A prospective, observational, multi-center, post-marketing safety surveillance study of the GSK combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b invasive infections (DTaP-IPV/Hib) in South Korean infants.

In South Korea, a combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b invasive infections (DTaP-IPV/Hib) is available since 2018 for vaccination of infants from the age of 2 months. This prospective, observational, non-comparative, post-marketing study evaluated the real-world safety of DTaP-IPV/Hib primary vaccination in eligible South Korean infants from the age of 2 months between 2018 and 2022. Infants were followed up for 30 days after each vaccine dose to assess the proportion of infants experiencing any adverse event (AE), including adverse drug reactions (ADRs), unexpected AEs, and serious AEs/serious ADRs (SAEs/SADRs). Of 660 infants vaccinated during the study period, 646 were included in the total safety cohort. A total of 194 AEs were reported in 143 (22.1%) infants; 158 AEs occurred after the first dose in 130 (20.1%) infants, 21 after the second dose in 20 (13.4%) infants, and 11 after the third dose in ten (8.1%) infants. The most frequent AEs by Medical Dictionary for Regulatory Activities Preferred Terms terminology were pyrexia (13.3%), injection site swelling (5.1%), and irritability (1.7%). Most of the AEs were mild, resolved without a medical visit, and were classified as possibly related to vaccination. The incidence proportions of ADRs, unexpected AEs, and SAEs/SADRs were 19.4%, 4.3%, and 0.9%, respectively. All SAEs/SADRs resolved after hospitalization or emergency room visit, and one event was possibly related to vaccination. These results are in line with the approved label and other national/international studies, confirming the acceptable safety profile of DTaP-IPV/Hib in the South Korean pediatric population.

In South Korea, a vaccine to help protect infants against five childhood diseases (diphtheria, tetanus, whooping cough, poliomyelitis, and Haemophilus influenzae type b invasive infections) called DTaP-IPV/Hib vaccine, has been available since 2018. As required by Korean regulation, this study aimed to confirm that DTaP-IPV/Hib was well tolerated by South Korean infants during its first 4 years of use in the country (2018­2022). This study followed 646 healthy infants aged 2­3 months who received up to three vaccine doses with 2-month intervals between doses, according to the Korean vaccination recommendations. The infants were followed for 30 days after each vaccination to evaluate how often adverse events (AEs) occurred during that period. An AE was defined as any untoward medical event after exposure to the vaccine, but not necessarily caused by that same vaccine. Overall, 194 AEs occurred during the study. On average, at least one AE was reported in 22% of infants within 30 days following vaccination. These AEs were mostly fever (body temperature >38.0°C), swelling at vaccine injection site, and irritability. A serious AE (SAE) was reported for 0.9% of infants. The infants always recovered from these SAEs after hospitalization or emergency room visit. The reported AEs are indicated in the vaccine package insert, meaning they were possibly expected to occur after vaccination. This study therefore confirms the acceptable safety profile of DTaP-IPV/Hib when given to South Korean infants in accordance with local prescribing recommendations and as part of routine childhood immunization.

Assessing the impact of COVID-19 on routine immunization in Sierra Leone.

BACKGROUND: The COVID-19 pandemic had a profound impact on healthcare systems and services, including routine immunization (RI). To date, there is limited information on the effects of the COVID-19 pandemic on RI in West African countries such as Sierra Leone, which had already experienced public health emergencies that disrupted its healthcare system. Here, we describe the impact of the COVID-19 pandemic on the RI of key antigens in Sierra Leone. METHODS: We used vaccination data from the District Health Information System for BCG, measles-rubella 1 and 2, and pentavalent 1 and 3 antigens. We compared 2019, 2020, 2021, and 2022 annual coverage rates for the selected antigens at the national and district levels. We used the Pearson chi-square test to assess the difference between annual coverage rates between 2019 and 2020, 2020-2021, and 2021-2022. RESULTS: National coverage rates for all antigens declined in 2019-2020, notably measles-rubella 1 and pentavalent 3 (-5.4% and - 4.9%). Between 2020 and 2021, there was an overall increase in coverage (+ 0.2% to + 2.5%), except for measles-rubella 2 (-1.8%). Measles-rubella antigens rebounded in 2021-2022, while others decreased between - 0.5 and - 1.9% in coverage. Overall, all district-level coverage rates in 2022 were lower than those in 2019. Most districts decreased between 2019 and 2022, though a few had a continuous increase; some had an increase/recovery between 2020 and 2021; some districts had recovered 2019 levels by 2022. CONCLUSION: The COVID-19 pandemic impacted Sierra Leone's national BCG, measles-rubella, and pentavalent antigen immunization, which were not fully restored in 2022. Most districts experienced notable coverage declines during the pandemic, though a few reached or surpassed 2019 rates in 2022. Examining pandemic impact can benefit from a focus beyond the national level to identify vulnerable regions. Sierra Leone's post-pandemic RI reestablishment needs targeted strategies and continual investments for equitable access and coverage, as well as to prevent vaccine-preventable diseases.

