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The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome. Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design. Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42–4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated. The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks. US Federal Government.

•Military medical records were searched electronically for myopericarditis.•The rate of myopericarditis after ACAM2000 smallpox vaccine was 20.06/100,000.•Myopericarditis rates were 21.1/100,000 for those < 40 years vs 6.3/100,000 for 40 + .•Myopericarditis rates were 21.8/100,000 for males vs 8.5/100,000 for females. To evaluate the rates of myopericarditis (primary objective) and rates of cardiovascular and neurological adverse events (secondary objectives) in temporal association with ACAM2000® smallpox vaccine. Observational cohort study conducted through monthly surveillance from 2009 to 2017 of electronic medical records of military service members (SM) for pre-specified cardiac and neurological International Classification of Diseases (ICD) codes reported in the 30 days following smallpox vaccination. ICD codes potentially predictive of myopericarditis and codes for encephalitis, Guillain-Barré syndrome, and sudden death were classified into Group 1. All other cardiovascular and neurological ICD codes were classified into Group 2. Medical records containing Group 1 codes were individually reviewed to confirm coding accuracy and to seek additional data in support of myopericarditis adjudication, which was performed by an independent clinical panel. Chart reviews were not performed for Group 2 codes, which were reported in aggregate only. 897,227 SM who received ACAM2000 smallpox vaccine and 450,000 SM who received Dryvax smallpox vaccine were included in the surveillance population. The rate of adjudicated myopericarditis among ACAM2000 smallpox vaccine recipients was 20.06/100,000 and was significantly higher for males (21.8/100,000) than females (8.5/100,000) and for those < 40 years of age (21.1/100,000) than for those 40 years or older (6.3/100,000). Overall rates for any cardiovascular event (Group 1 plus Group 2) were 113.5/100,000 for ACAM2000 vaccine and 439.3/100,000 for Dryvax vaccine; rate ratio, 0.26 (95% CI, 0.24–0.28). The rates of subjects with one or more defined neurological events were 2.12/100,000 and 1.11/100,000 for ACAM2000 and Dryvax vaccines respectively; rate ratio, 1.91 (95% CI, 0.71–5.10). Electronic records surveillance of the entire vaccinated SM population over a ten-year period found rates of myopericarditis, of defined neurological events, and of overall cardiac events that were consistent with those of prior passive surveillance studies involving Dryvax or ACAM2000 smallpox vaccines. Clinical trials registration: ClinicalTrials.gov NCT00927719.

•The duration and levels of VACV shedding from the vaccination site were lower among naïve smallpox vaccinees using PIO vs. control vaccinees.•At days 28 and 42, 10% and 3.4% of control vaccinees, respectively, continued to shed VACV compared with none of those using PIO.•Among subjects who returned scabs, VACV shedding was noted after scab separation in 23% (control subjects) and 8.3% (PIO subjects).•PIO applied starting on day 7 reduces VACV shedding at the vaccination site without compromising humoral and cellular immune responses.•To avoid inadvertent transmission of VACV, vaccinees should apply PIO starting on post-vaccination day 7, along with a nonocclusive dressing, and continue for 2 weeks after scab separation. The U.S. Department of Defense vaccinates personnel deployed to high-risk areas with the vaccinia virus (VACV)-based smallpox vaccine. Autoinoculations and secondary and tertiary transmissions due to VACV shedding from the vaccination site continue to occur despite education of vaccinees on the risks of such infections. The objectives of this study were to investigate, in naïve smallpox vaccinees, (a) whether the vaccination site can remain contagious after the scab separates and (b) whether the application of povidone iodine ointment (PIO) to the vaccination site inactivates VACV without affecting the immune response. These objectives were tested in 60 individuals scheduled to receive smallpox vaccine. Thirty individuals (control) did not receive PIO; 30 subjects (treatment) received PIO starting on post-vaccination day 7. Counter to current dogma, this study showed that VACV continues to shed from the vaccination site after the scab separates. Overall viral shedding levels in the PIO group were significantly lower than those in the control group (p=0.0045), and PIO significantly reduced the duration of viral shedding (median duration 14.5 days and 21 days in the PIO and control groups, respectively; p=0.0444). At least 10% of control subjects continued to shed VACV at day 28, and 3.4% continued to shed the virus at day 42. PIO reduced the proportion of subjects shedding virus from the vaccination site from day 8 until days 21–23 compared with control subjects. Groups did not differ significantly in the proportion of subjects mounting an immune response, as measured by neutralizing antibodies, IgM, IgG, and interferon-gamma enzyme-linked immunospot assay. When applied to the vaccination site starting on day 7, PIO reduced viral shedding without altering the immune response. The use of PIO in addition to a semipermeable dressing may reduce the rates of autoinoculation and contact transmission originating from the vaccination site in smallpox-vaccinated individuals.

