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Cureus Aug 2022The coronavirus disease 2019 (COVID-19) pandemic has claimed nearly 5.5 million lives worldwide. Adenovirus-based vaccines are safe and effective, but they are rarely...
The coronavirus disease 2019 (COVID-19) pandemic has claimed nearly 5.5 million lives worldwide. Adenovirus-based vaccines are safe and effective, but they are rarely associated with vaccine-induced thrombosis and thrombocytopenia (VITT) as well as cerebral venous sinus thrombosis (CVST). We conducted a systematic literature search of intracerebral hemorrhage (ICH) secondary to CVST associated with VITT from the Ad26.COV2.S vaccine, and we present the first case of this pathology in the reviewed literature of a patient who required neurosurgical decompression. The systematic literature review was completed on December 19, 2021, by searching PubMed and Ovid for articles with primary data on CVST associated with VITT following the Ad26.COV2.S vaccine. We also specifically searched for cases that required neurosurgical intervention. Articles were independently screened by two authors, and both secondary and tertiary searches were done as well. Descriptive statistics were collected and presented in table form. Nine studies were identified that met inclusion criteria. There were no cases identified of patients who underwent neurosurgical decompression after developing this pathology. We thus present the first case in the reviewed literature of a patient who developed ICH after receiving the Ad26.COV2.S vaccine and underwent decompressive hemicraniectomy. Despite severe thrombocytopenia and prolonged intensive care, the patient was discharged to neurorehabilitation. There is a much greater risk of CVST and ICH during COVID-19 infections than from the vaccines. However, as booster vaccines are approved and widely distributed, it is critical to make prompt, accurate diagnoses of this vaccine-related complication and consider neurosurgical decompression.
PubMed: 36127984
DOI: 10.7759/cureus.28083 -
Vaccines Dec 2022Vaccination is one of the most effective measures for children as the epidemic progresses. However, there is a significant research gap in the meta-analysis of the... (Review)
Review
Vaccination is one of the most effective measures for children as the epidemic progresses. However, there is a significant research gap in the meta-analysis of the COVID-19 vaccines for children younger than 18 years. This study is a comprehensive review of different COVID-19 vaccines. Published articles were retrieved from PubMed, Embase, and the Cochrane Library. Twelve randomized controlled trials (RCTs) of COVID-19 vaccines were included in the review until 21 October 2022. Most local and systemic adverse reactions were predominantly mild to moderate in severity and disappeared quickly after different types of vaccines. The subunit vaccine had the highest safety. The significant risk was lower in the subunit vaccine group after the initial (RR 1.66, 95% CI 1.26-2.17, = 0.0003) and booster vaccination (RR 1.40, 95% CI 1.02-1.92, = 0.04). Younger children had a more outstanding safety profile in the mRNA and inactivated vaccine groups. The humoral immune response was proportional to the number of doses in the inactivated and the adenovirus vaccine groups, and the strength of immunogenicity was negatively correlated with age in the inactivated vaccine. The mRNA and the subunit vaccines provided satisfactory prevention against COVID-19, especially seven days after the booster dose. However, more research and longer-term follow-up are needed to assess the duration of immune responses, efficacy, and safety.
PubMed: 36679932
DOI: 10.3390/vaccines11010087 -
Frontiers in Public Health 2022As the epidemic progresses, universal vaccination against COVID-19 has been the trend, but there are still some doubts about the efficacy and safety of COVID-19 vaccines... (Meta-Analysis)
Meta-Analysis
BACKGROUND
As the epidemic progresses, universal vaccination against COVID-19 has been the trend, but there are still some doubts about the efficacy and safety of COVID-19 vaccines in adolescents, children, and even infants.
PURPOSE
To evaluate the safety, immunogenicity, and efficacy of COVID-19 vaccines in the population aged 0-17 years.
METHOD
A comprehensive search for relevant randomized controlled trials (RCTs) was conducted in PubMed, Embase, and the Cochrane Library from inception to November 9, 2021. All data were pooled by RevMan 5.3 statistical software, with risk ratio (RR) and its 95% confidence interval as the effect measure. This study protocol was registered on PROSPERO (CRD42021290205).
