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Vaccines Jun 2024Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and...
Evaluating the Compatibility of New Recombinant Protein Antigens (Trivalent NRRV) with a Mock Pentavalent Combination Vaccine Containing Whole-Cell Pertussis: Analytical and Formulation Challenges.
Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and middle-income countries (LMICs). This case-study highlights the analytical and formulation challenges encountered with three recombinant non-replicating rotavirus vaccine (NRRV) antigens (t-NRRV formulated with Alhydrogel adjuvant, AH) combined with a mock multidose formulation of a pediatric pentavalent vaccine used in LMICs. This complex formulation contained (1) vaccine antigens (i.e., whole-cell pertussis (wP), diphtheria (D), tetanus (T), (Hib), and hepatitis B (HepB), (2) a mixture of aluminum-salt adjuvants (AH and Adju-Phos, AP), and (3) a preservative (thimerosal, TH). Selective, stability-indicating competitive immunoassays were developed to monitor binding of specific mAbs to each antigen, except wP which required the setup of a mouse immunogenicity assay. Simple mixing led to the desorption of t-NRRV antigens from AH and increased degradation during storage. These deleterious effects were caused by specific antigens, AP, and TH. An AH-only pentavalent formulation mitigated t-NRRV antigen desorption; however, the Hib antigen displayed previously reported AH-induced instability. The same rank-ordering of t-NRRV antigen stability (P[8] > P[4] > P[6]) was observed in mock pentavalent formulations and with various preservatives. The lessons learned are discussed to enable future multidose, combination vaccine formulation development with new vaccine candidates.
PubMed: 38932338
DOI: 10.3390/vaccines12060609 -
Communicable Diseases Intelligence... Jun 2024Following implementation of coronavirus diseases 2019 (COVID-19) non-pharmaceutical interventions (NPIs) in early 2020, declines in the incidence of other respiratory...
BACKGROUND
Following implementation of coronavirus diseases 2019 (COVID-19) non-pharmaceutical interventions (NPIs) in early 2020, declines in the incidence of other respiratory pathogens have been reported. This study aimed to assess the impact of these interventions on pertussis notifications in Australia.
METHODS
We compared monthly national notification rates for pertussis during the first two years of the COVID-19 pandemic (2020 and 2021) to those during the three pre-pandemic years (2017 to 2019). Incidence rate ratios (IRR) by age group and jurisdiction were calculated for 2020 and 2021 compared to the mean prepandemic annual notification rate.
RESULTS
A substantial progressive decline in pertussis notifications was seen across all age groups, with all-age notification rates more than 40% lower than the pre-pandemic period in all jurisdictions in 2020, and more than 80% lower in 2021. Notification rates decreased more slowly from a lower baseline in Victoria than in other states and territories, despite the stricter, more sustained NPIs implemented in Victoria.
CONCLUSION
The significant decrease in pertussis notifications across all jurisdictions and age groups has likely resulted in reduced infection-acquired immunity, making maintenance of high vaccine uptake, particularly among pregnant women and young infants, of key importance.
Topics: Humans; Whooping Cough; COVID-19; Australia; Disease Notification; Female; Infant; Child; Adult; Child, Preschool; Adolescent; SARS-CoV-2; Young Adult; Middle Aged; Male; Incidence; Pregnancy; Infant, Newborn; Aged; Pertussis Vaccine
PubMed: 38926654
DOI: 10.33321/cdi.2024.48.24 -
Vaccine Jun 2024In New Zealand, approximately half reported pertussis cases are adult. Studies indicate underestimated pertussis burden in this population and probable reservoir for...
Pertussis epidemiology in adults: Retrospective analysis of pertussis incidence and association with comorbidities among adult populations in Aotearoa New Zealand, using national administrative datasets.
BACKGROUND
In New Zealand, approximately half reported pertussis cases are adult. Studies indicate underestimated pertussis burden in this population and probable reservoir for childhood pertussis. Pertussis is linked to chronic obstructive pulmonary disease (COPD) development and increased risk with pre-existing COPD. While acellular pertussis vaccines are available for adults, data on pertussis disease burden in adults and association with COPD remain limited.
AIM
To estimate pertussis incidence in New Zealand adult health service user (HSU) population aged ≥ 18 between 2008-2019 and inform adult pertussis vaccination strategies by assessing disease burden and risk factors in different adult populations.
METHODS
Retrospective observational cohort study using an HSU cohort, formed by linking administrative health data using unique National Health Index identifier. For primary analysis, annual incidence rates were calculated using pertussis hospitalisations and notifications. In secondary analysis, Cox proportional hazards survival analyses explored association between pertussis in adults and chronic comorbidities.
