Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.
TL;DR: In this article, a rapid systematic review was conducted to evaluate the safety of COVID-19 vaccines selected by the Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons.
About: This article is published in Vaccine.The article was published on 2021-09-24 and is currently open access. It has received 33 citations till now. The article focuses on the topics: Vaccination.
Citations
More filters
TL;DR: It is found that vaccination prevented pregnant women from SARS-CoV-2 infection and COVID-19-related hospitalization and Messenger-RNA vaccines could reduce the risk of infection in pregnant women.
Abstract: We aimed to assess the effectiveness and safety of coronavirus disease 2019 (COVID-19) vaccines for pregnant women in real-world studies. We searched for observational studies about the effectiveness and safety of COVID-19 vaccines among vaccinated pregnant women from inception to 6 November 2021. A total of 6 studies were included. We found that vaccination prevented pregnant women from SARS-CoV-2 infection (OR = 0.50, 95% CI, 0.35–0.79) and COVID-19-related hospitalization (OR = 0.50, 95% CI, 0.31–0.82). Messenger-RNA vaccines could reduce the risk of infection in pregnant women (OR = 0.13, 95% CI, 0.03–0.57). No adverse events of COVID-19 vaccination were found on pregnant, fetal, or neonatal outcomes. Our analysis confirmed the effectiveness and safety of COVID-19 vaccines for pregnant women. Policy makers should formulate targeted strategies to improve vaccine coverage in pregnant women.
31 citations
TL;DR: The findings highlight the importance of the prevention of SARS-CoV-2 infection in pregnant individuals and the consideration of infection as a risk factor for adverse peripartum maternal outcomes.
Abstract: Key Points Question Does the association between SARS-CoV-2 infection and severe maternal morbidity (SMM), including nonrespiratory complications, vary by viral strain? Findings In this retrospective cohort study of 3129 patients with SARS-CoV-2 infection and 12 504 patients without infection giving birth in a large US health system between March 2020 and January 2022, the risk of SMM associated with SARS-CoV-2 infection was significantly higher during the phase of the pandemic when the Delta variant was predominant (July 2021-November 2021). This association was also noted specifically for both respiratory and nonrespiratory SMM. Meaning These findings highlight the importance of the prevention of SARS-CoV-2 infection in pregnant individuals and the consideration of infection as a risk factor for adverse peripartum maternal outcomes.
14 citations
TL;DR: In this paper , a cross-sectional, web-based study was conducted in Western, Eastern, North, South, and Central Regions in Saudi Arabia between July and September 2021 among pregnant women, using multi-stage sampling.
Abstract: Coronavirus disease 19 (COVID-19) vaccination has been established as preventing severe and mortal COVID-19. Vaccination is critical strategy in controlling the COVID-19 pandemic, to restrict infections and reduce disease severity. Vaccination coverage will be more extensive if we can better identify vaccination barriers in the population, especially among vulnerable groups, of which one is pregnant women. The aim of this study was to determine the level of acceptance of COVID-19 vaccination and detect the factors that influence vaccine acceptance among pregnant women in Saudi Arabia.This was a cross-sectional, web-based study conducted in Western, Eastern, North, South, and Central Regions in Saudi Arabia between July and September 2021 among pregnant women, using multi-stage sampling. All pregnant women above 18 years were invited to participate in the study. Pregnant under 18 years of age and those with a contraindication to receiving COVID-19 vaccination were excluded. Binomial logistic regression (univariate and multivariate) was used to identify the influencing factors on vaccination acceptance.Among the 5307 pregnant women, the acceptance level of COVID-19 vaccine was 68%. In the multivariate regression model analysis, the most common predictors of acceptance were living in North Region (P = 0.001, OR = 1.9), living in South Region (P = 0.000, OR = 3.06), and living in Central Region (P = 0.035, OR = 1.42) in comparison to living in Western Region. Gestational week (P = 0.018, OR=0.98), income more than 8000 SR (P = 0.000, OR = 0.51), education level (primary, secondary, and university; P = 0.002, 0.008, and 0.010, respectively), having had gestational diabetes mellitus (P = 0.013, OR = 1.86), being vaccinated with influenza vaccine during present pregnancy (P = 0.000, OR = 4.55, OR = 1.81), being vaccinated with tetanus vaccine during present pregnancy (P = 0.039), and believing that the COVİD-19 vaccine could harm their baby (P = 0.000, OR = 0.12).Our study reported high acceptance of COVID-19 vaccination. The major two reasons for refusal were concerns about a lack of data on COVID-19 vaccination safety and the possibility of harming the fetus. Continued public health efforts, such as educational television programs and awareness campaigns about the safety of the COVID-19 vaccine for pregnant women, are required to raise awareness. More studies of COVID-19 vaccine safety in pregnant women would assist in overcoming these obstacles and encourage pregnant women to be vaccinated.
