The impact of making vaccines thermostable in Niger's vaccine supply chain

Introduction 
Although vaccination is an effective intervention to reduce childhood mortality and morbidity, reasons for incomplete vaccination, including maternal living arrangements, have been marginally explored. This study aims at assessing whether maternal living arrangements are associated with vaccination status of children aged 12–23 months in Zimbabwe. It also explores other variables that may be associated with having children not fully vaccinated.


Materials and Methods 
A cross-sectional analysis was performed on the DHS-VI done in Zimbabwe in 2010–2011 (response rate 93%). Incomplete vaccination of children (outcome), was defined as not having received one dose of BCG and measles, 3 doses of polio and DPT/Pentavalent. Maternal living arrangements (main exposure), and other exposure variables were analysed. Survey logistic regression was used to calculate crude and adjusted OR for exposures against the outcome.


Results 
The dataset included 1,031 children aged 12–23 months. 65.8% of children were fully vaccinated. 65.7% of the mothers were married and cohabitating with a partner, 20.3% were married/partnered but living separately and 14% were not married. Maternal living arrangements were not associated with the vaccination status of children both in crude and adjusted analysis. Factors associated with poorer vaccination status of the children included: no tetanus vaccination for mothers during pregnancy (adjusted OR = 2.1, 95%CI 1.5;3.0), child living away from mother (adjusted OR = 1.5, 95%CI 1.2;1.8), mother’s education (adjusted OR = 0.6, 95%CI 0.4;0.9), high number of children living in the household (adjusted OR = 1.5, 95%CI 1.1;2.2), child age (adjusted OR = 0.7, 95%CI 0.5;0.9).


Discussion 
Maternal living arrangements were not associated with vaccination status of Zimbabwean children. Other factors, such as the mother’s health-seeking behaviour and education were major factors associated with the children’s vaccination status. Given the results of this study, it is strongly recommended that the vaccination coverage is increased by improving access to antenatal care and education for the parents.

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Do Maternal Living Arrangements Influence the Vaccination Status of Children Age 12–23 Months? A Data Analysis of Demographic Health Surveys 2010–11 from Zimbabwe

Objective: 
To describe trends in the report of headache as an adverse event following vaccination according to the Vaccine Adverse Events Reporting System (VAERS).
 Background: 
The VAERS is a national vaccine safety surveillance program sponsored by the Centers for Disease Control and Prevention/U.S. Food and Drug Administration. Headache is a common symptom of multiple vaccines post-licensure, yet systematic investigations are lacking.
 Methods: 
We searched the VAERS database to identify reports of headache after receipt of any vaccine in the U.S. during the time period from January 1990 to August 2015. We evaluated epidemiological features, including event characteristics, demographics and vaccine type.
 Results: 
Headache was the 5th most commonly reported symptom after fever, injection site reactions, pain, and rash. We retrieved 28,286 reports of headache. The majority(94.60[percnt])were unspecified headache types; however, 29[percnt] also had nausea or vomiting. Only 1,344 cases of migraine were reported, representing 4.75[percnt] of all the headache cases. The onset was within one day of vaccination in 69[percnt] of cases. Headache resulted in 11,162 (39.5[percnt]) emergency room visits, 2,426 (8.5[percnt]) hospitalizations, and 833 (2.94[percnt]) cases of permanent disability by report. There were 3,159 cases (11.17[percnt]) considered serious. Females accounted for 19,187 reports (67.83[percnt]) and males accounted for 8,801 reports (31.11[percnt]). Patient age range spanned from infants to the elderly; 75[percnt] of cases reported were between 6-59 years of age. Reports of headache per year increased in number since 1990, with the majority of cases (10.93[percnt]) reported in 2009. Vaccine against Influenza virus and Hepatitis B virus were those most frequently associated with headache, accounting for over a third of cases.
 Conclusions: 
Headache is a commonly reported vaccine related adverse event; a small subset of reports were considered serious. The development of vaccine-related classification criteria may be useful to better evaluate headache as an adverse event. Disclosure: Dr. Cocores has nothing to disclose. Dr. Monteith has nothing to disclose.

Post-Vaccination Headache Reporting Trends According to the Vaccine Adverse Events Reporting System (VAERS) (P1.147)

This study looked at differences in the presence of headache as an onset symptom of coronavirus disease 2019 (COVID‐19) and as a post‐COVID‐19 symptom in individuals previously hospitalized owing to infection with the Wuhan, Alpha, or Delta variants of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2).

Headache as a COVID‐19 onset symptom and post‐COVID‐19 symptom in hospitalized COVID‐19 survivors infected with the Wuhan, Alpha, or Delta SARS‐CoV‐2 variants

Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty®, Spikevax®, Vaxzevria® and Jcovden®. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results.