► We assessed the association between YF 17D and risk of malignant melanoma. ► Population included active US military personnel who received any vaccine. ► No association was found between YF 17D and risk of malignant melanoma in military in the 10 years following vaccination. Previous studies show that the tuberculosis and smallpox vaccine protect against melanoma because of sequence homologies they have with the melanoma antigen, HERV-K-MEL. The yellow fever 17D (YF 17D) vaccine is thought to have this property, so there is a possibility that the YF17D vaccine is able to protect against melanoma. This nested case–control study used the Defense Medical Surveillance System to assess the association between the YF17D vaccine and risk of malignant melanoma in active members of the United States military. Although point estimates hinted at a protective effect, none of the values reached a significant level. Therefore, this study concluded that in the ten year period following vaccination there is no association between the yellow fever 17D vaccine and risk of malignant melanoma in active members of the US armed forces.

The U.S. Army 1 Area Medical Laboratory (1 AML) is currently the only deployable medical CBRNE (Chemical, Biological, Radiological, Nuclear, and Explosives) laboratory in the Army's Forces Command. In support of the United States Agency for International Development Ebola response, the U.S. military initiated Operation United Assistance (OUA), and deployed approximately 2,500 service members to support the Government of Liberia's Ebola control efforts. Due to its unique molecular diagnostic and expeditionary capabilities, the 1 AML was ordered to deploy in October of 2014 in support of OUA via establishment of Ebola testing laboratories. To meet the unique mission requirements of OUA, the unit was re-organized to operate in a split-based configuration and sustain four separate Ebola testing laboratories. This article is a review of the 1 AML's OUA participation in a split-based configuration. Topics highlighted include pre-deployment planning/training, operational/logistical considerations in fielding/withdrawing laboratories, laboratory testing results, disease and non-battle injuries, and lessons learned. Fielding the 1 AML in a split-based configuration required careful pre-deployment planning, additional training, optimal use of personnel, and the acquisition of additional laboratory equipment. Challenges in establishing and sustaining remote laboratories in Liberia included: difficulties in transportation of equipment due to poor road infrastructure, heavy equipment unloading, and equipment damage during transit. Between November 26, 2014 and February 18, 2015 the four 1 AML labs successfully tested blood samples from patients and oral swabs collected by burial teams in rural Liberia. The most significant equipment malfunction during laboratory operations was generators powering the labs, with the same problem impacting headquarters. Generator failures delayed laboratory operations/result reporting, and put temperature sensitive reagents at risk. None of the 22 1 AML soldiers (at remote labs or headquarters) had an Ebola exposure, none were infected with malaria or other tropical diseases, and none required evacuation from the time deployed to remote sites. The primary medical condition encountered was acute gastroenteritis, and within the first week of arrival to Liberia, 19 (86%) soldiers were affected. With proper planning and training, the 1 AML can successfully conduct split-based operations in an outbreak setting, and this capability can be utilized in future operations. The performance of the 1 AML during the current Ebola outbreak highlights the value of this asset, and the need to continue its evolution to support U.S. military operations.

► AVA was associated with reduced risk of disability for Veterans with hostile fire pay records. ► Results by type of disability for Veterans without HFP were inconsistent, but mostly null. ► AVA was associated with reduced risk of separation from the Army with disability regardless of HFP. To protect troops against the use of anthrax as a biological weapon, the US Department of Defense began an anthrax vaccination program in 1998. 14 years after the inception of the vaccination program, there is no evidence suggesting vaccination against anthrax carries long-term health risks for Active Duty Soldiers. To investigate the association between Anthrax Vaccine Adsorbed (AVA) received while on Active Duty and subsequent disability determined by the Veterans Benefits Administration. Case–control study nested in the cohort of all Active Duty personnel known to have separated from the US Army between December 1, 1997 and December 31, 2005. Cases were ≥10% disabled, determined either by the Army prior to separation (N=5846) or by the Veterans Benefits Administration (VBA) after separation (N=148,934). Controls (N=937,705) separated from the Army without disability, and were not receiving pensions from the VBA as of April 2007. Data were from the Total Army Injury and Health Outcomes Database and the VBA Compensation and Pension and Benefits database. Disability status (yes/no); for primary disability, percent disabled (≥10%, 20%, >20%) and type of disability. Vaccination against anthrax was four times more likely among disabled Veterans with hostile fire pay records (HFP, a surrogate for deployment). Vaccinated Soldiers with HFP had lower odds of disability separation from the Army 0.89 (0.80, 0.98); there was no association between vaccine and receiving Army disability benefits among those without HFP (OR=1.05, CI: 0.96, 1.14). Vaccination was negatively associated with receiving VA disability benefits for those with HFP (OR=0.66, CI: 0.65, 0.67), but there was little or no association between vaccine and receipt of VA disability benefits for those without HFP (OR=0.95, CI: 0.93, 0.97). Risk of disability separation from the Army and receipt of disability compensation from the VA were not increased in association with prior exposure to AVA. This study provides evidence that vaccination against anthrax is not associated with long term disability.