13 citations
TL;DR: COVID-19 vaccine acceptance among HCWs in L-LMICs was considerably low as compared to those from UM-HICs, which underlines the need for the implementation of country-specific vaccine promotion strategies, with special focus on increasing vaccine supply in L and lower-middle income countries.
Abstract: Objectives Even though several effective vaccines are available to combat the COVID-19 pandemic, wide disparities in vaccine distribution, and vaccine acceptance rates between high- and low-income countries appear to be major threats toward achieving population immunity. Our global descriptive study aims to inform policymakers on factors affecting COVID-19 vaccine acceptance among healthcare workers (HCWs) in 12 countries, based on income index. We also looked for possible predictors of vaccine acceptance among the study sample. Methods A structured questionnaire prepared after consultation with experts in the field and guided by the “Report of the SAGE working group on vaccine hesitancy” was administered among 2,953 HCWs. Upon obtaining informed consent, apart from demographic information, we collected information on trust in vaccines and health authorities, and agreement to accept a COVID-19 vaccine. Results Although 69% of the participants agreed to accept a vaccine, there was high heterogeneity in agreement between HCWs in low and lower-middle income countries (L-LMICs) and upper-middle- and high-income countries (UM-HICs), with acceptance rates of 62 and 75%, respectively. Potential predictors of vaccine acceptance included being male, 50 years of age or older, resident of an UM-HIC, updating self about COVID-19 vaccines, greater disease severity perception, greater anxiety of contracting COVID-19 and concern about side effects of vaccines. Conclusions COVID-19 vaccine acceptance among HCWs in L-LMICs was considerably low as compared to those from UM-HICs. The lowest vaccine acceptance rates were among HCWs from the African continent. This underlines the need for the implementation of country-specific vaccine promotion strategies, with special focus on increasing vaccine supply in L-LMICs.
13 citations
TL;DR: Among hospitalized women in SSA, both SARS-CoV-2 infection and pregnancy independently increased risks of ICU admission, oxygen supplementation, and death and support international recommendations to prioritize COVID-19 vaccination among pregnant women.
Abstract: Abstract Background Few data are available on COVID-19 outcomes among pregnant women in sub-Saharan Africa (SSA), where high-risk comorbidities are prevalent. We investigated the impact of pregnancy on SARS-CoV-2 infection and of SARS-CoV-2 infection on pregnancy to generate evidence for health policy and clinical practice. Methods We conducted a 6-country retrospective cohort study among hospitalized women of childbearing age between 1 March 2020 and 31 March 2021. Exposures were (1) pregnancy and (2) a positive SARS-CoV-2 RT-PCR test. The primary outcome for both analyses was intensive care unit (ICU) admission. Secondary outcomes included supplemental oxygen requirement, mechanical ventilation, adverse birth outcomes, and in-hospital mortality. We used log-binomial regression to estimate the effect between pregnancy and SARS-CoV-2 infection. Factors associated with mortality were evaluated using competing-risk proportional subdistribution hazards models. Results Our analyses included 1315 hospitalized women: 510 pregnant women with SARS-CoV-2, 403 nonpregnant women with SARS-CoV-2, and 402 pregnant women without SARS-CoV-2 infection. Among women with SARS-CoV-2 infection, pregnancy was associated with increased risk for ICU admission (adjusted risk ratio [aRR]: 2.38; 95% CI: 1.42–4.01), oxygen supplementation (aRR: 1.86; 95% CI: 1.44–2.42), and hazard of in-hospital death (adjusted sub-hazard ratio [aSHR]: 2.00; 95% CI: 1.08–3.70). Among pregnant women, SARS-CoV-2 infection increased the risk of ICU admission (aRR: 2.0; 95% CI: 1.20–3.35), oxygen supplementation (aRR: 1.57; 95% CI: 1.17–2.11), and hazard of in-hospital death (aSHR: 5.03; 95% CI: 1.79–14.13). Conclusions Among hospitalized women in SSA, both SARS-CoV-2 infection and pregnancy independently increased risks of ICU admission, oxygen supplementation, and death. These data support international recommendations to prioritize COVID-19 vaccination among pregnant women.
12 citations
References
More filters
Monash University1, University of Amsterdam2, University of Paris3, Bond University4, University of Texas Health Science Center at San Antonio5, University of Ottawa6, American University of Beirut7, Oregon Health & Science University8, University of York9, Ottawa Hospital Research Institute10, University of Southern Denmark11, Johns Hopkins University12, Brigham and Women's Hospital13, Indiana University14, University of Bristol15, University College London16, University of Toronto17
TL;DR: The preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement as discussed by the authors was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found.
