scholarly journals Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review

2021 ◽  
Vol 12 ◽  
Author(s):  
Amit Bansal ◽  
Mai-Chi Trieu ◽  
Kristin G. I. Mohn ◽  
Rebecca Jane Cox
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Pregnant Women ◽  
Clinical Review ◽  
Influenza Vaccines ◽  
Current Evidence ◽  
Evidence Based ◽  
Eligibility Criteria ◽  
Vaccine Type ◽  
Women And Children

Annual influenza vaccination is often recommended for pregnant women and young children to reduce the risk of severe influenza. However, most studies investigating the safety, immunogenicity, and efficacy or effectiveness of influenza vaccines are conducted in healthy adults. In this evidence-based clinical review, we provide an update on the safety profile, immunogenicity, and efficacy/effectiveness of inactivated influenza vaccines (IIVs) in healthy pregnant women and children <5 years old. Six electronic databases were searched until May 27, 2021. We identified 3,731 articles, of which 93 met the eligibility criteria and were included. The IIVs were generally well tolerated in pregnant women and young children, with low frequencies of adverse events following IIV administration; however, continuous vaccine safety monitoring systems are necessary to detect rare adverse events. IIVs generated good antibody responses, and the seroprotection rates after IIVs were moderate to high in pregnant women (range = 65%–96%) and young children (range = 50%–100%), varying between the different influenza types/subtypes and seasons. Studies show vaccine efficacy/effectiveness values of 50%–70% in pregnant women and 20%–90% in young children against lab-confirmed influenza, although the efficacy/effectiveness depended on the study design, host factors, vaccine type, manufacturing practices, and the antigenic match/mismatch between the influenza vaccine strains and the circulating strains. Current evidence suggests that the benefits of IIVs far outweigh the potential risks and that IIVs should be recommended for pregnant women and young children.

scholarly journals Many Women and Providers Are Unprepared for an Evidence-Based, Educated Conversation About Birth

2011 ◽  
Vol 20 (4) ◽  
pp. 185-187 ◽  
Author(s):  
Michael C. Klein
Keyword(s):  
Decision Making ◽  
Pregnant Women ◽  
Maternity Care ◽  
Informed Decision ◽  
Current Evidence ◽  
Evidence Based ◽  
Informed Decision Making ◽  
Knowledge And Beliefs ◽  
Canadian Studies ◽  
First Time

Findings from recent Canadian studies on the knowledge and beliefs about birth practices among first-time pregnant women and among obstetricians and other birth providers indicate that many women are inadequately informed and many providers deliver non-evidence-based maternity care. Consequently, informed decision making is problematic for pregnant women and their providers. New strategies are needed to inform pregnant women about key procedures and approaches that might be used in birth so they can have an educated, shared discussion with their provider and successfully advocate for their preferred birth experience. In addition, providers can be encouraged to supplement their knowledge with current, evidence-based maternity care practices. To avoid a lack of informed decision making and to ensure that natural, safe, and healthy birth practices are based on current evidence, pregnant women and providers must work together to inform themselves and to add childbirth to the women’s health agenda.

scholarly journals Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

2015 ◽  
Vol 20 (43) ◽  
Author(s):  
Alexis Pillsbury ◽  
Patrick Cashman ◽  
Alan Leeb ◽  
Annette Regan ◽  
Darren Westphal ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Real Time ◽  
Surveillance System ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Influenza Vaccines ◽  
Safety Surveillance ◽  
Medical Attendance

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.

scholarly journals Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246540
Author(s):  
Tazio Vanni ◽  
Beatriz da Costa Thomé ◽  
Mayra Martho Moura de Oliveira ◽  
Vera Lúcia Gattás ◽  
Maria da Graça Salomão ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pregnant Women ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Vaccine Safety ◽  
Median Number ◽  
Influenza Vaccines ◽  
Guillain Barre Syndrome ◽  
Guillain Barré Syndrome ◽  
Guillain Barré

Introduction Active pharmacovigilance studies are pivotal to better characterize vaccine safety. Methods These are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS). Results A total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination. Conclusion The results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.

