A tailored COVID-19 vaccination pathway for children 5-11 years in Victoria, Australia.

BACKGROUND: Procedural anxiety was anticipated in children 5-11 years during the COVID-19 vaccine rollout in Victoria, Australia, as children in this age group receive few routine vaccines. Therefore, the Victorian state government designed a tailored, child-friendly vaccine program. This study aimed to assess parental satisfaction with elements of the bespoke vaccination pathway. METHODS: The Victorian government and state-run vaccination hubs in Victoria facilitated an online immunisation plan to help parents identify their child's support needs, and utilised experienced paediatric staff and additional supports for children with severe needle distress and/or disability. All parents/guardians of children 5-11 years who received a COVID-19 vaccine in a vaccination hub were sent a 16-item feedback survey via text message. RESULTS: Between 9 February and 31 May 2022 there were 9203 responses; 865 children (9.4%) had a first language other than English, 499 (5.4%) had a disability or special needs, and 142 (1.5%) were Aboriginal or Torres Strait Islander. Most parents (94.4%; 8687/9203) rated their satisfaction with the program as very good or excellent. The immunisation plan was used by 13.5% (1244/9203) of respondents, with usage more common for Aboriginal or Torres Strait Islander children (26.1%; 23/88) or families with a first language other than English (23.5%; 42/179). The child-friendly staff (88.5%, 255/288) and themed environment (66.3%, 191/288) were the most valued measures for vaccination. Additional support measures were required by 1.6% (150/9203) of children in the general population and 7.9%, (17/261) of children with a disability and/or special needs. CONCLUSION: A tailored COVID-19 vaccination program for children 5-11 years, with additional support for children with severe needle distress and/or disability, had high parental satisfaction. This model could be utilised for COVID-19 vaccination in pre-school children and for routine childhood vaccination programs to provide optimal support to children and their families.

Drivers of COVID-19 vaccine hesitancy among women of childbearing age in Victoria, Australia: A descriptive qualitative study.

Objective: Women of childbearing age, including pregnant and breastfeeding women, report higher COVID-19 vaccine hesitancy, but reasons for this hesitancy are unknown. We explored factors influencing vaccine decision-making among women of childbearing age in Victoria, Australia to inform strategies to increase COVID-19 vaccine uptake. Methods: Twenty-four women aged 18-40 years were interviewed July-October 2021. Interview data were analyzed thematically using an inductive, constructivist approach. Results: Of 24 participants, 14 (57%) were vaccine-hesitant, of whom 10/14 pregnant or breastfeeding. Six key themes were identified: weighing up perceived risks for self and baby; availability of information; change and contradictions; vaccination above everything; practical issues - hurdles of inconvenience. Vaccine-hesitant women's concerns included safety in pregnancy, breastfeeding and fertility effects. Some participants expressed a loss of trust in healthcare providers following vaccine mandates. Conclusions: Public health campaigns and communication should be tailored to address specific concerns to increase COVID-19 vaccine uptake and prevent negative COVID-19 outcomes for women of childbearing age. Findings suggest that effective strategies to address hesitancy in this group may include providing robust short- and long-term safety data across fertility, birth outcomes and child development following COVID-19 vaccination. Other supportive strategies may include systemic changes like making childcare available at vaccination points (where practical), and using data linkage infrastructure to track post-vaccination outcomes.

Vaccine decision-making begins in pregnancy: Correlation between vaccine concerns, intentions and maternal vaccination with subsequent childhood vaccine uptake.

