Monitoring the safety of COVID-19 vaccination in pregnancy in the UK: A national study using the UK Obstetric Surveillance System (UKOSS), UK Teratology Information Service (UKTIS) and Vaccination in Pregnancy (VIP) safety monitoring systems.
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ABSTRACT: Background
COVID-19 vaccines are protective against disease. Pregnant women benefit from vaccination as they are at higher risk of poor maternal and neonatal outcomes following infection.Methods
Following regulatory approval of two COVID-19 vaccines in the United Kingdom, a rapid national study of vaccination in pregnancy was instituted using three existing safety surveillance platforms: UKOSS, UKTIS and VIP. This preliminary report describes the data collected up to the 15th June 2021.Results
There were 971 reports of COVID-19 vaccination in the UKOSS/UKTIS (n = 493) and VIP (n = 478) monitoring systems describing 908 individual pregnancies. Pfizer-BioNTech mRNA vaccination was most common (n = 501, 55.2%), most women were vaccinated in their second or third trimester (n = 566, 62.3%), and were mainly vaccinated due to occupational infection risk (n = 577, 63.5%).Conclusion
Obstetric outcome data will be obtained by December 2021. However, women should not delay vaccination whilst awaiting further safety data to emerge.
SUBMITTER: Richardson JL
PROVIDER: S-EPMC10126751 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
Publications
Monitoring the safety of COVID-19 vaccination in pregnancy in the UK: A national study using the UK Obstetric Surveillance System (UKOSS), UK Teratology Information Service (UKTIS) and Vaccination in Pregnancy (VIP) safety monitoring systems.
Richardson Jonathan L JL Stephens Sally S Chappell Lucy C LC Campbell Helen H Amirthalingam Gayatri G O'Boyle Shennae S Bukasa Antoaneta A Knight Marian M Hodson Kenneth K KK
Obstetric medicine 20220208 1
<h4>Background</h4>COVID-19 vaccines are protective against disease. Pregnant women benefit from vaccination as they are at higher risk of poor maternal and neonatal outcomes following infection.<h4>Methods</h4>Following regulatory approval of two COVID-19 vaccines in the United Kingdom, a rapid national study of vaccination in pregnancy was instituted using three existing safety surveillance platforms: UKOSS, UKTIS and VIP. This preliminary report describes the data collected up to the 15<sup>t ...[more]
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Project description:ObjectivesEvidence on the effects of the SARS-CoV-2 Omicron variant on vaccinated and unvaccinated pregnant women is sparse. This study aimed to compare maternal and perinatal outcomes of women infected with SARS-CoV-2 during the Omicron wave in Italy, according to their vaccine protection.MethodsThis national prospective cohort study enrolled pregnant women with a positive SARS-CoV-2 nasopharyngeal swab within 7 days of hospital admission between 1 January and 31 May, 2022. Women who received at least one dose of vaccine during pregnancy and those who completed the vaccine cycle with the first booster were considered protected against moderate or severe COVID-19 (MSCD). A multivariable logistic regression model evaluated the association between vaccine protection and disease severity. Maternal age, educational level, citizenship, area of birth, previous comorbidities, and obesity were analysed as potential risk factors.ResultsMSCD was rare (41/2147, 1.9%; 95% CI, 1.4-2.6), and the odds of developing it were significantly higher among unprotected women (OR, 2.78; 95% CI, 1.39-5.57). Compared with protected women (n = 1069), the unprotected (n = 1078) were more often younger, with lower educational degrees, and foreigners. A higher probability of MSCD was found among women with previous comorbidities (OR, 2.86; 95% CI, 1.34-6.12) and those born in Asian countries (OR, 3.05; 95% CI, 1.23-7.56). The percentage of preterm birth was higher among women with MSCD compared with milder cases (32.0% [8/25] versus 8.4% [161/1917], p < 0.001) as well as the percentage of caesarean section (52.0% [13/25] versus 31.6% [606/1919], p 0.029).DiscussionAlthough severe maternal and perinatal outcomes were rare, their prevalence was significantly higher among women without vaccine protection. Vaccination during pregnancy has the potential to protect both the mother and the baby, and it is therefore strongly recommended.
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Project description:BackgroundVaccination against pertussis and seasonal influenza is recommended for all pregnant women in the UK. More recently COVID-19 vaccination has also been offered to women in pregnancy.ObjectivesTo evaluate the uptake of vaccines in pregnant women within a midwife-led immunisation clinic and to assess factors influencing pregnant women's decisions about accepting vaccination.MethodsUptake of vaccines amongst pregnant women referred to a single UK centre for antenatal care between 01/01/19 and 02/10/19 was assessed. Interviews with 20 pregnant women explored views of antenatal vaccination and experiences of the vaccination service.FindingsAmongst 4420 women, uptake was 90.6% for pertussis and 78.8% for influenza vaccines. Factors influencing vaccine-related decision-making amongst 20 interviewed women were: healthcare professional recommendation, perceived susceptibility and risk of infection, and previous experience of vaccination and vaccine-preventable disease.Conclusions and implications for practiceUptake of pertussis and influenza vaccines within a secondary care immunisation service was higher than the national or regional average. The model of vaccine delivery was associated with high levels of satisfaction. This model of vaccine delivery could be implemented elsewhere to increase vaccine uptake, and should be considered for delivery of COVID-19 vaccines in the future.