Abstract: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
16,613 citations
TL;DR: Pregnant and recently pregnant women are less likely to manifest covid-19 related symptoms of fever and myalgia than non-pregnant women of reproductive age, and high intensive care women without high risk of disease are potentially more likely to be risk factors for covid19 Pre-existing comorbidity.
Abstract: Objective To determine the clinical manifestations, risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed coronavirus disease 2019 (covid-19). Design Living systematic review and meta-analysis. Data sources Medline, Embase, Cochrane database, WHO COVID-19 database, China National Knowledge Infrastructure (CNKI), and Wanfang databases from 1 December 2019 to 6 October 2020, along with preprint servers, social media, and reference lists. Study selection Cohort studies reporting the rates, clinical manifestations (symptoms, laboratory and radiological findings), risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed covid-19. Data extraction At least two researchers independently extracted the data and assessed study quality. Random effects meta-analysis was performed, with estimates pooled as odds ratios and proportions with 95% confidence intervals. All analyses will be updated regularly. Results 192 studies were included. Overall, 10% (95% confidence interval 7% to 12%; 73 studies, 67 271 women) of pregnant and recently pregnant women attending or admitted to hospital for any reason were diagnosed as having suspected or confirmed covid-19. The most common clinical manifestations of covid-19 in pregnancy were fever (40%) and cough (41%). Compared with non-pregnant women of reproductive age, pregnant and recently pregnant women with covid-19 were less likely to have symptoms (odds ratio 0.28, 95% confidence interval 0.13 to 0.62; I2=42.9%) or report symptoms of fever (0.49, 0.38 to 0.63; I2=40.8%), dyspnoea (0.76, 0.67 to 0.85; I2=4.4%) and myalgia (0.53, 0.36 to 0.78; I2=59.4%). The odds of admission to an intensive care unit (odds ratio 2.13, 1.53 to 2.95; I2=71.2%), invasive ventilation (2.59, 2.28 to 2.94; I2=0%) and need for extra corporeal membrane oxygenation (2.02, 1.22 to 3.34; I2=0%) were higher in pregnant and recently pregnant than non-pregnant reproductive aged women. Overall, 339 pregnant women (0.02%, 59 studies, 41 664 women) with confirmed covid-19 died from any cause. Increased maternal age (odds ratio 1.83, 1.27 to 2.63; I2=43.4%), high body mass index (2.37, 1.83 to 3.07; I2=0%), any pre-existing maternal comorbidity (1.81, 1.49 to 2.20; I2=0%), chronic hypertension (2.0, 1.14 to 3.48; I2=0%), pre-existing diabetes (2.12, 1.62 to 2.78; I2=0%), and pre-eclampsia (4.21, 1.27 to 14.0; I2=0%) were associated with severe covid-19 in pregnancy. In pregnant women with covid-19, increased maternal age, high body mass index, non-white ethnicity, any pre-existing maternal comorbidity including chronic hypertension and diabetes, and pre-eclampsia were associated with serious complications such as admission to an intensive care unit, invasive ventilation and maternal death. Compared to pregnant women without covid-19, those with the disease had increased odds of maternal death (odds ratio 2.85, 1.08 to 7.52; I2=0%), of needing admission to the intensive care unit (18.58, 7.53 to 45.82; I2=0%), and of preterm birth (1.47, 1.14 to 1.91; I2=18.6%). The odds of admission to the neonatal intensive care unit (4.89, 1.87 to 12.81, I2=96.2%) were higher in babies born to mothers with covid-19 versus those without covid-19. Conclusion Pregnant and recently pregnant women with covid-19 attending or admitted to the hospitals for any reason are less likely to manifest symptoms such as fever, dyspnoea, and myalgia, and are more likely to be admitted to the intensive care unit or needing invasive ventilation than non-pregnant women of reproductive age. Pre-existing comorbidities, non-white ethnicity, chronic hypertension, pre-existing diabetes, high maternal age, and high body mass index are risk factors for severe covid-19 in pregnancy. Pregnant women with covid-19 versus without covid-19 are more likely to deliver preterm and could have an increased risk of maternal death and of being admitted to the intensive care unit. Their babies are more likely to be admitted to the neonatal unit. Systematic review registration PROSPERO CRD42020178076. Readers’ note This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This version is update 1 of the original article published on 1 September 2020 (BMJ 2020;370:m3320), and previous updates can be found as data supplements (https://www.bmj.com/content/370/bmj.m3320/related#datasupp). When citing this paper please consider adding the update number and date of access for clarity.
1,232 citations
TL;DR: To reduce the risk for severe illness and death from COVID-19, pregnant women should be counseled about the importance of seeking prompt medical care if they have symptoms and measures to prevent SARS-CoV-2 infection should be strongly emphasized for pregnant women and their families during all medical encounters, including prenatal care visits.