RESULTS
The cohort had 2,907,258 participants in 2008 and grew to 3,513,327 by 2019, with 11,139 pertussis cases reported. Highest annual incidence rate of 84.77 per 100,000 PYRS in 2012, notably affecting females, those aged 30-49 years, and European or Māori ethnicity. Adjusting for sociodemographic variables found no significant risk of prior pertussis notification leading to comorbidity diagnosis (Adjusted-HR: 0.972). However, individuals with prior comorbidity diagnosis had 16 % greater risk of receiving pertussis notification or diagnosis (Adjusted-HR: 1.162).
CONCLUSIONS
Study found significant pertussis burden among the HSU adult cohort and highlighted higher risk of pertussis for those with recent comorbidity diagnoses. Vaccination for pertussis should be recommended for individuals with comorbidities to reduce infection risk and disease severity. GPs must have capability to test for pertussis, given it is notifiable disease with implications for individuals, their families, and broader population. High-quality disease surveillance is crucial for informing policy decisions.
PubMed: 38910093
DOI: 10.1016/j.vaccine.2024.06.016 -
Drug Safety Jun 2024Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pregnancy, as clinical trials often exclude... (Review)
Review
INTRODUCTION
Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pregnancy, as clinical trials often exclude pregnant people. It is important to understand how pregnancy PV projects operate in low- and middle-income countries (LMICs), where there is a disproportionate lack of PV data yet a high burden of adverse pregnancy outcomes. We conducted a scoping review to assess how exposures and outcomes were measured in recently published pregnancy PV projects in LMICs.
METHODS
We utilized a search string, secondary review, and team knowledge to review publications focusing on therapeutic or vaccine exposures among pregnant people in LMICs. We screened abstracts for relevance before conducting a full text review, and documented measurements of exposures and outcomes (categorized as maternal, birth, or neonatal/infant) among other factors, including study topic, setting, and design, comparator groups, and funding sources.
RESULTS
We identified 31 PV publications spanning at least 24 LMICs, all focusing on therapeutics or vaccines for infectious diseases, including HIV (n = 17), tuberculosis (TB; n = 9), malaria (n = 7), pertussis, tetanus, and diphtheria (n = 1), and influenza (n = 3). As for outcomes, n = 15, n = 31, and n = 20 of the publications covered maternal, birth, and neonatal/infant outcomes, respectively. Among HIV-specific publications, the primary exposure-outcome relationship of focus was exposure to maternal antiretroviral therapy and adverse outcomes. For TB-specific publications, the main exposures of interest were second-line drug-resistant TB and isoniazid-based prevention therapeutics for pregnant people living with HIV. For malaria-specific publications, the primary exposure-outcome relationship of interest was antimalarial medication exposure during pregnancy and adverse outcomes. Among vaccine-focused publications, the exposure was assessed during a specific time during pregnancy, with an overall interest in vaccine safety and/or efficacy. The study settings were frequently from Africa, designs varied from cohort or cross-sectional studies to clinical trials, and funding sources were largely from high-income countries.
CONCLUSION
The published pregnancy PV projects were largely centered in Africa and concerned with infectious diseases. This may reflect the disease burden in LMICs but also funding priorities from high-income countries. As the prevalence of non-communicable diseases increases in LMICs, PV projects will have to broaden their scope. Birth and neonatal/infant outcomes were most reported, with fewer reporting on maternal outcomes and none on longer-term child outcomes; additionally, heterogeneity existed in definitions and ascertainment of specific measures. Notably, almost all projects covered a single therapeutic exposure, missing an opportunity to leverage their projects to cover additional exposures, add scientific rigor, create uniformity across health services, and bolster existing health systems. For many publications, the timing of exposure, specifically by trimester, was crucial to maternal and neonatal safety. While currently published pregnancy PV literature offer insights into the PV landscape in LMICs, further work is needed to standardize definitions and measurements, integrate PV projects across health services, and establish longer-term monitoring.
PubMed: 38907172
DOI: 10.1007/s40264-024-01445-1 -
Nature Reviews. Microbiology Jun 2024Pertussis, which is caused by Bordetella pertussis, has plagued humans for at least 800 years, is highly infectious and can be fatal in the unvaccinated, especially... (Review)
Review
Pertussis, which is caused by Bordetella pertussis, has plagued humans for at least 800 years, is highly infectious and can be fatal in the unvaccinated, especially very young infants. Although the rollout of whole-cell pertussis (wP) vaccines in the 1940s and 1950s was associated with a drastic drop in incidence, concerns regarding the reactogenicity of wP vaccines led to the development of a new generation of safer, acellular (aP) vaccines that have been adopted mainly in high-income countries. Over the past 20 years, some countries that boast high aP coverage have experienced a resurgence in pertussis, which has led to substantial debate over the basic immunology, epidemiology and evolutionary biology of the bacterium. Controversy surrounds the duration of natural immunity and vaccine-derived immunity, the ability of vaccines to prevent transmission and severe disease, and the impact of evolution on evading vaccine immunity. Resolving these issues is made challenging by incomplete detection of pertussis cases, the absence of a serological marker of immunity, modest sequencing of the bacterial genome and heterogeneity in diagnostic methods of surveillance. In this Review, we lay out the complexities of contemporary pertussis and, where possible, propose a parsimonious explanation for apparently incongruous observations.
