Toward a dimensional model of risk and protective factors influencing children's early cognitive, social, and emotional development during the COVID-19 pandemic.

Variation in infants' home environment is implicated in their cognitive and psycho-social development. The pandemic has intensified variations in home environments through exacerbating socioeconomic inequalities, and increasing psychological stressors for some families. This study investigates the effects of parental (predominantly maternal) mental health, enriching activities and screen use on 280 24- to 52-month-olds' executive functions, internalising and externalising problems, and pro-social behaviour; with socioeconomic status and social support as contextual factors. Our results indicate that aspects of the home environment are differentially associated with children's cognitive and psycho-social development. Parents who experienced sustained mental distress during the pandemic tended to report higher child externalising and internalising problems, and executive function difficulties at follow-up. Children who spent more time engaged in enriching activities with their parents showed stronger executive functions and social competence six months later. Screen use levels during the first year of the pandemic were not associated with outcomes. To mitigate the risk of persistent negative effects for this 'pandemic generation' of infants, our study highlights the importance of supporting parents' mental health. As our results demonstrate the impact of social support on mental health, investing in support services and interventions promoting building support networks are likely to be beneficial.

Caregiver sensitivity supported young children's vocabulary development during the Covid-19 UK lockdowns.

Previous studies have shown that caregivers' sensitive, responsive interactions with young children can boost language development. We explored the association between caregivers' sensitivity and the vocabulary development of their 8-to-36-month-olds during COVID-19 when family routines were unexpectedly disrupted. Measuring caregivers' sensitivity from home interaction videos at three timepoints, we found that children who experienced more-sensitive concurrent interactions had higher receptive and expressive vocabularies (N=100). Children whose caregivers showed more-sensitive interactions at the beginning of the pandemic showed greater expressive vocabulary growth six (but not 12) months later (n=58). Significant associations with receptive vocabulary growth were not observed. Our findings highlight the importance of sensitivity at a time when other positive influences on language development were compromised.

The neural correlates of inhibitory control in 10-month-old infants: A functional near-infrared spectroscopy study.

Inhibitory control, a core executive function, emerges in infancy and develops rapidly across childhood. Methodological limitations have meant that studies investigating the neural correlates underlying inhibitory control in infancy are rare. Employing functional near-infrared spectroscopy alongside a novel touchscreen task that measures response inhibition, this study aimed to uncover the neural underpinnings of inhibitory control in 10-month-old infants (N = 135). We found that when inhibition was required, the right prefrontal and parietal cortices were more activated than when there was no inhibitory demand. This demonstrates that inhibitory control in infants as young as 10 months of age is supported by similar brain areas as in older children and adults. With this study we have lowered the age-boundary for localising the neural substrates of response inhibition to the first year of life.

Development of directed global inhibition, competitive inhibition and behavioural inhibition during the transition between infancy and toddlerhood.

Inhibitory control (IC) is a core executive function integral to self-regulation and cognitive control, yet is itself multi-componential. Directed global inhibition entails stopping an action on demand. Competitive inhibition is engaged when an alternative response must also be produced. Related, but not an executive function, is temperamentally-driven wariness of novelty, known as behavioural inhibition. Understanding early development of these components has been hampered by a shortage of suitable measures. We combine established and novel measures to capture directed global inhibition (Toy Prohibition, Touchscreen Prohibition), competitive inhibition (A-not-B, Early Childhood Inhibitory Touchscreen Task; ECITT) and behavioural inhibition (Touchscreen Approach) in 113 10- and 16-month-olds (73 seen longitudinally). ECITT performance shows good 1-week test-retest reliability at 10-months (r = 0.30-0.60) but little stability to 16-months. Directed global inhibition performance shows developmental progression but little stability of individual differences from 10 to 16 months. Performance on measures targeting similar IC components shows greater coherence at 16-months (r = 0.23-0.59) compared with 10-months (r = 0.09-0.35). Probing of ECITT condition effects indicates toddlers are more able, compared with infants, to override immediate prepotencies; indicative of increasingly flexible control over behaviour. However, exerting IC over cumulative prepotencies appears just as challenging for toddlers as infants. Exploratory analyses show little evidence for cross-sectional or longitudinal associations between behavioural, directed global and competitive inhibition. In combination, these findings indicate that IC is not yet a stable, unidimensional construct during the transition between infancy and toddlerhood, and highlight the need for careful selection of multiple measures for those interested in capturing early variation in IC.