To evaluate the potential for long-term or delayed onset health effects, we extended a previous cohort study of disability separation from the army associated with vaccination against anthrax. Analyses included stratified Cox proportional hazards and multiple logistic regression models. Forty-one percent of 1,001,546 soldiers received at least one anthrax vaccination; 5.21% were evaluated for disability. No consistent patterns or statistically significant differences in risk of disability evaluation, disability determination, or reason for disability were associated with anthrax vaccination. There was a dose-related trend in risk of disability for soldiers with 2 years’ service, limited to those entering service in 2000 or later. Divergent patterns in risk suggest confounding by temporal or occupational risks of disability.

In response to the 2009 H1N1 pandemic and subsequent vaccination program, the Department of Health and Human Services and collaborators developed the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program as a demonstration project to detect rare adverse events rapidly. The program monitored three million people who had received the H1N1 vaccine by linking data from large private health plans and from public immunization registries that had originally not been designed to share data, and on a larger scale than had been previously attempted. The program generated safety data in two weeks rather than three to six monty 10ths-the standard time frame achievable using health plan data. PRISM substantially contributed to the understanding of the safety of H1N1 vaccines. Its use in the case of H1N1 highlights the necessity of proactive planning, scalable infrastructure, and public-private partnerships in tracking adverse events after vaccination in epidemics. It also illustrates how data could be integrated to produce policy-relevant information for other medical products.

Non-battle related injuries are the greatest cause of morbidity and mortality in the US military. Within the category of non-battle injuries, musculoskeletal injuries are the leading cause of disability. Tendon ruptures in particular, require long rehabilitation programs and can result in permanent disability. The consequence of tendon rupture is degradation in unit readiness and operational effectiveness. Case reports and case studies have linked tendon ruptures with quinolone antibiotic usage in the civilian population. This retrospective cohort study utilized a Department of Defense administrative database to estimate the risk of tendon rupture in active duty personnel associated with quinolone use compared with the use of cephalosporin antibiotics. It identifies an induction period from quinolone exposure to tendon rupture while also identifying risk factors that are associated with an increased risk of tendon ruptures. Data from military personnel June 2005 through May 2006 were collected. Internal validity was confirmed using macro-level assessment techniques. Survival analysis was used to estimate the hazard function and the Cox proportional hazards model was employed to produce hazard ratios for the main treatment and other independent risk factors. There was a significant increase in the risk of tendon ruptures over a 60-day period between active duty personnel who used quinolones compared to those who used cephalosporins (HR=1.65, 95%CI 1.33–2.04). The risk was highest during the 26 to 35 day window which marked the average induction period. Risk factors were days of supply (HR=1.02, 95%CI 1.018–1.022); military occupation (HR=1.53, 95%CI 1.24–1.89); age (HR=1.02, 95%CI 1.01–1.03); provider specialty (HR=2.40, 95%CI 1.92–2.99); Marine Corps service (HR=1.65, 95%CI 1.20–2.28); GI/GU antibiotic indication (HR=1.25, 95%CI 0.99–1.57). This is the first study to identify an increased risk of tendon rupture from quinolone use in a demographically diverse population. The risk is elevated upon the first day of therapy and increases incrementally until it reaches its maximum between days 26–35. The risk of tendon rupture is augmented by advancing age, length of treatment, and working in a physically demanding occupation. These findings are important as they provide evidence that a significant portion of this debilitating injury is avoidable by identifying specific risk factors and incorporating them into the patient care plan.

Many organisms carry extra, non-essential chromosomes known as B chromosomes (Bs), which are selfishly transmitted at super-mendelian levels to offspring. This heightened transmission, termed drive, occurs during gametogenesis, usually in one of the two parents. In some cases, Bs can experience an opposing process, drag, which reduces their transmission. If these processes occur together in the same organism, one in each parental sex, then they may facilitate the spread of Bs while countering their accumulation in the genome to harmful levels. While previous studies have elucidated mechanistic aspects of B drive, little is known about drag or other factors that govern the inheritance of these selfish genetic elements. Here, we examined the inheritance of Paternal Sex Ratio (PSR), a single-copy B in the jewel wasp, Nasonia vitripennis , which is transmitted paternally to offspring. PSR drives by converting female-destined embryos into PSR-transmitting males. Using genetic manipulation, we produced exceptional PSR-carrying females, which were used to assess B transmission potential. We found that females transmit PSR at an unexpectedly low level compared to univalent chromosomes in other organisms. This reduced transmission stems from remarkable loss of PSR from the egg’s nucleus upon entry into meiosis, an effect that may be caused by an absence of microtubule-based spindle fibers in meiosis I-arrested wasp eggs. We also found that PSR is strictly limited to a single copy per genome, likely because wasps having two PSR copies die during development. Our findings reveal the successful inheritance of this selfish B chromosome involves its restriction to a single copy and hidden female meiotic drag in addition to strong paternal drive.