Is the Immunization of Pregnant Women against COVID-19 Justified?

Maternal immunization against some infectious diseases can offer significant advantages for women, preventing maternal morbidity and mortality, or for offspring, preventing fetal disease and conferring passive immunity to neonates. Recently, clinical trials specifically to evaluate the immunogenicity, safety, and tolerability of some of the available coronavirus disease 2019 (COVID-19) vaccines in pregnant and lactating women have been planned, initiated and, in some cases, completed. This paper discusses whether the immunization of pregnant women against COVID-19 is justified and presents knowledge about the immunogenicity and safety of mRNA COVID-19 vaccines for these subjects. The results of recent studies indicate that pregnant women are at increased risk of developing severe disease compared with nonpregnant women of the same age. Studies carried out with mRNA vaccines indicate that the immunogenicity, safety and tolerability of these preventive measures in pregnant women are not different from those in nonpregnant women of the same age. Moreover, antibodies are efficiently transferred through the placenta and can be detected in breastmilk, suggesting a potential prevention of infection in the child. All these findings authorize the use of mRNA vaccines in pregnant women to protect both the mother and the child. However, further studies with larger sample size and with follow-up of the pregnant women vaccinated during different periods of pregnancy and their children are needed to better characterize the immune response of pregnant women, to define when these vaccines should be administered to obtain the best protection, and to measure vaccine efficacy against virus variants in both mothers and infants. COVID-19 vaccines based on different technological platforms cannot presently be used, and their role in pregnant women should be clarified.

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Safety of COVID-19 vaccines, their components or their platforms for pregnant women: A rapid review

10.1101/2021.06.03.21258283 ◽

2021 ◽

Author(s):

Agustin Ciapponi ◽

Ariel Bardach ◽

Agustina Mazzoni ◽

Tomas Alconada ◽

Steven A. Anderson ◽

...

Keyword(s):

Pregnant Women ◽

Messenger Rna ◽

Viral Vector ◽

Severe Disease ◽

Rapid Review ◽

Virus Protein ◽

Safety Concerns ◽

Increased Risk ◽

Syncytial Virus ◽

Technological Platforms

Background Pregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed. Methods We conducted a rapid review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO- CRD42021234185). We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period. Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus. Results We identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included. Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) from Pfizer & Moderna COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) -corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. Conclusion This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG in August 2020 or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

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Impact of educational intervention regarding anaemia and its preventive measures among pregnant women: an interventional study

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20175137 ◽

2017 ◽

Vol 6 (12) ◽

pp. 5317 ◽

Cited By ~ 1

Author(s):

Pankajkumar B. Nimbalkar ◽

Jaldhara N. Patel ◽

Nilesh Thakor ◽

Mansi Patni

Keyword(s):

Pregnant Women ◽

Preventive Measures ◽

Signs And Symptoms ◽

Contributory Factor ◽

Interventional Study ◽

Post Intervention ◽

Medical College ◽

Maternal Morbidity And Mortality ◽

Before And After ◽

Baseline Knowledge

Background: Iron deficiency anaemia (IDA) is the most common nutritional deficiency in pregnancy and major contributory factor to maternal morbidity and mortality. Objective of present study was to assess knowledge of pregnant women regarding anaemia and its preventive measures before and after educational interventional training.Methods: The present study was an interventional study undertaken in purposively selected pregnant women attending the out patient Department of Obstetrics and Gynecology Department of GMERS Medical College, Gandhinagar During the month of October 2017. Total 100 pregnant women were included after written informed consent. Baseline knowledge of pregnant women regarding anaemia and its preventive measures was assessed by pre-designed, pre-tested and semi structured questionnaire. Single educational interventional training for 45 minutes was given to selected pregnant women. Post– intervention knowledge of pregnant women for the same was assessed after training. Thus, collected data was analyzed /using Epi info 7.Results: Baseline knowledge of the pregnant women regarding causes, signs and symptoms of anemia and dietary sources of iron was 21%, 23% and 40% respectively which was significantly increased to 64%, 66% and 72% respectively after the intervention. Baseline knowledge of the pregnant women regarding factors which inhibit and increase iron absorption was 25% and 4% respectively which was significantly increased to 55% and 41 % respectively after the intervention. Baseline knowledge of the pregnant women regarding treatment of anaemia was 30% which was significantly increased to 79 % after the intervention.Conclusions: There was significant improvement in the knowledge regarding anaemia and its preventive measures among pregnant women after our single educational session.

