Highlights • Group B streptococcus is the leading cause of neonatal sepsis and meningitis in many countries. • Intrapartum antibiotics have no impact on late onset infections and minimal impact on ...meningitis. • A suitable vaccine, given in pregnancy, could provide an effective solution in all settings. • The leading vaccine candidates are capsular polysaccharide-protein conjugate vaccines. • Licensure may require efficacy trials or be based on serological correlates of protection.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Abstract Streptococcus agalactiae (group B streptococcus (GBS)), remains the leading cause of neonatal sepsis and meningitis in many countries and an important cause of disease in pregnant women, ...immunocompromised adults and the elderly. Intrapartum antibiotic strategies have reduced the incidence of early-onset neonatal GBS where applied, but have had no impact on late onset GBS infection and only a limited impact on disease in pregnant women. In low/middle income settings, the disease burden remains uncertain although in several countries of Southern Africa appears comparable to that of high-income countries. Disease may be rapidly fulminating and cases therefore missed before appropriate samples are obtained. This may lead to significant underestimation of the true burden and be a particular issue in many African and Asian countries; comprehensive epidemiological data from such countries are urgently required. The available data suggest that the serotype distribution of GBS isolates is similar in Africa, Western Pacific, Europe, the Americas and the Eastern Mediterranean regions and has not changed over the past 30 years. Five serotypes (Ia, Ib, II, III, V) account for the majority of disease; conjugate vaccines including some or all of these serotypes therefore hold great promise for preventing this important disease.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Summary Background Despite widespread use of intrapartum antibiotic prophylaxis, group B streptococcus remains a leading cause of morbidity and mortality in infants in Europe, the Americas, and ...Australia. However, estimates of disease burden in many countries outside of these regions is not available. We aimed to examine the current global burden of invasive disease and the serotype distribution of group B streptococcus isolates. Methods We searched Medline, Embase, and Wholis databases for studies on invasive early-onset (day 0–6) and late-onset (day 7–89) group B streptococcal disease. Eligible studies were those that described incidence, deaths, or serotypes. We also reviewed reference lists and contacted experts to seek unpublished data and data missed by our search. Random effects meta-analysis was used to pool data. Findings 74 studies met the inclusion criteria; 56 studies reported incidence, 29 case fatality, and 19 serotype distribution. An additional search for studies that reported serotype distribution from Jan 1, 1980, yielded a total of 38 articles. Only five low-income countries were represented in the review and contributed 5% weight to the meta-analysis. 47 (69%) studies reported use of any intrapartum antibiotic prophylaxis. Substantial heterogeneity existed between studies. Mean incidence of group B streptococcus in infants aged 0–89 days was 0·53 per 1000 livebirths (95% CI 0·44–0·62) and the mean case fatality ratio was 9·6% (95% CI 7·5–11·8). Incidence of early-onset group B streptococcus (0·43 per 1000 livebirths 95% CI 0·37–0·49) and case fatality (12·1%, 6·2–18·3) were two-times higher than late-onset disease. Serotype III (48·9%) was the most frequently identified serotype in all regions with available data followed by serotypes Ia (22·9%), Ib (7·0%), II (6·2%), and V (9·1%). Studies that reported use of any intrapartum antibiotic prophylaxis were associated with lower incidence of early-onset group B streptococcus (0·23 per 1000 livebirths 95% CI 0·13–0·59) than studies in which patients did not use prophylaxis (0·75 per 1000 livebirths 0·58–0·89). Interpretation More high-quality studies are needed to accurately estimate the global burden of group B streptococcus, especially in low-income countries. A conjugate vaccine incorporating five serotypes (Ia, Ib, II, III, V) could prevent most global group B streptococcal disease. Funding Child Epidemiology Reference Group (CHERG), WHO.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
In a phase 3 trial involving more than 15,000 participants, two doses of NVX-CoV2373, a recombinant SARS-CoV-2 nanoparticle vaccine, administered 21 days apart had a vaccine efficacy of 89.7%. ...Reactogenicity was generally mild and transient, and adverse events were infrequent and of low grade.
Concerns have been raised regarding a potential surge of COVID-19 in pregnancy, secondary to the rising numbers of COVID-19 in the community, easing of societal restrictions, and vaccine hesitancy. ...Although COVID-19 vaccination is now offered to all pregnant women in the United Kingdom; limited data exist on its uptake and safety.
This study aimed to investigate the uptake and safety of COVID-19 vaccination among pregnant women.