INTRODUCTION: Maternal and childhood vaccine decision-making begins prenatally. Amongst pregnant Australian women we aimed to ascertain vaccine information received, maternal immunisation uptake and attitudes and concerns regarding childhood vaccination. We also aimed to determine any correlation between a) intentions and concerns regarding childhood vaccination, (b) concerns about pregnancy vaccination, (c) socioeconomic status (SES) and (d) uptake of influenza and pertussis vaccines during pregnancy and routine vaccines during childhood. METHODS: Women attending public antenatal clinics were recruited in three Australian states. Surveys were completed on iPads. Follow-up phone surveys were done three to six months post delivery, and infant vaccination status obtained via the Australian Childhood Immunisation Register (ACIR). RESULTS: Between October 2015 and March 2016, 975 (82%) of 1184 mothers consented and 406 (42%) agreed to a follow up survey, post delivery. First-time mothers (445; 49%) had significantly more vaccine concerns in pregnancy and only 73% had made a decision about childhood vaccination compared to 89% of mothers with existing children (p-value<0.001). 66% of mothers reported receiving enough information during pregnancy on childhood vaccination. In the post delivery survey, 46% and 82% of mothers reported receiving pregnancy influenza and pertussis vaccines respectively. The mother's degree of vaccine hesitancy and two attitudinal factors were correlated with vaccine uptake post delivery. There was no association between reported maternal vaccine uptake or SES and childhood vaccine uptake. CONCLUSION: First time mothers are more vaccine hesitant and undecided about childhood vaccination, and only two thirds of all mothers believed they received enough information during pregnancy. New interventions to improve both education and communication on childhood and maternal vaccines, delivered by midwives and obstetricians in the Australian public hospital system, may reduce vaccine hesitancy for all mothers in pregnancy and post delivery, particularly first-time mothers.

Nutritional status, exclusive breastfeeding and management of acute respiratory illness and diarrhea in the first 6 months of life in infants from two regions of Indonesia.

BACKGROUND: Infant morbidity and mortality rates remain high in Indonesia, with acute respiratory illnesses (ARI) and diarrhea the leading two health problems in children under 5 years. We aimed to describe the nutritional status, feeding practice and case management of ARI and diarrhea of infants from two regions of Indonesia during the first 6 months of life. METHODS: This study was an observational study conducted in parallel to an immunogenicity and efficacy trial of an oral rotavirus vaccine (RV3-BB) in the Klaten and Yogyakarta regions, Indonesia. Mothers were interviewed at 3 time points: within the first 6 days of their infant's life, and at 8-10 and 22-24 weeks of age. Questions asked included pregnancy history, infant nutritional status, feeding status and health of infants within up to 2 weeks prior to the assessment. RESULTS: Between February 2013 and January 2014, 233 mother-infant pairs were recruited. 60% (136/223) of infants were exclusively breastfed (EBF) until 6 months of age with the strongest support for EBF reported by mothers themselves 70% (101/223) and 25% (36/223) from their partners. At 6 months, 6% (14/223) of infants were underweight and severely underweight; 4% (8/ 223) wasted and severely wasted; and 12% (28/223) were stunted and severely stunted. Non-recommended medication use was high, with 54% (21/39) of infants with reported cough within 2 weeks of an assessment receiving cough medication, 70% (27 /39) an antihistamine, 26% (10/39) a mucolytic and 15% (6 /39) an oral bronchodilator. At age 22-24 week, infants with reported diarrhea within 2 weeks of an assessment had low use of oral rehydration solutions (ORS) (3/21;14%) and zinc therapy (2/ 21;10%). CONCLUSION: In this unique observational study, breastfeeding rates of 60% at 6 months were below the Indonesian national target of >75%. Adherence to WHO guidelines for management of ARI and diarrhea was poor, with high use of non-recommended cough medications and oral bronchodilators in the first 6 months of life and low use of ORS and zinc therapy. Ongoing education of primary health care workers and parents regarding management of common illness is needed in Indonesia.

Surveillance of adverse events following the introduction of 13-valent pneumococcal conjugate vaccine in infants, and comparison with adverse events following 7-valent pneumococcal conjugate vaccine, in Victoria, Australia.