Not all babies are in the same boat: Exploring the effects of socioeconomic status, parental attitudes, and activities during the 2020 COVID-19 pandemic on early Executive Functions.

Early executive functions (EFs) lay the foundations for academic and social outcomes. In this parent-report study of 575 UK-based 8- to 36 month olds (218 followed longitudinally), we investigate how variation in the home environment before and during the 2020 pandemic relates to infants' emerging EFs. Parent-infant enriching activities were positively associated with infant Cognitive Executive Function (CEF) (encompassing inhibitory control, working memory, cognitive flexibility). During the most-restrictive UK lockdown-but not subsequently-socioeconomic status (SES) was positively associated with levels of parent-infant enriching activities. Parents who regard fostering early learning, affection, and attachment as important were more likely to engage in parent-infant enriching activities, yet there was no significant pathway from parental attitudes or SES to CEF via activities. Infant screen use was negatively associated with CEF and Regulation. Screen use fully mediated the effect of SES on CEF, and partially mediated the effect of SES on regulation. Parental attitudes toward early learning, affection, and attachment did not significantly influence screen use. These results indicate that although parental attitudes influence the development of early EFs, interventions targeting attitudes as a means of increasing enriching activities, and thus EF are likely to be less effective than reducing barriers to engaging in enriching activities.

Inhibitory control and problem solving in early childhood: Exploring the burdens and benefits of high self-control.

Low inhibitory control (IC) is sometimes associated with enhanced problem-solving amongst adults, yet for young children high IC is primarily framed as inherently better than low IC. Here, we explore associations between IC and performance on a novel problem-solving task, amongst 102 English 2- and 3-year-olds (Study 1) and 84 Swedish children, seen at 18-months and 4-years (Study 2). Generativity during problem-solving was negatively associated with IC, as measured by prohibition-compliance (Study 1, both ages, Study 2 longitudinally from 18-months). High parent-reported IC was associated with poorer overall problem-solving success, and greater perseveration (Study 1, 3-year-olds only). Benefits of high parent-reported IC on persistence could be accounted for by developmental level. No concurrent association was observed between problem-solving performance and IC as measured with a Delay-of-Gratification task (Study 2, concurrent associations at 4-years). We suggest that, for young children, high IC may confer burden on insight- and analytic-aspects of problem-solving.

Seroprevalence of SARS-CoV-2-specific antibodies in Sydney after the first epidemic wave of 2020.

OBJECTIVES: To estimate SARS-CoV-2-specific antibody seroprevalence after the first epidemic wave of coronavirus disease 2019 (COVID-19) in Sydney. SETTING, PARTICIPANTS: People of any age who had provided blood for testing at selected diagnostic pathology services (general pathology); pregnant women aged 20-39 years who had received routine antenatal screening; and Australian Red Cross Lifeblood plasmapheresis donors aged 20-69 years. DESIGN: Cross-sectional study; testing of de-identified residual blood specimens collected during 20 April - 2 June 2020. MAIN OUTCOME MEASURE: Estimated proportions of people seropositive for anti-SARS-CoV-2-specific IgG, adjusted for test sensitivity and specificity. RESULTS: Thirty-eight of 5339 specimens were IgG-positive (general pathology, 19 of 3231; antenatal screening, 7 of 560; plasmapheresis donors, 12 of 1548); there were no clear patterns by age group, sex, or location of residence. Adjusted estimated seroprevalence among people who had had general pathology blood tests (all ages) was 0.15% (95% credible interval [CrI], 0.04-0.41%), and 0.29% (95% CrI, 0.04-0.75%) for plasmapheresis donors (20-69 years). Among 20-39-year-old people, the age group common to all three collection groups, adjusted estimated seroprevalence was 0.24% (95% CrI, 0.04-0.80%) for the general pathology group, 0.79% (95% CrI, 0.04-1.88%) for the antenatal screening group, and 0.69% (95% CrI, 0.04-1.59%) for plasmapheresis donors. CONCLUSIONS: Estimated SARS-CoV-2 seroprevalence was below 1%, indicating that community transmission was low during the first COVID-19 epidemic wave in Sydney. These findings suggest that early control of the spread of COVID-19 was successful, but efforts to reduce further transmission remain important.

