Showing posts with label pregnancy. Show all posts
Showing posts with label pregnancy. Show all posts

Wednesday, March 25, 2026

Mild #SARS-CoV-2 #maternal #infection in mice induces transient offspring #neurodevelopmental aberrance

 


Significance

The rising global numbers of SARS-CoV-2 infections highlight the need to assess potential neurodevelopmental and psychiatric impact in children born to infected mothers. Human cohorts have provided conflicting conclusions, while mouse studies have focused on moderate-to-severe infection despite most infections in pregnant women being mild or asymptomatic. Our study shows that mild, respiratory tract–restricted SARS-CoV-2 infection in pregnant mice was sufficient to cause placental inflammation and transient changes in offspring brain gene expression, without altering gross brain structure or behavior under our experimental conditions. These findings suggest that soluble factors induced by maternal respiratory infection mediate placental inflammation and changes in offspring brain gene expression during the fetal and neonatal periods, which resolve in later childhood.


Abstract

Maternal viral infection during pregnancy has been identified as a risk factor for psychiatric disorders and neurodevelopmental abnormalities in offspring. With cumulative SARS-CoV-2 infections now numbering in the hundreds of millions globally, there is a need to evaluate the effects of maternal SARS-CoV-2 infection on offspring brain development and behavior. We developed a mouse model of mild COVID-19 during pregnancy in which SARS-CoV-2 infection is restricted to the respiratory tract. Infected mothers did not show weight loss or changes in litter size, but did exhibit detectable local and systemic immune responses, including placental inflammation. Characterization of the offspring’s cerebral cortex revealed transcriptomic changes in the fetus at E15 and on postnatal day 5 (P5), but no gross alterations in cytoarchitecture, synaptic density, or microglial abundance. We did not detect any significant changes in open-field or novel object recognition tests in P50 offspring born to SARS-CoV-2-infected dams. These findings suggest that mild maternal respiratory SARS-CoV-2 infection induces soluble factors that mediate placental inflammation and transient cerebral cortex alterations in offspring that resolve by later childhood.

Source: 


Link: https://www.pnas.org/doi/abs/10.1073/pnas.2518294123?af=R

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Friday, March 6, 2026

#Report of the 49th meeting of #WHO Global Advisory #Committee on #Vaccine #Safety 27–28 November 2025 (Excerpt, Mar. 6 '26)

 


{Excerpt}

(...)

COVID-19 current vaccine safety status and insights 

-- Since 2021, GACVS has regularly reviewed the safety of COVID-19 vaccines, including through global pharmacovigilance data and dedicated reviews of myocarditis, pregnancy outcomes and other adverse events of special interest (AESI). 

-- The most recent updates reaffirmed that the benefits of vaccination outweigh the risks across all groups and advised continued monitoring for younger males and follow-up of persons who have reported vaccine-associated myocarditis

-- Many individuals have received three or more doses of COVID-19 vaccine. 

-- Some adverse events – such as myocarditis – seem to occur mainly after the second dose of mRNA COVID- 19 vaccines. 

-- However, the outcomes were less severe in persons who developed myocarditis after vaccination compared to those unvaccinated and following infections, including SARS- CoV-2. 

-- Also, children under six months of age seem to be at higher risk of severe COVID-19 infection along with people over the age of 65 years

-- WHO has recommended continued vaccination for high-priority groups while acknowledging that gaps remain in the evidence on the safety of repeated dosing, long-term outcomes, and in subgroups such as children and pregnant women

-- As of October 2025, for all COVID-19 vaccines, there were only 32 cases of perturbation of fetal development in EudraVigilance, of which most were reported with the original vaccine strains

-- An analysis of safety of protein-based COVID-19 vaccines by the Uppsala Monitoring Centre (UMC) showed that as of November 2025 there were almost 6 million reports for all COVID-19 vaccines in UMC’s VigiBase. 

-- Of these, 16 548 reports concerned updated COVID-19 vaccine variants; among these were 5085 reports for updated protein-subunit vaccines. 

-- Around 17.4% of these were serious, and 50 reported a fatal outcome

-- Most reports were for the variant NVX CoV 2373 and most deaths were older vaccinees aged 75 years or more

-- GACVS reviewed findings from the Scandinavian collaboration called SCOPE (Scandinavian studies of COvid-19 in PrEgnancy). 