RESULTS
There was a total of six randomized controlled trials included in this systematic review and meta-analysis, enrolling participants in the age range of 3-17 years, and containing three types of COVID-19 vaccines. Compared with mRNA vaccines and adenovirus vector vaccines, inactivated vaccines have a more satisfactory safety profile, both after initial (RR 1.40, 95% CI 1.04-1.90, = 0.03) and booster (RR 1.84, 95% CI 1.20-2.81, = 0.005) vaccination. The risk of adverse reactions was significantly increased after the first and second doses, but there was no significant difference between the first two doses (RR 1.00, 95%CI 0.99-1.02, = 0.60). Nevertheless, the two-dose regimen is obviously superior to the single-dose schedule for immunogenicity and efficacy. After booster vaccination, both neutralizing antibodies (RR 144.80, 95%CI 44.97-466.24, < 0.00001) and RBD-binding antibodies (RR 101.50, 95%CI 6.44-1,600.76, = 0.001) reach optimal levels, but the cellular immune response seemed not to be further enhanced. In addition, compared with younger children, older children and adolescents were at significantly increased risk of adverse reactions after vaccination, with either mRNA or inactivated vaccines, accompanied by a stronger immune response.
CONCLUSION
The available evidence suggests that the safety, immunogenicity and efficacy of COVID-19 vaccines are acceptable in people aged 3-17 years. However, there is an urgent need for additional multicenter, large-sample studies, especially in younger children under 3 years of age and even in infants, with long-term follow-up data.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021290205, identifier: CRD42021290205.
Topics: Adolescent; COVID-19; COVID-19 Vaccines; Child; Child, Preschool; Humans; Multicenter Studies as Topic; Vaccination; Vaccines
PubMed: 35493393
DOI: 10.3389/fpubh.2022.829176 -
The Journal of Allergy and Clinical... Oct 2021Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of... (Meta-Analysis)
Meta-Analysis Review
The Risk of Allergic Reaction to SARS-CoV-2 Vaccines and Recommended Evaluation and Management: A Systematic Review, Meta-Analysis, GRADE Assessment, and International Consensus Approach.
Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.
Topics: Anaphylaxis; COVID-19; COVID-19 Vaccines; Consensus; GRADE Approach; Humans; RNA, Viral; SARS-CoV-2
PubMed: 34153517
DOI: 10.1016/j.jaip.2021.06.006 -
Expert Review of Vaccines Sep 2022A number of vaccines have now been developed against COVID-19. Differences in reactogenicity and safety profiles according to the vaccine technologies employed are... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
A number of vaccines have now been developed against COVID-19. Differences in reactogenicity and safety profiles according to the vaccine technologies employed are becoming apparent from clinical trials.
METHODS
Five databases (Medline, EMBASE, Science Citation Index, Cochrane Central Register of Controlled Trials, London School of Hygiene and Tropical Medicine COVID-19 vaccine tracker) were searched for relevant randomized controlled trials between 1 January 2020 and 12 January 2022 according to predetermined criteria with no language limitations.
RESULTS
Forty-two datasets were identified, with 20 vaccines using four different technologies (viral vector, inactivated, mRNA and protein sub-unit). Adults and adolescents over 12 years were included. Control groups used saline placebos, adjuvants, and comparator vaccines. The most consistently reported solicited adverse events were fever, fatigue, headache, pain at injection site, redness, and swelling. Both doses of mRNA vaccines, the second dose of protein subunit and the first dose of adenovirus vectored vaccines were the most reactogenic, while the inactivated vaccines were the least reactogenic.
CONCLUSIONS
The different COVID-19 vaccines currently available appear to have distinct reactogenicity profiles, dependent on the vaccine technology employed. Awareness of these differences may allow targeted recommendations for specific populations. Greater standardization of methods for adverse event reporting will aid future research in this field.