PubMed: 38907021
DOI: 10.1038/s41579-024-01064-8 -
Archivos de Bronconeumologia May 2024Chronic respiratory diseases (CRD) are responsible for more than four million deaths worldwide and have become especially prevalent in developed countries. Although the... (Review)
Review
Chronic respiratory diseases (CRD) are responsible for more than four million deaths worldwide and have become especially prevalent in developed countries. Although the current therapies help manage daily symptoms and improve patients' quality of life, there is a major need to prevent exacerbations triggered mainly by respiratory infections. Therefore, CRD patients are a prime target for vaccination against infectious agents. In the present manuscript we review the state of the art of available vaccines specifically indicated in patients with CRDs. In addition to pneumococcus, influenza, pertussis, and SARS-CoV-2 vaccines, recently added immunization options like vaccines and monoclonal antibodies against respiratory syncytial virus, are particularly interesting in CRD patients. As new products reach the market, health authorities must be agile in updating immunization recommendations and in the programming of the vaccination of vulnerable populations such as patients with CRDs. Organizational and educational strategies might prove useful to increase vaccine uptake by CRD patients.
PubMed: 38876918
DOI: 10.1016/j.arbres.2024.05.026 -
Euro Surveillance : Bulletin Europeen... Jun 2024We describe a pertussis outbreak in the Vallès region of Catalonia, from September 2023 to April 2024. Incidence was high in children aged 10-14 years compared with...
We describe a pertussis outbreak in the Vallès region of Catalonia, from September 2023 to April 2024. Incidence was high in children aged 10-14 years compared with previous outbreaks. Limited impact in newborns could be explained by the high vaccination coverage during pregnancy and at 11 months of age in 2022, at 85% and 94.1 %, respectively. A third booster vaccine dose during preadolescence should be considered and vaccination coverage in pregnant women be improved to control future outbreaks.
Topics: Humans; Whooping Cough; Spain; Female; Adolescent; Child; Incidence; Disease Outbreaks; Infant; Pertussis Vaccine; Pregnancy; Child, Preschool; Male; Infant, Newborn; Vaccination; Adult; Vaccination Coverage; Immunization, Secondary; Young Adult; Bordetella pertussis; Age Distribution; Population Surveillance
PubMed: 38873794
DOI: 10.2807/1560-7917.ES.2024.29.24.2400332 -
BMJ (Clinical Research Ed.) Jun 2024
Topics: Humans; Whooping Cough; Female; Pregnancy; Vaccination; Pertussis Vaccine; Pregnancy Complications, Infectious
PubMed: 38871363
DOI: 10.1136/bmj.q1289 -
Revista Panamericana de Salud Publica =... 2024To assess changes in reproductive, maternal, newborn, child, and adolescent health (RMNCAH) in Haiti from August 2018 to September 2021, before and during the COVID-19...
OBJECTIVE
To assess changes in reproductive, maternal, newborn, child, and adolescent health (RMNCAH) in Haiti from August 2018 to September 2021, before and during the COVID-19 pandemic.
METHODS
A retrospective study using surveillance data from the Haitian Unique Health Information System, examining two periods: pre- and peri-COVID-19 pandemic. Health indicators at the national level in the two periods were compared using two-sample -tests for proportions, and average absolute monthly changes were calculated using variance-weighted regression.
RESULTS
There was a statistically significant decline in the proportion of most of the indicators assessed from the pre- to the peri-COVID-19 pandemic period. However, the most affected indicators were the proportions of pregnant women with four antenatal care visits, with five antenatal care visits or more, and those who received a second dose of tetanus vaccine, which decreased by over 4 percentage points during the two periods. Likewise, the proportions of children who received diphtheria, tetanus, and pertussis (DTaP), BCG, polio, pentavalent, and rotavirus vaccines also all declined by over 8 percentage points. In contrast, pneumococcal conjugate vaccine increased by over 4 percentage points. A statistically significant decrease was also observed in the average absolute monthly changes of several reproductive and child health indicators assessed.
CONCLUSIONS
The COVID-19 pandemic may have contributed to the decline observed in several RMNCAH indicators in Haiti. However, the role played by the sociopolitical crisis and control exercised by armed groups over the population in the last three years cannot be ruled out.
PubMed: 38859812
DOI: 10.26633/RPSP.2024.57