The risk of miscarriage after COVID-19 vaccination before and during pregnancy.

PURPOSE: Pregnant women are at higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection, which can be prevented by vaccination. Observational studies are needed to ascertain the safety of COVID-19 vaccination during pregnancy. We aimed to determine whether COVID-19 vaccination before and during pregnancy is associated with the risk of miscarriage. METHODS: In this cohort study, we included 4640 pregnant women (mean age: 32.8 ± 3.7 years) from the Dutch Pregnancy Drug Register between February 2021 and August 2022. Information on COVID-19 vaccinations, miscarriage, and confounders was self-reported, using web-based questionnaires. The hazard ratio (HR) of miscarriage (in gestational weeks 6-20) after a COVID-19 vaccination, was estimated using the survival analyses. A COVID-19 vaccination during pregnancy (≥1 COVID-19 vaccination between week 2 and 20 of pregnancy) was included as a time-dependent exposure and vaccination prior to pregnancy was included as a binary exposure. RESULTS: A total of 3202 pregnant women (69%) received ≥1 COVID-19 vaccine in gestational week 2-20. We observed no association of vaccination during pregnancy with the risk of miscarriage (adjusted HR = 1.29, 95% CI = 0.93-1.74). Vaccination prior to pregnancy, however, was associated with a decreased risk of miscarriage (adjusted HR = 0.69, 95% CI = 0.48-0.99). CONCLUSIONS: We demonstrated that COVID-19 vaccination during pregnancy is not associated with an increased risk of miscarriage in gestational weeks 6-20. This study adds to the growing body of evidence demonstrating the safety of COVID-19 vaccination during pregnancy.

Anterolateral thigh measurements by ultrasound in neonates and young infants to ensure safe intramuscular injections during vaccination in low- and middle-income countries.

BACKGROUND: Use of same length needle for intramuscularly administered vaccines had been reported to cause under-and over-penetration among infants due to their different body weights and underlying variations in the fat and muscle thickness. Normative data regarding thigh compartment thickness are, however, lacking among neonates and infants aged ≤12 weeks particularly in low- and middle-incoming countries with high burden of low birth weight/growth restricted infants. METHODS: Present study investigated skin to muscle and skin to bone (STBD) distances of anterolateral thigh of babies (n = 300) aged ≤12 weeks (1-80 days) with different weight groups (<3 kg, 3-4 kg and >4 kg) by ultrasonography during their intramuscular vaccinations. RESULTS: Overall, mean [standard deviation (SD)] STBD was 17.04 (2.66) mm with range of 10.60-23.30 mm. Stratifying by current body weight, mean (SD) STBD in infants weighing less than 3 kg was 14.39 (1.23) mm. For infants weighing between 3-4 kg and >4 kg, the mean (SD) STBD were 16.69 (1.43) mm and 17.04 (2.66) mm, respectively. Estimated safety (no risk of over-penetration) of 16 mm was observed in 57.33% (172) infants whereas 25 mm needle had 100% over-penetration risk in the study cohort. Current body weight of infants was a significant predictor of safe injection [area under the receiver operating characteristic (ROC) curve 0.95; 95% CI 0.92-0.97]. CONCLUSIONS: Our study offers objective normative measurements of anterolateral thigh for safe intramuscular vaccination in young infants especially for low birth weight and growth restricted infants in low- and middle-income countries.

Inactivated SARS-CoV-2 vaccination does not disturb the clinical course of Graves' disease: An observational cohort study.

SARS-CoV-2 vaccination has been reported to be associated with the induction of thyroid disorders. To investigate the influence of SARS-CoV-2 vaccination on the disease course of patients who were undergoing treatment for Graves' disease (GD), a total of 651 consecutive GD patients who attended follow-up visits in Jiangyuan Hospital were enrolled in this retrospective study, including 443 inactivated SARS-CoV-2 vaccine recipients and 208 unvaccinated participants. The changes in serum levels of free triiodothyronine (fT3), free thyroxine (fT4), thyroid stimulating hormone (TSH) and TSH receptor antibody (TRAb) were analyzed. Crude and adjusted hazard ratios (HRs) were estimated using Cox regression models to investigate the risks in incident TRAb positivity and hyperthyroidism recurrence following vaccination. The median levels of TRAb and fT3 significantly decreased in both vaccinated and unvaccinated groups during the GD hyperthyroidism treatment. The fT4 levels of both groups were well within normal limits and presented downward trends simultaneously. Although the present study observed an increasing trend of TSH level during follow-up, significant difference was not seen in both vaccinated and unvaccinated groups. Except for newly diagnosed GD patients, vaccinated participants had significantly lower risks of incident TRAb positivity (adjusted HR = 0.22; 95%CI: 0.10-0.48, P < 0.001) after adjusted for sex, age, disease duration and MMI dose at baseline. Besides, vaccination was unlikely to serve as a risk factor for hyperthyroidism recurrence (adjusted HR = 1.20; 95%CI: 0.51-2.83, P = 0.678). Notably, newly diagnosed patients who received vaccination were just as likely to achieve remission of thyrotoxicosis as those not receiving the vaccination at any time. Our results concluded that inactivated SARS-CoV-2 vaccination would not disturb the treatment course among GD hyperthyroidism patients.