Abstract: Studies suggest that pregnant women might be at increased risk for severe illness associated with coronavirus disease 2019 (COVID-19) (1,2). This report provides updated information about symptomatic women of reproductive age (15-44 years) with laboratory-confirmed infection with SARS-CoV-2, the virus that causes COVID-19. During January 22-October 3, CDC received reports through national COVID-19 case surveillance or through the National Notifiable Diseases Surveillance System (NNDSS) of 1,300,938 women aged 15-44 years with laboratory results indicative of acute infection with SARS-CoV-2. Data on pregnancy status were available for 461,825 (35.5%) women with laboratory-confirmed infection, 409,462 (88.7%) of whom were symptomatic. Among symptomatic women, 23,434 (5.7%) were reported to be pregnant. After adjusting for age, race/ethnicity, and underlying medical conditions, pregnant women were significantly more likely than were nonpregnant women to be admitted to an intensive care unit (ICU) (10.5 versus 3.9 per 1,000 cases; adjusted risk ratio [aRR] = 3.0; 95% confidence interval [CI] = 2.6-3.4), receive invasive ventilation (2.9 versus 1.1 per 1,000 cases; aRR = 2.9; 95% CI = 2.2-3.8), receive extracorporeal membrane oxygenation (ECMO) (0.7 versus 0.3 per 1,000 cases; aRR = 2.4; 95% CI = 1.5-4.0), and die (1.5 versus 1.2 per 1,000 cases; aRR = 1.7; 95% CI = 1.2-2.4). Stratifying these analyses by age and race/ethnicity highlighted disparities in risk by subgroup. Although the absolute risks for severe outcomes for women were low, pregnant women were at increased risk for severe COVID-19-associated illness. To reduce the risk for severe illness and death from COVID-19, pregnant women should be counseled about the importance of seeking prompt medical care if they have symptoms and measures to prevent SARS-CoV-2 infection should be strongly emphasized for pregnant women and their families during all medical encounters, including prenatal care visits. Understanding COVID-19-associated risks among pregnant women is important for prevention counseling and clinical care and treatment.
876 citations
TL;DR: This review presents findings from 25 studies comparing inactivated parenteral influenza vaccine against placebo or do-nothing control groups as the most relevant to decision-making over single influenza seasons in North America, South America, and Europe between 1969 and 2009.
Abstract: Background
Different types of influenza vaccines are currently produced worldwide. Healthy adults are presently targeted mainly in North America.
Objectives
Identify, retrieve and assess all studies evaluating the effects of vaccines against influenza in healthy adults.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2010, issue 2), MEDLINE (January 1966 to June 2010) and EMBASE (1990 to June 2010).
Selection criteria
Randomised controlled trials (RCTs) or quasi-RCTs comparing influenza vaccines with placebo or no intervention in naturally-occurring influenza in healthy individuals aged 16 to 65 years. We also included comparative studies assessing serious and rare harms.
Data collection and analysis
Two review authors independently assessed trial quality and extracted data.
Main results
We included 50 reports. Forty (59 sub-studies) were clinical trials of over 70,000 people. Eight were comparative non-RCTs and assessed serious harms. Two were reports of harms which could not be introduced in the data analysis. In the relatively uncommon circumstance of vaccine matching the viral circulating strain and high circulation, 4% of unvaccinated people versus 1% of vaccinated people developed influenza symptoms (risk difference (RD) 3%, 95% confidence interval (CI) 2% to 5%). The corresponding figures for poor vaccine matching were 2% and 1% (RD 1, 95% CI 0% to 3%). These differences were not likely to be due to chance. Vaccination had a modest effect on time off work and had no effect on hospital admissions or complication rates. Inactivated vaccines caused local harms and an estimated 1.6 additional cases of Guillain-Barre Syndrome per million vaccinations. The harms evidence base is limited.
Authors' conclusions
Influenza vaccines have a modest effect in reducing influenza symptoms and working days lost. There is no evidence that they affect complications, such as pneumonia, or transmission.
WARNING:
This review includes 15 out of 36 trials funded by industry (four had no funding declaration). An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to the vaccines. The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in light of this finding.
870 citations
Haidong Wang1, Zulfiqar A Bhutta2, Zulfiqar A Bhutta3, Matthew M Coates1 +610 more•Institutions (263)
TL;DR: The Global Burden of Disease 2015 Study provides an analytical framework to comprehensively assess trends for under-5 mortality, age-specific and cause-specific mortality among children under 5 years, and stillbirths by geography over time and decomposed the changes in under- 5 mortality to changes in SDI at the global level.
591 citations