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Introduction: A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season., Methods: We conducted a case-control study over three influenza seasons (2012-13, 2013-14, 2014-15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1-28, 29-56, and >56 days before the SAB date., Results: Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28 day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6-1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1-28 day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception., Conclusion: During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Importance: Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.Objectives: To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, Setting, and Participants: This study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.Exposures: Receipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main Outcomes and Measures: Incidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.Results: A total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and Relevance: In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing. [ABSTRACT FROM AUTHOR]

Background: Asthma was associated with influenza hospitalizations in children during the 2009 pandemic, but it is unclear if asthma is associated with serious illness during seasonal epidemics. Little is known regarding the effect of vaccination on influenza severity in children with asthma. Methods: Children aged 5‐17 years in a community cohort presenting with acute respiratory illness were prospectively enrolled and tested for influenza from 2007‐08 through 2017‐18 (excluding the 2009‐10 pandemic season). Data from the electronic health record were extracted to determine asthma status and serious outcomes associated with influenza infection. A serious outcome was defined as hospitalization, emergency department visit, and/or pneumonia diagnosis within 30 days of symptom onset. Multivariable logistic regression models were used to assess asthma status and effect of vaccination on odds of a serious outcome. Results: One thousand seven hundred and sixty four medically‐attended influenza infections among school‐aged children were included. Asthma was confirmed in 287 (16%) children. A serious influenza‐associated outcome occurred in 104 (6%) children. The odds of a serious outcome did not differ between those with confirmed asthma and those without asthma [adjusted odds ratio (aOR): 1.35, 95% confidence interval (CI): (0.77‐2.35), P =.3]. The effect of vaccination on serious outcomes was not modified by asthma status [aOR for children without asthma: 0.55 (95% CI: 0.28‐1.07), children with asthma: 1.39 (95% CI: 0.53‐3.69); interaction P‐value =.12]. Conclusions: Asthma was not a risk factor for serious illness among children with influenza. Additional studies are needed to better understand the role of influenza vaccination in preventing serious outcomes among children with asthma. [ABSTRACT FROM AUTHOR]

• Receipt of provider recommendation for influenza vaccine was common. • Vaccination was associated with primigravida status, higher educational attainment. • Vaccination was associated with employment in health care. • The majority of women vaccinated in pregnancy received influenza vaccine annually. • Vaccinated more than unvaccinated women feel the vaccine is safe and effective. Influenza vaccination coverage among pregnant women in the United States is suboptimal. We surveyed women who were pregnant during the 2016–17 influenza season to assess knowledge and attitudes regarding influenza vaccination. We identified and sampled pregnant women to include approximately equal numbers of vaccinated and unvaccinated women from strata defined by vaccination status and trimester from four integrated health systems in the Vaccine Safety Datalink (VSD). Potential participants were contacted via mail and telephone to complete a standardized survey. Characteristics and responses of women vaccinated and unvaccinated during pregnancy were compared. The survey was completed by 510 (48%) of 1062 contacted women; 500 were included in the analysis. Vaccine receipt while pregnant was associated with primigravida status (p = 0.02), college degree (p = 0.01), employment in health care (p < 0.01), and history of routine annual influenza vaccination (p < 0.01). Among 330 vaccinated women, the primary reasons for vaccination included protection of self and baby from influenza (n = 233, 71%), and medical professional recommendation (n = 46, 14%). Multiple reasons were given for nonvaccination, but concern about 'negative effects' was cited most often (n = 44, 29%). Vaccinated women were significantly more likely to believe that influenza vaccines are safe and effective, and to recognize the potential for harm from influenza infection. Nearly all women reported receiving at least one influenza vaccination recommendation from a healthcare provider. Vaccinated pregnant women were more likely to receive routine annual influenza vaccine compared to those not vaccinated. Recommendations by obstetric providers should be supplemented with efforts to encourage women of childbearing age to receive annual vaccination. [ABSTRACT FROM AUTHOR]

Background Human papillomavirus (HPV) vaccination uptake remains lower than other recommended adolescent vaccines in the United States. Parental attitudes are important predictors of vaccine uptake, yet little is known about how they have changed over time. Methods Participants included US residents aged 13–17 years with documented vaccination status who had received <3 doses of HPV vaccine whose parents responded to the National Immunization Survey–Teen, 2010–2015. Results Of the 76971 participants, 63.0% were male, 58.8% were non-Hispanic white, and 14.4 years was the median age. The percentage of unvaccinated teens decreased from 2010 to 2015, yet, annually, parents of unvaccinated teens of both sexes most often reported that they were “not likely at all” to vaccinate their teen. The percentage decreased significantly from 41.5% to 31.2% (P <.001) for parents of unvaccinated females from 2010 to 2015 but did not change among parents of males from 2012 to 2015. Conversely, parents of undervaccinated teens of both sexes reported higher and increasing vaccination intent over time. In 2015, nearly one-third of parents of unvaccinated teens reported that the vaccine was “not needed/necessary.” Concerns about vaccine safety and side effects declined among parents of unvaccinated females but increased among parents of males (7.3% to 14.8%; P <.001). Conclusions Although parental vaccination intent and knowledge improved over time, intent remains low and many parents still have significant concerns about HPV vaccination, even after series initiation. Multiple strategies are needed to improve series initiation and completion in the United States. [ABSTRACT FROM AUTHOR]

Background MMR vaccine is given routinely to young children but may be given at other ages. We described MMR use in adolescent and adult populations in the Vaccine Safety Datalink (VSD) and estimated the incidence of medically-attended outcomes after MMR to inform future studies estimating vaccine-associated risk. Methods The study population included adolescents (9–17 years) and adults (≥18 years) in VSD who received at least one MMR vaccine from 2010 through 2016. Outcomes were pre-specified based on previous vaccine safety studies and categorized as clinically serious (anaphylaxis, encephalitis/myelitis, GBS, meningitis, seizure) or non-serious (allergic reaction, arthropathy, fever, injection site reaction, lymphadenopathy, nonspecific reaction, parotitis, rash, syncope). Outcomes were identified by searching for ICD-9 and ICD-10 diagnosis codes in post-vaccination exposure windows. Medical records were reviewed for all serious outcomes to verify incident diagnoses. Incidence and 95% confidence intervals were calculated for validated serious and all non-serious outcomes. Results 146,503 adolescents and adults received 162,992 MMR vaccines during the study period. The mean age at vaccination was 33.7 years, 65% were female, and 53% received at least one other vaccine simultaneously. Demographic and vaccination characteristics varied across age groups (Table 1). The analysis of post-vaccination outcomes included 162,053 MMR vaccinations. The incidence of validated serious outcomes was low, ranging from 0 to 6.8 per 100,000 vaccinations. Only one serious outcome (anaphylaxis) was noted to be vaccine-associated in the medical record. Incidence of clinically non-serious outcomes varied from 0.4 to 56.0 per 10,000 vaccinations. Injection site reactions were more common among adolescents (118.1 per 10,000 vaccinations), who also had a higher frequency of simultaneous vaccination (80%). Conclusion Clinically serious outcomes were rare following MMR vaccination. Rates of clinically non-serious outcomes varied but were similar to or lower than previous reports in children. This descriptive analysis did not evaluate the association between MMR and adverse events. Future analysis with an appropriate comparison group is needed for risk estimation. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population. Members 18–39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0–7 days post-vaccination. From December 14, 2020 – January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0–7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5–34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7–64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0–7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02–2.54). Both vaccines were associated with increased risk of myocarditis and pericarditis in 18–39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2. [ABSTRACT FROM AUTHOR]