Maternal first trimester COVID-19 vaccination and risk of major non-genetic congenital anomalies.

BACKGROUND: Information regarding the risk of early pregnancy COVID-19 vaccination on the development of major congenital anomalies in the offspring is still limited. Here, we study the association between any COVID-19 vaccination during the 1st trimester and at least one major non-genetic congenital anomaly in the offspring. METHODS: We used data from the Dutch Pregnancy Drug Register, an ongoing cohort study. We selected participants with a pregnancy that ended after at least 20 weeks gestation. Pregnant participants self-reported their COVID-19 vaccination status and the presence of congenital anomalies in the offspring. We used logistic regression analyses to study the association between 1st trimester COVID-19 vaccination (gestational week 2 + 0 to 12 + 6) and the risk of at least one major non-genetic congenital anomaly in the offspring. Clustering of anomalies on the ICD10 level by 1st trimester COVID-19 vaccination status was explored using Fisher exact tests. RESULTS: We included 3721 participants of whom 795 (21.4%) were COVID-19 vaccinated during the 1st trimester. The percentage of participants who gave birth to a child with at least one major non-genetic congenital anomaly was comparable between participants who were 1st trimester vaccinated (1.1%) and participants who were not (1.2%) (adjusted odd ratio 0.78 [95% confidence interval 0.35-1.71]). We found no clustering of major non-genetic congenital anomalies by 1st trimester COVID-19 vaccination status (p > .05). CONCLUSIONS: There were no indications of an increased risk of major non-genetic congenital anomalies in the offspring after maternal 1st trimester COVID-19 vaccination. Our findings suggest COVID-19 vaccines are safe during early pregnancy.

Safety of Inactivated SARS-CoV-2 Vaccines Among Adults with Experience of Allergies to Food or Medicines.

The global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), commonly known as COVID-19, poses significant risk to human health worldwide. The primary strategy for controlling the disease is through vaccination. However, there is an urgent need to establish confidence in the safety of global vaccination efforts, particularly among populations with allergies, as evidence on the adverse effects of SARS-CoV-2 vaccines in this group remains limited. To address this gap, our study aimed to evaluate the safety of inactivated SARS-CoV-2 vaccines in individuals with food and/or drug allergies. The study enrolled a total of 150 participants, who were subjected to a series of questionnaires to evaluate local and systemic reactions within 7 days after each dose. The results revealed that the most prevalent adverse reactions were pain at the injection site (30%) and fatigue (16%) following the initial vaccination. Notably, the incidence of both local and systemic adverse reactions decreased after the second vaccination, which was unexpected. The food allergy and drug allergy subgroups exhibited a similar phenomenon. Furthermore, the incidence of adverse events observed in this study was consistent with the range reported in Phase III clinical trials of inactivated SARS-CoV-2 vaccines. Our findings suggest that individuals with pre-existing food and/or drug allergies have a favorable safety profile when receiving inactivated SARS-CoV-2 vaccination.

Safety of COVID-19 vaccination in pregnant women: A study of the adverse perinatal outcomes.

OBJECTIVE: To compare adverse perinatal outcome among coronavirus disease 2019 (COVID-19)-vaccinated and -unvaccinated pregnant women. METHOD: Retrospective equivalence cohort study comparing 930 women who received at least one BNT162b2 (Pfizer/BioNTech) COVID-19 vaccine during the second or third trimester of pregnancy and 964 unvaccinated women. The primary outcome was a composite adverse perinatal outcome including at least one of the following: preterm delivery <35 weeks of gestation, intrauterine fetal death >23 weeks of gestation, intrauterine growth restriction defined as birth weight < 10th percentile, 5-min APGAR score ≤ 7, and neonatal care unit admission. RESULTS: The authors found no effect of the COVID-19 vaccine on the rate of the individual adverse perinatal outcomes. At least one adverse perinatal outcome was found in 108 (11.25%) of unvaccinated women versus 82 (8.82%) of vaccinated pregnant women (P = 0.080). The observed proportion difference (unvaccinated minus vaccinated) was 0.024. In the equivalence analysis with a margin of 0.05, the 90% confidence interval (0.01-0.05) was entirely within the equivalence zone (-0.05 to 0.05) with a P value of 0.032. CONCLUSION: The present study demonstrated an equivalent rate of adverse perinatal outcomes among vaccinated and unvaccinated women, thus supporting vaccine safety during the second and third trimesters of pregnancy. The authors believe this information is useful in counseling pregnant women regarding COVID-19 vaccination during pregnancy.

