Immunization Safety Research Articles

COVID 19 vaccine in the pediatric age: the recommendation of the Italian Pediatric Society

Vaccine is an important and effective tool to protect from preventable infectious diseases. Neverthless, in the COVID-19 pandemic era, scientific and accurate information are required to responde to false and misleading information on efficacy and safety of immunization in the pediatric age.

COVID-19 mRNA vaccine safety during the first 6 months of roll-out in the USA

COVID-19 mRNA vaccine safety during the first 6 months of roll-out in the USA

Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a prospective, open-label, interventional, phase IV clinical study

ABSTRACT Objective This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (EupentaTM) based on the occurrence of adverse events (AEs) following vaccination. Methods This was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks. Results In all, 3000 subjects were enrolled and received at least one dose of the study vaccine. Of these, 2717 (90.6%) experienced at least one AE. Immediate reactions, solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs each, considered related to the study vaccine. Six (0.2%) subjects died due to unsolicited AEs, none of which were considered related to the study vaccine. No AEs were reported at the end-of-study follow-up visit. Conclusions The study vaccine had a safety profile similar to that reported in a previous clinical study, and did not result in an increased risk of AEs known to be associated with DTwP-based vaccines or previously unrecognized SAEs.

Vaccination against SARS-CoV-2 in rheumatic diseases: Safety issues

The problem of coronavirus disease 2019 (Coronavirus diseases, COVID-19) two years later still remains relevant both socially and medically. As one of the methods of combating the current COVID-19 pandemic, most experts rely on the widespread use of vaccination. However, the use of vaccines against SARS-CoV-2 in patients with rheumatic diseases (RD) raises a number of issues related to the effectiveness, immunogenicity, and safety of immunization, including leveling the risks of exacerbation of the underlying disease or the development of new autoimmune phenomena. For this reason it is very important to analyze data on the above-mentioned aspects in real time, especially given that patients of the rheumatology circle were excluded from the clinical development programs of vaccines against SARS-CoV-2. This review presents the results of last year’s research on the safety of vaccination against COVID-19 in patients with RS. A brief description of the main anticovedic vaccines is given. Post-vaccination adverse events were quite frequent after the first, second or both doses of vaccines in patients with RS, which is consistent with the data obtained in the general population. In general, the frequency of exacerbation of RD after vaccination against COVID-19 seems to be quite low (5–7%) and has no significant associations with a specific vaccine or anti-rheumatic therapy. At the same time, unambiguous interpretation of these data is difficult for at least three reasons: a) in many studies, only the symptoms developing after the first dose of the vaccine were taken into account; b) the time-limited post-vaccination follow-up period; c) significant discrepancies in the interpretation of exacerbations of the disease. Within the framework of the problem under consideration, there are still a lot of questions, the answers to which should be obtained in large prospective controlled studies.

Reported cases of multisystem inflammatory syndrome in children aged 12–20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation

BackgroundMultisystem inflammatory syndrome in children (MIS-C) is a hyperinflammatory condition associated with antecedent SARS-CoV-2 infection. In the USA, reporting of MIS-C after vaccination is required under COVID-19 vaccine emergency use authorisations. We aimed to investigate reports of individuals aged 12–20 years with MIS-C after COVID-19 vaccination reported to passive surveillance systems or through clinician outreach to the US Centers for Disease Control and Prevention (CDC).MethodsIn this surveillance activity, we investigated potential cases of MIS-C after COVID-19 vaccination reported to CDC's MIS-C national surveillance system, the Vaccine Adverse Event Reporting System (co-administered by CDC and the US Food and Drug Administration), and CDC's Clinical Immunization Safety Assessment Project. A multidisciplinary team adjudicated cases by use of the CDC MIS-C definition. Any positive SARS-CoV-2 serology test satisfied case criteria; although anti-nucleocapsid antibodies indicate previous SARS-CoV-2 infection, anti-spike protein antibodies indicate either past or recent infection or COVID-19 vaccination. We describe the demographic and clinical features of cases, stratified by laboratory evidence of SARS-CoV-2 infection. To calculate the reporting rate of MIS-C, we divided the count of all individuals meeting the MIS-C case definition, and of those without evidence of SARS-CoV-2 infection, by the number of individuals aged 12–20 years in the USA who received one or more COVID-19 vaccine doses up to Aug 31, 2021, obtained from CDC national vaccine surveillance data.FindingsUsing surveillance results from Dec 14, 2020, to Aug 31, 2021, we identified 21 individuals with MIS-C after COVID-19 vaccination. Of these 21 individuals, median age was 16 years (range 12–20); 13 (62%) were male and eight (38%) were female. All 21 were hospitalised: 12 (57%) were admitted to an intensive care unit and all were discharged home. 15 (71%) of 21 individuals had laboratory evidence of past or recent SARS-CoV-2 infection, and six (29%) did not. As of Aug 31, 2021, 21 335 331 individuals aged 12–20 years had received one or more doses of a COVID-19 vaccine, making the overall reporting rate for MIS-C after vaccination 1·0 case per million individuals receiving one or more doses in this age group. The reporting rate in only those without evidence of SARS-CoV-2 infection was 0·3 cases per million vaccinated individuals.InterpretationHere, we describe a small number of individuals with MIS-C who had received one or more doses of a COVID-19 vaccine before illness onset; the contribution of vaccination to these illnesses is unknown. Our findings suggest that MIS-C after COVID-19 vaccination is rare. Continued reporting of potential cases and surveillance for MIS-C illnesses after COVID-19 vaccination is warranted.FundingUS Centers for Disease Control and Prevention.