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Early Description of Coronavirus 2019 Disease in Kidney Transplant Recipients in New York

Journal of the American Society of Nephrology ◽

10.1681/asn.2020030375 ◽

2020 ◽

Vol 31 (6) ◽

pp. 1150-1156 ◽

Cited By ~ 80

Author(s):

Keyword(s):

New York ◽

Kidney Transplant ◽

Severe Disease ◽

Treatment Protocol ◽

Current Treatment ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Radiographic Findings ◽

Increased Risk

BackgroundThe novel SARS-CoV-2 virus has caused a global pandemic of coronavirus disease 2019 (COVID-19). Although immunosuppressed individuals are thought to be at an increased risk of severe disease, little is known about their clinical presentation, disease course, or outcomes.MethodsWe report 15 kidney transplant recipients from the Columbia University kidney transplant program who required hospitalization for confirmed COVID-19, and describe their management, clinical course, and outcomes.ResultsPatients presented most often with a fever (87%) and/or cough (67%). Initial chest x-ray most commonly showed bilateral infiltrates, but 33% had no acute radiographic findings. Patients were managed with immunosuppression reduction and the addition of hydroxychloroquine and azithromycin. Although 27% of our patients needed mechanical ventilation, over half were discharged home by the end of follow-up.ConclusionsKidney transplant recipients with COVID-19 have presentations that are similar to that of the general population. Our current treatment protocol appears to be associated with favorable outcomes, but longer follow-up of a larger cohort of patients is needed.

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20 Years of Follow-up Alloimmunization and Hemolytic Disease in Newborn: Has Anything Changed in the Field Over the Years?

Klinische Pädiatrie ◽

10.1055/a-1248-2329 ◽

2020 ◽

Vol 232 (06) ◽

pp. 314-320

Author(s):

Marjana Jerkovic Raguz ◽

Zeljka Prce ◽

Vedran Bjelanovic ◽

Ivana Bjelanovic ◽

Sanja Dzida ◽

...

Keyword(s):

Pregnant Women ◽

Preventive Measures ◽

Newborn Infants ◽

Significant Progress ◽

Hemolytic Disease ◽

The West ◽

The Past ◽

Precautionary Measures ◽

In Pregnancy

Abstract Objective of the study is to research the epidemiological aspects of maternal alloimmunization against erythrocyte antigens of fetuses (AB0, Rhesus, Lewis, Kell, Duffy and others) and to identify the most common types of hemolytic disease of the newborn (HDN) in the West Herzegovina region. Study Design The 20-year retrospective epidemiological study includes all pregnant women who had been immunologically tested and newborn treated for HDN. Results The indirect antiglobulin (IAT) detected antibodies against antigens in 545 (1.8%) pregnant women of the 29 663 who were tested at the Department of Transfusion Medicine. During the 20-year-long study 310 (1.0%) newborn with HDN were treated. Our results indicate that 42% (230/545) of the pregnant women had AB0 immunization. The most common form of HDN is AB0 HDN 64% (199/310), whereas RhD HDN was treated in 19% (59/310) of the newborn infants. ETR was performed on 29 (19%) infants, 21 (72.4%) with AB0 HDN, and 7 (26%) with RhD HDN. Conclusion This 20-year-long study concludes that, even though there has been significant progress in the prevention of immunization and proactive treatment of HDN, precautionary measures are still required as is the need for gynecologists and obstetricians to be active. The reasons for this are the non-existence of preventive measures for non-RhD immunization, the irregular immunological screening of RhD positive women in pregnancy in the region encompassed by the study in the past few years. The above raises new questions and recommends further research and monitoring of immunization and HDN treatment worldwide.