Safety of Immunizations for the Adult Patient With Inflammatory Bowel Disease-A Systematic Review and Meta-analysis.

BACKGROUND: Patients with inflammatory bowel disease (IBD) have low vaccination rates for vaccine-preventable diseases. Fear of adverse reactions (AEs) appear to negatively affect vaccination efforts. We aimed to systemically review the risks for AEs following immunization for patients with IBD. METHODS: We searched PubMed and Embase until April 15, 2020, for studies evaluating the safety of vaccinations among patients with IBD. The primary outcome was the incidence of systemic and local AEs among vaccinated patients. Secondary outcome was the rate of IBD flare following immunization. We utilized a random effects meta-analysis of proportions using the DerSimonian-Laird approach to estimate the safety of immunizations. RESULTS: A total of 13 studies with 2116 patients was included in our analysis after fulfilling our inclusion criteria. Seven studies examined the influenza vaccine, 4 the pneumococcal vaccine, 1 the recombinant zoster vaccine, and 1 the hepatitis B vaccine. Follow-up of patients was up to 6 months. The majority of AEs were local, with a pooled incidence of 24% (95% CI, 9%-42%) for all vaccines. Systemic AEs were mostly mild, without resulting in hospitalizations or deaths, with a pooled incidence of 16% (95% CI, 6%-29%) for all vaccines. Flare of inflammatory bowel disease after vaccination found with a pooled incidence of 2% (95% CI, 1%-4%) and we include in the analysis data from all immunizations examined. DISCUSSION: Our study demonstrated that AEs after vaccination are mainly local or mildly systemic and do not differ significantly from the expected AE after recommended immunizations for the general population. Thus, gastroenterologists should reinforce that vaccines are safe in patients with IBD.

Attitudes toward vaccinations are becoming more polarized in New Zealand: Findings from a longitudinal survey.

BACKGROUND: Despite continuing vaccine controversies, little is known about the trajectory of change in vaccine confidence over time. The current study examined whether there are subpopulations among the New Zealand public with diverging trajectories of confidence in the safety of childhood vaccinations from 2013 to 2017. METHODS: Using longitudinal survey data from the New Zealand Attitudes and Values Study, latent class growth models identified subpopulations with distinct rates and directions of change in vaccine confidence from 2013 to 2017 (N= 12,423; 11,912; 12,009; 10,254). The demographic profiles of these subpopulations were examined. FINDINGS: Most New Zealanders' (60%) maintained strong vaccine confidence throughout the years (i.e. vaccine believers), but 30% expressed decreasing confidence over time (i.e. vaccine skeptics). Around 10% were former skeptics who had low vaccine confidence in 2013 but showed increasing confidence thereafter. Men, Europeans/Others, those more educated and living in more affluent regions were more likely to be vaccine believers. Relative to former skeptics, women, older individuals and those with lower education were more likely to be vaccine skeptics. INTERPRETATION: Attitudes toward the safety of childhood vaccinations are becoming increasingly polarized in New Zealand. Roughly 30% of the population are becoming more concerned about vaccine safety over time, 10% are becoming more confident, whereas 60% show consistent high vaccine confidence. It is vital to further investigate the key contributors to decreasing confidence among vaccine skeptics and implement target interventions. FUNDING: Templeton Religion Trust Grant (TRT0196) for data collection; Corresponding author supported by University of Auckland Doctoral Scholarship.

Parental Opinions and Attitudes about Children's Vaccination Safety in Silesian Voivodeship, Poland.

Despite mandatory vaccinations in Poland, the final decision on vaccination in children is taken by their parents or legal guardians. Understanding parents' attitudes and opinions regarding vaccinations is essential for planning and undertaking extensive and properly targeted educational actions aimed at preventing their hesitancy. In 2016, a cross-sectional study was conducted in the Silesian Voivodeship (Poland) in 11 randomly selected educational institutions. The authors' self-administered questionnaire contained 24 mixed-type questions. It was distributed among 3000 parents or legal guardians of children aged 6-13 years; prior consent of the relevant bioethics committee had been obtained. The response rate was 41.3% (N = 1239). Data were analysed using descriptive and analytical statistics, and focused on parental opinions regarding the safety of vaccines. Results of simple and multivariable analyses showed that perceived risk of adverse vaccine reaction (AVR), contraindications and perception of the qualification procedure for vaccination as substandard were significant factors associated with the rating of children's vaccination as unsafe (p < 0.001). Respondents with a lower level of education, compared with those with higher, more often declared vaccinations to be safe (p = 0.03); however, results of multivariable analysis did not confirm that effect. AVR occurrence, finding of contraindication to vaccinations and perception of qualification procedure for vaccination were found to be the most important factors responsible for influencing general public opinions in the field of vaccination safety.