Role of Lactoferrin in Neonates and Infants: An Update

2018 ◽  
Vol 35 (06) ◽  
pp. 561-565 ◽  
Author(s):  
Alberto Dall'Agnola ◽  
Daniel Tomé ◽  
David Kaufman ◽  
Elena Tavella ◽  
Marta Pieretto ◽  
...  
Keyword(s):  
Quality Control ◽  
Young Children ◽  
Current Evidence ◽  
Evidence Based ◽  
Respiratory Pathogens ◽  
Bioactive Proteins ◽  
Different Types ◽  
Neonates And Infants ◽  
Infants And Young Children

AbstractLactoferrin is one of the most represented and important bioactive proteins in human and mammal milk. In humans, lactoferrin is responsible for several actions targeting anti-infective, immunological, and gastrointestinal domains in neonates, infants, and young children. Evidence-based data vouch for the ability of supplemented lactoferrin to prevent sepsis and necrotizing enterocolitis in preterm infants and to reduce the burden of morbidity related to gastrointestinal and respiratory pathogens in young children. However, several issues remain pending regarding answers and clarification related to quality control, correct intakes, optimal schedules and schemes of supplementations, interactions with probiotics, and different types of milk and formulas. This review summarizes the current evidence regarding lactoferrin and discusses the areas in need of further guidance prior to the adoption of strategies that include a routine use of lactoferrin in neonates and young children.

Update on Early Speech and Language Intervention for Children With Craniofacial Conditions

2016 ◽  
Vol 1 (5) ◽  
pp. 50-58
Author(s):  
Nancy J. Scherer
Keyword(s):  
Early Intervention ◽  
Young Children ◽  
Parent Training ◽  
Language Intervention ◽  
Current Evidence ◽  
Evidence Based ◽  
Speech And Language ◽  
Early Speech ◽  
Structure Parent

This article discusses the current evidence for early intervention for children with craniofacial conditions. The article describes the evidence-based intervention approaches, strategies, and parent training options to support language and speech outcomes in young children with clefts. Use of coaching to structure parent training is discussed.

scholarly journals Statins and/or fibrates for diabetic retinopathy: a systematic review and meta-analysis

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Vânia Mozetic ◽  
Rafael Leite Pacheco ◽  
Carolina de Oliveira Cruz Latorraca ◽  
Rachel Riera
Keyword(s):  
Systematic Review ◽  
Diabetic Retinopathy ◽  
Adverse Events ◽  
Macular Edema ◽  
Outcome Data ◽  
High Rate ◽  
Lipid Lowering ◽  
Current Evidence ◽  
Main Concern ◽  
Eligibility Criteria

Abstract Evidence from observational studies have found a relationship between serum cholesterol and diabetic retinopathy (DR). Apart of the assumption that cholesterolemic control has benefits for patients with diabetes with or without retinopathy, the effects of lipid-lowering drugs have not been properly mapped and critically assessed so far. The objective of this study was to evaluate the effects of statins and/or fibrates on prevention and progression of DR. We conducted a Systematic review of randomized controlled trials (RCTs) following the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. GRADE approach was used to summarize the certainty of the evidence. Eight RCTs that fulfilled our eligibility criteria were included, assessing the effects of fibrates (n = 4), statins (n = 3) and fibrate plus statins (n = 1) for therapy (n = 8) or prevention (n = 4) of DR. Overall, the main concern regarding risk of bias assessment was due to incomplete outcome data because high rate of losses in five RCTs. Furthermore, the risk of reporting bias was rated unclear due the lack of previously published protocol in seven RCTs. Fibrates seemed to be associated with a 45% risk reduction of macular edema incidence (Relative Risk 0.55, 95% confidence interval of 0.38 to 0.81, 1309 participants, 2 RCTs, I2 = 0%, low certainty of the evidence). The certainty of evidence for other outcomes was also very low or low, and we are uncertain regarding the effects of fibrates for DR. Overall, adverse events seemed to be similar between fibrate and placebo, but again based on the width of the confidence intervals, an important increase of adverse events cannot be rule out. The combination statin/fibrate did not seem to have benefit for visual acuity but is likely that further studies can modify this estimate since the current evidence is limited. Adverse events and quality of life were not measured or reported. Concluding, this study found eight RCTs, with limited methodological quality, that assessed the effects of fibrates and/or statins for DR. Based on these findings, we are uncertain about the effects of statins for DR. Fibrates seemed to reduce the incidence of macular edema (low certainty evidence) without increase adverse events (low to very low certainty evidence). Number of Protocol registration PROSPERO CRD42016029746.