This was a cohort study of pregnant women who gave birth at St George’s University Hospitals National Health Service Foundation Trust, London, United Kingdom, between March 1, 2020, and July 4, 2021. The primary outcome was uptake of COVID-19 vaccination and its determinants. The secondary outcomes were perinatal safety outcomes. Data were collected on COVID-19 vaccination uptake, vaccination type, gestational age at vaccination, and maternal characteristics, including age, parity, ethnicity, index of multiple deprivation score, and comorbidities. Further data were collected on perinatal outcomes, including stillbirth (fetal death at ≥24 weeks’ gestation), preterm birth, fetal and congenital abnormalities, and intrapartum complications. Pregnancy and neonatal outcomes of women who received the vaccine were compared with that of a matched cohort of women with balanced propensity scores. Effect magnitudes of vaccination on perinatal outcomes were reported as mean differences or odds ratios with 95% confidence intervals. Factors associated with antenatal vaccination were assessed with logistic regression analysis.
Data were available for 1328 pregnant women of whom 140 received at least 1 dose of the COVID-19 vaccine before giving birth and 1188 women who did not; 85.7% of those vaccinated received their vaccine in the third trimester of pregnancy and 14.3% in the second trimester of pregnancy. Of those vaccinated, 127 (90.7%) received a messenger RNA vaccine and 13 (9.3%) a viral vector vaccine. There was evidence of reduced vaccine uptake in younger women (P=.001), women with high levels of deprivation (ie, fifth quintile of the index of multiple deprivation; P=.008), and women of Afro-Caribbean or Asian ethnicity compared with women of White ethnicity (P<.001). Women with prepregnancy diabetes mellitus had increased vaccine uptake (P=.008). In the multivariable model the fifth deprivation quintile (most deprived) (adjusted odds ratio, 0.10; 95% confidence interval, 0.02–0.10; P=.003) and Afro-Caribbean ethnicity (adjusted odds ratio, 0.27; 95% confidence interval, 0.06–0.85; P=.044) were significantly associated with lower antenatal vaccine uptake, whereas prepregnancy diabetes mellitus was significantly associated with higher antenatal vaccine uptake (adjusted odds ratio, 10.5; 95% confidence interval, 1.74–83.2; P=.014). In a propensity score–matched cohort, the rates of adverse pregnancy outcomes of 133 women who received at least 1 dose of the COVID-19 vaccine in pregnancy were similar to that of unvaccinated pregnant women (P>.05 for all): stillbirth (0.0% vs 0.2%), fetal abnormalities (2.2% vs 2.5%), postpartum hemorrhage (9.8% vs 9.0%), cesarean delivery (30.8% vs 34.1%), small for gestational age (12.0% vs 12.8%), maternal high-dependency unit or intensive care admission (6.0% vs 4.0%), or neonatal intensive care unit admission (5.3% vs 5.0%). Intrapartum pyrexia (3.7% vs 1.0%; P=.046) was significantly increased but the borderline statistical significance was lost after excluding women with antenatal COVID-19 infection (P=.079). Mixed-effects Cox regression showed that vaccination was not significantly associated with birth at <40 weeks’ gestation (hazard ratio, 0.93; 95% confidence interval, 0.71–1.23; P=.624).