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COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal

Abstract Background Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are used to reduce the risk of developing Coronavirus Disease 2019 (COVID-19). Despite the significant benefits in terms of reduced risk of hospitalization and death, different adverse events may present after vaccination: among them, headache is one of the most common, but nowadays there is no summary presentation of its incidence and no description of its main features. Methods We searched PubMed and EMBASE covering the period between January 1 st 2020 and August 6 th , 2021, looking for record in English and with an abstract and using three main search terms (with specific variations): COVID-19/SARS-CoV-2; Vaccination; headache/adverse events. We selected manuscript including information on subjects developing headache after injection, and such information had to be derived from a structured form (i.e. no free reporting). Pooled estimates and 95% confidence intervals were calculated. Analyses were carried out by vaccine vs. placebo, by first vs. second dose, and by mRNA-based vs. “traditional” vaccines; finally, we addressed the impact of age and gender on post-vaccine headache onset. Results Out of 9338 records, 84 papers were included in the review, accounting for 1.57 million participants, 94% of whom received BNT162b2 or ChAdOx1. Headache was generally the third most common AE: it was detected in 22% (95% CI 18–27%) of subjects after the first dose of vaccine and in 29% (95% CI 23–35%) after the second, with an extreme heterogeneity. Those receiving placebo reported headache in 10–12% of cases. No differences were detected across different vaccines or by mRNA-based vs. “traditional” ones. None of the studies reported information on headache features. A lower prevalence of headache after the first injection of BNT162b2 among older participants was shown. Conclusions Our results show that vaccines are associated to a two-fold risk of developing headache within 7 days from injection, and the lack of difference between vaccine types enable to hypothesize that headache is secondary to systemic immunological reaction than to a vaccine-type specific reaction. Some descriptions report onset within the first 24 h and that in around one-third of the cases, headache has migraine-like features with pulsating quality, phono and photophobia; in 40–60% of the cases aggravation with activity is observed. The majority of patients used some medication to treat headache, the one perceived as the most effective being acetylsalicylic acid. 

/pdf/headache-onset-after-vaccination-against-sars-cov-2-a-3bg9plp0.pdf

Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis

Introduction : L'information apportée par la recherche opérationnelle menée dans le cadre du DIU

Background: Despite its high prevalence, the clinical course of pediatric migraine has not been fully understood, and previous studies present conflicting results. We present here the findings of a 10-year follow-up study involving children with severe migraine pain admitted to our emergency department. Furthermore, all studies were carried out on selected outpatient clinical case studies. Our aim was to evaluate a population of migraine children admitted to an emergency department because of increased severity or frequency of pain or even because of very anxious parents concerning their child’s headache in order to describe their long-term outcomes, whether it differed from that of outpatient populations and to identify possible predictors of prognosis. Methods: We recruited 80 subjects with migraine headaches (mean age 8 years with a range of 4–14 years, 50% females), attending the baseline examination of a population admitted for a headache to the Emergency Department in the first half year of 2012. Of the 80 subjects, 48 (60%) were eligible for follow-up in 2022. We included in our study only patients diagnosed with migraine, according to the diagnostic criteria of the International Classification of Headache Disorders. All were contacted by telephone, and a semi-structured questionnaire was provided to them by email. The association between several possible prognostic factors (gender, familiar neurologic disorders, prenatal and perinatal disorders, social activities, sleep disorders, etc.) and the long-term persistence of migraine headaches were explored using logistic regression analysis. Results: Of 48 subjects with migraine headaches at baseline, 31 (65%) had persistent migraine, and 17 (35%) experienced remission. The preliminary results showed that the presence of neurologic disorders in parents (p < 0.01—odds ratio 9.34 (2.53–41.64) and sleep disorders (p < 0.01—odds ratio 13.18 (2.25–252.74) significantly predicted the 10-year persistence of migraine headaches, while the other considered predictors were found not to influence prognosis. Conclusions: To our knowledge, this was the first study conducted on a selected pediatric population upon admission to the emergency room. Our study suggests that a population of pediatric migraine selected for admission to the emergency department also shows a favorable long-term prognosis, like the studies conducted in the outpatient sample. Familial neurological comorbidity and sleep disorders were unfavorable factors for predicting good outcomes.

https://www.mdpi.com/2077-0383/12/7/2475/pdf?version=1679652391

M. L. Manzo

Papers

Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis

Introduction : L'information apportée par la recherche opérationnelle menée dans le cadre du DIU

Evolution of Pediatric Migraine Patients Admitted at an Emergency Department after a 10-Year Follow-Up