-- Findings showed no increased risk of adverse pregnancy, maternal or neonatal outcomes after mRNA COVID-19 vaccination in pregnancy in Denmark, Norway and Sweden. 

-- As of September 2025, the recommendation for vaccination in pregnancy was revised to apply only to specific high-risk groups

-- A case-control study by SCOPE of all women with a miscarriage before 14 weeks and all women with a primary care-based confirmation of an ongoing pregnancy in the first trimester revealed no evidence of increased risk of early pregnancy loss after COVID-19 vaccination. 

-- A further investigation of COVID-19 infection and vaccination with mRNA vaccines during the first trimester of pregnancy and the risk of congenital anomalies, in a population-based cohort of 150 000 live-born infants in Denmark, Norway and Sweden, showed no increased risk of major congenital anomalies among infants whose mothers were vaccinated against COVID-19 during the first trimester. 

-- A SCOPE investigation of the association between COVID-19 vaccination and several pregnancy outcomes among a cohort of almost 160 000 singleton pregnancies between January 2021 and 2022 in Norway and Sweden showed that vaccination against COVID-19 during pregnancy was not associated with any of the studied adverse pregnancy outcomes

-- In another SCOPE study of COVID-19 vaccination during pregnancy and the risk of severe postpartum haemorrhage, including more than 300 000 single-term deliveries in Denmark, Norway and Sweden, no evidence was found of an association between COVID-19 vaccination at any time during pregnancy and severe postpartum hemorrhage. 

-- Finally, SCOPE investigated neonatal outcomes after COVID-19 vaccination with mRNA vaccine during pregnancy in a cohort of almost 200 000 infants in Norway and Sweden. 

-- Again, no increased odds were found of any adverse neonatal outcomes and neonatal mortality. 

-- In consideration of the evidence presented, GACVS members agreed the following: 

- Repeated-dose safety (including boosters with variant-containing vaccines): 

* Current evidence remains reassuring, with no new safety signals recently identified. 

- Safety of protein-based vaccines

* While generally well tolerated, reported adverse events include a proportion of serious individual case safety reports (ICSRs) in the global database. Several potential signals (e.g. tinnitus, antibody-dependent enhancement, thrombosis) require further evaluation. Additional data collection and analysis are therefore recommended to strengthen the evidence base for these vaccines. 

- Long-term outcomes of known risks (e.g. myocarditis, pregnancy outcomes): 

* Myocarditis continues to occur predominantly in younger adults, typically with mild-to- moderate severity and most frequently after the second dose. Longer follow-up studies are needed to define the long-term prognosis and risks of revaccination in affected individuals. 

- Subgroup-specific safety (children, young males, older adults, immunocompromised individuals, pregnant women): 

* Evidence to date shows no harmful effects of mRNA COVID-19 vaccination during pregnancy, including no increase in congenital anomalies, adverse perinatal outcomes, or some post-natal complications. Some studies even suggest lower odds of intracranial haemorrhage, cerebral ischaemia and neonatal mortality among infants of vaccinated mothers. 

- Safety monitoring during the transition to endemic COVID-19 vaccination: 

* Continued vigilance is required, particularly regarding more recent variant-adapted vaccines which remain safe on the basis of current data. Enhanced monitoring of protein-based vaccines is important given the comparatively limited evidence and the presence of identified risks that warrant further investigation.

(...)

Source: 


Link: https://www.who.int/publications/journals/weekly-epidemiological-record

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Friday, February 6, 2026

Avian #Influenza #H5N1 #Infection During #Pregnancy: Preparing for the Next Flu #Pandemic and Improving Perinatal Outcomes

 


Abstract

Influenza (flu) is a common respiratory virus with seasonal global spread. Zoonotic viruses can occasionally cross species, leading to pandemic-level spread, and for flu viruses, this is considered an “antigenic shift”. The flu can be particularly severe during pregnancy due to immune system adaptations that occur during pregnancy, with prior global pandemics causing excess hospitalizations, deaths, and other complications in the mothers and the neonates. We aim to review the current literature with respect to novel avian H5N1 and the potential impact of infection with flu during pregnancy. A systematic literature search was conducted. Here we provide a rapid summary of epidemiology and understanding of viral spread, published risks of H5N1 in pregnancy, the unique physiologic, cellular, and molecular adaptations making H5N1 infection unique in pregnancy, implementation of an effective vaccine program in event of a pandemic specific to pregnant individuals, optimizing peripartum care for infected individuals, and direction for future research to direct vaccine strategy and mitigate risks in a future flu pandemic.