Topics: Adjuvants, Immunologic; Adolescent; Adult; COVID-19; COVID-19 Vaccines; Humans; Vaccines, Inactivated
PubMed: 35796029
DOI: 10.1080/14760584.2022.2098719 -
Vaccines Jan 2022(1) Background: The objective of this study was to assess the effectiveness of SARS-CoV-2 vaccines in terms of prevention of disease and transmission in the pre-Delta... (Review)
Review
(1) Background: The objective of this study was to assess the effectiveness of SARS-CoV-2 vaccines in terms of prevention of disease and transmission in the pre-Delta era. The evaluation was narrowed to two mRNA vaccines and two modified adenovirus-vectored vaccines. (2) Methods: The overall risk of any SARS-CoV-2 infection confirmed by positive real-time Polymerase Chain Reaction (PCR) test was estimated in partially and fully vaccinated individuals. The evidence synthesis was pursued through a random-effects meta-analysis. The effect size was expressed as relative risk (RR) and RRR (RR reduction) of SARS-CoV-2 infection following vaccination. Heterogeneity was investigated through a between-study heterogeneity analysis and a subgroup meta-analysis. (3) Results: The systematic review identified 27 studies eligible for the quantitative synthesis. Partially vaccinated individuals presented a RRR = 73% (95%CI = 59-83%) for positive SARS-CoV-2 PCR (RR = 0.27) and a RRR=79% (95%CI = 30-93%) for symptomatic SARS-CoV-2 PCR (RR = 0.21). Fully vaccinated individuals showed a RRR = 94% (95%CI = 88-98%) for SARS-CoV-2 positive PCR (RR = 0.06) compared to unvaccinated individuals. The full BNT162b2 vaccination protocol achieved a RRR = 84-94% against any SARS-CoV-2-positive PCR and a RRR = 68-84% against symptomatic positive PCR. (4) Conclusions: The meta-analysis results suggest that full vaccination might block transmission. In particular, the risk of SARS-CoV-2 infection appeared higher for non-B.1.1.7 variants and individuals aged ≥69 years. Considering the high level of heterogeneity, these findings must be taken with caution. Further research on SARS-CoV-2 vaccine effectiveness against emerging SARS-CoV-2 variants is encouraged.
PubMed: 35214615
DOI: 10.3390/vaccines10020157 -
Neurology Nov 2021There is accumulating evidence supporting an association between the thrombosis and thrombocytopenia syndrome (TTS) and adenovirus vector-based vaccines against severe... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVES
There is accumulating evidence supporting an association between the thrombosis and thrombocytopenia syndrome (TTS) and adenovirus vector-based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Yet TTS and TTS-associated cerebral venous sinus thrombosis (CVST) remain poorly characterized. We aim to systematically evaluate the proportion of CVST among TTS cases and assess its characteristics and outcomes.
METHODS
We performed a systematic review and meta-analysis of clinical trials, cohorts, case series, and registry-based studies with the aim to assess (1) the pooled mortality rate of CVST, TTS-associated CVST, and TTS and (2) the pooled proportion of patients with CVST among patients with any thrombotic event and TTS. Secondary outcomes comprised clinical characteristics of patients with postvaccination thrombotic event. This meta-analysis is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was written according to the Meta-analysis of Observational Studies in Epidemiology proposal.
RESULTS
Sixty-nine studies were included in the qualitative analysis comprising 370 patients with CVST out of 4,182 patients with any thrombotic event associated with SARS-CoV-2 vector-based vaccine administration. Twenty-three studies were included further in quantitative meta-analysis. Among TTS cases, the pooled proportion of CVST was 51% (95% confidence interval [CI] 36%-66%; = 61%). TTS was independently associated with a higher likelihood of CVST when compared to patients without TTS with thrombotic events after vaccination (odds ratio 13.8; 95% CI 2.0-97.3; = 78%). The pooled mortality rates of TTS and TTS-associated CVST were 28% (95% CI 21%-36%) and 38% (95% CI 27%-49%), respectively. Thrombotic complications developed within 2 weeks of exposure to vector-based SARS-CoV-2 vaccines (mean interval 10 days; 95% CI 8-12) and affected predominantly women (69%; 95% CI 60%-77%) under age 45, even in the absence of prothrombotic risk factors.
DISCUSSION
Approximately half of patients with TTS present with CVST; almost one-third of patients with TTS do not survive. Further research is required to identify independent predictors of TTS following adenovirus vector-based vaccination.
REGISTRATION INFORMATION
The prespecified study protocol has been registered in the International Prospective Register of Ongoing Systematic Reviews PROSPERO (CRD42021250709).
