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Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose.ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing.Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were eligible for inclusion in the assessment of the primary endpoint (6024 in the Ad26.COV2.S group and 5615 in the placebo group). The median (IQR) follow-up post-booster vaccination was 36·0 (15·0-62·0) days. Vaccine efficacy was 75·2% (adjusted 95% CI 54·6-87·3) against moderate to severe-critical COVID-19 (14 cases in the Ad26.COV2.S group and 52 cases in the placebo group). Most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621); endpoints for the primary analysis accrued from Nov 16, 2020, to June 25, 2021, before the global dominance of delta (B.1.617.2) or omicron (B.1.1.529). The booster vaccine exhibited an acceptable safety profile. The overall frequencies of solicited local and systemic adverse events (evaluated in the safety subset, n=6067) were higher among vaccine recipients than placebo recipients after the primary and booster doses. The frequency of solicited adverse events in the Ad26.COV2.S group were similar following the primary and booster vaccinations (local adverse events, 1676 [55·6%] of 3015 vs 896 [57·5%] of 1559, respectively; systemic adverse events, 1764 [58·5%] of 3015 vs 821 [52·7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1-2 in severity.A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults had an acceptable safety profile and was efficacious against moderate to severe-critical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed.Janssen ResearchDevelopment.

The coastal zones of Small Island States are hotspots of human habitation and economic endeavour. In the Pacific region, as elsewhere, there are large gaps in understandings of the exposure and vulnerability of people in coastal zones. The 22 Pacific Countries and Territories (PICTs) are poorly represented in global analyses of vulnerability to seaward risks. We combine several data sources to estimate populations to zones 1, 5 and 10 km from the coastline in each of the PICTs. Regional patterns in the proximity of Pacific people to the coast are dominated by Papua New Guinea. Overall, ca. half the population of the Pacific resides within 10 km of the coast but this jumps to 97% when Papua New Guinea is excluded. A quarter of Pacific people live within 1 km of the coast, but without PNG this increases to slightly more than half. Excluding PNG, 90% of Pacific Islanders live within 5 km of the coast. All of the population in the coral atoll nations of Tokelau and Tuvalu live within a km of the ocean. Results using two global datasets, the SEDAC-CIESIN Gridded Population of the World v4 (GPWv4) and the Oak Ridge National Laboratory Landscan differed: Landscan under-dispersed population, overestimating numbers in urban centres and underestimating population in rural areas and GPWv4 over-dispersed the population. In addition to errors introduced by the allocation models of the two methods, errors were introduced as artefacts of allocating households to 1 km x 1 km grid cell data (30 arc-seconds) to polygons. The limited utility of LandScan and GPWv4 in advancing this analysis may be overcome with more spatially resolved census data and the inclusion of elevation above sea level as an important dimension of vulnerability.

Compare estimates of the numbers of people living within 1, 5, and 10 km from the coast in Pacific Island Countries and Territories (PICTs). These distances are somewhat arbitrary, but in the absence of generally agreed definitions of the ‘coastal zone’ and of more integrated analyses that include elevation above sea level, livelihood portfolios and other measure of exposure to the ocean, they provide a logical basis for the analyses. Three coastal zones at 1, 5, and 10 km were mapped onto every populated island for each PICT. People residing within 1 km were considered to live on the coast, those within 5 km included those who could still easily walk to the coast and 10 km, those who interact with coastal communities (e.g. in terms of access to markets or other activities) and who would be able to easily get to the coast with some form of transport. The two global datasets used to spatially distribute populations were the SEDAC-CIESIN Gridded Population of the World v4 and the Oak Ridge National Laboratory LandScan™. GPWv4 is a minimally modelled population dataset that uniformly distributes census data from their native enumeration areas. LandScan™ allocates population census data using dasymetric cartographic techniques relying on ancillary data such as land cover, roads, terrain slope, urban extent, and accessibility to model population density at 30 arc-second grid resolution within administrative boundaries. Both global datasets distributed populations within enumeration areas to 30 arc second cells (approximate 1 km2 at the Equator). The following protocol explains the workflow used to calculate the Coastal Population Estimates for PICTs. The protocol involves three main steps: Generation of 1, 5 and 10 km coastal buffers Spatial disaggregation of the census population datasets using one of the three methods based on data availability. This step is not applicable for the global population grids. Overlay the coastal buffer mask on the disaggregated population datasets and sum the population contained within the coastal buffers to calculate the percentage of the country’s population within each of the three coastal zones.

Background The present study, #CPRinSchools, explores healthcare professionals in training as leaders of BLS teaching in UK secondary schools for children in aged 11–16. This initiative which has gained endorsement from the UK Foundation Programme Organisation and attracted medical education stakeholder interest (GMC, AoMRC, RCP) has been piloted amongst foundation doctors nationally and delivered to over 1000 pupils. Aims BLS training in schools is associated with improved cardiac arrest outcomes. The present study aims to: A) Identify an evidence-based approach to leading BLS teaching in schools, B) Explore the extent to which trainee engagement with #CPRinSchools enhances their leadership skills as per the Medical Leadership Competency Framework (MLCF). Methods BLS teaching using Laedel Resusci Anne mannequins was delivered by foundation doctors to 270 students aged 11–16 years using the #CPRinSchools programme. Pre and post-test questionnaires were used to assess student knowledge. 90 students completed these. Surveys and focus groups were carried out among foundation doctors to explore impacts of leading BLS teaching through #CPRinSchools on developing leadership skills. Results Results identified a statistically significant improvement in children’s ability to identify when to commence chest compressions or put someone in the recovery position and, where indicated, how long to carry out chest compressions. Phenomenographic analysis identified perceived significant improvements in foundation doctors’ leadership qualities in the MLCF domains: ‘Demonstrating personal qualities’ and ‘Working with others’. Conclusions #CPRinSchools significantly improves secondary school children’s knowledge of the key principles of Basic Life Support. Foundation Doctor engagement with #CPRinSchools improves their personal qualities and teamworking skills which they can apply in other contexts within the clinical environment to improve patient care and outcomes.