Of pregnant women eligible for COVID-19 vaccination, less than one-third accepted COVID-19 vaccination during pregnancy, and they experienced similar pregnancy outcomes with unvaccinated pregnant women. There was lower uptake among younger women, non-White ethnicity, and lower socioeconomic background. This study has contributed to the body of evidence that having COVID-19 vaccination in pregnancy does not alter perinatal outcomes. Clear communication to improve awareness among pregnant women and healthcare professionals on vaccine safety is needed, alongside strategies to address vaccine hesitancy. These strategies include postvaccination surveillance to gather further data on pregnancy outcomes, particularly after first-trimester vaccination, and long-term infant follow-up.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The virus subsequently spread rapidly throughout China and other countries worldwide, and on March 11, 2020, the outbreak was declared a pandemic. Since March 11, 2020, the virus has continued to ...spread, causing substantial morbidity and mortality in many countries. A systematic review and meta-analysis of mainly small case series reported that a high proportion of women with confirmed COVID-19 infection had preterm birth (<37 weeks 22%) and caesarean delivery (48%).5 Estimated rates of admission to the intensive care unit among pregnant women (7%) were higher than those of non-pregnant women (4%) and around 1·9% of infants born to these women tested positive for SARS-CoV-2.5 Thus far, the literature has focused on symptomatic women with confirmed infection, however, this might underestimate the rates of admission, since many individuals are asymptomatic.6 Many important questions remain unanswered, including the extent of asymptomatic or mild infection and the effect of COVID-19 on miscarriage, intrauterine fetal growth restriction, congenital anomalies, long-term growth, and neurodevelopmental outcomes. The need for intensive care support among patients with COVID-19 is of particular concern for pregnant women who reside in low-income and middle-income countries.5 These factors suggest that pregnant women should be considered as candidates for preventative measures, of which vaccination is the gold standard. Since the immune responses to vaccination in pregnant women cannot be assumed from that of non-pregnant women and because the assessment of safety of vaccination in pregnancy is unique, pregnant women should be included in appropriately designed vaccine trials.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Increasingly, vaccine efficacy studies are being recommended in low-and-middle-income countries (LMIC), yet often facilities are unavailable to take and store infant blood samples correctly. Dried ...blood spots (DBS), are useful for collecting blood from infants for diagnostic purposes, especially in low-income settings, as the amount of blood required is miniscule and no refrigeration is required. Little is known about their utility for antibody studies in children. This systematic review aims to investigate the correlation of antibody concentrations against infectious diseases in DBS in comparison to serum or plasma samples that might inform their use in vaccine clinical trials.
We searched MEDLINE, Embase and the Cochrane library for relevant studies between January 1990 to October 2020 with no language restriction, using PRISMA guidelines, investigating the correlation between antibody concentrations in DBS and serum or plasma samples, and the effect of storage temperature on DBS diagnostic performance. We included 40 studies in this systematic review. The antibody concentration in DBS and serum/plasma samples reported a good pooled correlation, (r2 = 0.86 (ranged 0.43 to 1.00)). Ten studies described a decline of antibody after 28 days at room temperature compared to optimal storage at -20°C, where antibodies were stable for up to 200 days. There were only five studies of anti-bacterial antibodies.
There is a good correlation between antibody concentrations in DBS and serum/plasma samples, supporting the wider use of DBS in vaccine and sero-epidemiological studies, but there is limited data on anti-bacterial antibodies. The correct storage of DBS is critical and may be a consideration for longer term storage.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Maternal vaccination is an effective means of protecting pregnant women, their fetuses, and infants from vaccine-preventable infections. Despite the availability of sufficient safety data to support ...the use of vaccines during pregnancy, maternal immunization remains an underutilized method of disease prevention, often because of concerns from both healthcare providers and pregnant women about vaccine safety. Such concerns have been reflected in the low uptake of the COVID-19 vaccine among pregnant women seen in many parts of the world. Here, we present an update of the current recommendations for the use of vaccines during pregnancy, including the evidence supporting the use of novel vaccine platforms. We also provide an overview of the data supporting the use of COVID-19 vaccines in pregnancy and an update of the status of vaccines that are currently under development for use in pregnant women.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
This randomized trial of RSV F protein nanoparticle vaccination during pregnancy did not show efficacy (according to the prespecified success criterion) against RSV-associated, medically significant ...lower respiratory tract infection but suggested possible benefits with respect to other RSV-related outcomes.
This study is conducted to summarise and present the current knowledge on antenatal vaccination against pertussis with regard to national recommendations, coverage, immunogenicity, safety and ...effectiveness of the current available vaccines.
A systematic review of the literature in English was undertaken from January 2011 to May 2016 with searches in four databases. The review conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
47 studies fulfilled the inclusion criteria. Antenatal vaccination against pertussis induces high antibody concentrations in pregnant women, which are efficiently transferred transplacentally to the fetus and protect newborns when they are most vulnerable to pertussis. This strategy has been demonstrated to be safe, with no evidence of adverse pregnancy, birth or neonatal outcomes. Several countries have already introduced antenatal pertussis vaccination into their national immunisation programme with varying vaccination coverage influenced by various factors. Barriers to achieving high immunisation rates could be improved through better education of the public and healthcare professionals.
There is now an increasing body of evidence to support the safety, immunogenicity and effectiveness of antenatal vaccination to reduce the morbidity and mortality associated with pertussis in neonates and young infants before they receive their primary immunisations. Narrowing the gap between scientific evidence and public health policies is critical in order to protect the most vulnerable as quickly as possible. The lessons learnt have important implications for implementation of new vaccines into the antenatal immunisation programme.
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