Source: 


Link: https://www.mdpi.com/1999-4915/18/2/212

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Thursday, October 30, 2025

Updated #Evidence for #Covid19, #RSV, and #Influenza #Vaccines for 2025–2026

 


Abstract

Background

Changes in the vaccine advisory process in the United States have disrupted immunization guidance, which reinforces the need for independent evidence review to inform decisions regarding immunization for respiratory viruses during the 2025–2026 season.

Methods

We conducted a systematic review of U.S.-licensed immunizations against coronavirus disease 2019 (Covid-19), respiratory syncytial virus (RSV), and influenza. We searched databases on PubMed/MEDLINE, Embase, and Web of Science for updates of the most recent review by the Advisory Committee on Immunization Practices (ACIP) Evidence-to-Recommendations for each disease, which was performed during the 2023–2024 period. Outcomes included vaccine efficacy and effectiveness against hospitalization, other clinical end points, and safety.

Results

Of 17,263 identified references, 511 studies met the inclusion criteria. Covid-19 mRNA vaccines against the XBB.1.5 subvariant had pooled vaccine effectiveness against hospitalization of 46% (95% confidence interval [CI], 34 to 55; from cohort studies) and 50% (95% CI, 43 to 57; from case–control studies) among adults and 37% (95% CI, 29 to 44) among immunocompromised adults. In a case–control study, vaccines against the KP.2 subvariant showed an effectiveness of 68% (95% CI, 42 to 82). Maternal RSV vaccination (for infant protection), nirsevimab for infants, and RSV vaccines in adults who were 60 years of age or older showed vaccine effectiveness of 68% or more against hospitalization. Influenza vaccination had a pooled vaccine effectiveness of 48% (95% CI, 39 to 55) in adults between the ages of 18 and 64 years and 67% (95% CI, 58 to 75) in children against hospitalization. Safety profiles were consistent with previous evaluations. The diagnosis of myocarditis associated with Covid-19 vaccines occurred at rates of 1.3 to 3.1 per 100,000 doses in male adolescents, with lower risk associated with longer dosing intervals. The RSVpreF vaccine was associated with 18.2 excess cases of Guillain–BarrĂ© syndrome per million doses in older adults; a significant association with preterm birth was not observed when the vaccine was administered at 32 to 36 weeks’ gestation.

Conclusions

Ongoing peer-reviewed evidence supports the safety and effectiveness of immunizations against Covid-19, RSV, and influenza during the 2025–2026 season. (Funded by the Center for Infectious Disease Research and Policy and the Alumbra Innovations Foundation.)

Source: The New England Journal of Medicine, https://www.nejm.org/doi/full/10.1056/NEJMsa2514268?query=TOC

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Tuesday, October 7, 2025

Maternal #Influenza A Virus #Infection Induces Antiviral and Immune Dysregulation in the #Placenta and #Fetus Without Vertical Transmission

 


Abstract

Influenza A virus (IAV) infection during pregnancy is associated with stillbirth and preterm birth, possibly by disrupting placental and fetal immunity. To investigate this, pregnant pigtail macaques were inoculated with IAV [A/California/07/2009 (H1N1)] and examined at necropsy 5 days post-infection (N=11) versus uninfected controls (N=16). Stillbirth occurred in 18% of infected pregnancies but not in controls. While vertical transmission was not observed, low levels of viral RNA were detected in two placentas. Maternal IAV infection was associated with increased placental IL-1β and IFN-β levels and an upregulated type I interferon and integrated stress transcriptional response. Fetuses exposed to IAV had greater frequencies of innate immune cells in lymph nodes and CD4+ T cells in lungs. These results suggest that placental and fetal immune environments undergo immune activation independent of the severity of maternal lung infection. Influenza vaccination during pregnancy may protect against potentially harmful effects on fetal development.


Competing Interest Statement

The authors have declared no competing interest.


Funder Information Declared

National Institutes of Health, https://ror.org/01cwqze88, AI164588, AI176777, AI007509

Foundation for the National Institutes of Health, https://ror.org/00k86s890, OD010425, TR002318, GM007266, OD011123

Source: BioRxIV, https://www.biorxiv.org/content/10.1101/2025.10.06.675688v1

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Wednesday, September 24, 2025

#WHO #statement on #autism-related issues (September 23 '25)

 


The World Health Organization (WHO) emphasizes that there is currently no conclusive scientific evidence confirming a possible link between autism and use of acetaminophen (also known as paracetamol) during pregnancy. 