scholarly journals Contraception for women with multiple sclerosis: Guidance for healthcare providers

2017 ◽  
Vol 23 (6) ◽  
pp. 757-764 ◽  
Author(s):  
Maria K Houtchens ◽  
Lauren B Zapata ◽  
Kathryn M Curtis ◽  
Maura K Whiteman
Keyword(s):  
Multiple Sclerosis ◽  
Contraceptive Use ◽  
Treatment Plan ◽  
Reproductive Age ◽  
Current Evidence ◽  
Hormonal Contraceptives ◽  
Comprehensive Treatment ◽  
Evidence Based ◽  
Eligibility Criteria ◽  
Unintended Pregnancies

Family planning is essential for any comprehensive treatment plan for women of reproductive age with multiple sclerosis (MS), including counseling on using effective contraception to optimally time desired and prevent unintended pregnancies. This topical review summarizes the first evidence-based recommendations on contraception safety for women with MS. In 2016, evidence-based recommendations for contraceptive use by women with MS were included in US Medical Eligibility Criteria for Contraceptive Use. They were developed after review of published scientific evidence on contraception safety and consultation with experts. We summarize and expand on the main conclusions of the Centers for Disease Control and Prevention guidance. Most contraceptive methods appear based on current evidence to be safe for women with MS. The only restriction is use of combined hormonal contraceptives among women with MS with prolonged immobility because of concerns about possible venous thromboembolism. Disease-modifying therapies (DMTs) do not appear to decrease the effectiveness of hormonal contraception although formal drug–drug interaction studies are limited. Neurologists can help women with MS make contraceptive choices that factor their level of disability, immobility, and medication use. For women with MS taking potentially teratogenic medications, highly effective methods that are long-acting (e.g. intrauterine devices, implants) might be the best option.

scholarly journals Historical and legal analysis of the regulation of the problem of serving a sentence of imprisonment of pregnant women and women with young children

2014 ◽  
Vol 1 (4) ◽  
pp. 198-205
Author(s):  
O A Omelchenko
Keyword(s):  
Young Children ◽  
Pregnant Women ◽  
Historical Development ◽  
Statistical Data ◽  
Legal Analysis ◽  
The Public ◽  
Women And Children ◽  
The Subject ◽  
Executive System

This article is devoted to studying the problem of serving a sentence of imprisonment of pregnant women and women with young children. In view of maloizuchennyh of the subject and its increasing relevance in modern conditions of development of the penitentiary system attempts to review and to analyze the degree of attention of state authorities, the criminal-Executive system and the public to the problem at different stages of historical development: from pre-revolutionary times to the present day. The statistics showing the number of women and children in prison from 2003 to 2014 and the influence of serial humanization of punishment in the form of deprivation of freedom for statistical data.

scholarly journals Clinical guidance and perinatal care in the era of coronavirus disease 2019 (COVID-19)

2020 ◽  
Vol 48 (9) ◽  
pp. 925-930
Author(s):  
Yalda Afshar ◽  
Neil S. Silverman ◽  
Christina S. Han ◽  
Lawrence D. Platt
Keyword(s):  
Pregnant Women ◽  
Perinatal Care ◽  
Current Evidence ◽  
Maternal Outcomes ◽  
Evidence Based ◽  
Maternal Infection ◽  
Clinical Practices ◽  
Maternal Fetal Medicine ◽  
Fetal Medicine ◽  
Potential Risks

AbstractPregnant women may be at risk for more severe manifestations and sequelae of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). At this time, there remain significant evidence gaps to allow for comprehensive counseling of pregnant women and their families, specifically regarding the risks of gestational-age specific maternal outcomes and potential risks of intrauterine or peripartum viral transmission to the fetus or newborn. As maternal fetal medicine providers and consultants, we are uniquely positioned to mitigate the risks associated with maternal infection and to guide the care for infected pregnant women by being able to provide the most current evidence-based recommendations. Such care requires incorporating the rapidly evolving data regarding this virus and its impact on pregnancy, as well as taking a stand to advocate for best scientific and clinical practices to optimize both women’s health and public health during this pandemic.

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