Transformative vaccination: A pentavalent shield against COVID-19 and influenza with betulin-based adjuvant for enhanced immunity.

The development of an effective combined vaccine represents a crucial strategy for preventing outbreaks of infectious diseases and reducing the burden on healthcare resources. Developing a combined vaccine against both influenza and the coronavirus is a promising approach, but it is still in the early stages of development. This paper reports on a novel combined pentavalent candidate vaccine that has shown promising results in mice, with statistically significant differences in mean antibody titer against the coronavirus and the influenza antigens compared to placebo. We have shown that the coronavirus antigen is capable of inducing an immune response autonomously, regardless of the presence of the influenza antigens in a combined vaccine. On the other hand, the presence of the coronavirus antigen in a combined vaccine showed to enhance the immune response against some of the studied influenza antigens, suggesting that these antigens may act in synergy and elicit an enhanced immune response. The absence of dose-dependent difference in mean antibody titer within the same antigenic groups of vaccine preparations suggested that even small amounts of the coronavirus and the influenza antigens could induce an immune response just as good as high-dose vaccine preparations, which certainly has important safety and cost implications. The vaccine is soon to be ready for clinical trials and mass production.

Change in Prevalence of Meningitis among Children with Febrile Seizure after the Pentavalent Vaccination.

Introduction: One of the most significant current discussions in pediatrics is whether lumbar puncture (LP) should be performed in children with febrile seizure (FS) as in the past. Objectives: We compared the prevalence of meningitis among FS children before and after the pentavalent vaccine to determine the importance of the LP in these children. Methods: We performed a retrospective cross-sectional study on the prevalence and etiology of bacterial meningitis (BM) in 1314 children with FS before and after pentavalent vaccination. Results: We found that complex FS was more prevalent in patients aged under 12 months compared to other patients. The peak incidence of aseptic meningitis and BM was in the age group of 12- to 18- and 18- to 36-month-old, respectively (P value <0.001 and <0.05, respectively). Children with complex FS had a significantly higher rate of BM and a lower rate of seizure recurrence than those with simple FS (P value <0.05). There was a significant relationship between getting the pentavalent vaccine and reducing the prevalence of BM and Hib-induced BM, but no SP-induced BM (P value <0.05 and 0.05 and 0.104, respectively). Conclusion: This study offers some insights into the effectiveness of the pentavalent vaccine. In addition, the low prevalence of BM in vaccinated FS cases does not support strong recommendations for LP in FS children.

BACKSLIDING ON CHILDHOOD IMMUNIZATIONS DUE TO ONGOING COVID-19 PANDEMIC: A RETROSPECTIVE STUDY IN BANADIR REGION, SOMALIA.

