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Detection and surveillance of vaccine safety hazards is a public health staple. In the post-marketing phase, when vaccines are used in mass, it is crucial to monitor potential signals of adverse reactions that may have been missed in the pre-marketing phase. We analysed spontaneous reports of drug adverse events in El Salvador to assess a potential safety signal related to an increase in febrile seizures following the pentavalent (diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae Type B) vaccine in 2019. This was a retrospective observational study of adverse event notifications in the national electronic drug safety database from 2011 to 2019. We performed standard disproportionality analysis computing Proportional Reporting Risk (PRR), Reporting Odds Ratio (ROR), Relative Reporting Ratio (RRR), Chi-squared, and Information Component (IC), comparing the pairing of febrile seizures and pentavalent vaccine to all other drugs and adverse events recorded in 2019. The occurrence of febrile seizures following pentavalent vaccination exceeded the WHO expected rate of six cases × 100 000 doses administered from April 2019, with a maximum of 9.2 in September. IC was 4.3, ORR 421.9 (95% Confidence Interval, CI: 123.8–1437.7), PRR 223.5 (95 %CI: 70.2–710.9), RRR was 19.5. The first booster presented the highest rate (14.6 per 100,000 doses) of febrile seizures, more than double than expected. Rates for 2018 remained below expected. Reports of febrile seizures following pentavalent vaccine were also on the increase globally since 2014, with highest rates in 2018 and 2019. There was a disproportion of febrile seizures notifications following pentavalent in El Salvador in 2019, suggesting the existence of a safety signal. This may be due to the change in provider. Further studies should assess the causes of the increase and compute costs and benefits of this vaccination to determine if switching to a less reactogenic vaccine formulation is indicated.

Historically, the human prevalence of Wuchereria bancrofti infection in Wallis and Futuna (WAF) was among the highest in the Pacific and mass drug administration (MDA) against lymphatic filariasis (LF) either with diethylcarbamazine citrate (DEC) or the combination of DEC and albendazole had been implemented for decades. To determine whether LF antigen prevalence in WAF was lower than 1%, the infection threshold for elimination in an area where Aedes spp. are the principal vectors, we conducted the WHO-recommended transmission assessment survey in 2012. We present the results of a school-based survey, which targeted 1,014 students in all 13 elementary schools in WAF. From a fingerprick, the circulating filarial antigen (CFA) positivity was checked for grade 2-5 students using BinaxNOW filariasis test (immunochromatographic test). Of 935 children tested, three were positive for CFA in two schools. At the territory level, this was below the critical cutoff of nine cases, if the whole territory was considered as a single evaluation unit. The prevalence of CFA in WAF is less than 1%, reaching the goal for LF elimination set by the WHO. We were able to recommend stopping LF MDA and move to post-MDA surveillance to detect any recrudescence. This survey successfully paved the way for WAF to be validated as achieving LF elimination as a public health problem by 2020.

Background In response to a cholera outbreak among mobile, difficult-to-reach fishermen on Lake Chilwa, Malawi in 2016, a novel vaccine distribution strategy exploited the proven vaccine thermostability. Fishermen, while taking the first vaccine dose under supervision, received the second dose in a sealed bag, and were told to drink it two weeks later. This study assessed short-term vaccine protection of this strategy. Methods Patients with diarrhoea admitted to health facilities around lake were interviewed and a stool sample collected for PCR testing. Vaccine effectiveness was assessed in a case-control test-negative design by comparing cases (PCR-positive for V. cholerae O1) and controls (patients with diarrhoea but PCR-negative) and with the screening method that compared the proportions of vaccinated among cholera cases versus the general fishermen population. Results Of 145 study participants, 120 were fishermen living on the lake. Vaccine effectiveness at three-months was 90.0% [95% CI: 38.8; 98.4] among fishermen and 83.3% [95% CI: 20.8; 96.5] among all participants in the case-control test-negative design, and 97.5% [95% CI: 90.9; 99.3] with the screening method. Conclusion This strategy was effective in providing short-term protection in fishermen against cholera. Further research is needed to determine the adding value of the second dose and to identify the optimal vaccination strategies for different contexts.