Topics: COVID-19; COVID-19 Vaccines; Female; Humans; Middle Aged; SARS-CoV-2; Sinus Thrombosis, Intracranial; Thrombocytopenia; Thrombosis
PubMed: 34610990
DOI: 10.1212/WNL.0000000000012896 -
The Lancet. Global Health Jun 2024Information on the causes of deaths from diarrhoea in children younger than 5 years is needed to design improved preventive and therapeutic approaches. We aimed to...
BACKGROUND
Information on the causes of deaths from diarrhoea in children younger than 5 years is needed to design improved preventive and therapeutic approaches. We aimed to conduct a systematic analysis of studies to report estimates of the causes of deaths from diarrhoea in children younger than 5 years at global and regional levels during 2000-21.
METHODS
For this systematic review and Bayesian multinomial analysis, we included 12 pathogens with the highest attributable incidence in the Global Enteric Multicenter Study. We searched PubMed, Scopus, Embase, Web of Science, Global Health Index Medicus, Global Health OVID, IndMed, Health Information Platform for the Americas (PLISA), Africa-Wide Information, and Cochrane Collaboration for articles published between Jan 1, 2000, and Dec 31, 2020, using the search terms "child", "hospital", "diarrhea", "diarrhoea", "dysentery", "rotavirus", "Escherichia coli", "salmonella", "shigella", "campylobacter", "Vibrio cholerae", "cryptosporidium", "norovirus", "astrovirus", "sapovirus", and "adenovirus". To be included, studies had to have a patient population of children younger than 5 years who were hospitalised for diarrhoea (at least 90% of study participants), at least a 12-month duration, reported prevalence in diarrhoeal stools of at least two of the 12 pathogens, all patients with diarrhoea being included at the study site or a systematic sample, at least 100 patients with diarrhoea, laboratory tests done on rectal swabs or stool samples, and standard laboratory methods (ie, quantitative PCR [qPCR] or non-qPCR). Studies published in any language were included. Studies were excluded if they were limited to nosocomial, chronic, antibiotic-associated, or outbreak diarrhoea or to a specific population (eg, only children with HIV or AIDS). Each article was independently reviewed by two researchers; a third arbitrated in case of disagreement. If both reviewers identified an exclusion criterion, the study was excluded. Data sought were summary estimates. Data on causes from published studies were adjusted when necessary to account for the poor sensitivity of non-qPCR methods and for attributable fraction based on quantification of pathogens in children who are ill or non-ill. The causes of deaths from diarrhoea were modelled on the causes of hospitalisations for diarrhoea. We separately modelled studies reporting causes of diarrhoea in children who were hospitalised in low-income and middle-income countries (LMICs) and in high-income countries (HICs).
FINDINGS
Of 74 282 papers identified in the initial database search, we included 138 studies (91 included data from LMICs and 47 included data from HICs) from 73 countries. We modelled estimates for 194 WHO member states (hereafter referred to as countries), including 42 HICs and 152 LMICs. We could attribute a cause to 1 003 448 (83·8%) of the estimated 1 197 044 global deaths from diarrhoea in children younger than 5 years in 2000 and 360 730 (81·3%) of the estimated 443 833 global deaths from diarrhoea in children younger than 5 years in 2021. The cause with the largest estimated global attribution was rotavirus; in LMICs, the proportion of deaths from diarrhoea due to rotavirus in children younger than 5 years appeared lower in 2021 (108 322 [24·4%] of 443 342, 95% uncertainty interval 21·6-29·5) than in 2000 (316 382 [26·5%] of 1 196 134, 25·7-28·5), but the 95% CIs overlapped. In 2000, the second largest estimated attribution was norovirus GII (95 817 [8·0%] of 1 196 134 in LMICs and 225 [24·7%] of 910 in HICs); in 2021, Shigella sp had the second largest estimated attribution in LMICs (36 082 [8·1%] of 443 342), but norovirus remained with the second largest estimated attribution in HICs (84 [17·1%] of 490).
INTERPRETATION
Our results indicate progress in the reduction of deaths from diarrhoea caused by 12 pathogens in children younger than 5 years in the past two decades. There is a need to increase efforts for prevention, including with rotavirus vaccine, and treatment to eliminate further deaths.