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Determinants of weight gain in pregnant women attending a public prenatal care facility in Rio de Janeiro, Brazil: a prospective study, 2005-2007

Cadernos de Saúde Pública ◽

10.1590/s0102-311x2008001400012 ◽

2008 ◽

Vol 24 (suppl 2) ◽

pp. s272-s284 ◽

Cited By ~ 13

Author(s):

Patricia Lima Rodrigues ◽

Elisa Maria de Aquino Lacerda ◽

Michael Maia Schlüssel ◽

Maria Helena Constantino Spyrides ◽

Gilberto Kac

Keyword(s):

Weight Gain ◽

Prenatal Care ◽

Regression Model ◽

Pregnant Women ◽

Rio De Janeiro ◽

Family Income ◽

Care Facility ◽

Multiple Linear Regression Model ◽

Increased Risk

The objective of this study was to evaluate the determinants of weight gain during pregnancy. The study adopted a prospective cohort design with four follow-up waves and included a sample of 255 pregnant women that received prenatal care at a public health care facility in Rio de Janeiro, Brazil. A mixed-effects linear longitudinal regression model was used, having as the dependent variable the weight assessed in four follow-up waves, and as independent variables: demographic, socioeconomic, reproductive, behavioral, and nutritional data. Mean weight gain was 0.413kg per gestational week, consistent with recommendations by the Institute of Medicine. Per capita family income and smoking were associated with total weight gain during gestation. According to the longitudinal multiple linear regression model, age (² = 0.6315), menarche (² = -2.3861), triglycerides (² = 0.0437), blood glucose (² = 0.1544), and adequacy of energy consumption (² = -0.0642) were associated with gestational weight gain. Special attention should be given to these sub-groups, due to increased risk of excessive weight gain.

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Management of pregnant women in times of COVID-19 our experience from Kashmir valley

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20210988 ◽

2021 ◽

Vol 10 (4) ◽

pp. 1379

Author(s):

Syed Naseer ◽

Syed Uzma Andrabi ◽

Syed Ishfa Andrabi ◽

Humaira Tabasum

Keyword(s):

Pregnant Women ◽

Severe Disease ◽

Virus Transmission ◽

Safe Motherhood ◽

Normal Vaginal Delivery ◽

Global Public Health ◽

Transmission Potential ◽

Medical College ◽

Global Pandemic ◽

Increased Risk

Background: The coronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus 2, is a global public health emergency. COVID-19 is a rapidly evolving situation, and there is limited data reporting its impact on pregnant women. Our study aimed to find the symptomatology, clinical courses and outcome of pregnant women with COVID-19 and to assess the vertical transmission potential of COVID-19 in pregnancy.Methods: This prospective observational study was conducted at Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Medical College, Department of Gynaecology and obstetrics, Srinagar from May 2020 to September 2020. All COVID-19 positive pregnant patients admitted in our institution were included in our study.Results: The study included 100 Covid-19 positive pregnant women. Most of them were between 30 to 40 years of age. Median gestational age was 32.8 weeks. Comorbidity was present in 18 of our patients. 7 patients had gestational diabetes and 1 with overt diabetes, 5 were hypertensive, 3 had hypothyroidism, 1 with anti-phospholipid antibody syndrome (APLA) and 1 with asthma.44 patients were primigravidae and 56 were multigravidae. 27 patients delivered preterm and 44 with term pregnancy. 47 had undergone caesarean section and 24 normal vaginal delivery.88% of our patients were asymptomatic for covid-19 disease while as 12 patients had Covid-19 disease symptoms. The main complaints reported by patients related to covid-19 disease was mild dry cough and fever (9%). Two patients developed severe covid-19 pneumonia with ARDS and were put on ventilator, expired after 20 days of illness. All neonates were subjected to RT-PCR with none producing positive results.Conclusions: Appropriate and timely management of Covid-19 positive pregnant women is a principle for safe motherhood and healthy offspring in times of global pandemic. The present data do not suggest an increased risk of severe disease among pregnant women. We encourage the breast feeding immediately after delivery as benefits overweigh any potential risks of virus transmission if any.

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An Epidemiological Cohort Study of SARS-CoV-2 and COVID-19 in German Healthcare Workers – Interim Analysis after Six Months of Follow-up

10.21203/rs.3.rs-688656/v1 ◽

2021 ◽

Author(s):

Stephan Gehring ◽

Omar Okasha ◽

Frank Kowalzik ◽

Tobias Engelmann ◽

Daniel Schreiner ◽

...