Safety of COVID-19 vaccines in patients with immunoinflammatory rheumatic diseases (preliminary data)

Objective: to assess the safety of COVID-19 vaccines in patients with immunoinflammatory rheumatic diseases (IRD) in real clinical practice.Patients and methods. A cross-sectional study of patients with IRD, who were admitted to V.A. Nasonova Research Institute of Rheumatology for inpatient or outpatient treatment. All patients received at least 1 dose of vaccine against COVID-19 (main group). The control group consisted of vaccinated persons without IRD. All participants were interviewed by the researcher by filling out a unified questionnaire, additional information was obtained from medical records.Results and discussion. The study included 204 patients with IRD (151 of them were vaccinated with Sputnik V, 31 with Sputnik Light, 19 with СoviVac, 3 with EpiVacCorona; 173 patients received the second component of vaccine) and 131 subjects without IRD (101 of them were vaccinated with Sputnik V, 17 – CoviVak, 5 – Sputnik Light, 2 – EpiVacCorona, 6 – Pfizer/BioNTech; 124 patients received the second component of the vaccine). The number of patients with IRD who had both local and systemic reactions after administration of the first component of the vaccine was significantly less than in the control group (19.6 and 38.9%, respectively; p<0.001). Similar differences were noted after the administration of the second component (15.6 and 27.4%, respectively; p=0.013). Adverse events (AEs) such as pain at the injection site without restriction of movement, weakness, fever, arthralgia/myalgia and chills were significantly more common in the control group after the administration of the first component of the vaccine. After complete immunization, AEs were absent in 35.8% of patients with IRD and in 21% of controls (p=0.006). Exacerbations of IRD and new autoimmune phenomena were not registered in any case.Conclusion. According to preliminary data, vaccination against COVID-19 in patients with IRD appears to be quite safe. Further studies are needed to investigate the safety, immunogenicity, and clinical efficacy of COVID-19 immunization in rheumatic patients.

Myocarditis and pericarditis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions.The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports.Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document.

Saudi Healthcare Students' Perceptions and Beliefs About Immunizations: a Descriptive, Cross-Sectional Study.

Immunization has been one of the most successful public health measures ever undertaken. However, a degree of hesitancy about vaccine use still exists. Healthcare professionals are in a unique position to provide advice and education to the public and may influence the decision to undergo immunization. The aim of this study was to explore perceptions and beliefs regarding immunizations and immunization-preventable diseases. A descriptive cross-sectional study was undertaken at the Imam Abdulrahman bin Faisal University, located in Dammam, Saudi Arabia. In the Kingdom of Saudi Arabia, a survey of 564 Saudi undergraduate healthcare students was conducted. 77.8% of participants replied (439). Information was collected regarding perceptions of; severity of immunization-preventable diseases, contracting these diseases, immunization safety, and immunization beliefs. The statistical analysis was performed using the Statistical Package for the Social Sciences (IBM SPSS v25). Non-parametric analyses were utilized. Descriptive data were generated as appropriate, including frequencies, median, and inter-quartile range. Statistical relationships of demographic variables were explored using Kruskal Wallis H-Test and Spearman's Rank-Order Correlation. A p-value < 0.05 was considered statistically significant. Meningitis was perceived as the most severe disease and COVID-19 as having the highest likelihood of infection. Concern regarding vaccine side effects was most evident for the COVID-19 vaccine. Student year level and profession resulted in statistically significant differences for all three assessed perceptions. Substantial differences were also identified regarding views on immunization belief statements. This study identified considerable heterogeneity in Saudi healthcare students' perceptions and beliefs regarding immunization-preventable diseases and vaccination. Further education is required to produce well-informed and confident healthcare professionals around these issues.