The 13-valent pneumococcal vaccine (PCV13) replaced the 7-valent vaccine (PCV7) on the Australian National Immunization Program (NIP) in 2011. Post-marketing surveillance of adverse events following immunization (AEFI) is crucial for detecting potential safety signals and maintaining confidence in the NIP. This study describes all AEFI reported to Surveillance of Adverse Events following Vaccination in the Community (SAEFVIC), Melbourne, Australia, following both the primary series of PCV13 (children <7 months) and the catch-up dose (12 months-35 months) in its first year of inclusion on the NIP. AEFI reporting rates per 100,000 doses of vaccine administered were compared for the PCV13 primary series and PCV7 primary series in the previous year. SAEFVIC received 229 reports describing 406 AEFI following PCV13 vaccine in the 12 months post introduction. There was no difference in the total number of AEFI cases reported between the vaccines but 7 AEFI categories were reported at a significantly higher rate following PCV13 compared with PCV7. No difference in reporting rate was observed for serious AEFI (p = 0.25). Post-hoc analysis of a further 12 months of PCV13 data revealed that all 7 AEFI categories that were initially reported at a significantly higher rate following PCV13 compared to PCV7 in the first 12 months post introduction, were no longer significantly increased in the 13-24 month period. The initial high reporting rate for several common AEFI post PCV13 compared to PCV7 may be explained by heightened awareness of the new vaccine. There were no safety signals detected for rare or serious AEFI that would require further investigation at this time.

Clinical research potential in Victorian hospitals: the Victorian clinician researcher needs analysis survey.

BACKGROUND: The 2012 McKeon Review highlighted the role of clinician researchers in patient based research and the need to foster this capacity. While anecdotal evidence suggests that clinician researchers are under threat and underfunded, Australian data on barriers and enablers of clinician-led research are scant. AIMS: To describe (i) characteristics of clinician researchers; (ii) for research-active clinicians: areas of research, barriers/enablers of research and factors associated with funding success; and (iii) for research-inactive clinicians: enablers of future research. METHODS: An online survey distributed through the Bio21 Cluster to clinicians (doctors, nurses, allied health professionals) in 15 Victorian hospitals between November 2011 and January 2012. RESULTS: Seven hundred and seventy of 1027 (75%) of respondents were research-active and were more likely to be male, medical doctors, aged 45-54 years, to work full-time and have a higher degree (all P < 0.01). Of clinicians with a higher degree, 28% were research-inactive. Clinicians identified protected research time (50%), designated research space (42%), clinical trial coordinators (35%), institutional funding (34%) and mentoring (33%) as critical enablers of research. Research-inactive clinicians identified protected research time as the key enabler of future research. CONCLUSIONS: To realise recommendations in the McKeon Review, hospitals and research bodies will need to protect research time and provide space and funding. Engaging research-inactive clinicians will build research capacity.

Phase I trial of RV3-BB rotavirus vaccine: a human neonatal rotavirus vaccine.

INTRODUCTION: RV3 is a human neonatal rotavirus strain (G3P[6]) that has been associated with asymptomatic neonatal infection and replicates well in the infant gut. RV3-BB rotavirus vaccine has been developed as a rotavirus vaccine candidate for administration at birth. METHODS: A single-centre, double-blind, randomised placebo-controlled Phase I study evaluated the safety and tolerability of a single oral dose of the second generation RV3-BB rotavirus vaccine (8.3×10(6)FFU/mL) in 20 adults, 20 children and 20 infants (10 vaccine and 10 placebo per age cohort). Vaccine take was defined as seroconversion (a 3-fold increase in serum anti-rotavirus IgA or serum neutralising antibody (SNA) from baseline at day 28 post-dose) or evidence of RV3-BB viral replication in the faeces by RT-PCR analysis 3-6 days post-vaccination. RV3-BB presence was confirmed by sequence analysis. RESULTS: The RV3-BB vaccine was well tolerated in all participants, with no pattern of adverse events shown to be associated with the study vaccine. In the infant cohort, vaccine take was demonstrated in 8/9 infants following a single dose of vaccine compared with 2/7 placebo recipients. In the infant vaccine group, 5/9 infants exhibited either IgA or SNA seroconversion and 7/9 infants had evidence of RV3-BB replication on days 3-6, compared with 2/7 infants who seroconverted and 0/10 infants with evidence of replication in the placebo group. Two infants in the placebo group had serological evidence of a rotavirus infection within the 28-day study period: one demonstrated an IgA and the other an SNA response, with wild-type virus replication detected in another infant. CONCLUSION: A single dose of RV3-BB rotavirus vaccine was well tolerated in adults, children and infants. Most infants (8/9) who received RV3-BB demonstrated vaccine take following a single dose. These data support progression of RV3-BB to Phase II immunogenicity and efficacy trials.

Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia.

INTRODUCTION: In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq(®) and Rotarix(®) vaccines under the National Immunization Program (NIP) in July 2007. METHODS: Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1-7 and 1-21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. RESULTS: Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to <3 months of age, there was suggestive evidence of excess intussusception cases 1-7 and 1-21 days following dose 1 (1-7 days: RotaTeq(®) relative risk (RR)=5.3, 95% confidence interval [CI] 1.1,15.4; Rotarix(®) RR 3.5, 95% CI 0.7,10.1; 1-21 days: RotaTeq(®) RR 3.5, 95% CI 1.3, 7.6; Rotarix(®)RR 1.5, 95% CI 0.4, 3.9). There was no evidence that clinical outcome of intussusception occurring within 21 days of rotavirus vaccination differed from that in cases occurring later post-vaccination. CONCLUSION: Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the first dose of both vaccines. Larger population-based studies using linked databases are required to provide more definitive evidence.

Maternal antibodies to rotavirus: could they interfere with live rotavirus vaccines in developing countries?

INTRODUCTION: Past experience with live oral vaccines including licensed rotavirus vaccines demonstrates a trend towards reduced vaccine efficacy in developing countries compared with developed countries. The reasons behind this disparity are not well understood. Transplacental transfer of maternal antibodies and breast milk ingestion may attenuate vaccine responses in infants in developing countries where rotavirus infections are endemic, and maternal antibody levels are high. We examined the prevalence and level of rotavirus antibody in maternal and cord serum, colostrum and breast milk in a developing country setting. METHODS: 100 mother-infant pairs were prospectively recruited from December 2008 to February 2009 at Dr. Sardjito Hospital, Yogyakarta, Indonesia. Maternal and cord sera were collected during delivery. Colostrum and transitional breast milk were collected between day 0-3 and day 7-10 postpartum respectively. Rotavirus-specific IgA and IgG were estimated for all specimens and virus neutralization assays were conducted on a subset of milk specimens. RESULTS: All maternal and cord serum samples were positive for rotavirus-specific IgG antibodies with a strong correlation between levels of rotavirus-specific IgG in mothers and levels transferred to infants in cord blood (r=0.86; p=0.001). 78% of colostrum and 67% of transitional breast milk specimens were positive for rotavirus-specific IgA. There was a median 4-fold decrease in rotavirus-specific IgA from colostrum to transitional breast milk. Neutralizing antibodies were present in 56% of colostrum specimens assayed (19/34) and in 41% of transitional milk specimens assayed (14/34). CONCLUSIONS: Maternal serum and breast milk antibodies to rotavirus are highly prevalent in a developing country setting. Evaluation of the impact of maternal anti-rotavirus serum and breast milk antibody upon vaccine immunogenicity would help to inform rotavirus vaccination strategies, especially in developing settings.

New normal ranges of antistreptolysin O and antideoxyribonuclease B titres for Australian children.

OBJECTIVE: To determine age-specific upper limit of normal (ULN) values of the ASO and ADB titres in children aged 4-14 years in urban Melbourne. Serology is often used to diagnose a preceding Streptococcus pyogenes infection, particularly in potential cases of rheumatic fever and post-streptococcal glomerulonephritis. The most commonly used antigens are antistreptolysin O (ASO) and antideoxyribonuclease B (ADB). Reference ranges used in Australia for these serological markers are usually based on data in adults from other countries. There are no age-specific reference values for Australian children. METHODS: Sixty-six sera from children with no history of recent streptococcal infection were obtained in May-June 2002. The children were divided into three age groups for analysis: 4-5 (n = 20), 6-9 (n = 19) and 10-14 (n = 25) years. The geometric mean titre and ULN (defined as the 80th percentile) for the ASO and ADB titres for each age group were determined in both international and log units. RESULTS: The ULN for ASO titres in each age group was 120 (2.08 log units), 480 (2.68) and 320 (2.51). The ULN for ADB titres in each age group was 100 (2.00 log units), 400 (2.60) and 380 (2.58). CONCLUSION: The ASO and ADB ULN values in school-aged children are higher than the current reference ranges suggest.