FUNDING
Bill & Melinda Gates Foundation via Johns Hopkins University and the University of Virginia.
Topics: Humans; Diarrhea; Bayes Theorem; Infant; Child, Preschool; Global Health; Cause of Death; Infant, Newborn
PubMed: 38648812
DOI: 10.1016/S2214-109X(24)00078-0 -
Journal of Clinical Virology : the... Aug 2022Children and adolescents form a large proportion of societies and play an important role in the transmission of COVID-19. On the other hand, their education, mental and... (Meta-Analysis)
Meta-Analysis
Immunologic response, Efficacy, and Safety of Vaccines against COVID-19 Infection in Healthy and immunosuppressed Children and Adolescents Aged 2 - 21 years old: A Systematic Review and Meta-analysis.
Children and adolescents form a large proportion of societies and play an important role in the transmission of COVID-19. On the other hand, their education, mental and physical wellness, and safety are compromised which makes vaccination a crucial step to return to normal life. In the current systematic review, the COVID-19 vaccination was evaluated in a total of 50,148 children and adolescents in 22 published studies and 5,279 participants in two ongoing clinical trials. The study was registered in the PROSPERO with the ID# CRD42022303615. Data were collected about multiple vaccines including BNT162b2 (Pfizer), mRNA-1273 (Moderna), JNJ-78436735 (Johnson and Johnson), CoronaVac (Sinovac), BBIBP-CorV (Sinopharm), adenovirus type-5-vectored vaccine, ZyCov-D, and BBV152 (COVAXIN). The immune response and efficacy of such vaccines were 96% - 100% in healthy children and adolescents and were also acceptable in those with underlying diseases and suppressed immune systems. The current systematic review revealed favorable safety profiles of employed vaccines in children and adolescents; however, adverse reactions such as myocarditis and myopericarditis were reported which were transient and resolved entirely. Consequently, vaccinating children and adolescents aged 2 - 21 years old is beneficial to abort the COVID-19 pandemic. Moreover, the risk-benefit assessments revealed favorable results for vaccinating children and adolescents, especially those with underlying diseases and immunosuppressed conditions, alongside adults to prevent transmission, severe infection, negative outcomes, and new variants formation. Also, according to the meta-analysis, the efficacy and immune response of vaccines after the first and second doses were 91% and 92%, respectively. Meanwhile, overall immune response for all vaccines was 95% and 91% for Pfizer vaccine.
Topics: Ad26COVS1; Adolescent; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; Child; Child, Preschool; Humans; Myocarditis; Pandemics; Young Adult
PubMed: 35716417
DOI: 10.1016/j.jcv.2022.105196 -
Human Vaccines & Immunotherapeutics Sep 2016This systematic review evaluated the epidemiology of community-acquired pneumonia in children <6 y of age within 90 developing and newly industrialized countries.... (Review)
Review
Epidemiology of community-acquired pneumonia and implications for vaccination of children living in developing and newly industrialized countries: A systematic literature review.
This systematic review evaluated the epidemiology of community-acquired pneumonia in children <6 y of age within 90 developing and newly industrialized countries. Literature searches (1990-2011), based on MEDLINE, EMBASE, Cochrane, CAB Global Health, WHO, UNICEF, country-specific websites, conferences, health-technology-assessment agencies, and the reference lists of included studies, yielded 8,734 records; 62 of 340 studies were included in this review. The highest incidence rate among included studies was 0.51 episodes/child-year, for children <5 y of age in Bangladesh. The highest prevalence was in Chinese children <6 months of age (37.88%). The main bacterial pathogens were Streptococcus pneumoniae, Haemophilus influenzae and Mycoplasma pneumoniae and the main viral pathogens were respiratory syncytial virus, adenovirus and rhinovirus. Community-acquired pneumonia remains associated with high rates of morbidity and mortality. Improved and efficient surveillance and documentation of the epidemiology and burden of community-acquired pneumonia across various geographical regions is warranted.
Topics: Bacteria; Child, Preschool; Community-Acquired Infections; Developed Countries; Developing Countries; Humans; Incidence; Infant; Infant, Newborn; Pneumonia, Bacterial; Pneumonia, Viral; Prevalence; Viruses
PubMed: 27269963
DOI: 10.1080/21645515.2016.1174356