Safety and Immunogenicity of Heterologous Boost Immunisation With an Aerosolized Ad5-nCoV After Two-Dose Priming With an Inactivated SARS-CoV-2 Vaccine CoronaVac in Adults: A Randomised, Open-Label, Parallel-Control Trial

Safety and Immunogenicity of Heterologous Boost Immunisation With an Aerosolized Ad5-nCoV After Two-Dose Priming With an Inactivated SARS-CoV-2 Vaccine CoronaVac in Adults: A Randomised, Open-Label, Parallel-Control Trial

COVID-19 immunizations in occupational medicine

This article discusses issues related to exposure to SARS-CoV-2 in the work environment and employee's vaccination against COVID-19. The new SARS-CoV-2 coronavirus identified as the etiologic agent of COVID-19 prompted the World Health Organization (WHO) to declare a pandemic in March 2020. The droplet route transmits the virus. Therefore, health care workers in contact with sick people and anyone employed in direct contact with large numbers of people are particularly vulnerable to infection. The introduction of COVID-19 vaccination removes the need for quarantine, reduces the risk of disease, limits transmission within the workplace, and reduces sickness absence. The role of the occupational health services is to promote vaccination against COVID-19 by providing reliable information on the safety and efficacy of immunization and organizing and carrying out vaccination in workplaces. Med Pr. 2021;72(6):701-10.

Emergency department visits for vaccine-related severe allergic reactions among US adults: 2006-2018

Emergency department visits for vaccine-related severe allergic reactions among US adults: 2006-2018

Safety of Immunizations for the Adult Patient With Inflammatory Bowel Disease-A Systematic Review and Meta-analysis.

Patients with inflammatory bowel disease (IBD) have low vaccination rates for vaccine-preventable diseases. Fear of adverse reactions (AEs) appear to negatively affect vaccination efforts. We aimed to systemically review the risks for AEs following immunization for patients with IBD. We searched PubMed and Embase until April 15, 2020, for studies evaluating the safety of vaccinations among patients with IBD. The primary outcome was the incidence of systemic and local AEs among vaccinated patients. Secondary outcome was the rate of IBD flare following immunization. We utilized a random effects meta-analysis of proportions using the DerSimonian-Laird approach to estimate the safety of immunizations. A total of 13 studies with 2116 patients was included in our analysis after fulfilling our inclusion criteria. Seven studies examined the influenza vaccine, 4 the pneumococcal vaccine, 1 the recombinant zoster vaccine, and 1 the hepatitis B vaccine. Follow-up of patients was up to 6 months. The majority of AEs were local, with a pooled incidence of 24% (95% CI, 9%-42%) for all vaccines. Systemic AEs were mostly mild, without resulting in hospitalizations or deaths, with a pooled incidence of 16% (95% CI, 6%-29%) for all vaccines. Flare of inflammatory bowel disease after vaccination found with a pooled incidence of 2% (95% CI, 1%-4%) and we include in the analysis data from all immunizations examined. Our study demonstrated that AEs after vaccination are mainly local or mildly systemic and do not differ significantly from the expected AE after recommended immunizations for the general population. Thus, gastroenterologists should reinforce that vaccines are safe in patients with IBD.

Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries.