Development and validation of the Early Executive Functions Questionnaire: A carer-administered measure of Executive Functions suitable for 9- to 30-month-olds.

Executive functions (EFs) enable us to control our attention and behavior in order to set and work toward goals. Strong EF skills are linked to better academic performance, and greater health, wealth, and happiness in later life. Research into EF development has been hampered by a lack of scalable measures suitable for infancy through to toddlerhood. The 31-item Early Executive Functions Questionnaire (EEFQ) complements temperament measures by targeting cognitive and regulatory capabilities. Exploratory Factor Analysis (n = 486 8- to 30-month-olds) and Confirmatory Factor Analysis (n = 317 9- to 30-month-olds) indicate Inhibitory Control, Flexibility, and Working Memory items load onto a common "Cognitive Executive Function (CEF)" factor, while Regulation items do not. The CEF factor shows strong factorial measurement invariance for sex, and partial strong factorial measurement invariance for age. CEF and Regulation scores show limited floor and ceiling effects, good internal consistency, short-term stability, and convergent validity with carer-report measures of attentional control. The EEFQ is sensitive to developmental change. Results indicate that the widely overlooked period between late infancy and early toddlerhood may be a sensitive period for EF development. The low-resource demands of the EEFQ afford the possibility to study emergent EFs at scale; opening up new opportunities in basic developmental and intervention research.

Early childhood education and care (ECEC) during COVID-19 boosts growth in language and executive function.

High-quality, centre-based education and care during the early years benefit cognitive development, especially in children from disadvantaged backgrounds. During the COVID-19 pandemic and its associated lockdowns, access to early childhood education and care (ECEC) was disrupted. We investigate how this period affected the developmental advantages typically offered by ECEC. Using parent-report data from 189 families living in the UK, we explore associations between time spent in ECEC by 8-to-36-month-olds, their socioeconomic background, and their growth in language and executive functions between Spring and Winter 2020. Receptive vocabulary growth was greater in children who continued to attend ECEC during the period, with a stronger positive effect for children from less advantaged backgrounds. The growth of cognitive executive functions (CEFs) was boosted by ECEC attendance during the period, regardless of socioeconomic background. Our findings highlight the importance of high-quality ECEC for the development of key skills and for levelling socioeconomic inequalities.

"No jab, no pay": catch-up vaccination activity during its first two years.

OBJECTIVES: To assess catch-up vaccination of older children and adolescents during the first two years of the "No jab, no pay" policy linking eligibility for federal family assistance payments with childhood vaccination status. DESIGN, SETTING, PARTICIPANTS: Cross-sectional analysis of Australian Immunisation Register data on catch-up vaccination of children aged 5 to less than 7 years before (January 2013 - December 2014; baseline) and during the first two years of "No jab, no pay" (December 2015 - December 2017), and of children aged 7 to less than 10 years and young people aged 10 to less than 20 years ("No jab, no pay" period only). MAIN OUTCOMES: Catch-up vaccination rates for measles-mumps-rubella vaccine second dose (MMR2), by age group, Indigenous status, and socio-economic status; catch-up vaccination of children aged 5 to less than 7 years (third dose of diphtheria-tetanus-pertussis vaccine [DTPa3], MMR1), before and after introduction of "No jab, no pay". RESULTS: The proportion of incompletely vaccinated children aged 5 to less than 7 years who received catch-up DTPa3 was higher under "No jab, no pay" than during the baseline period (15.5% v 9.4%). Of 407 332 incompletely vaccinated people aged 10 to less than 20 years, 71 502 (17.6%) received catch-up MMR2 during the first two years of "No jab, no pay", increasing overall coverage for this age group from 86.6% to 89.0%. MMR2 catch-up activity in this age group was greater in the lowest socio-economic status areas than in the highest status areas (29.1% v 7.6%), and also for Indigenous than for non-Indigenous Australians (35.8% v 17.1%). MMR2 catch-up activity in 2016 and 2017 peaked mid-year. CONCLUSIONS: Linking family assistance payments with childhood vaccination status and associated program improvements were followed by substantial catch-up vaccination activity, particularly in young people from families of lower socio-economic status.

Look duration at the face as a developmental endophenotype: elucidating pathways to autism and ADHD.