Background: SARS-CoV-2 has resulted in a global public health crisis. During the pandemic, considerable delay was observed making it impossible for some children to receive their due vaccines on time. Like most resource-poor countries, COVID-19 pandemic is thought to have a negative impact on Somalia's immunization coverage. Materials and methods: This study aimed to assess the impact of the COVID-19 pandemic on routine childhood immunization coverage in Somalia. A retrospective comparative cross-sectional approach was employed to investigate the number of under-5-year children who got their immunization from the two major mother and child hospital, (Banadir and SOS hospitals) in Mogadishu, Somalia from October 2019 to December 2020. To do this, a total of 112, 060 data relating to the routine childhood immunization (measles, polio, whooping cough, hepatitis B, pneumonia, and tuberculosis) were collected from the monthly immunization report-data from the two hospitals. Results: The results showed that all the vaccines except birth vaccines have remarkably dropped with Penta-3 (27%), Penta-2 (11%), measles (10%) and Penta-1 (8%) respectively. However, the birth vaccines (BCG and Polio 0) were not affected as observed in this study. The reduction in children immunization rate in Somalia may be a combination of many other factors, we however recognize that the COVID-19 pandemic may have contributed significantly to this outcome . Conclusion: The government needed to take proactive measures to encourage parents to present their children for immunizations, including increasing community awareness concerning the importance of these routine childhood immunizations despite the ongoing COVID-19 pandemics.

The development and use of an inactivated vaccine against animals trichophytosis.

Background: The annual increase in the number of camels entails a parallel increase in the incidence of trichophytosis, which poses a great threat to the health and life of both this species of animals and other organisms that contact and surround them. Aim: The aim of the study was to develop and establish the quality of vaccines inactivated by ultrasonic exposure for the prevention and treatment of trichophytosis in camels, and to compare them with chemically deactivated vaccines. Methods: The peculiarity of the technology of production of these vaccines was the use of an innovative method of inactivation of fungal strains by ultrasonic waves, which allowed to achieve high positive results in theory, and was subsequently confirmed in practice by immunizing sick and healthy animals. The first tests of the obtained vaccines were conducted in laboratory conditions on experimental rabbits. Results: The results of prophylactic and therapeutic vaccinations were one hundred percent positive, which made it possible to conduct further tests directly on camels of industrial farms, the expected result of which was also positively confirmed at the end of the research. Conclusion: As a result of this experiment, the effectiveness, stability, and safety of the manufactured vaccines were established, which made it possible to approve the regulatory and technical documentation and patent them as an innovative and effective development for the prevention and treatment of camel trichophytosis, which will reduce the growth of infection and further overcome the mass spread of the disease both among camels and among the surrounding organisms to which it is transmitted.

Penta- and hexavalent vaccination of extremely and very-to-moderate preterm infants born at less than 34 weeks and/or under 1500 g: A systematic literature review.

Debate regarding vaccinating high-risk infants with penta- and hexavalent vaccines persists, despite their good immunogenicity and acceptable safety profile in healthy full-term infants. We report the findings of a systematic literature search that aimed to present data on the immunogenicity, efficacy, effectiveness, safety, impact, compliance and completion of penta- and hexavalent vaccination in high-risk infants, including premature newborns. Data from the 14 studies included in the review showed that the immunogenicity and the safety profile of penta- and hexavalent vaccines in preterm infants was generally similar to those seen in full-term infants, with the exception of an increase in cardiorespiratory adverse events such as apnea, bradycardia and desaturation following vaccination in preterm infants. Despite recommendations of vaccinating preterm infants according to their actual age, and the relatively high completion rate of the primary immunization schedule, vaccination was often delayed, increasing the vulnerability of this high-risk population to vaccine-preventable diseases.

Combined vaccines such as penta- and hexavalent vaccines against multiple childhood diseases are widely used in healthy babies born at term. However, it is still debated whether these vaccines act the same way in babies considered to be high-risk: babies born prematurely at <34 weeks of pregnancy, those with a birthweight of <1500 g or babies with chronic diseases. We did a systematic literature search to find studies on such high-risk babies vaccinated with penta- or hexavalent vaccines; we focused on their antibody levels following vaccination, side effects, and protection from the diseases against which they were vaccinated. We also analyzed whether they were vaccinated on time and with all the doses recommended for healthy full-term babies. We found 14 studies that included premature babies. The results of these studies suggest that premature babies' immune systems respond to penta- and hexavalent vaccines in largely the same way as those of full-term babies; side effects of penta- and hexavalent vaccines are also mostly similar to those seen in full-term babies. However, side effects like pauses in breathing, slow heart rate or low blood oxygen levels seem to be more common in preterm babies; for safety, these babies should be monitored closely after vaccination. Preterm babies are often vaccinated with a delay compared to the recommended schedule. No studies reported data on protection from the diseases covered by penta- and hexavalent vaccinations in preterm babies. More research is needed on penta- and hexavalent vaccination of other high-risk babies besides those born prematurely.