The Brighton Collaboration Global Alignment of Immunization Safety in Pregnancy (GAIA) project developed case definitions for the assessment of adverse events in mothers and infants following maternal immunization. This study evaluated the applicability of these definitions to data collected in routine clinical care and research trial records across 7 sites in high-resource settings. Data collection forms were designed and used to retrospectively abstract the key elements of the GAIA definitions from records for 5 neonatal and 5 maternal outcomes, as well as gestational age. Level of diagnostic certainty was assessed by the data abstractor and an independent clinician, and then verified by Automated Brighton Case logic. The ability to assign a level of diagnostic certainty for each outcome and the positive predictive value (PPV) for their respective ICD-10 codes were evaluated. Data from 1248 case records were abstracted: 624 neonatal and 622 maternal. Neonatal outcomes were most likely to be assessable and assigned by the level of diagnostic certainty. PPV for preterm birth, low birth weight, small for gestational age and respiratory distress were all above 75%. Maternal outcomes for preeclampsia and fetal growth restriction showed PPV over 80%. However, microcephaly (neonatal outcome) and dysfunctional labor (maternal outcome) were often nonassessable, with low PPVs. The applicability of GAIA case definitions to retrospectively ascertain and classify maternal and neonatal outcomes was variable among sites in high-resource settings. The implementation of the case definitions is largely dependent on the type and quality of documentation in clinical and research records in both high- and low-resource settings. While designed for use in the prospective evaluation of maternal vaccine safety, the GAIA case definitions would likely need to be specifically adapted for observational studies using alternative sources of data, linking various data sources and allowing flexibility in the ascertainment of the elements and levels of certainty of the case definition.

WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization

Standardized case definitions strengthen post-marketing safety surveillance of new vaccines by improving generated data, interpretation and comparability across surveillance systems. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project developed standardized case definitions for 21 key obstetric and neonatal terms following the Brighton Collaboration (BC) methodology.In this prospective cohort study, we assessed the applicability of GAIA definitions for maternal immunization exposure and for low birth weight (LBW), preterm birth, small for gestational age (SGA), stillbirth, neonatal death, neonatal infection, and congenital microcephaly. We identified the missing data elements that prevented identified cases and exposures from meeting the case definition (level 1–3 of BC diagnostic certainty). Over a one-year period (2019–2020), all births occurring in 21 sites (mostly secondary and tertiary hospitals) in 6 Low Middle Income Countries and 1 High Income Country were recorded and the 7 perinatal and neonatal outcome cases were identified from routine medical records. Up to 100 cases per outcome were recruited sequentially from each site.Most cases recruited for LBW, preterm birth and neonatal death met the GAIA case definitions. Birth weight, a key parameter for all three outcomes, was routinely recorded at all sites. The definitions for SGA, stillbirth, neonatal infection (particularly meningitis and respiratory infection) and congenital microcephaly were found to be less applicable. The main barrier to obtaining higher levels of diagnostic certainty was the lack of sonographic documentation of gestational age in first or second trimester. The definition for maternal immunization exposure was applicable, however, the highest level of diagnostic certainty was only reached at two sites. Improved documentation of maternal immunization will be important for vaccine safety studies. Following the field-testing of these 8 GAIA definitions, several improvements are suggested that may lead to their easier implementation, increased standardization and hence comparison across studies.