Globally, nearly 62 million people (1 in 127) have autism spectrum disorder, a diverse group of conditions related to development of the brain. Although awareness and diagnosis have improved in recent years, the exact causes of autism have not been established, and it is understood there are multiple factors that can be involved.  

Extensive research has been undertaken over the past decade, including large-scale studies, looking into links between acetaminophen use during pregnancy and autism. At this time, no consistent association has been established. 

WHO recommends that all women continue to follow advice of their doctors or health workers, who can help assess individual circumstances and recommend necessary medicines. Any medicine should be used with caution during pregnancy, especially in the first three months, and in line with advice from health professionals. 

Also, a robust, extensive evidence base exists showing childhood vaccines do not cause autism. Large, high-quality  studies from many countries have all reached the same conclusion. Original studies suggesting a link were flawed and have been discredited. Since 1999, independent experts advising WHO have repeatedly confirmed that vaccines—including those with thiomersal or aluminum—do not cause autism or other developmental disorders.   

Childhood vaccine schedules are developed through a careful, extensive and evidence-based process involving global experts and country input. The childhood immunization schedule, carefully guided by WHO, has been adopted by all countries, and has saved at least 154 million lives over the past 50 years. The schedule remains essential for the health and wellbeing of every child and every community. These schedules have continually evolved with science and now safeguard children, adolescents and adults against 30 infectious diseases.  

Every vaccine recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE), an independent advisory group to WHO, is grounded in rigorous review of evidence and carefully designed to offer the best protection against serious diseases and to be delivered when most needed.   

When immunization schedules are delayed or disrupted, or altered without evidence review, there is a sharp increase in the risk of infection not only for the child, but also for the wider community. Infants too young to be vaccinated and people with weakened immune systems or underlying health conditions are at greatest risk.  

Autism and neurodevelopmental disorders are among priority mental health and neurological conditions being discussed at the 4th UN High-Level Meeting on NCDs and mental health this Thursday, 25 September.  As a global community, we need to do more to understand the causes of autism and how best to care for and support the needs of autistic people and their families.   

WHO is committed to advancing this goal working together with partners including autistic-led organizations and other organizations representing persons with lived experience. WHO also stands with people who are living with autism and their families, a dignified community entitled to evidence-based considerations free of stigma.

Source: World Health Organization, https://www.who.int/news/item/24-09-2025-who-statement-on-autism-related-issues

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Tuesday, September 9, 2025

Heterologous two-dose #Ebola #vaccine regimen in #pregnant women in #Rwanda: a randomized controlled phase 3 trial

 


Abstract

Risk of death for both mother and fetus following Ebola virus infection is extremely high. In this study, healthy women in Rwanda aged ≥18 years were randomized to two-dose Ebola vaccination (Ad26.ZEBOV, MVA-BN-Filo) during pregnancy (group A) or postpartum (group B). Unvaccinated pregnant group B women served as control. This was a parallel, randomized, controlled, open-label, single-center trial to evaluate the safety (primary endpoint—outcomes of interest and serious adverse events (SAEs)) and immunogenicity (secondary endpoint) of the two-dose Ebola vaccination. Among 3,484 women screened, 2,013 were randomized, and 2,012 women and 1,945 infants born alive were descriptively analyzed. Adverse outcomes of interest occurred in women (5.2% in group A and 7.3% in group B) and infants (26.0% in group A and 25.6% in group B). The most common maternal outcome of interest was pathways to preterm birth (3.2% in group A and 3.4% in group B), and the most common infant outcome of interest was small for gestational age (14.3% in group A and 11.8% in group B). Maternal/fetal and neonatal/infant SAE frequencies were comparable between groups (9.8% in group A, 9.0% in group B and 21.9% in group A, 15.9% in group B, respectively). Anti-Ebola virus glycoprotein-specific binding antibody response (secondary endpoint) was sustained in ≥90% of women at 1 year postdose 1. In group A, binding antibodies were detected in cord blood (99%) and infant serum (95%) samples 14 weeks postbirth. The trial met all primary and secondary objectives. Ad26.ZEBOV, MVA-BN-Filo did not raise concerns regarding adverse maternal/fetal or neonatal/infant outcomes, had no unexpected safety issues, and induced binding antibody responses in women and offspring through passive transfer. ClinicalTrials.gov registration: NCT04556526.