Acute adverse events following immunization with DTP-HB-Hib pentavalent vaccine in the first year of life.

Background: Since November 2014, the pentavalent (Diptheria+Tetanus+Pertussis and Hepatitis B and Hib or DTP-HBHib) vaccine has been integrated into the Iranian national vaccination programme. Aims: We conducted a prospective study in Zahedan in the southeast of the Islamic Republic of Iran to determine the incidence of adverse events following immunization (AEFI) with the pentavalent vaccine in children aged under one year. Methods: Using cluster sampling, 1119 children aged 2-10 months at 15 public health clinics were invited, through their parents, to participate in the study. The parents were trained to register and report any AEFIs in a questionnaire. They were instructed to return the child to the clinic for further examination by a physician if they observed any complications within 3 days of vaccination. Results: The most commonly reported AEFIs were fever (50.94%), mild (41.46%) and severe (1.70%) injection site complications, persistent crying for 3 hours or more (1.88%), hypotonic hyporesponsive episode (0.36%), vomiting (1.88%), diarrhoea (2.95%), and sterile abscess (0.62%). There were no cases of convulsion, purulent abscess or rash. The work experience of vaccinators (OR = 1.85; 95% CI: 1.4-2.46) showed a significant statistical association with the incidence of mild local complications at the injection site. Those with a history of Bacillus Calmette-Guérin (BCG) lymphadenitis (OR = 3.89; 95% CI:1.04-14.49) had a higher risk of severe local complications at the injection site. Conclusions: The observed incidence of serious AEFIs following pentavalent vaccine injection in the study population was within the expected range. However, some of the relationships observed in this study require further research.

Commercial Vaccines Do Not Confer Protection against Two Genogroups of Piscirickettsia salmonis, LF-89 and EM-90, in Atlantic Salmon.

In Atlantic salmon, vaccines have failed to control and prevent Piscirickettsiosis, for reasons that remain elusive. In this study, we report the efficacy of two commercial vaccines developed with the Piscirickettsia salmonis isolates AL100005 and AL 20542 against another two genogroups which are considered highly and ubiquitously prevalent in Chile: LF-89 and EM-90. Two cohabitation trials were performed to mimic field conditions and vaccine performance: (1) post-smolt fish were challenged with a single infection of LF-89, (2) adults were coinfected with EM-90, and a low level coinfection of sea lice. In the first trial, the vaccine delayed smolt mortalities by two days; however, unvaccinated and vaccinated fish did not show significant differences in survival (unvaccinated: 60.3%, vaccinated: 56.7%; p = 0.28). In the second trial, mortality started three days later for vaccinated fish than unvaccinated fish. However, unvaccinated and vaccinated fish did not show significant differences in survival (unvaccinated: 64.6%, vaccinated: 60.2%, p = 0.58). Thus, we found no evidence that the evaluated vaccines confer effective protection against the genogroups LF-89 and EM-90 of P. salmonis with estimated relative survival proportions (RPSs) of -9% and -12%, respectively. More studies are necessary to evaluate whether pathogen heterogeneity is a key determinant of the lack of vaccine efficacy against P. salmonis.

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

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.

Effect of mobile phone text message and call reminders in the completeness of pentavalent vaccines in Kano state, Nigeria.