MULTISYSTEM INFLAMMATORY SYNDROME IN AN ADULT POST-SARS-COV-2 INFECTION

TOPIC: Chest Infections TYPE: Fellow Case Reports INTRODUCTION: An acute respiratory syndrome associated to the novel coronavirus SARS-CoV-2 has affected the entire world. Pediatric patients can rarely present with a severe complication identified as multisystem inflammatory syndrome in children (MIS-C).(1) After its recognition by the CDC and media reports of young adults with the same syndrome, a series of cases in adults (MIS-A) was published in late 2020.(2) CASE PRESENTATION: A 25-year-old Hispanic male who tested positive for SARS-CoV-2 by RT-PCR six weeks prior presented to the emergency department with one week of sore throat, fever, non-bloody diarrhea, conjunctivitis, and mild confusion. On examination, the patient was febrile, had tender submandibular lymph nodes and redness on the oropharynx. Initial laboratory results showed systemic inflammation. COVID-19 RT-PCR test was negative, coronavirus IgG was positive, and chest radiograph was normal. On the third day, the patient's clinical status deteriorated despite antibiotic use with hypotension and hypoxemia requiring vasopressor support and ICU admission. An echocardiogram showed left ventricular ejection fraction (EF) of 35% with hypokinesia. Due to persistent shock state and elevated inflammatory markers after 36 hours, we started him on methylprednisolone 1.5 mg/kg daily. After 24 hours, clinical status and inflammatory markers improved significantly. A follow-up echocardiogram four weeks after discharge showed normalization of EF. DISCUSSION: Since the beginning of the pandemic, different countries reported cases of a hyperinflammatory process in children that had features similar to atypical Kawasaki disease.(3) A larger study described MIS-C in 99 patients under 21 years of age in New York.(4) The case definition MIS-C was established by the CDC. For a time, it was unknown if this syndrome was specific to children or whether it also occurred in adults. A MIS-A working case definition includes five criteria: severe illness requiring hospitalization in a person aged at least 21 years;a positive test result for current or previous SARS-CoV-2 infection;severe dysfunction of one or more extrapulmonary organ systems;laboratory evidence of severe inflammation;and absence of severe respiratory illness.(2) Case definitions for MIS-C/A with degrees of diagnostic certainty have also been elaborated.(5) We are presenting a patient that meets clinical and laboratory criteria for MIS-A. His respiratory dysfunction occurred after admission when his inflammatory markers were already elevated. This case includes a temporal correlation after the initial peak of COVID-19 cases in Houston by 31 days. CONCLUSIONS: The number of cases of MIS-A is unclear. It is important to keep this condition in our differential in the context of recent SARS-CoV-2 infection for early identification and appropriate treatment to reduce further harm and mortality. REFERENCE #1: 1. Centers for Disease Control and Prevention. Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease 2019 (COVID-19). Published online May 14, 2020. Accessed April 22, 2020. https://emergency.cdc.gov/han/2020/han00432.asp2. Morris SB, Schwartz NG, Patel P, et al. Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection — United Kingdom and United States, March–August 2020. MMWR Morb Mortal Wkly Rep. 2020;69(40):1450-1456. doi:10.15585/mmwr.mm6940e1 REFERENCE #2: 3. Verdoni L, Mazza A, Gervasoni A, et al. An outbreak of severe Kawasaki-like disease at the Italian epicentre of the SARS-CoV-2 epidemic: an observational cohort study. The Lancet. 2020;395(10239):1771-1778. doi:10.1016/S0140-6736(20)31103-X4. Dufort EM, Koumans EH, Chow EJ, et al. Multisystem Inflammatory Syndrome in Children in New York State. N Engl J Med. 2020;383(4):347-358. doi:10.1056/NEJMoa2021756 REFERENCE #3: 5. Vogel TP, Top KA, Karatzios C, et al. Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collectio , analysis, and presentation of immunization safety data. Vaccine. Published online February 2021:S0264410X21000931. doi:10.1016/j.vaccine.2021.01.054 DISCLOSURES: No relevant relationships by Luis Chug, source=Web Response No relevant relationships by Julin Mathew, source=Web Response No relevant relationships by Nora Moron Cabrera, source=Web Response No relevant relationships by Rohini Rao, source=Web Response No relevant relationships by Juan Salvatierra, source=Web Response

Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database.

IntroductionPregnancy outcome identification and precise estimates of gestational age (GA) are critical in drug safety studies of pregnant women. Validated pregnancy outcome algorithms based on the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) have not previously been published.MethodsWe developed algorithms to classify pregnancy outcomes and estimate GA using ICD-10-CM/PCS and service codes on claims in the 2016–2018 IBM® MarketScan® Explorys® Claims-EMR Data Set and compared the results with ob-gyn adjudication of electronic medical records (EMRs). Obstetric services were grouped into episodes using hierarchical and spacing requirements. GA was based on evidence with the highest clinical accuracy. Among pregnancies with obstetric EMRs, 100 full-term live births (FTBs), 100 preterm live births (PTBs), 100 spontaneous abortions (SAs), and 24 stillbirths were selected for review. Physicians adjudicated cases using Global Alignment of Immunization safety Assessment in pregnancy (GAIA) definitions applied to structured EMRs.ResultsThe claims-based algorithms identified 34,204 pregnancies, of which 9.9% had obstetric EMRs. Of sampled pregnancies, 92 FTBs, 93 PTBs, 75 SAs, and 24 stillbirths were adjudicated. Among these pregnancies, the percent agreement was 97.8%, 62.4%, 100.0%, and 70.8% for FTBs, PTBs, SAs, and stillbirths, respectively. The percent agreement on GA within 7 and 28 days, respectively, was 85.9% and 100.0% for FTBs, 81.7% and 98.9% for PTBs, 61.3% and 94.7% for SAs, and 66.7% and 79.2% for stillbirths.ConclusionsThe pregnancy outcome algorithms had high agreement with physician adjudication of EMRs and may inform post-market maternal safety surveillance.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40264-021-01113-8.

Reporting Encounters for Immunization Safety Counseling

As physicians and other qualified health care professionals field increasing numbers of concerns about immunization safety, International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) offers a new code, Z71.85, for identifying immunization safety counseling as a reason for an encounter provided on or after October 1, 2021.

