scholarly journals Breastfeeding Mother and Child Clinical Outcomes After COVID-19 Vaccination

2021 ◽  
pp. 089033442110565
Author(s):  
Jia Ming Low ◽  
Le Ye Lee ◽  
Yvonne Peng Mei Ng ◽  
Youjia Zhong ◽  
Zubair Amin
Keyword(s):  
Adverse Effects ◽  
Study Protocol ◽  
Messenger Rna ◽  
Hospital Admissions ◽  
Vaccine Dose ◽  
Common Side Effect ◽  
Short Term ◽  
Serious Adverse Events ◽  
Axillary Lymphadenopathy ◽  
Breastfed Infants

Background: Pre-approval clinical trials of the Pfizer/BioNTech messenger RNA COVID-19 vaccine, BNT162b2 did not include participants who were breastfeeding. Therefore, there is limited evidence about outcomes of breastfeeding mother–child dyads and effects on breastfeeding after vaccination. Research Aims: To determine: (1) solicited adverse effects (e.g., axillary lymphadenopathy, mastitis, and breast engorgement), which are unique to lactating individuals; and (2) systemic and local adverse effects of COVID-19 mRNA vaccine on mothers and potential effects on their breastfed infants. Method: This was a prospective cohort study of lactating healthcare workers ( N = 88) in Singapore who received two doses of BNT162b2 vaccination (Pfizer/BioNTech). The outcomes of mother–child dyads within 28 days after the second vaccine dose were determined through a participant-completed questionnaire. Results: Minimal effects related to breastfeeding were reported by this cohort; three of 88 (3.4%) participants had mastitis, one (1.1%) participant experienced breast engorgement, five of 88 (5.7%) participants reported cervical or axillary lymphadenopathy. There was no change in human milk supply after vaccination. The most common side effect was pain/redness/swelling at the injection site, which was experienced by 57 (64.8%) participants. There were no serious adverse events of anaphylaxis or hospital admissions. There were no short-term adverse effects reported in the infants of 67 lactating participants who breastfed within 72 hr after BNT162b2 vaccination. Conclusions: BNT162b2 vaccination was well tolerated in lactating participants and was not associated with short-term adverse effects in their breastfed infants. Study Protocol Registration: The study protocol was registered at clinicaltrials.gov (NCT04802278).

scholarly journals Breastfeeding mother-child clinical outcomes after COVID-19 vaccination

2021 ◽  
Author(s):  
Jia Ming Low ◽  
Le Ye Lee ◽  
Yvonne Peng Mei Ng ◽  
Youjia Zhong ◽  
Zubair Amin
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Side Effect ◽  
Prospective Cohort ◽  
Hospital Admissions ◽  
Vaccine Dose ◽  
Common Side Effect ◽  
Serious Adverse Events ◽  
Lactating Women ◽  
Structured Questionnaire

This is a prospective cohort study of 88 lactating women in Singapore who received two doses of BNT162b2 vaccination (Pfizer/BioNTech), whereby outcomes of mother-child dyads within 28 days after the second vaccine dose were determined through a structured questionnaire. Minimal effects related to breastfeeding were reported in this cohort; 3 of 88 (3.4%) women had mastitis with 1 of 88 (1.1%) women experiencing breast engorgement. We report an incidence of lymphadenopathy in our cohort at 5 of 88 (5.7%). Reassuringly, there was no change in reported breastmilk supply after vaccination. The most common side effect was pain/redness/swelling at the injection site, which was experienced by 57 of 88 (64.8%) women. There were no serious adverse events of anaphylaxis and hospital admissions. No adverse symptoms were reported in 67 of 88 (76.1%) breastfed children.

scholarly journals COVID-19 and autoinflammatory diseases: prevalence and outcomes of infection and early experience of vaccination in patients on biologics

2021 ◽  
Vol 5 (2) ◽  
Author(s):  
Claire J Peet ◽  
Charalampia Papadopoulou ◽  
Bella Ruth M Sombrito ◽  
Michael R Wood ◽  
Helen J Lachmann
Keyword(s):  
Messenger Rna ◽  
Autoinflammatory Disease ◽  
Hospital Admissions ◽  
Biologic Therapy ◽  
Safety Data ◽  
Underlying Disease ◽  
Autoinflammatory Diseases ◽  
Serious Adverse Events ◽  
Web Based ◽  
Survey Responses

Abstract Objectives The systemic autoinflammatory diseases are rare conditions; to date, data on coronavirus disease 2019 (COVID-19) infection and vaccination safety are scarce. Agents targeting innate immune pathways have transformed the management of affected patients, and their outcomes are of wider interest given the role of inflammation in both viral clearance and severe COVID-19 disease. We surveyed patients with systemic autoinflammatory disease on biologic therapy to determine the prevalence and outcomes of COVID-19 infection and to gather early safety data on vaccination. Methods Electronic medical records of 248 patients with systemic autoinflammatory disease on biologic therapy at a national centre were reviewed. Patients were then surveyed in clinic or using a Web-based survey. Results In the cohort of 248 patients, no deaths were recorded. One hundred and seventy-five survey responses were received. Among the respondents, 27 reported suspected COVID-19 infection, of which 14 were confirmed by testing (8.0%). Two patients required hospital admission owing to dehydration. No patient required respiratory support or intensive care. One hundred and thirty-eight doses of COVID-19 vaccine had been administered to 130 patients. Side effects were reported after 71 of 138 (51.4%) administrations and were consistent with a flare of the underlying disease in 26 of 138 (18.8%) instances. No serious adverse events or hospital admissions were reported after vaccination. Conclusion These data, including the largest published series of patients on anti-IL-1/6 biologics to receive any adenoviral vector or messenger RNA vaccine, show no serious early concerns regarding vaccination and will provide an urgently needed resource to inform decision-making of these patients and their clinicians.

