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1.
PLoS One ; 16(9): e0256891, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34478463

RESUMEN

BACKGROUND: Research on COVID-19 during pregnancy has mainly focused on women hospitalized for COVID-19 or other reasons during their pregnancy. Little is known about COVID-19 in the general population of pregnant women. OBJECTIVE: To describe the prevalence of COVID-19, symptoms, consequent healthcare use, and possible sources of COVID-19 exposure among a population-based sample of pregnant women residing in Northern California. METHODS: We analyzed data from 19,458 members of Kaiser Permanente Northern California who were pregnant between January 2020 and April 2021 and responded to an online survey about COVID-19 testing, diagnosis, symptoms, and their experiences during the COVID-19 pandemic. Medical diagnosis of COVID-19 during pregnancy was defined separately by self-report and by documentation in electronic health records (EHR). We examined relationships of COVID-19 with sociodemographic factors, underlying comorbidities, and survey measures of COVID-19-like symptoms, consequent healthcare utilization, and possible COVID-19 exposures. RESULTS: Among 19,458 respondents, the crude prevalence of COVID-19 was 2.5% (n = 494) according to self-report and 1.4% (n = 276) according to EHR. After adjustment, the prevalence of self-reported COVID-19 was higher among women aged <25 years compared with women aged ≥35 years (prevalence ratio [PR], 1.75, 95% CI: 1.23, 2.49) and among Hispanic women compared with White women (PR, 1.91, 95% CI: 1.53, 2.37). Prevalence of self-reported COVID-19 was higher among women affected by personal or partner job loss during the pandemic (PR, 1.23, 95% CI: 1.02, 1.47) and among women living in areas of high vs. low neighborhood deprivation (PR, 1.74, 95% CI: 1.33, 2.27). We did not observe differences in self-reported COVID-19 between women with and without underlying comorbidities. Results were similar for EHR-documented COVID-19. Loss of smell or taste was a unique and common symptom reported among women with COVID-19 (42.3% in self-reported; 54.0% in EHR-documented). Among women with symptomatic COVID-19, approximately 2% were hospitalized, 71% had a telehealth visit, and 75% quarantined at home. Over a third of women with COVID-19 reported no known exposure to someone with COVID-19. CONCLUSIONS: Observed COVID-19 prevalence differences by sociodemographic and socioeconomic factors underscore social and health inequities among reproductive-aged women. Women with COVID-19 reported unique symptoms and low frequency of hospitalization. Many were not aware of an exposure to someone with COVID-19.


Asunto(s)
COVID-19/diagnóstico , COVID-19/epidemiología , Pandemias , Adolescente , Adulto , COVID-19/patología , COVID-19/virología , Prueba de COVID-19 , California/epidemiología , Registros Electrónicos de Salud , Grupo de Ascendencia Continental Europea , Femenino , Hispanoamericanos , Humanos , Embarazo , Mujeres Embarazadas , SARS-CoV-2/aislamiento & purificación , SARS-CoV-2/patogenicidad , Autoinforme , Factores Socioeconómicos , Encuestas y Cuestionarios , Adulto Joven
2.
JAMA ; 326(14): 1390-1399, 2021 10 12.
Artículo en Inglés | MEDLINE | ID: mdl-34477808

RESUMEN

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.