PURPOSE: This study assessed the effect of mobile phone text message and call reminders in the completeness of the pentavalent vaccine administered against diphtheria, pertussis, tetanus, hepatitis B, and Haemophilus influenza. DESIGN AND METHODS: The population for this quasi-experimental study were recent mothers of children not more than three weeks old selected from six local government areas of Kano State, Northern Nigeria. Three local government areas were each allocated to the intervention (reminder) and control groups of the study. Mobile phone reminders (SMS and follow-up calls) were sent to mothers in the reminder group three days to and on the due date of their child's schedule for the 1st, 2nd and 3rd doses of the pentavalent vaccine. All statistical data were entered into the Statistical Package for Social Sciences (SPSS) version 23.0 and analysed using descriptive and inferential statistics. RESULTS: A total of 541 mothers (271 in the intervention group and 270 in the control group) participated in the study. Completion rates for the three doses of the pentavalent vaccine were observed to be higher for children in the reminder group (n = 161, 59.4%) compared to those in the control group (n = 92, 34.1%). CONCLUSION: Mobile phone reminders were effective and improved the rate of completeness of the pentavalent vaccine in the studied population. In line with the findings of the study, it is recommended that future studies should focus on identifying the best approach to remind parents either through SMS, phone calls, or voice messages or a combination of any of the approaches. PRACTICE IMPLICATION: Nurses and other health care providers will have empirical evidence on the use of mobile phone technology to improve the health and wellbeing of children by protecting them from vaccine-preventable diseases.

Probable Hydrocephalus Decompensation after Immunization with Pentavalent Vaccine: Case Report and Literature Review / Descompensação provável de hidrocefalia após imunização com vacina pentavalente: Relato de caso e revisão da literatura

There are several complications associated with immunization with the pentavalent vaccine. Most of them are mild reactions, of spontaneous resolution; however, though rare, serious and potentially-fatal adverse effects can occur. We report a case of acute intracranial hypertension syndrome in an infant with a previously-unknown suprasellar arachnoid cyst who developed acute obstructive hydrocephalus after immunization with the pentavalent vaccine. He underwent neuroendoscopic treatment, showing complete resolution of the condition. The present article aims to compare the activation of the immune system by the pertussis component of the vaccine and the mechanisms that hypothetically potentiated the pathological decompensation.

Várias são as complicações associadas à imunização com a vacina pentavalente (VP). Em geral, são reações leves, de resolução espontânea; entretanto, raramente podem ocorrer efeitos adversos graves, potencialmente fatais. Relatamos um caso de síndrome de hipertensão intracraniana aguda (HIA) em lactente portador de cisto aracnoide suprasselar até então desconhecido, que desenvolveu hidrocefalia obstrutiva aguda pós imunização com VP. Ele foi submetido a tratamento neuroendoscópico, e apresentou resolução completa do quadro. Este artigo pretende comparar a ativação do sistema imune pelo componente pertússis da vacina e os mecanismos que hipoteticamente potencializaram a descompensação patológica.

Disproportionality analysis of reported drug adverse events to assess a potential safety signal for pentavalent vaccine in 2019 in El Salvador.

Detection and surveillance of vaccine safety hazards is a public health staple. In the post-marketing phase, when vaccines are used in mass, it is crucial to monitor potential signals of adverse reactions that may have been missed in the pre-marketing phase. We analysed spontaneous reports of drug adverse events in El Salvador to assess a potential safety signal related to an increase in febrile seizures following the pentavalent (diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae Type B) vaccine in 2019. This was a retrospective observational study of adverse event notifications in the national electronic drug safety database from 2011 to 2019. We performed standard disproportionality analysis computing Proportional Reporting Risk (PRR), Reporting Odds Ratio (ROR), Relative Reporting Ratio (RRR), Chi-squared, and Information Component (IC), comparing the pairing of febrile seizures and pentavalent vaccine to all other drugs and adverse events recorded in 2019. The occurrence of febrile seizures following pentavalent vaccination exceeded the WHO expected rate of six cases × 100 000 doses administered from April 2019, with a maximum of 9.2 in September. IC was 4.3, ORR 421.9 (95% Confidence Interval, CI: 123.8-1437.7), PRR 223.5 (95 %CI: 70.2-710.9), RRR was 19.5. The first booster presented the highest rate (14.6 per 100,000 doses) of febrile seizures, more than double than expected. Rates for 2018 remained below expected. Reports of febrile seizures following pentavalent vaccine were also on the increase globally since 2014, with highest rates in 2018 and 2019. There was a disproportion of febrile seizures notifications following pentavalent in El Salvador in 2019, suggesting the existence of a safety signal. This may be due to the change in provider. Further studies should assess the causes of the increase and compute costs and benefits of this vaccination to determine if switching to a less reactogenic vaccine formulation is indicated.