scholarly journals Self-reported safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among Iranian people with multiple sclerosis

2021 ◽  
Author(s):  
Masoud Etemadifar ◽  
Amir Parsa Abhari ◽  
Hosein Nouri ◽  
Amirhossein Akhavan Sigari ◽  
Seyed Mohammad Piran Daliyeh ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Regression Model ◽  
Vaccine Dose ◽  
Short Term ◽  
Multivariable Logistic Regression Model ◽  
Serious Adverse Events ◽  
Post Vaccination ◽  
Neurological Event ◽  
Vaccination Hesitancy

To affirm the short-term safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among people with multiple sclerosis (pwMS), 517 vaccinated and 174 unvaccinated pwMS were interviewed. 16.2% of the vaccinated pwMS reported at least one neurological event in their respective at-risk periods (ARP), a period from the first until two weeks after the second vaccine dose. In a multivariable logistic regression model, presence of comorbidities (P = 0.01), being on natalizumab (P = 0.03), and experiencing post-vaccination myalgia (P < 0.01) predicted the development of post-vaccination neurological symptoms. One MS relapse, one COVID-19 contraction, and one ulcerative colitis flare after the first, and five MS relapses after the second dose, were the only reported serious adverse events during the ARPs. A multivariable Poisson regression model accounting for possible confounders failed to show any statistically-significant increase in relapse rates during the ARPs of vaccinated, compared to the prior year of unvaccinated pwMS (P = 0.78). Hence, the BBIBP-CorV vaccine does not seem to affect short-term MS activity. Furthermore, as 83.33% of the unvaccinated pwMS reported fear of possible adverse events to be the reason of their vaccination hesitancy; hence, provision of misinformed pwMS with evidence-based consultations in this regard is encouraged.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Oil pollution and fisheries

1982 ◽  
Vol 297 (1087) ◽  
pp. 401-411 ◽  
Keyword(s):  
Water Quality ◽  
Adverse Effects ◽  
Oil Pollution ◽  
Coastal Areas ◽  
Short Term ◽  
Fish Stocks ◽  
Local Impacts ◽  
Reduced Water ◽  
Long Term Adverse Effects

The term ‘pollution’ is taken in its broadest sense and effects are recognized to be due to interference, tainting and toxicity. Each of these types of impact is discussed and assessed. It is concluded that no long-term adverse effects on fish stocks can be attributed to oil but that local impacts can be extremely damaging in the short term and that produce from specific localities can be tainted and unmarketable for long periods. In some coastal areas oil can be one among several contributors to reduced water quality, and the implications of this are discussed.

scholarly journals Spatio-temporal associations of air pollutant concentrations, GP respiratory consultations and respiratory inhaler prescriptions: a 5-year study of primary care in the borough of Lambeth, South London

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Mark Ashworth ◽  
◽  
Antonis Analitis ◽  
David Whitney ◽  
Evangelia Samoli ◽  
...  
Keyword(s):  
Primary Care ◽  
Negative Binomial ◽  
Hospital Admissions ◽  
Air Pollutant ◽  
Respiratory Morbidity ◽  
Short Term ◽  
Short Term Exposure ◽  
Short And Long Term ◽  
Spatio Temporal

Abstract Background Although the associations of outdoor air pollution exposure with mortality and hospital admissions are well established, few previous studies have reported on primary care clinical and prescribing data. We assessed the associations of short and long-term pollutant exposures with General Practitioner respiratory consultations and inhaler prescriptions. Methods Daily primary care data, for 2009–2013, were obtained from Lambeth DataNet (LDN), an anonymised dataset containing coded data from all patients (1.2 million) registered at general practices in Lambeth, an inner-city south London borough. Counts of respiratory consultations and inhaler prescriptions by day and Lower Super Output Area (LSOA) of residence were constructed. We developed models for predicting daily PM2.5, PM10, NO2 and O3 per LSOA. We used spatio-temporal mixed effects zero inflated negative binomial models to investigate the simultaneous short- and long-term effects of exposure to pollutants on the number of events. Results The mean concentrations of NO2, PM10, PM2.5 and O3 over the study period were 50.7, 21.2, 15.6, and 49.9 μg/m3 respectively, with all pollutants except NO2 having much larger temporal rather than spatial variability. Following short-term exposure increases to PM10, NO2 and PM2.5 the number of consultations and inhaler prescriptions were found to increase, especially for PM10 exposure in children which was associated with increases in daily respiratory consultations of 3.4% and inhaler prescriptions of 0.8%, per PM10 interquartile range (IQR) increase. Associations further increased after adjustment for weekly average exposures, rising to 6.1 and 1.2%, respectively, for weekly average PM10 exposure. In contrast, a short-term increase in O3 exposure was associated with decreased number of respiratory consultations. No association was found between long-term exposures to PM10, PM2.5 and NO2 and number of respiratory consultations. Long-term exposure to NO2 was associated with an increase (8%) in preventer inhaler prescriptions only. Conclusions We found increases in the daily number of GP respiratory consultations and inhaler prescriptions following short-term increases in exposure to NO2, PM10 and PM2.5. These associations are more pronounced in children and persist for at least a week. The association with long term exposure to NO2 and preventer inhaler prescriptions indicates likely increased chronic respiratory morbidity.