Identifying developmental endophenotypes on the pathway between genetics and behavior is critical to uncovering the mechanisms underlying neurodevelopmental conditions. In this proof-of-principle study, we explored whether early disruptions in visual attention are a unique or shared candidate endophenotype of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD). We calculated the duration of the longest look (i.e., peak look) to faces in an array-based eye-tracking task for 335 14-month-old infants with and without first-degree relatives with ASD and/or ADHD. We leveraged parent-report and genotype data available for a proportion of these infants to evaluate the relation of looking behavior to familial (n = 285) and genetic liability (using polygenic scores, n = 185) as well as ASD and ADHD-relevant temperament traits at 2 years of age (shyness and inhibitory control, respectively, n = 272) and ASD and ADHD clinical traits at 6 years of age (n = 94).Results showed that longer peak looks at the face were associated with elevated polygenic scores for ADHD (ß = 0.078, p = .023), but not ASD (ß = 0.002, p = .944), and with elevated ADHD traits in mid-childhood (F(1,88) = 6.401, p = .013, $\eta _p^2$=0.068; ASD: F (1,88) = 3.218, p = .076), but not in toddlerhood (ps > 0.2). This pattern of results did not emerge when considering mean peak look duration across face and nonface stimuli. Thus, alterations in attention to faces during spontaneous visual exploration may be more consistent with a developmental endophenotype of ADHD than ASD. Our work shows that dissecting paths to neurodevelopmental conditions requires longitudinal data incorporating polygenic contribution, early neurocognitive function, and clinical phenotypic variation.

Intimate partner violence identified through routine antenatal screening and maternal and perinatal health outcomes.

BACKGROUND: This study investigated the association between intimate partner violence (IPV) identified on routine prenatal screening and perinatal outcomes for mother and infant. METHODS: Routinely collected perinatal data for a cohort of all women and their infants born in public health facilities in Sydney (Australia) over the period 2014-2016 (N = 52,509) were analysed to investigate the risk of adverse maternal and perinatal outcomes associated with a history of IPV. The association between an affirmative response on prenatal IPV screening and low birth weight (LBW) < 2.5 kg, preterm birth < 37 weeks, breastfeeding indicators and postnatal depressive symptoms (PND) was investigated in a series of logistic regression models. RESULTS: IPV was associated with an increased risk of PND (OR = 2.53, 95% CI 1.76-3.63), not breastfeeding at birth (OR = 1.65, 95% CI 1.30-2.09), non-exclusive breastfeeding at discharge (OR = 1.66, 95% CI 1.33-2.07) and first post-natal visit (OR = 1.54, 95% CI 1.24-1.91). Self-reported fear of a partner was strongly associated with an increased risk of PND (OR = 3.53, 95% CI 2.50-5.00), and also LBW (OR = 1.58, 95% CI 1.12-2.22), preterm birth (OR = 1.38, 95% CI 1.08-1.76), lack of early initiation of breastfeeding (OR = 1.67, 95% CI 1.28-2.17), non-exclusive breastfeeding at discharge from hospital (OR = 1.60, 95% CI 1.24-2.06) and at the first post-natal visit (OR = 1.27, 95% CI 0.99-3.04). CONCLUSIONS: IPV reported at the time of pregnancy was associated with adverse infant and maternal health outcomes. Although women may be disinclined to report IPV during pregnancy, universal, routine antenatal assessment for IPV is essential for early identification and appropriate management to improve maternal and newborn health.

Closing the vaccination coverage gap in New South Wales: the Aboriginal Immunisation Healthcare Worker Program.