Keyword(s):

Healthcare Workers ◽

Natural Infection ◽

Severe Disease ◽

Smartphone Application ◽

Case Definitions ◽

Humoral Immune ◽

Increased Risk ◽

Transmission Period ◽

Incident Cases

Abstract BackgroundHealthcare workers (HCWs) are at increased risk of SARS-CoV-2 infection. We assessed incidence of SARS-CoV-2 infection and COVID-19 before the roll out of COVID-19 vaccines in a cohort of HCWs in Mainz, Germany.MethodsUsing prospective observational cohort design, antibody status was assessed at baseline and every 6 weeks (±2 weeks). Daily self-reported COVID-19 symptoms were collected using a smartphone application. Symptomatic HCWs were tested using RT-PCR. We estimated symptomatic and asymptomatic SARS-CoV-2 infection rates based on two case definitions of varying sensitivity and specificity.Results3664 HCWs were enrolled with a median follow-up of 101 days. The seroprevalence of anti-SARS-CoV-2 antibodies increased from 2.7% at baseline to 3.8%, with the number of seroconversions (65) outweighing seroreversions (26) by end of follow-up. Among HCWs who seroconverted, 12 (~19%) did not report any symptoms. The estimated incidence rate was 4.5 per 1000 person-months, but none the incident cases developed severe disease. Anti-SARS-CoV-2 antibodies fell below diagnostic cut-off value in a third of those positive at baseline and in one incident case.ConclusionsWe observed increasing COVID-19 rates among HCWs during an accelerated community transmission period, with relatively lower rate of asymptomatic infections. Our findings indicate a relatively long-lasting humoral immune response following natural infection.

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Transition to severe phenotype in systemic lupus erythematosus initially presenting with non-severe disease: implications for the management of early disease

Lupus Science & Medicine ◽

10.1136/lupus-2020-000394 ◽

2020 ◽

Vol 7 (1) ◽

pp. e000394 ◽

Cited By ~ 1

Author(s):

Dionysis S Nikolopoulos ◽

Myrto Kostopoulou ◽

Antigoni Pieta ◽

Sofia Flouda ◽

Katerina Chavatza ◽

...

Keyword(s):

Lupus Erythematosus ◽

Disease Duration ◽

Severe Disease ◽

Irreversible Damage ◽

Mild Phenotype ◽

Double Stranded Dna ◽

Increased Risk ◽

Damage Accrual ◽

Baseline Factors

ObjectiveChanges in the care of patients with SLE dictate a re-evaluation of its natural history and risk factors for disease deterioration and damage accrual. We sought to decipher factors predictive of a deterioration in phenotype (‘transition’) in patients initially presenting with non-severe disease.MethodsPatients from the ‘Attikon’ cohort with disease duration ≥1 year were included. Disease at diagnosis was categorised as mild, moderate or severe, based on the British Isles Lupus Assessment Group manifestations and physician judgement. ‘Transition’ in severity was defined as an increase in category of severity at any time from diagnosis to last follow-up. Multivariable logistic regression was performed to identify baseline factors associated with this transition.Results462 patients were followed for a median (IQR) of 36 (120) months. At diagnosis, more than half (56.5%) had a mild phenotype. During disease course, transition to more severe forms was seen in 44.2%, resulting in comparable distribution among severity patterns at last follow-up (mild 28.4%, moderate 33.1%, severe 38.5%). Neuropsychiatric involvement at onset (OR 6.33, 95% CI 1.22 to 32.67), male sex (OR 4.53, 95% CI 1.23 to 16.60) and longer disease duration (OR 1.09 per 1 year, 95% CI 1.04 to 1.14) were independently associated with transition from mild or moderate to severe disease. Patients with disease duration ≥3 years who progressed to more severe disease had more than 20-fold increased risk to accrue irreversible damage.ConclusionAlmost half of patients with initially non-severe disease progress to more severe forms of SLE, especially men and patients with positive anti-double-stranded DNA or neuropsychiatric involvement at onset. These data may have implications for the management of milder forms of lupus.

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Risk factors for recurrent wheezing after bronchiolitis in infants: 2-year follow up in China

BMC Infectious Diseases ◽

10.1186/s12879-021-05937-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sainan Chen ◽

Wenjing Gu ◽

Min Wu ◽

Chuangli Hao ◽

Canhong Zhu ◽

...