Immune Response of Indian Preterm Infants to Pentavalent Vaccine Varies With Component Antigens and Gestational Age.

Childhood vaccination plays critical role in protecting infants from several dreaded diseases. Of the global 15 million preterm (PT) infants with compromised immune system born annually, India contributes to >3.5 million. Generation of adequate vaccine-induced immune response needs to be ensured of their protection. Immune response of Indian PT (n = 113) and full-term (FT, n = 80) infants to pentavalent vaccine administered as per the national recommendation was studied. Antibody titers against component antigens of pentavalent vaccine, immune cells profiling (T and B cells, monocytes and dendritic cells) and plasma cytokines were determined pre- and post-vaccination. Additionally, cell-mediated recall immune responses to pentavalent antigens were evaluated after short time antigenic exposure to infant PBMCs. Irrespective of gestational age (GA), all the infants developed adequate antibody response against tetanus, diphtheria, and protective but lower antibody levels for Haemophilus influenzae type-b and hepatitis B in preterm infants. Lower (~74%) protective antibody response to pertussis was independent of gestational age. PT-infants exhibited lower frequencies of CD4 T cells/dendritic cells/monocytes, increased plasma IL-10 levels and lower proliferation of central and effector memory T cells than in term-infants. Proliferative central memory response of FT-infants without anti-pertussis antibodies suggests protection from subsequent infection. Responder/non-responder PT-infants lacked immunological memory and could be infected with Bordetella. For hepatitis B, the recall response was gestational age-dependent and antibody status-independent. Humoral/cellular immune responses of PT-infants were dependent on the type of the immunogen. Preterm infants born before 32 weeks of gestation may need an extra dose of pentavalent vaccine for long lived robust immune response.

Development and Characteristics of Novel PLGA-chitosan as a New Nanocarrier for Pentavalent Vaccine Delivery.

BACKGROUND: Lately, the employment of nano-carriers has been known as an optimistic means of drug and vaccine delivery. OBJECTIVE: Nano vaccines are a novel tier of vaccines that can develop humoral and cellular immune responses and can be introduced as a practical and secure nano vaccine candidate for the prevention of diseases. The purpose of this study was to accomplish and use biodegradable nano-carriers for the synthesis of pentavalent vaccine and immunogenicity evaluation in the animal models. The PLGA nanoparticle was prepared and modified with chitosan nanoparticles. Nano-carrier PLGA-chitosan was loaded by the DTP-HepB-Hib antigens and confirmed by DLS, SEM, TEM and FT-IR, then in vitro loading and release were evaluated. Toxicity was assessed by the MTT method in the Hec293 cells. Antigenicity evaluation and histopathological study were conducted by injection of new nano pentavalent vaccines in the BALB/c mice and the immune response was measured in the serum samples through an indirect ELISA method. RESULTS: Conclusions drawn from the current study exhibited the plausible ability of nano-carrier to deliver the vaccine. A notable increase was shown in total IgG and IgM antibodies examined in mice vaccinated with new nano vaccines. The histopathological study in the treated mice showed no toxicity in the vital organs of mice. CONCLUSION: The engineered vaccine delivery system showed the ability to induce robust immune responses and also suitability features of the PLGA-chitosan as a promising carrier to improve vaccine delivery.

Timeliness of Vaccination among Children Attending Immunization Clinic at a Tertiary Hospital in South-East Nigeria.