OBJECTIVES: To assess vaccination coverage and timeliness among Indigenous and non-Indigenous children in New South Wales and the rest of Australia, with a particular focus on changes in the vaccination coverage gaps after the introduction of the Aboriginal Immunisation Healthcare Worker (AIHCW) Program in NSW in 2012. DESIGN: Cross-sectional analysis of Australian Immunisation Register data (2008-2016). MAIN OUTCOME MEASURES: Annual estimates of full vaccination coverage at 9, 15 and 51 months of age for Indigenous and non-Indigenous children in NSW and the rest of Australia; differences in coverage between Indigenous and non-Indigenous children at each milestone. RESULTS: The proportion of Indigenous and non-Indigenous children classified as fully vaccinated at 9, 15, and 51 months increased significantly in both NSW and the rest of Australia after the introduction of the AIHCW Program. The mean annual difference in full vaccination coverage between Indigenous and non-Indigenous children in NSW aged 9 months declined from 6.6 (95% CI, 5.2-8.0) during 2008-2011 to 3.7 percentage points (95% CI, 2.5-4.8) during 2012-2016; for those aged 15 months it declined from 4.6 (95% CI, 3.1-6.0) to 2.2 percentage points (95% CI, 1.0-3.4), and for those aged 51 months it declined from 8.5 (95% CI, 7.2-9.8) to 0.6 percentage points (95% CI, -0.6 to 1.8). Reductions in the differences in coverage were not as marked in the rest of Australia. In 2016, there was no statistically significant difference in coverage at any of the three milestones in NSW: at 9 months the difference was 1.6 percentage points (95% CI, -1.0 to 4.1); at 15 months, 0.4 percentage points (95% CI, -2.2 to 2.9); and at 51 months, -1.8 percentage points (95% CI, -4.4 to 0.8). CONCLUSION: Our findings suggest that a dedicated program can help overcome barriers to timely vaccination and significantly improve timely vaccination rates in Indigenous Australian children.

Determinants of antenatal depression and postnatal depression in Australia.

BACKGROUND: Depression is a leading source of morbidity and health loss in Australian women. This study investigates the determinants of antenatal depressive symptoms and postnatal depressive symptoms in an Australian population, including people from culturally and linguistically diverse (CALD) backgrounds. METHOD: The study used a retrospective cohort of mothers of all live births in public health facilities in 2014 (N = 17,564) within South Western Sydney Local Health District and Sydney Local Health District in New South Wales, Australia. Prevalence of antenatal and postnatal depressive symptoms were estimated for the cohort. Multivariate logistic regression models were conducted to investigate the sociodemographic, psychological and health service determinants of antenatal and postnatal depressive symptoms, measured using the Edinburgh Postnatal Depression Scale (EPDS). RESULTS: The prevalence of antenatal and postnatal depressive symptoms was 6.2% and 3.3% of the cohort, respectively. Significant risk factors for maternal depressive symptoms during pregnancy were, a lack of partner support, history of intimate partner violence, being from the CALD population and low socioeconomic status. Self-reported antenatal depressive symptoms were strongly associated with postnatal depressive symptoms. Risk factors for postnatal depressive symptoms were similar to those for antenatal depressive symptoms, as well as assisted delivery. CONCLUSION: Factors relating to demographic and psychosocial disadvantage were associated with subsequent antenatal and postnatal depressive symptoms in New South Wales, Australia. Our study suggests that screening for probable depression and timely referral for expert assessment of at-risk mothers may be an effective strategy to improve maternal mental health outcomes.

Evaluation of bacille Calmette-Guérin immunisation programs in Australia.

BACKGROUND: bacille Calmette-Guérin (BCG) immunisation programs in Australia are funded and operated by the individual states and territories. In recent years BCG vaccine shortages have required use of unregistered products. We aimed to evaluate BCG immunisation programs in Australia, with particular reference to program implementation and national consistency.
 Methods: Between September and November 2015, 12 key stakeholders, representing Australian states and territories, completed surveys. We analysed BCG vaccination coverage data from the Australian Childhood Immunisation Register (ACIR), and data on adverse events following immunisation (AEFI) with BCG vaccine from the Therapeutic Goods Administration's Adverse Drug Reactions System, for 2001 to 2014.
 Results: Access to BCG vaccination varies between jurisdictions, with some states providing this only in major city locations. Analysis of ACIR data suggests significant differences in vaccine delivery between jurisdictions, but varying levels of under-reporting to the ACIR were also acknowledged. The rate of BCG AEFI appeared to increase between 2011 and 2014; however, these data need to be interpreted with caution due to small numbers, likely under-reporting of both numerator (AEFI) and denominator (vaccine doses administered), and the general increase in reporting of AEFI related to other vaccines in children over this period.
 Conclusions: BCG immunisation programs aim to prevent severe forms of tuberculosis in young children who live in or travel to high burden settings. A range of factors, particularly inconsistent vaccine supply are leading to low, variable and inequitable vaccine delivery across Australian jurisdictions. Improved BCG vaccination uptake and AEFI data quality are required for accurate monitoring of program delivery and vaccine safety - this is particularly important given the current need to use unregistered vaccines. Improved and consistent access to BCG vaccine is suggested to optimise equity for at-risk children Australia-wide.