Background In addition to improving water, sanitation and hygiene (WASH) measures and optimal case management, the introduction of Oral cholera vaccine (OCV) is a complementary strategy for cholera prevention and control for vulnerable population groups. In October 2016, the Mozambique Ministry of Health implemented a mass vaccination campaign using a two-dose regimen of the Shanchol™ OCV in six high-risk neighborhoods of Nampula city, in Northern Mozambique. Overall 193,403 people were targeted by the campaign, which used a door-to-door strategy. During campaign follow-up, a population survey was conducted to assess: (1) OCV coverage; (2) frequency of adverse events following immunization; (3) vaccine acceptability and (4) reasons for non-vaccination. Methodology/Principal findings In the absence of a household listing and clear administrative neighborhood delimitations, we used geospatial technology to select households from satellite images and used the support of community leaders. One person per household was randomly selected for interview. In total, 636 individuals were enrolled in the survey. The overall vaccination coverage with at least one dose (including card and oral reporting) was 69.5% (95%CI: 51.2–88.2) and the two-dose coverage was 51.2% (95%CI: 37.9–64.3). The campaign was well accepted. Among the 185 non-vaccinated individuals, 83 (44.6%) did not take the vaccine because they were absent when the vaccination team visited their houses. Among the 451 vaccinated individuals, 47 (10%) reported minor and non-specific complaints, and 78 (17.3%) mentioned they did not receive any information before the campaign. Conclusions/Significance In spite of overall coverage being slightly lower than expected, the use of a mobile door-to-door strategy remains a viable option even in densely-populated urban settings. Our results suggest that campaigns can be successfully implemented and well accepted in Mozambique in non-emergency contexts in order to prevent cholera outbreaks. These findings are encouraging and complement the previous Mozambican experience related to OCV.

Rotavirus vaccine was introduced in El Salvador in 2006 and is recommended to be given concomitantly with DTP–HepB–Haemophilus influenzae type b (pentavalent) vaccine at ages 2 months (upper age limit 15 weeks) and 4 months (upper age limit 8 months) of age. However, rotavirus vaccination coverage continues to lag behind that of pentavalent vaccine, even in years when national rotavirus vaccine stock-outs have not occurred. We analyzed factors associated with receipt of oral rotavirus vaccine among children who received at least 2 doses of pentavalent vaccine in a stratified cluster survey of children aged 24–59 months conducted in El Salvador in 2011. Vaccine doses included were documented on vaccination cards (94.4%) or in health facility records (5.6%). Logistic regression and survival analysis were used to assess factors associated with vaccination status and age at vaccination. Receipt of pentavalent vaccine by age 15 weeks was associated with rotavirus vaccination (OR: 5.1; 95% CI 2.7, 9.4), and receipt of the second pentavalent dose by age 32 weeks was associated with receipt of two rotavirus vaccine doses (OR: 5.0; 95% CI 2.1–12.3). Timely coverage with the first pentavalent vaccine dose was 88.2% in the 2007 cohort and 91.1% in the 2008 cohort (p=0.04). Children born in 2009, when a four-month national rotavirus vaccine stock-out occurred, had an older median age of receipt of rotavirus vaccine and were less likely to receive rotavirus on the same date as the same dose of pentavalent vaccine than children born in 2007 and 2008. Upper age limit recommendations for rotavirus vaccine administration contributed to suboptimal vaccination coverage. Survey data suggest that late rotavirus vaccination and co-administration with later doses of pentavalent vaccine among children born in 2009 helped increase rotavirus vaccine coverage following shortages.

