a systematic review concerning the approach of pregnant women towards vaccination against COVID-19, with particular regard to determinants of vaccination acceptance. Materials and Methods: Articles were reviewed in which the aim was to evaluate-via a survey or questionnaire-the acceptance and decision to undergo vaccination against COVID-19. The articles were subjected to review according to recommendations of Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement (PRISMA). Results: In various studies, the percentage of pregnant women accepting the COVID-19 vaccine was between 29.7% and 77.4%. The strongest factors co-existing with the acceptance of the COVID-19 vaccination in pregnancy were trust in the importance and effectiveness of the vaccine, explicit communication about the safety of COVID-19 vaccines for pregnant women, acceptance of other vaccinations such as those for influenza, belief in the importance of vaccines/mass vaccination in one's own country, anxiety about COVID-19, trust in public health agencies/health science, as well as compliance to mask guidelines. The remaining factors were older age, higher education, and socioeconomic status. Conclusions: This review allowed us to show that geographic factors (Asian, South American countries) and pandemic factors (different threats and risks from infection) significantly influence the acceptance of vaccines. The most significant factors affecting acceptance are those related to public awareness of the risk of infection, vaccine safety, and the way in which reliable information about the need and safety of vaccines is provided. Professional and reliable patient information by obstetricians and qualified medical personnel would significantly increase the level of confidence in vaccination against COVID-19.

The Approach of Pregnant Women to Vaccination Based on a COVID-19 Systematic Review.

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.

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

https://doi.org/10.1016/j.ajog.2022.10.001

SARS-CoV-2 placentitis, stillbirth, and maternal COVID-19 vaccination: clinical–pathologic correlations

COVID‐19 vaccine and pregnancy outcomes: A systematic review and meta‐analysis

Objective Pregnancy is a known risk factor for severe Coronavirus disease 2019. It is important to develop safe vaccines that elicit strong maternal and fetal antibody responses. Methods Registries (ClinicalTrials.gov, the WHO Clinical Trial Registry, and the European Union Clinical Trial Registry) and databases (MEDLINE, ScienceDirect, Cochrane Library, Proquest, Springer, medRxiv, and bioRxiv) were systematically searched in June 20–22, 2021, for research articles pertaining to Covid-19 and pregnancy. Manual searches of bioRxiv and medRxiv were also conducted. Inclusion criteria were studies that focused on Covid-19 vaccination among pregnant women, while review articles and non-human studies were excluded. Infection rate, maternal antibody response, transplacental antibody transfer, and adverse events were described. Results There were 13 observational studies with a total of 48,039 pregnant women who received mRNA vaccines. Of those, three studies investigated infection rate, six studies investigated maternal antibody response, seven studies investigated antibody transfer, three studies reported local adverse events, and five studies reported systemic adverse events. The available data suggested that the mRNA-based vaccines (Pfizer–BioNTech and Moderna) can prevent future SARS-CoV-2 infection. These vaccines did not show clear harm in pregnancy. The most commonly encountered adverse reactions were pain at the injection site, fatigue, and headache, but these were transient. Antibody responses were rapid after the first vaccine dose. After the booster, antibody responses were stronger and associated with better transplacental antibody transfer. Longer intervals between first vaccination dose and delivery were also associated with higher antibody fetal IgG and a better antibody transfer ratio. Conclusions The SARS-CoV-2 mRNA vaccines are encouraged for pregnancy. These vaccines can be a safe option for pregnant women and their fetuses. Two vaccine doses are recommended for more robust maternal and fetal antibody responses. Longer latency is associated with higher fetal antibody responses. Further research about its long-term effect on pregnancy is needed. Systematic review registration PROSPERO (CRD42021261684).