3.
N Engl J Med ; 385(15): 1355-1371, 2021 10 07.
Artículo en Inglés | MEDLINE | ID: mdl-34496194

RESUMEN

BACKGROUND: There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the United States with respect to hospitalization, admission to an intensive care unit (ICU), or ambulatory care in an emergency department or urgent care clinic. METHODS: We conducted a study involving adults (≥50 years of age) with Covid-19-like illness who underwent molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed 41,552 admissions to 187 hospitals and 21,522 visits to 221 emergency departments or urgent care clinics during the period from January 1 through June 22, 2021, in multiple states. The patients' vaccination status was documented in electronic health records and immunization registries. We used a test-negative design to estimate vaccine effectiveness by comparing the odds of a positive test for SARS-CoV-2 infection among vaccinated patients with those among unvaccinated patients. Vaccine effectiveness was adjusted with weights based on propensity-for-vaccination scores and according to age, geographic region, calendar time (days from January 1, 2021, to the index date for each medical visit), and local virus circulation. RESULTS: The effectiveness of full messenger RNA (mRNA) vaccination (≥14 days after the second dose) was 89% (95% confidence interval [CI], 87 to 91) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization, 90% (95% CI, 86 to 93) against infection leading to an ICU admission, and 91% (95% CI, 89 to 93) against infection leading to an emergency department or urgent care clinic visit. The effectiveness of full vaccination with respect to a Covid-19-associated hospitalization or emergency department or urgent care clinic visit was similar with the BNT162b2 and mRNA-1273 vaccines and ranged from 81% to 95% among adults 85 years of age or older, persons with chronic medical conditions, and Black or Hispanic adults. The effectiveness of the Ad26.COV2.S vaccine was 68% (95% CI, 50 to 79) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization and 73% (95% CI, 59 to 82) against infection leading to an emergency department or urgent care clinic visit. CONCLUSIONS: Covid-19 vaccines in the United States were highly effective against SARS-CoV-2 infection requiring hospitalization, ICU admission, or an emergency department or urgent care clinic visit. This vaccine effectiveness extended to populations that are disproportionately affected by SARS-CoV-2 infection. (Funded by the Centers for Disease Control and Prevention.).


Asunto(s)
Atención Ambulatoria/estadística & datos numéricos , Vacunas contra la COVID-19 , COVID-19/prevención & control , Hospitalización/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , COVID-19/epidemiología , Vacunas contra la COVID-19/inmunología , Femenino , Humanos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Readmisión del Paciente/estadística & datos numéricos , Estados Unidos/epidemiología
4.
Expert Rev Vaccines ; : 1-9, 2021 Oct 08.
Artículo en Inglés | MEDLINE | ID: mdl-34555994

RESUMEN

INTRODUCTION: Despite high vaccination coverage among children and adolescents, pertussis remains a public health problem, with large outbreaks occurring periodically in the US and other developed countries. AREAS COVERED: We examine lessons learned more than 20 years after implementation of programs which use only acellular pertussis vaccines and propose avenues for possible effective use of acellular pertussis vaccine to prevent large outbreaks. EXPERT OPINION: Acellular pertussis vaccines were introduced more than 20 years ago, yet the incidence of pertussis has been increasing over the past decade, with periodic large outbreaks marked by notable shifts in disease burden from infants and young children toward fully vaccinated adolescents and young adults. This age shift is mainly driven by the waning of vaccine immunity. To better protect adolescents against pertussis, modification of the current acellular pertussis vaccination schedule or adoption of new vaccination strategies should be considered. For infants not yet eligible to be vaccinated, maternal vaccination against pertussis during pregnancy is an effective way to protect infants from infection, severe disease and death. Implementation of maternal vaccination programs should be encouraged in countries without one or efforts to improve coverage should be supported in countries with existing program.

5.
Artículo en Inglés | MEDLINE | ID: mdl-34432371

RESUMEN

Among approximately 4.6 million members of Kaiser Permanente Northern California, we examined associations of severe COVID-19 with demographic factors and comorbidities. As of July 23, 2021, 16 182 had been hospitalized, 2416 admitted to an ICU, and 1525 died due to COVID-19. Age was strongly associated with hospitalization, ICU admission, and death. Black persons and Hispanic ethnicity had higher risk of death compared with Whites. Among the comorbidities examined, Alzheimer's disease was associated with the highest risk for hospitalization (aHR 3.19, CI: 2.88-3.52) and death (aHR 4.04, CI: 3.32-4.91). Parkinson's disease had the second highest risk of death (aHR = 2.07, CI: 1.50-2.87).