Background: Timely vaccination of children is one of the most cost-effective interventions that ensure childhood survival. We determined the proportion of children who received timely vaccination and examined the factors associated with timely receipt of Bacillus Calmette Guerin (BCG) and third dose of pentavalent vaccine (Penta 3). Methodology: We conducted a cross-sectional survey among 599 caregivers-infant pair aged less than 24months, attending the immunization clinic of a tertiary hospital in Nigeria, selected using systematic sampling methods. Using a structured questionnaire, we access the proportion of children who received timely vaccination, the relationship between the timely receipt of BCG, Penta 3 vaccine and infant/caregiver characteristics was examined using chi-square and multiple logistic regression at a 5% level of significance. Results: The mean age of the respondents was 30.1±5.0 years. The majority (73.8%) had attained tertiary education, lived in an urban setting (90.9%), had received antenatal care during pregnancy (99.3%) and was delivered in a hospital (97.0%). About half of the children (52.9%) were male. About 18% of the caregivers reported missing scheduled immunization visits, due to forgetfulness (18%), child illness (14%) and being busy (5%). About 88% (482) of the children got their BCG vaccines on time, 91.1% got timely OPV0, however, only 29.5% of the newborns got HBV0 within 24 hours of birth. Only 65.7% and 65.0% received the timely measles-containing vaccine and yellow fever vaccine. None of the factors examined predicted timely receipt of BCG and Penta 3 vaccines. Conclusion: Interventions that remind caregivers about the immunization schedules, could improve timely vaccination.

Comparative tetanus antibody response of Nigerian children to diphtheria-pertussis-tetanus and pentavalent vaccines.

BACKGROUND: In Nigeria and many parts of the world, the pentavalent vaccine is replacing the diphtheria-pertussis-tetanus (DPT) vaccine in tetanus prevention. AIMS AND OBJECTIVES: The aim of this study was to compare the anti-tetanus immunoglobulin G (IgG) response of children who received DPT with those who received the pentavalent vaccine. SUBJECTS AND METHODS: A cross-sectional survey of anti-tetanus IgG levels in children aged 6 months to 5 years who received DPT and in children who received the pentavalent vaccine. IgG antibody levels were determined using enzyme-linked immunosorbent assay. The protective level was set at ≥0.1 IU/ml. RESULTS: One hundred and twenty-two out of 130 children (93.9%) who had received DPT had protective levels of anti-tetanus IgG compared to 278 out of 288 children (96.5%) who had received the pentavalent vaccine. The difference was not statistically significant (P = 0.21). The median IgG antibody level in those who received DPT was 1.1 IU/ml (interquartile range (IQR) 0.4-1.8) compared with 0.6 IU/ml (IQR 0.4-1.4) in those who received pentavalent vaccine (P = 0.006), with age being the only predictor of variability in the multivariate analysis. CONCLUSION/RECOMMENDATION: DPT and pentavalent vaccines are equally effective in inducing protective levels of anti-tetanus IgG in children. Vaccination with the pentavalent vaccine, which is the current policy in Nigeria and many other parts of the world, should continue.

Revised World Health Organization (WHO)'s causality assessment of adverse events following immunization-a critique.

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product-related-reaction. Deaths observed during post-marketing surveillance are not considered as "consistent with causal association with vaccine", if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as 'coincidental deaths' or 'unclassifiable', and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is "no other factor intervening in the processes." Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

Safety and tolerability of a liquid bovine rotavirus pentavalent vaccine (LBRV-PV) in adults.

BACKGROUND: Rotavirus Gastroenteritis (RVGE) is an important global public health problem. Recently a Lyophilized Pentavalent Human Bovine Reassortant Rotavirus vaccine (BRV-PV, Rotasiil) was licensed in India. A Liquid formulation of the same vaccine (LBRV-PV) was tested in a Phase I clinical trial. METHODS: Total 20 healthy adults were given a single oral dose of LBRV-PV and were followed for one month for safety outcomes: immediate reactions, solicited reactions, unsolicited adverse events and serious adverse events. RESULTS: All 20 adults completed the study without any major protocol deviations. No immediate reaction, solicited reactions and unsolicited adverse events were reported during the study. No clinically significant changes were seen in the vital parameters and safety laboratory test results. CONCLUSIONS: LBRV-PV developed in India was safe and well tolerated in adults. Further clinical development of this vaccine in infants should be undertaken. Trial Registration - CTRI/2015/11/006,384.