scholarly journals Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand

Vaccines ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 3
Author(s):  
Zoltán Kis ◽  
Cleo Kontoravdi ◽  
Robin Shattock ◽  
Nilay Shah
Keyword(s):  
Production Process ◽  
Messenger Rna ◽  
Vaccination Campaign ◽  
Vaccine Dose ◽  
Economic Feasibility ◽  
Small Scale ◽  
Production Scale ◽  
Working Volume ◽  
Global Demand ◽  
The Impact

To overcome pandemics, such as COVID-19, vaccines are urgently needed at very high volumes. Here we assess the techno-economic feasibility of producing RNA vaccines for the demand associated with a global vaccination campaign. Production process performance is assessed for three messenger RNA (mRNA) and one self-amplifying RNA (saRNA) vaccines, all currently under clinical development, as well as for a hypothetical next-generation saRNA vaccine. The impact of key process design and operation uncertainties on the performance of the production process was assessed. The RNA vaccine drug substance (DS) production rates, volumes and costs are mostly impacted by the RNA amount per vaccine dose and to a lesser extent by the scale and titre in the production process. The resources, production scale and speed required to meet global demand vary substantially in function of the RNA amount per dose. For lower dose saRNA vaccines, global demand can be met using a production process at a scale of below 10 L bioreactor working volume. Consequently, these small-scale processes require a low amount of resources to set up and operate. RNA DS production can be faster than fill-to-finish into multidose vials; hence the latter may constitute a bottleneck.

scholarly journals Effect of ambient fine particulates (PM2.5) on hospital admissions for respiratory and cardiovascular diseases in Wuhan, China

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhan Ren ◽  
Xingyuan Liu ◽  
Tianyu Liu ◽  
Dieyi Chen ◽  
Kuizhuang Jiao ◽  
...  
Keyword(s):  
Air Pollution ◽  
Hospital Admission ◽  
Hospital Admissions ◽  
Conditional Logistic Regression ◽  
Warm Season ◽  
Central China ◽  
Air Pollution Control ◽  
Short Term ◽  
Short Term Exposure ◽  
Increased Risk

Abstract Background Positive associations between ambient PM2.5 and cardiorespiratory disease have been well demonstrated during the past decade. However, few studies have examined the adverse effects of PM2.5 based on an entire population of a megalopolis. In addition, most studies in China have used averaged data, which results in variations between monitoring and personal exposure values, creating an inherent and unavoidable type of measurement error. Methods This study was conducted in Wuhan, a megacity in central China with about 10.9 million people. Daily hospital admission records, from October 2016 to December 2018, were obtained from the Wuhan Information center of Health and Family Planning, which administrates all hospitals in Wuhan. Daily air pollution concentrations and weather variables in Wuhan during the study period were collected. We developed a land use regression model (LUR) to assess individual PM2.5 exposure. Time-stratified case-crossover design and conditional logistic regression models were adopted to estimate cardiorespiratory hospitalization risks associated with short-term exposure to PM2.5. We also conducted stratification analyses by age, sex, and season. Results A total of 2,806,115 hospital admissions records were collected during the study period, from which we identified 332,090 cardiovascular disease admissions and 159,365 respiratory disease admissions. Short-term exposure to PM2.5 was associated with an increased risk of a cardiorespiratory hospital admission. A 10 μg/m3 increase in PM2.5 (lag0–2 days) was associated with an increase in hospital admissions of 1.23% (95% CI 1.01–1.45%) and 1.95% (95% CI 1.63–2.27%) for cardiovascular and respiratory diseases, respectively. The elderly were at higher PM-induced risk. The associations appeared to be more evident in the cold season than in the warm season. Conclusions This study contributes evidence of short-term effects of PM2.5 on cardiorespiratory hospital admissions, which may be helpful for air pollution control and disease prevention in Wuhan.

Increased hospital admissions for asthma from short-term exposure to cold spells in Beijing, China

2021 ◽  
Vol 238 ◽  
pp. 113839
Author(s):  
Yuxiong Chen ◽  
Dehui Kong ◽  
Jia Fu ◽  
Yongqiao Zhang ◽  
Yakun Zhao ◽  
...  
Keyword(s):  
Hospital Admissions ◽  
Short Term ◽  
Exposure To Cold ◽  
Short Term Exposure ◽  
Beijing China
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