6.
MMWR Morb Mortal Wkly Rep ; 70(28): 985-990, 2021 Jul 16.
Artículo en Inglés | MEDLINE | ID: mdl-34264911

RESUMEN

COVID-19 vaccination is critical to ending the COVID-19 pandemic. Members of minority racial and ethnic groups have experienced disproportionate COVID-19-associated morbidity and mortality (1); however, COVID-19 vaccination coverage is lower in these groups (2). CDC used data from CDC's Vaccine Safety Datalink (VSD)* to assess disparities in vaccination coverage among persons aged ≥16 years by race and ethnicity during December 14, 2020-May 15, 2021. Measures of coverage included receipt of ≥1 COVID-19 vaccine dose (i.e., receipt of the first dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines or 1 dose of the Janssen COVID-19 vaccine [Johnson & Johnson]) and full vaccination (receipt of 2 doses of the Pfizer-BioNTech or Moderna COVID-19 vaccines or 1 dose of Janssen COVID-19 vaccine). Among 9.6 million persons aged ≥16 years enrolled in VSD during December 14, 2020-May 15, 2021, ≥1-dose coverage was 48.3%, and 38.3% were fully vaccinated. As of May 15, 2021, coverage with ≥1 dose was lower among non-Hispanic Black (Black) and Hispanic persons (40.7% and 41.1%, respectively) than it was among non-Hispanic White (White) persons (54.6%). Coverage was highest among non-Hispanic Asian (Asian) persons (57.4%). Coverage with ≥1 dose was higher among persons with certain medical conditions that place them at higher risk for severe COVID-19 (high-risk conditions) (63.8%) than it was among persons without such conditions (41.5%) and was higher among persons who had not had COVID-19 (48.8%) than it was among those who had (42.4%). Persons aged 18-24 years had the lowest ≥1-dose coverage (28.7%) among all age groups. Continued monitoring of vaccination coverage and efforts to improve equity in coverage are critical, especially among populations disproportionately affected by COVID-19.


Asunto(s)
Vacunas contra la COVID-19/administración & dosificación , Seguro de Salud/estadística & datos numéricos , Cobertura de Vacunación/estadística & datos numéricos , Adolescente , Adulto , Anciano , COVID-19/epidemiología , COVID-19/etnología , COVID-19/prevención & control , Grupos de Población Continentales/estadística & datos numéricos , Prestación Integrada de Atención de Salud , Grupos Étnicos/estadística & datos numéricos , Femenino , Disparidades en el Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Estados Unidos/epidemiología , Adulto Joven
7.
MMWR Morb Mortal Wkly Rep ; 70(24): 895-899, 2021 Jun 18.
Artículo en Inglés | MEDLINE | ID: mdl-34138834

RESUMEN

COVID-19 vaccines are critical for ending the COVID-19 pandemic; however, current data about vaccination coverage and safety in pregnant women are limited. Pregnant women are at increased risk for severe illness and death from COVID-19 compared with nonpregnant women of reproductive age, and are at risk for adverse pregnancy outcomes, such as preterm birth (1-4). Pregnant women are eligible for and can receive any of the three COVID-19 vaccines available in the United States via Emergency Use Authorization.* Data from Vaccine Safety Datalink (VSD), a collaboration between CDC and multiple integrated health systems, were analyzed to assess receipt of ≥1 dose (first or second dose of the Pfizer-BioNTech or Moderna vaccines or a single dose of the Janssen [Johnson & Johnson] vaccine) of any COVID-19 vaccine during pregnancy, receipt of first dose of a 2-dose COVID-19 vaccine (initiation), or completion of a 1- or 2-dose COVID-19 vaccination series. During December 14, 2020-May 8, 2021, a total of 135,968 pregnant women were identified, 22,197 (16.3%) of whom had received ≥1 dose of a vaccine during pregnancy. Among these 135,968 women, 7,154 (5.3%) had initiated and 15,043 (11.1%) had completed vaccination during pregnancy. Receipt of ≥1 dose of COVID-19 vaccine during pregnancy was highest among women aged 35-49 years (22.7%) and lowest among those aged 18-24 years (5.5%), and higher among non-Hispanic Asian (Asian) (24.7%) and non-Hispanic White (White) women (19.7%) than among Hispanic (11.9%) and non-Hispanic Black (Black) women (6.0%). Vaccination coverage increased among all racial and ethnic groups over the analytic period, likely because of increased eligibility for vaccination† and increased availability of vaccine over time. These findings indicate the need for improved outreach to and engagement with pregnant women, especially those from racial and ethnic minority groups who might be at higher risk for severe health outcomes because of COVID-19 (4). In addition, providing accurate and timely information about COVID-19 vaccination to health care providers, pregnant women, and women of reproductive age can improve vaccine confidence and coverage by ensuring optimal shared clinical decision-making.