Knowledge, attitude, and practices of mothers from a rural community in Pampanga, Philippines toward childhood immunization: A cross sectional survey

Background/ObjectivesVaccination offers protection against common preventable diseases, and mothers have a significant role in determining the vaccination status of their children. The study aimed to assess the mothers’ knowledge, attitude, and practice toward childhood immunization and associate these variables to their demographic profile. MethodsA cross-sectional survey was conducted from February to May 2019 involving 240 mothers from a rural community in Pampanga, Philippines. ResultsBased on the results, 67.50% of the mothers showed a high level of knowledge and a positive attitude toward vaccination especially on the importance (96.30%), benefits (92.10%), and safety (95.30%) of immunization. Majority of the mothers also have good practices showing that 90.40% of them have children who are completely immunized, and 91.70% of them complied with the vaccination schedule. It was also reported that 63.75% obtain information about immunization from health care workers. Majority of them (91.30%) go to government facilities to avail of immunization because of the free services and easy accessibility. However, there were no significant associations on mothers’ knowledge, attitude, and practice and their demographic profile. ConclusionThe study revealed that mothers in the selected locale showed a high level of knowledge, a positive attitude, and good practices toward childhood immunization. Strengthening of primary health care facilities are needed to further increase the number of mothers with high knowledge on immunization and address other issues concerning childhood vaccination.

Active and Passive Immunization with Myelin Basic Protein as a Method for Early Treatment of Traumatic Spinal Cord Injury; a Meta-Analysis.

Introduction:Traumatic spinal cord injury (SCI), as a dangerous central nervous system damage, continues to threaten communities by imposing various disabilities and costs. Early adjustment of the immune system response using Myelin Basic Protein (MBP) immunization may prevent the SCI-related secondary damages. As a result, the current study is designed to review and analyse the evidence on active and passive immunization with MBP for treatment of traumatic SCI.Methods:Medline, Embase, Scopus, and Web of Science databases were systematically searched until the end of 2020. Criteria for inclusion in the current study included pre-clinical studies, which performed passive (injection of MBP-activated T cells) or active (administration of MBP or MBP-modified peptides) immunization with MBP after traumatic SCI. Exclusion criteria was defined as lack of a non-treated SCI group, lack of evaluation of locomotion, review studies, and combination therapy. Finally, analyses were conducted using STATA software, and a standardized mean difference (SMD) with a 95% confidence interval (CI) were reported.Results:Data from 17 papers were included in the present study. Finally, analysis of these data showed that passive immunization (SMD=0.87; 95%CI: 0.19-1.55; p=0.012) and active immunization (SMD=2.08, 95%CI: 1.42-2.73; p<0.001) for/with MBP both have good efficacy in improving locomotion following traumatic SCI. However, significant heterogeneity was observed in both of them. The most important sources of heterogeneity in active immunization were differences in SCI models, route of administration, time interval between SCI and transplantation, and type of vaccine used. In passive immunization, however, these sources were the model of SCI and the time interval between SCI and transplantation. Although, there was substantial heterogeneity among studies, subgroup analysis showed that active immunization improved locomotion after traumatic SCI in all tested conditions (with differences in injury model, severity of injury, method of administration, different time interval between SCI to vaccination, etc.). Conclusion:The results of the present study demonstrated that immunization with MBP, especially in its active form, could significantly improve motor function following SCI in rats and mice. Therefore, it could be considered as a potential treatment in acute settings such as emergency departments. However, the safety of this method is still under debate. Therefore, it is recommended for future research to focus on the investigation of safety of MBP immunization in animal studies, before conducting human clinical trials.

Heterologous ChAdOx1-nCoV19–BNT162b2 vaccination provides superior immunogenicity against COVID-19

At the height of the COVID-19 vaccination campaign, supply and local availability issues for the approved vaccines—together with worries about rare side-effects (thrombotic thrombocytopenia)—necessitated the switch to heterologous vaccination schedules, commonly known as mixing vaccines. Several studies have now been completed addressing the efficacy and safety of this practice during the battle for immunisation against SARS-CoV-2 and its variants. In The Lancet Respiratory Medicine, David Hillus and colleagues report the interim results of a study from the Charité—Universitätsmedizin in Berlin, Germany, on the safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with the non-replicating chimpanzee adenovirus vaccine ChAdOx1-nCoV19 (AstraZeneca, Cambridge, UK) and mRNA vaccine BNT162b2 (Pfizer-BioNtech, Mainz, Germany).