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Project description:The World Health Organization (WHO) recommends iron-folic acid (IFA) supplementation during pregnancy to improve maternal and infant health outcomes. Multiple micronutrient (MMN) supplementation in pregnancy has been implemented in select countries and emerging evidence suggests that MMN supplementation in pregnancy may provide additional benefits compared to IFA alone. In 2015, WHO, the United Nations Children's Fund (UNICEF), and the Micronutrient Initiative held a "Technical Consultation on MMN supplements in pregnancy: implementation considerations for successful incorporation into existing programmemes," which included a call for indicators needed for monitoring, evaluation, and surveillance of MMN supplementation programmes. Currently, global surveillance and monitoring data show that overall IFA supplementation programmes suffer from low coverage and intake adherence, despite inclusion in national policies. Common barriers that limit the effectiveness of IFA-which also apply to MMN programmes-include weak supply chains, low access to antenatal care services, low-quality behaviour change interventions to support and motivate women, and weak or non-existent monitoring systems used for programme improvement. The causes of these barriers in a given country need careful review to resolve them. As countries heighten their focus on supplementation during pregnancy, or if they decide to initiate or transition into MMN supplementation, a priority is to identify key monitoring indicators to address these issues and support effective programmes. National and global monitoring and surveillance data on IFA supplementation during pregnancy are primarily derived from cross-sectional surveys and, on a more routine basis, through health and logistics management information systems. Indicators for IFA supplementation exist; however, the new indicators for MMN supplementation need to be incorporated. We reviewed practice-based evidence, guided by the WHO/Centers for Disease Control and Prevention logic model for vitamin and mineral interventions in public health programmes, and used existing manuals, published literature, country reports, and the opinion of experts, to identify monitoring, evaluation, and surveillance indicators for MMN supplementation programmes. We also considered cross-cutting indicators that could be used across programme settings, as well as those specific to common delivery models, such as antenatal care services. We then described mechanisms for collecting these data, including integration within existing government monitoring systems, as well as other existing or proposed systems. Monitoring data needs at all stages of the programme lifecycle were considered, as well as the feasibility and cost of data collection. We also propose revisions to global-, national-, and subnational-surveillance indicators based on these reviews.
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Project description:ObjectiveWe conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.MethodsElectronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.ResultsOf 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.ConclusionsEvidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.
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Project description:The siloed nature of maternity care has been noted as a system-level factor negatively impacting maternal outcomes. Veterans Health Administration (VA) provides multi-specialty healthcare before, during, and after pregnancy but purchases obstetric care from community providers. VA providers may be unaware of perinatal complications, while community-based maternity care providers may be unaware of upstream factors affecting the pregnancy. To optimize maternal outcomes, the VA has initiated a system-level surveillance and review process designed to improve non-obstetric care for veterans experiencing a pregnancy. This quality improvement project aimed to describe the VA-based maternal mortality review process and to report maternal mortality (pregnancy-related death up to 42 days postpartum) and pregnancy-associated mortality (death from any cause up to 1 year postpartum) among veterans who use VA maternity care benefits. Pregnancies and pregnancy-associated deaths between fiscal year (FY) 2011-2020 were identified from national VA databases. All deaths underwent individual chart review and abstraction that focused on multi-specialty care received at the VA in the year prior to pregnancy until the time of death. Thirty-two pregnancy-associated deaths were confirmed among 39,720 pregnancies (PAMR = 80.6 per 100,000 live births). Fifty percent of deaths occurred among individuals who had experienced adverse social determinants of health. Mental health conditions affected 81%. Half (n = 16, 50%) of all deaths occurred in the late postpartum period (43-365 days postpartum) after maternity care had ended. More than half of these late postpartum deaths (n = 9, 56.2%) were related to suicide, homicide, or overdose. Integration of care delivered during the perinatal period (pregnancy through postpartum) from primary, mental health, emergency, and specialty care providers may be enhanced through a system-based approach to pregnancy-associated death surveillance and review. This quality improvement project has implications for all healthcare settings where coordination between obstetric and non-obstetric providers is needed.