/pdf/mrna-covid-19-vaccines-in-pregnancy-a-systematic-review-1fmgrvkh.pdf

mRNA Covid-19 vaccines in pregnancy: A systematic review

http://www.cell.com/article/S2405844022001232/pdf

Remdesivir for pregnancy: A systematic review of antiviral therapy for COVID-19

Background: There is a need for evaluation regarding vaccine effectiveness (VE) and the urgency of booster vaccination against Covid-19 B.1.1.529 (Omicron) variant. Methods: Systematic search was conducted on April 6th, 2022, on databases (PubMed, ScienceDirect, CENTRAL, Web of Science, Scopus). VE difference (VED) estimates were assessed using random-effects model and DerSimonian-Laird tau estimators. Two models result, i.e., within 3 months and within 3 months or more, are compared. VE versus time meta-regression analysis was evaluated using mixed-effects model with Restricted-Maximum Likelihood tau estimators and Hartung-Knapp adjustments. Results: Ad26.COV2.S, BNT162b2, ChAdOx1 nCov-19, and mRNA-1273 vaccines were included in the analyses. Compared to full dose, booster dose of overall vaccines provided better protection against any (VED=22% (95%CI 15%-29%), p<0.001), severe (VED=20% (95%CI 8%-32%), p=0.001) and symptomatic (VED=22% (95%CI 11%-34%), p<0.001) Omicron infections within 3 months, as well as within 3 months or more (VED=30% (95%CI 24%-37%), p<0.001 for any, VED=18% (95%CI 13%-23%), p<0.001 for severe and VED=37% (95%CI 29%-46%), p<0.001 for symptomatic infections). The meta-regression analysis of overall vaccines revealed that the full dose VE against any and symptomatic Omicron infections were significantly reduced each month by 3.0% (95%CI 0.9%-4.8%, p=0.004) and 5.2% (95%CI 3.3%-7.1%, p=0.006), respectively; whereas booster dose effectiveness against severe and symptomatic Omicron infections were decreased by 3.7% (95%CI 5.1%-12.6%, p=0.030) and 3.9% (95%CI 1.2%-6.5%, p=0.006), respectively. Conclusion: Compared to full dose only, a booster dose addition provides better protection against B.1.1.529 infection. Although the VE estimates of Ad26.COV2.S, BNT162b2, ChAdOx1 nCov-19, and mRNA-1273 vaccines against B.1.1.529 infection after both full and booster doses are generally moderate, and the booster dose provides excellent protection against severe infection, it is important to note that the VE estimates decline over time, suggesting the need for a regular Covid-19 booster injection after certain period of time to maintain VE.

/pdf/effectiveness-of-covid-19-vaccines-against-sars-cov-2-2lk9b6tt.pdf

Effectiveness of COVID-19 Vaccines against SARS-CoV-2 Omicron Variant (B.1.1.529): A Systematic Review with Meta-Analysis and Meta-Regression

Objective Pregnancy is a risk factor for severe Covid-19. Looking for safe vaccines that evoke protective maternal and fetal antibody response is important. Methods We searched from registries (ClinicalTrials.gov, the WHO Clinical Trial Registry, and the EU Clinical Trial Registry) and databases (MEDLINE, ScienceDirect, Cochrane Library, Proquest, and Springer) up until June 20, 2021. Articles were selected based on inclusion and exclusion criteria after duplicates were removed. Infection rate, maternal antibody response, placental antibody transfer, and adverse events were described. This systematic review was performed with quality assessment and semi-quantitative synthesis according to PRISMA guidelines. Results Twelve observational studies with a total of 40.509 pregnant women included. The mRNA based vaccines (Pfizer-BioNTech and Moderna) can prevent future SARS-CoV-2 infections (p=0.0004). Both vaccines did not affect pregnancy, delivery, and neonatal outcomes. The most commonly encountered adverse reactions are injection-site pain, fatigue, and headache but only transient. Antibody responses were rapid after the prime dose of vaccines. After booster, antibody responses were higher and associated with better placental antibody transfer. Longer intervals between first vaccination dose and delivery were also associated with higher antibody fetal IgG and better antibody transfer ratio. Conclusions The Pfizer-BioNTech and Moderna vaccines are efficacious for preventing future SARS-CoV-2 infections. These vaccines can be considered as a safe option for pregnancy and their fetus. Two doses of vaccines were recommended for more robust maternal and fetal antibody responses. Longer latency was associated with higher fetal antibody responses. Systematic Review Registration PROSPERO (CRD42021261684)

https://medrxiv.org/content/10.1101/2021.07.04.21259985v1.full.pdf

Covid-19 Vaccination in Pregnancy: A Systematic Review

Oral Delivery of Purple Sweet Potato (Ipomoea batatas L.) Extract-Loaded Carboxymethyl Chitosan and Alginate Nanocapsule in Streptozotocininduced Diabetic Mice

Ifan Ali Wafa

Papers

mRNA Covid-19 vaccines in pregnancy: A systematic review

Remdesivir for pregnancy: A systematic review of antiviral therapy for COVID-19

Effectiveness of COVID-19 Vaccines against SARS-CoV-2 Omicron Variant (B.1.1.529): A Systematic Review with Meta-Analysis and Meta-Regression

Covid-19 Vaccination in Pregnancy: A Systematic Review

Oral Delivery of Purple Sweet Potato (Ipomoea batatas L.) Extract-Loaded Carboxymethyl Chitosan and Alginate Nanocapsule in Streptozotocininduced Diabetic Mice