SUMMARYWe used the clustered lot quality assurance sampling (clustered-LQAS) technique to identify districts with low immunization coverage and guide mop-up actions during the last 4 days of a combined oral polio vaccine (OPV) and yellow fever (YF) vaccination campaign conducted in Cameroon in May 2009. We monitored 17 pre-selected districts at risk for low coverage. We designed LQAS plans to reject districts with YF vaccination coverage

The prevalence of hepatitis B virus (HBV) in Wallis and Futuna (WAF) was one of the highest in the Pacific and was the driving factor for introducing hepatitis B (HepB) vaccination in 1992 and HepB birth dose (HepB-BD) in 2006. Using lymphatic filariasis (LF) transmission assessment survey (TAS) as a survey platform for eliminating LF, we assessed HBV surface antigen (HBsAg) seroprevalence, HepB vaccination coverage, and its timeliness among schoolchildren in WAF. From one finger prick of all registered fourth and fifth grade students, we tested HBsAg and filariasis antigen simultaneously, and estimated HepB vaccination coverage and timeliness by reviewing students' immunization cards. Since the children targeted were born when the three-dose HepB schedule was 2, 3, and 8 months, we defined timely vaccination if each dose was given by 3, 4, and 12 months. Of 476 targeted, 427 were enrolled. HBsAg prevalence was 0.9%. Estimated HepB vaccination coverage was 97%, 97%, and 96% for the first, second, and third doses, respectively, yielding coverage for all three doses of 96%. Proportion of timely vaccination was lower: 80%, 56%, and 65%, respectively, and less than 50% for all three doses combined. The seroprevalence of HBsAg among schoolchildren in WAF is less than 1%, close to the control goal. HepB vaccination coverage was high, but many children were vaccinated late. We recommend increasing the efforts for timely HepB vaccination. By combining an HBV seroprevalence survey and coverage assessment, we demonstrated the benefit of using TAS as a public health platform to access schoolchildren.

SUMMARYThe EPIET Alumni Network (EAN) is an association of professionals who have completed field epidemiology or public health microbiology training programmes in the European Union. In 2013, we conducted a survey of EAN members to investigate this network's role within European public health. We distributed an online questionnaire to members registered at the time, collecting data on demographics, professional background, and attitudes towards EAN. Out of 362 registered members, 189 (52%) responded; 97% were from Europe; 65% were female. Their mean age was 39 years. The highest academic qualification was PhD for 44% and Master's degree for 55%. The majority (60%) worked in public health institutes. They were especially satisfied with having access to job offers and professional networking via EAN, but requested more learning opportunities and knowledge-sharing between members. EAN is a unique platform where highly skilled professionals can connect to control infectious diseases locally and internationally. Having a network of professionals that know each other, speak the same ‘language’, and can easily access each other's expertise, represents an important resource for European and global public health, which should be nurtured by encouraging more collaborations devoted to professional development.

MenAfriVac™ is a conjugate vaccine against meningitis A specifically designed for Africa. In Niger, the MenAfriVac™ vaccination campaign was conducted in people aged 1-29 years in three phases. The third phase was conducted in November/December 2011 targeting more than 7 million people. We estimated vaccination coverage for the third phase; classified the 31 target districts according to vaccination coverage levels; analysed the factors associated with being vaccinated; described the reasons for non-vaccination; and estimated coverage of the MenAfriVac™ introduction in Niger by aggregating data from all three phases. We classified the districts by clustered lot quality assurance sampling according to a 75% lower threshold and a 90% upper threshold. We estimated coverage using a minimum cluster-sample of 30 x 10 in each region. Two criteria were used to document vaccination status: presentation of vaccination card only or by card and/or verbal history of vaccination (card+history). We surveyed 2390 persons. After the third phase, estimated coverage was 68.8% (95% CI 64.9-72.8) by card only and 90.9% (95% CI 88.6-93.2) by card+history. Five districts were accepted for coverage above 75% based on card only, whereas 25 were accepted based on card+history. Factors positively associated with being vaccinated were younger age (15 years), female sex, residing in the same household for more than three months, and being informed about the vaccination campaign. The main reason for non-vaccination was not being at home during the campaign. Overall coverage for MenAfriVac™ introduction via 3 phases was 76.1% (95% CI: 72.5-79.6) by card only and 91.9% (95%CI: 89.7-94.1) by card+history.Although estimated coverage was high, pockets of non-vaccination probably still exist in the country; thus, the implementation of mop-up campaigns should be considered. Priorities for the future should include incorporating meningitis A vaccination into the existing immunization schedule and assessing its impact at a population level.

During 2002-2013, a total of 1,890 tuberculosis cases were recorded in Fiji. Notification rates per 100,000 population increased from 17.4 cases in 2002 to 28.4 in 2013. Older persons were most affected, but tuberculosis also increased sharply in persons 25-44 years of age.