Source: Nature Medicine, https://www.nature.com/articles/s41591-025-03932-z

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Tuesday, September 2, 2025

#Placental transfer of #medications to treat #COVID19, #molnupiravir, #favipiravir and #nirmatrelvir/ritonavir, in the ex vivo human cotyledon model

 


Abstract

Objectives

There have been few studies in pregnant women of medications that are used to reduce severe complications from COVID-19 infection. Currently, nirmatrelvir/ritonavir (Paxlovid) is recommended by the National Institutes for Health to treat non-hospitalized pregnant patients with mild-to-moderate COVID-19 illness. The aim of this study was to determine the transplacental passage of molnupiravir, nirmatrelvir/ritonavir and favipiravir utilizing an ex vivo placental perfusion model.

Methods

Human placental cotyledons were continuously perfused in a double open circuit. The study molecules and antipyrine, a marker of placental viability, were dissolved in the maternal solution. The experiment was conducted over 90 minutes, and every 5 minutes, samples of the maternal solution and fetal exchange solutions were collected for analysis. We calculated the concentrations of study molecules, fetal transfer ratios and the clearance indexes to determine placental transfer.

Results

Of 18 placentas analysed, 14 were validated by antipyrine transfer. Nirmatrelvir alone had low placental transfer, with a fetal transfer ratio of 0.025. Its placenta transfer increased in the presence of ritonavir, with a fetal transfer ratio of 0.06. The molnupiravir metabolite, β-D-N-4-hydroxycytidine (EIDD 1931), showed low placental transfer, with an average fetal transfer ratio of 0.04. By contrast, favipiravir crossed the placenta with an average fetal transfer ratio of 0.425.

Conclusions

Placental transfer was high for the nucleoside analogue favipiravir, while it was low for molnupiravir and low for the protease inhibitor nirmatrelvir but increased by ritonavir. Clinical data are required to confirm the placental transfer and determine the safety of COVID antivirals in pregnancy.

Source: Journal of Antimicrobial Chemotherapy, https://academic.oup.com/jac/advance-article-abstract/doi/10.1093/jac/dkaf302/8245204?redirectedFrom=fulltext

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Wednesday, April 30, 2025

#SARS-CoV-2, the #human #placenta, and adverse perinatal #outcomes

Abstract

The relationship among timing and severity of COVID-19 during pregnancy, placental pathology, and adverse pregnancy outcomes is not well understood. A prospective cohort study of 497 pregnant patients with COVID-19 whose placentas underwent systematic pathologic examination was conducted. The main exposure was timing of COVID-19 during pregnancy (first/second versus third trimester). The primary outcome was composite placental pathology that included high grade maternal vascular malperfusion or greater than 25 percent perivillous fibrin deposition. There were 63 patients who had the composite placental pathology outcome. In adjusted analyses that controlled for maternal age, parity, active infection at delivery, interval from time of diagnosis to delivery and COVID-19 variant, timing of COVID-19 during pregnancy was not associated with risk of the composite placental pathology outcome. Among secondary COVID-19 related exposures that were investigated, severity of disease and treatment for COVID-19 were associated with risk of the composite placental pathology outcome. In addition, patients with COVID-19 in the first nine months of the pandemic had the highest rate of the composite placental pathology outcome. In this large cohort, placental vascular pathology was common among COVID-19 cases but was unrelated to timing of COVID-19 during pregnancy or adverse pregnancy outcomes. These findings suggest that uncomplicated COVID-19 during pregnancy does not require intensive fetal surveillance or detailed pathologic examination of the placenta after delivery.

Source: American Journal of Pathology, https://ajp.amjpathol.org/article/S0002-9440(25)00150-6/abstract?rss=yes

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Saturday, April 19, 2025

Insights into the #clinical and molecular #epidemiology of an infections #outbreak of human #parvovirus B19 in #France, 2023-2024

Highlights

• A large B19V French outbreak of an unexpected magnitude occurred, with a monthly rate that has reached 21.4%.

• During this outbreak, 50% of infected pregnant women exhibited fetal complications.

• Phylogenetic analysis revealed the co-circulation of several B19V lineages of genotype 1a, the main epidemic lineage of which emerged in 2017.