Keyword(s):

Risk Factors ◽

Risk Factor ◽

Independent Risk Factor ◽

Severe Disease ◽

Recurrent Wheezing ◽

Increased Risk ◽

Tnf Α ◽

History Of ◽

Outpatient Appointments

Abstract Background Infants with bronchiolitis have an increased risk of developing recurrent wheezing and asthma. However, the risk factors for the development of recurrent wheezing after bronchiolitis remains controversial. Our study was to investigate risk factors of post-bronchiolitis recurrent wheezing. Methods Infants with bronchiolitis were enrolled from November 2016 through March 2017. Nasopharyngeal aspirates were obtained for detection of respiratory viruses which were analyzed by reverse transcriptase polymerase chain reaction (RT-PCR) and direct immunofluorescent assay. Serum cytokines including TSLP, IL2, IL13, TIMP-1, MMP-9, IL33, IL5, IL4, IL25, TNF- α and MIP-1α were measured by flow cytometry. Patients were followed up every 3 months for a duration of 2 years by telephone or at outpatient appointments. Results We enrolled 89 infants, of which 81 patients were successfully followed up. In total, 22.2% of patients experienced recurrent wheezing episodes. The proportion of patients with history of eczema, systemic glucocorticoid use and patients with moderate-to-severe disease were significantly higher in the recurrent wheezing group than the non-recurrent wheezing group (83.3% vs 52.4%; 66.7% vs 36.5%; 61.1% vs 33.3%, respectively, all P < 0.05); There were no significant differences between patients with and without recurrent wheezing episodes in the levels of TSLP, IL2, IL13, TIMP-1, MMP-9, IL33, IL5, IL4, IL25, TNF- α and MIP-1α (P > 0.05). Logistic regression analysis showed that history of eczema was an independent risk factor for post-bronchiolitis recurrent wheezing (odds ratio [OR] = 5.622; 95% confidence interval [CI], 1.3–24.9; P = 0.023). Conclusion The incidence of recurrent wheezing among infants after contracting bronchiolitis was 22.2% during a 2-year follow-up. History of eczema was the only independent risk factor identified and no correlation was found between the specific virus and disease severity in children with post-bronchiolitis recurrent wheezing.

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SARS-CoV-2 infections in people with PCD: neither frequent, nor particularly severe

10.1101/2020.12.20.20248420 ◽

2020 ◽

Author(s):

Eva SL Pedersen ◽

Myrofora Goutaki ◽

Amanda L Harris ◽

Lucy Dixon ◽

Michele Manion ◽

...

Keyword(s):

Incidence Rate ◽

Severe Symptom ◽

Demographic Data ◽

Severe Disease ◽

Median Number ◽

Disease Course ◽

Increased Risk ◽

Using Data ◽

Ciliary Dyskinesia

AbstractPeople with pre-existing chronic health conditions are reportedly at high risk of getting the coronavirus disease (COVID-19) and of having a severe disease course but little data exist on rare diseases such as Primary Ciliary Dyskinesia (PCD). We studied risk and severity of SARS-CoV-2 infections among people with PCD using data from the COVID-PCD, a participatory study that collects data in real-time directly from people with PCD. Data was collected using online questionnaires. A baseline questionnaire collected information on demographic data, information about the PCD diagnosis and severity. A short weekly questionnaire collected information about current symptoms and incident SARS-CoV-2 infections. 578 people participated in the COVID-PCD by December 7, 2020, with a median number of follow-up weeks of 9 (interquartile range: 4-19 weeks). 256 (45%) of the participants had been tested for SARS-CoV-2 and 12 tested positive prior to study entry or during study follow up (2.1% of the total included population, 95% confidence interval (CI) 1.1-3.6%). 4 people tested positive during the study follow-up, corresponding to an incidence rate of 2.5 per 100 person-years (95% CI: 0.9-6.5). Overall, reported severity was mild with two reporting no symptoms, eight reporting mild symptoms, one reporting severe symptom without hospitalisation, and one reporting hospitalisation for 9 days. The study suggests that with careful personal protection, people with PCD do not seem to have an increased risk of infection with SARS-COV-2, nor an especially severe disease course.Take home messageIn this longitudinal study of people with PCD followed weekly via online questionnaires, the incidence rate of COVID-19 and the proportion of participants infected were low, and the observed severity mostly mild.

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