MenAfriVac™ is a new meningococcal A conjugate vaccine developed to prevent meningitis outbreaks in Africa. It was first introduced during the last quarter of 2010 in three West African countries. We report on the monitoring of adverse events following immunization (AEFI) in Burkina Faso where more than 11 million people aged 1-29 years were vaccinated. Vaccine pharmacovigilance relied on stimulated passive AEFI surveillance countrywide and active surveillance for 12 clinical conditions in one sentinel district (Ziniaré) with 97,715 people eligible for vaccination. All AEFI occurring during the 10 days of mass campaign or the 42 subsequent days were to be notified. Serious AEFI were submitted to a national expert committee (NEC) for causality assessment. A total of 11,466,950 people were vaccinated with 1471 vaccinees reported to have experienced at least one AEFI (12.83 cases per 100,000). 1444 AEFI were minor; the most common of which were fever, headache, gastro-intestinal disorders and local reactions (2-7 cases per 100,000). Of 27 serious AEFI reported, four cases were classified by the NEC as related to vaccine (1 case per 3 million vaccinated) including one case each of exanthematous pustulosis, angioedema, bronchospasm and severe vomiting. Active surveillance identified 71 cases of the 12 conditions of interest. Convulsions, urticaria and bronchospasm were more frequently reported. Attack rates for those conditions were similar to the baseline rates recorded in the same population, over the same time period, a year earlier. With the exception of convulsions in the days following vaccination the distribution of time intervals between vaccination and the occurrence of symptoms did not reveal any temporal clustering. The monitoring of AEFI of MenAfriVac™ in Burkina Faso did not suggest special concern regarding the vaccine safety. However, reported possible hypersensitivity reactions to vaccine components would require further review to rule out any anaphylactic reaction.

OBJECTIVES To evaluate oral poliovirus vaccine (OPV) coverage of the November 2009 round in five Northern Nigeria states with ongoing wild poliovirus transmission using clustered lot quality assurance sampling (CLQAS). METHODS We selected four local government areas in each pre-selected state and sampled six clusters of 10 children in each Local Government Area, defined as the lot area. We used three decision thresholds to classify OPV coverage: 75-90%, 55-70% and 35-50%. A full lot was completed, but we also assessed in retrospect the potential time-saving benefits of stopping sampling when a lot had been classified. RESULTS We accepted two local government areas (LGAs) with vaccination coverage above 75%. Of the remaining 18 rejected LGAs, 11 also failed to reach 70% coverage, of which four also failed to reach 50%. The average time taken to complete a lot was 10 h. By stopping sampling when a decision was reached, we could have classified lots in 5.3, 7.7 and 7.3 h on average at the 90%, 70% and 50% coverage targets, respectively. CONCLUSIONS Clustered lot quality assurance sampling was feasible and useful to estimate OPV coverage in Northern Nigeria. The multi-threshold approach provided useful information on the variation of IPD vaccination coverage. CLQAS is a very timely tool, allowing corrective actions to be directly taken in insufficiently covered areas.

OBJECTIVE To estimate the yellow fever (YF) vaccine coverage for the endemic and non-endemic areas of Bolivia and to determine whether selected districts had acceptable levels of coverage (>70%). METHODS We conducted two surveys of 600 individuals (25 x 12 clusters) to estimate coverage in the endemic and non-endemic areas. We assessed 11 districts using lot quality assurance sampling (LQAS). The lot (district) sample was 35 individuals with six as decision value (alpha error 6% if true coverage 70%; beta error 6% if true coverage 90%). To increase feasibility, we divided the lots into five clusters of seven individuals; to investigate the effect of clustering, we calculated alpha and beta by conducting simulations where each cluster's true coverage was sampled from a normal distribution with a mean of 70% or 90% and standard deviations of 5% or 10%. RESULTS Estimated coverage was 84.3% (95% CI: 78.9-89.7) in endemic areas, 86.8% (82.5-91.0) in non-endemic and 86.0% (82.8-89.1) nationally. LQAS showed that four lots had unacceptable coverage levels. In six lots, results were inconsistent with the estimated administrative coverage. The simulations suggested that the effect of clustering the lots is unlikely to have significantly increased the risk of making incorrect accept/reject decisions. CONCLUSIONS Estimated YF coverage was high. Discrepancies between administrative coverage and LQAS results may be due to incorrect population data. Even allowing for clustering in LQAS, the statistical errors would remain low. Catch-up campaigns are recommended in districts with unacceptable coverage.