Abstract

Background

The human parvovirus B19 (B19V) infections cycle occurs in 3- to 4-year periods and is responsible for benign childhood erythema infectiosum. It is also associated with transient aplastic crisis in patients with underlying hemolytic diseases and with severe fetal sometimes fatal infection. This study investigated the epidemiological, clinical and molecular characteristics of an unusually large 2023-2024 outbreak of B19V.

Methods.

Laboratory-confirmed cases were retrospectively and prospectively recorded at the Clermont-Ferrand University Hospital, France, between January, 2018 and November, 2023 and between December 2023 and May 2024 (2023/2024), respectively. Demographical and clinical data were investigated for the 2023/2024 period. Subgenome sequences (2,690 nt) were obtained by next generation sequencing for virus genotyping and temporal molecular analysis.

Results

The positive rate of B19V positive laboratory-confirmed cases was seven times higher between December 2023 and May 2024 than in the previous 5-year period (14.6% vs 2.1%, p<0.001). No atypical clinical presentation or increased pathogenicity were observed, but this large outbreak resulted in a higher number of severe infections in pregnant women (8/16, 50.0% of fetal complications) and those with chronic anemia. Phylogenetic analysis revealed that the 2023/2024 outbreak in France and Europe was mainly driven by a pre-existing lineage of B19V 1a subgenotype that emerged in 2017 (95% highest posterior density interval: 2000-2018).

Conclusions

The recent epidemic of B19V infections re-illustrates the immunity gap of the post-pandemic COVID-19 pandemic. This highlight the impact of any outbreak on at-risk population and the need for a more global and genomic surveillance.

Source: Journal of Clinical Virology, https://www.sciencedirect.com/science/article/pii/S138665322500040X?dgcid=rss_sd_all

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Tuesday, March 11, 2025

#Congenital #Oropouche in #Humans: Clinical Characterization of a Possible New #Teratogenic Syndrome

Abstract

Oropouche fever is caused by the Oropouche virus (OROV; Bunyaviridae, Orthobunyavirus), one of the most frequent arboviruses that infect humans in the Brazilian Amazon. This year, an OROV outbreak was identified in Brazil, and its vertical transmission was reported, which was associated with fetal death and microcephaly. We describe the clinical manifestations identified in three cases of congenital OROV infection with confirmed serology (OROV-IgM) in the mother-newborn binomial. One of the newborns died, and post-mortem molecular analysis using real-time RT-qPCR identified the OROV genome in several tissues. All three newborns were born in the Amazon region in Brazil, and the mothers reported fever, rash, headache, myalgia, and/or retro-orbital pain during pregnancy. The newborns presented with severe microcephaly secondary to brain damage and arthrogryposis, suggestive of an embryo/fetal disruptive process at birth. Brain and spinal images identified overlapping sutures, cerebral atrophy, brain cysts, thinning of the spinal cord, corpus callosum, and posterior fossa abnormalities. Fundoscopic findings included macular chorioretinal scars, focal pigment mottling, and vascular attenuation. The clinical presentation of vertical OROV infection resembled congenital Zika syndrome to some extent but presents some distinctive features on brain imaging and in several aspects of its neurological presentation. A recognizable syndrome with severe brain damage, neurological alterations, arthrogryposis, and fundoscopic abnormalities can be associated with in utero OROV infection.

Source: Viruses, https://www.mdpi.com/1999-4915/17/3/397

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Friday, December 13, 2024

Systematic #Review of Avian #Influenza Virus #Infection and #Outcomes during #Pregnancy

 Source: US National Library of Medicine, https://pubmed.ncbi.nlm.nih.gov/39668388/ 


Abstract

Human cases of avian influenza A(H5N2) and A(H5N1) viruses associated with outbreaks in birds and mammals are increasing globally, raising concerns about the possibility of a future avian influenza pandemic. We conducted a systematic review examining 30 reported cases of avian influenza in pregnant women. We found high mortality rates for mothers (90.0%, 27/30) and their babies (86.7%, 26/30) when women were infected with avian influenza virus during pregnancy. Despite being a high-risk population and having worse health outcomes across multiple pandemics, pregnant women are often excluded from vaccine trials. However, as the risk for a new pandemic increases and human vaccines against avian influenza are developed, early inclusion of pregnant women in clinical trials can inform the risk-benefit analysis for both the mother and their newborn infant. Early inclusion of pregnant women in public health vaccination programs is vital for protecting this high-risk population.

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