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Project description:The COVID-19 pandemic has posed significant risks to pregnant women and those recently pregnant, leading to heightened mortality and morbidity rates. Vaccination has emerged as a pivotal strategy in reducing COVID-19-related deaths and illnesses worldwide. However, the initial exclusion of pregnant individuals from most clinical trials raised concerns about vaccine safety in this population, contributing to vaccine hesitancy. This review aims to consolidate the existing literature to assess the safety and efficacy of COVID-19 vaccination in pregnant populations and neonatal outcomes. Diverse studies were included evaluating various aspects of safety for women and their newborns, encompassing mild to severe symptoms across different vaccines. The findings indicate the overall safety and efficacy of COVID-19 vaccination, with minimal adverse outcomes observed, including mild side effects like pain and fever. Although most studies reported the absence of severe adverse outcomes, isolated case reports have raised concerns about potential associations between maternal COVID-19 vaccination and conditions such as fetal supraventricular tachycardia and immune-mediated diseases. Our review underscores the importance of ongoing surveillance and monitoring to ensure vaccine safety in pregnant women. Overall, COVID-19 vaccination during pregnancy remains a safe and effective strategy, emphasizing the need for continued research and vigilance to safeguard maternal and fetal health.
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Project description:BackgroundIn February 2018, Canada's National Advisory Committee on Immunization recommended maternal vaccination with tetanus-diphtheria-acellular pertussis (Tdap) vaccine during pregnancy to prevent severe pertussis infection in young infants. This study assessed the relation between maternal Tdap vaccination and obstetric and perinatal outcomes in Ontario.MethodsWe performed a population-based cohort study of all births from April 2012 to March 2017 using multiple linked health administrative databases. We used Cox regression with a time-dependent exposure variable to estimate adjusted hazard ratios (HRs) for preterm birth (< 37 wk), very preterm birth (< 32 wk) and stillbirth. We assessed remaining outcomes (gestational hypertension, chorioamnionitis, postpartum hemorrhage, severe postpartum hemorrhage, being small for gestational age, neonatal intensive care unit stay > 24 h, composite neonatal morbidity) using log-binomial regression to generate adjusted risk ratios (RRs). We adjusted estimates for potential confounding using propensity score weighting.ResultsOf 615 213 infants (live births and stillbirths), 11 519 were exposed to Tdap vaccination in utero. There was no increased risk for preterm birth (adjusted HR 0.98, 95% confidence interval [CI] 0.91-1.06), very preterm birth (adjusted HR 1.10, 95% CI 0.86-1.41), stillbirth (adjusted HR 1.15, 95% CI 0.82-1.60) or being small for gestational age (adjusted RR 0.96, 95% CI 0.90-1.02). The risks of a neonatal intensive care unit stay exceeding 24 hours (adjusted RR 0.82, 95% CI 0.76-0.88) and neonatal morbidity (adjusted RR 0.81, 95% CI 0.75-0.87) were decreased. There was no association with chorioamnionitis (adjusted RR 1.17, 95% CI 0.99-1.39), postpartum hemorrhage (adjusted RR 1.01, 95% CI 0.91-1.13) or severe postpartum hemorrhage (adjusted RR 0.79, 95% CI 0.55-1.13), but we observed a reduced risk of gestational hypertension (adjusted RR 0.87, 95% CI 0.78-0.96).InterpretationOur results complement evidence that maternal Tdap vaccination is not associated with adverse outcomes in mothers or infants. Ongoing evaluation in Canada is needed as maternal Tdap vaccination coverage increases in coming years.
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Project description:IntroductionThe feasibility and accuracy of text messaging to monitor events after influenza vaccination throughout pregnancy and the neonatal period has not been studied, but may be important for seasonal and pandemic influenza vaccines and future maternal vaccines.MethodsThis prospective observational study was conducted during 2013-2014 and analyzed in 2015-2016. Enrolled pregnant women receiving inactivated influenza vaccination at a gestational age <20 weeks were sent text messages intermittently through participant-reported pregnancy end to request fever, health events, and neonatal outcomes. Text message response rates, Day 0-2 fever (≥100.4°F), health events, and birth/neonatal outcomes were assessed.ResultsMost (80.2%, n=166) eligible women enrolled. Median gestational age was 8.9 (SD=3.9) weeks at vaccination. Response rates remained high (80.0%-95.2%). Only one Day 0-2 fever was reported. Women reported via text both pregnancy- and non-pregnancy-specific health events, not all associated with medical visits. Most pregnancy-specific events in the electronic medical record (EMR) were reported via text message. Of all enrollees, 84.9% completed the study (131 reported live birth, ten reported pregnancy loss). Two losses reported via text were not medically attended; there was one additional EMR-identified loss. Gestational age and weight at birth were similar between text message-reported and EMR-abstracted data and 95% CIs were overlapping for proportions of prematurity, low birth weight, small for gestational age, and major birth defects, as identified by text message-reported versus EMR-abstracted plus text message-reported versus EMR-abstracted data only.ConclusionsThis study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance sustained throughout pregnancy. In these women receiving inactivated influenza vaccination during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes was observed.
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