While assessing immunization programmes, not only vaccination coverage is important, but also timely receipt of vaccines. We estimated both vaccination coverage and timeliness, as well as reasons for non-vaccination, and identified predictors of delayed or missed vaccination, for vaccines of the first two years of age, in El Salvador. We conducted a cluster survey among children aged 23-59 months. Caregivers were interviewed about the child immunization status and their attitudes towards immunization. Vaccination dates were obtained from children immunization cards at home or at health facilities. We referred to the 2006 vaccination schedule for children below two years: one dose of BCG (Bacillus Calmette-Guerin) at birth; rotavirus at two and four months; three doses of pentavalent - DTP (diphtheria-tetanus-pertussis), hepatitis B, and Haemophilus influenzae type b (Hib) - and of oral poliomyelitis vaccine (polio) at two, four, and six months; first MMR (measles-mumps-rubella) at 12 months; and first boosters of DTP and OPV at 18 months. Timeliness was assessed with Kaplan-Meier analysis; Cox and logistic regression were used to identify predictors of vaccination. We surveyed 2550 children. Coverage was highest for BCG (991%; 95% CI: 98.8-99.5) and lowest for rotavirus, especially second dose (86.3%; 95% CI: 84.2-88.4). The first doses of MMR and DTP had 991% (95% CI: 98.5-99.6) and 977% (95% CI: 970-985), respectively. Overall coverage was 837% (95% CI: 81.4-86.0); 96.4% (95% CI: 95.4-97.5), excluding rotavirus. However, only 26.7% (95% CI: 24.7-28.8) were vaccinated within the age interval recommended by the Expanded Programme on Immunization. Being employed and using the bus for transport to the health facility were associated with age-inappropriate vaccinations; while living in households with only two residents and in the "Paracentral", "Occidental", and "Oriental" regions was associated with age-appropriate vaccinations. Vaccination coverage was high in El Salvador, but general timeliness and rotavirus uptake could be improved.

SUMMARYOrnithosis outbreaks in poultry processing plants are well-described, but evidence for preventive measures is currently lacking. This study describes a case-control study into an outbreak of ornithosis at a poultry processing plant in the East of England, identified following three employees being admitted to hospital. Workers at the affected plant were recruited via their employer, with exposures assessed using a self-completed questionnaire. Cases were ascertained using serological methods or direct antigen detection in sputum. 63/225 (28%) staff participated, with 10% of participants showing evidence of recent infection. Exposure to the killing/defeathering and automated evisceration areas, and contact with viscera or blood were the main risk factors for infection. Personal protective equipment (goggles and FFP3 masks) reduced the effect of exposure to risk areas and to self-contamination with potentially infectious material. Our study provides some evidence of effectiveness for respiratory protective equipment in poultry processing plants where there is a known and current risk of ornithosis. Further studies are required to confirm this tentative finding, but in the meantime respiratory protective equipment is recommended as a precautionary measure in plants where outbreaks of ornithosis occur.