Immunisation coverage annual report, 2014.

This 8th annual immunisation coverage report shows data for 2014 derived from the Australian Childhood Immunisation Register and the National Human Papillomavirus Vaccination Program Register. This report includes coverage data for 'fully immunised' and by individual vaccines at standard age milestones and timeliness of receipt at earlier ages according to Indigenous status. Overall, 'fully immunised' coverage has been mostly stable at the 12- and 24-month age milestones since late 2003, but at 60 months of age, it has increased by more than 10 percentage points since 2009. As in previous years, coverage for 'fully immunised' at 12 months of age among Indigenous children was 3.7% lower than for non-Indigenous children overall, varying from 6.9 percentage points in Western Australia to 0.3 of a percentage point in the Australian Capital Territory. In 2014, 73.4% of Australian females aged 15 years had 3 documented doses of human papillomavirus vaccine (jurisdictional range 67.7% to 77.4%), and 82.7% had at least 1 dose, compared with 71.4% and 81.5%, respectively, in 2013. The disparity in on-time vaccination between Indigenous and non-Indigenous children in 2014 diminished progressively from 20.2% for vaccines due by 12 months to 11.5% for those due by 24 months and 3.0% at 60 months of age.

Who is our cohort: recruitment, representativeness, baseline risk and retention in the "Watch Me Grow" study?

BACKGROUND: The "Watch Me Grow" (WMG) study examines the current developmental surveillance system in South West Sydney. This paper describes the establishment of the study birth cohort, including the recruitment processes, representativeness, follow-up and participants' baseline risk for future developmental risk. METHODS: Newborn infants and their parents were recruited from two public hospital postnatal wards and through child health nurses during the years 2011-2013. Data was obtained through a detailed participant questionnaire and linked with the participant's electronic medical record (EMR). Representativeness was determined by Chi-square analyses of the available clinical, psychosocial and sociodemographic EMR data, comparing the WMG participants to eligible non-participants. Reasons for non-participation were also elicited. Participant characteristics were examined in six, 12, and 18-month follow-ups. RESULTS: The number of infants recruited totalled 2,025, with 50 % of those approached agreeing to participate. Reasons for parents not participating included: lack of interest, being too busy, having plans to relocate, language barriers, participation in other research projects, and privacy concerns. The WMG cohort was broadly representative of the culturally diverse and socially disadvantaged local population from which it was sampled. Of the original 2025 participants enrolled at birth, participants with PEDS outcome data available at follow-up were: 792 (39 %) at six months, 649 (32 %) at 12 months, and 565 (28 %) at 18 months. Participants with greater psychosocial risk were less likely to have follow-up outcome data. Almost 40 % of infants in the baseline cohort were exposed to at least two risk factors known to be associated with developmental risk. CONCLUSIONS: The WMG study birth cohort is a valuable resource for health services due to the inclusion of participants from vulnerable populations, despite there being challenges in being able to actively follow-up this population.

Adverse events following immunisation with bacille Calmette-Guérin vaccination: baseline data to inform monitoring in Australia following introduction of new unregistered BCG vaccine.

In recent years there has been a global shortage of bacille Calmette-Guérin (BCG) vaccine and, from September 2012, unregistered vaccines have needed to be used in Australia (a Danish product initially until the end of 2015, and a Polish product used in some jurisdictions from early 2016). We examined rates and types of adverse events following immunisation (AEFI) with BCG vaccine reported to the Therapeutic Goods Administration between 2009 and 2014 in children aged less than 7 years. Reporting rates of AEFI with BCG vaccine increased from 87 per 100,000 doses (registered Sanofi Pasteur product) in 2009 to 201 per 100,000 doses (unregistered Danish Statens Serum Institute product) in 2014, with Victoria having the highest rate each year. Substantial variation between jurisdictions exists, suggesting differential reporting of BCG vaccine doses administered and/or BCG vaccine-related AEFI. The most commonly reported reactions were abscess (31%), injection site reaction (27%) and lymphadenopathy/lymphadenitis (17%). This study provides baseline data on BCG vaccine safety to inform surveillance. Given the current use of unregistered vaccines in the context of vaccine supply issues, improved recording of both administered BCG vaccine doses and the reporting of BCG vaccine-related AEFI are required to facilitate close monitoring of vaccine safety.