Introduction MenAfriVac is a new conjugate vaccine against Neisseria meningitidis serogroup A, the major cause of meningitis outbreaks in sub-Saharan Africa. In Niger, the MenAfriVac introduction campaign was conducted in the District of Filingue, during September 2010, targeting 392,211 individuals aged 1–29 years. We set up an enhanced spontaneous surveillance system to monitor adverse events following immunization (AEFI) during the campaign period and 42 days thereafter. Methods All the 33 health centres of the district have been designated as surveillance units, which reported AEFIs on a daily basis to the health district headquarters. Health care workers were instructed to screen patients presenting with predefined conditions of interest and patients spontaneously presenting at units or at vaccination posts with complaints after vaccination. Cases were classified as serious (resulting in death, hospitalization or long-term disability) or minor. A National Expert Committee was established to determine if serious cases were causally associated with the vaccine. Results In total, 356,532 vaccine doses were administered. During 61 days of monitoring, 82 suspected AEFIs were reported: 16 severe and 66 minor. The cumulative incidence was of 23.0 per 100,000 doses. Among severe cases, 14 were classified as coincidences, one urticaria complicated by respiratory distress was classified as a probable vaccine reaction, and one death was unclassifiable because post-mortem information was unavailable. The number of units that reported at least one case was 19/33 (57.6%). Conclusions Although these results are limited by underreporting of cases, we did not identify safety concerns with MenAfriVac. The lessons learned from this experience should be used to reinforce the national pharmacovigilance system in Niger to make it complaint with international standards. In order to do so, we recommend using a lighter system for routine; and conducting regular training and supervisory activities to increase its acceptance among local health workers.

MenAfriVac is a new conjugate vaccine against Neisseria meningitidis serogroup A developed for the African “meningitis belt”. In Niger, the first two phases of the MenAfriVac introduction campaign were conducted targeting 3,135,942 individuals aged 1 to 29 years in the regions of Tillabéri, Niamey, and Dosso, in September and December 2010. We evaluated the campaign and determined which sub-populations or areas had low levels of vaccination coverage in the regions of Tillabéri and Niamey. After Phase I, conducted in the Filingué district, we estimated coverage using a 30×15 cluster-sampling survey and nested lot quality assurance (LQA) analysis in the clustered samples to identify which subpopulations (defined by age 1–14/15–29 and sex) had unacceptable vaccination coverage (

Summary Objective Vaccination programmes targeting disease elimination aim to achieve very high coverage levels (e.g. 95%). We calculated the precision of different clustered lot quality assurance sampling (LQAS) designs in computer-simulated surveys to provide local health officers in the field with preset LQAS plans to simply and rapidly assess programmes with high coverage targets. Methods We calculated sample size (N), decision value (d) and misclassification errors (alpha and beta) of several LQAS plans by running 10 000 simulations. We kept the upper coverage threshold (UT) at 90% or 95% and decreased the lower threshold (LT) progressively by 5%. We measured the proportion of simulations with ≤d individuals unvaccinated or lower if the coverage was set at the UT (pUT) to calculate beta (1-pUT) and the proportion of simulations with >d unvaccinated individuals if the coverage was LT% (pLT) to calculate alpha (1-pLT). We divided N in clusters (between 5 and 10) and recalculated the errors hypothesising that the coverage would vary in the clusters according to a binomial distribution with preset standard deviations of 0.05 and 0.1 from the mean lot coverage. We selected the plans fulfilling these criteria: alpha ≤ 5% beta ≤ 20% in the unclustered design; alpha ≤ 10% beta ≤ 25% when the lots were divided in five clusters. Result When the interval between UT and LT was larger than 10% (e.g. 15%), we were able to select precise LQAS plans dividing the lot in five clusters with N = 50 (5 × 10) and d = 4 to evaluate programmes with 95% coverage target and d = 7 to evaluate programmes with 90% target. Conclusion These plans will considerably increase the feasibility and the rapidity of conducting the LQAS in the field.

SUMMARYIn England, there is no surveillance system for vaccines offered to healthcare workers apart from that in place annually for the seasonal influenza vaccine. To inform the feasibility of a general vaccine uptake surveillance system and to understand which policies are currently in place, we conducted a survey in the 162 National Health Service Foundation and Acute Hospital trusts in England, by submitting a questionnaire to their occupational health departments on immunization policies and methods of storing vaccine uptake data. In total, 104 hospital trusts (64·2%) responded. All responders offer hepatitis B, tuberculosis, measles-mumps-rubella, and influenza vaccines to healthcare workers; 0·9% reported not offering varicella and 13·5% not offering tetanus-diphtheria-polio; 66·4% record staff eligible for immunizations and 68·2% record staff they have immunized. Our study suggests that setting up a surveillance system to monitor vaccine uptake in healthcare workers is possible but would be challenging, given the variation in current systems.