Asunto(s)
Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , Mujeres Embarazadas , Cobertura de Vacunación/estadística & datos numéricos , Adolescente , Adulto , COVID-19/epidemiología , Prestación Integrada de Atención de Salud , Femenino , Humanos , Persona de Mediana Edad , Embarazo , Mujeres Embarazadas/etnología , Estados Unidos/epidemiología , Adulto Joven
8.
Ther Adv Drug Saf ; 12: 20420986211021233, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34178302

RESUMEN

Background: Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data. Methods: We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time. Results: Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births. Conclusion: The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies. Plain Language Summary: Improving identification of pregnancies in the Vaccine Safety Datalink electronic medical record databases to allow for better and faster monitoring of vaccination safety during pregnancy Introduction: It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child.Methods: The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements, we manually reviewed medical records and compared the results with the algorithm. We also developed a new algorithm, the Dynamic Pregnancy Algorithm (DPA), to identify women earlier in pregnancy, allowing us to conduct more timely vaccine safety assessments.Results: The new version of the PEA identified 2,485,410 pregnancies in the VSD database. The enhanced algorithm more precisely estimated the beginning of pregnancies, especially those that did not result in live births, due to the new sources of gestational age data.Conclusion: Our new algorithm, the DPA, was successful at identifying pregnancies earlier in gestation than the PEA. The enhanced PEA and the new DPA will allow us to better evaluate the safety of current and future vaccinations administered during or around the time of pregnancy.

9.
Hum Vaccin Immunother ; 17(6): 1763-1769, 2021 06 03.
Artículo en Inglés | MEDLINE | ID: mdl-33351701

RESUMEN

Children have elevated fever risk 1 to 2 weeks after the first dose of a measles-containing vaccine (MCV), which is likely affected by genetic, immunologic, and clinical factors. Fever after MCV is associated with febrile seizures, though may also be associated with higher measles antibody titers. This exploratory study investigated genetic and immunologic associations with a fever after MCV. Concurrent with a randomized Phase 3 clinical trial of 12-15-month-olds who received their first measles-mumps-rubella (MMR) vaccine in which parents recorded post-vaccination temperatures daily, we consented a subset to collect additional blood and performed human leukocyte antigens (HLA) typing. Association between fever 5-12 days after MMR ("MMR-associated") and HLA type was assessed using logistic regression. We compared 42-day post-vaccination geometric mean titers (GMT) to measles between children who did and did not have fever using a t-test. We enrolled 86 children and performed HLA typing on 82; 13 (15.1%) had MMR-associated fever. Logistic regressions identified associations between MMR-associated fever and HLA Class I loci A-29:02 (P = .036), B-57:01 (P = .018), C-06:02 (P = .006), C-14:02 (P = .022), and Class II loci DRB1-15 (P = .045). However, Bonferroni's adjustment for multiple comparisons suggests that these associations could have been due to chance. Ninety-eight percent of children had protective antibody titers to measles; however, GMT was higher among those with fever compared with children without fever (P = .006). Fever after the measles vaccine correlated with genetic factors and higher immune response. This study suggests a possible genetic susceptibility to MMR-associated fever.


Asunto(s)
Sarampión , Paperas , Rubéola (Sarampión Alemán) , Anticuerpos Antivirales , Vacuna contra la Varicela , Niño , Humanos , Lactante , Vacuna contra el Sarampión-Parotiditis-Rubéola , Vacunas Combinadas
10.
Am J Epidemiol ; 189(11): 1379-1388, 2020 11 02.
Artículo en Inglés | MEDLINE | ID: mdl-32735018

RESUMEN

Uptake of influenza vaccine among pregnant women remains low. We investigated whether unvaccinated pregnant women were clustered geographically and determined factors associated with failure to vaccinate using spatial and multivariate logistic regression analyses. Pregnant women who were members of Kaiser Permanente Northern California in 2015 or 2016 were included in the study. More than half (53%) of the 77,607 included pregnant women were unvaccinated. Spatial analysis identified 5 clusters with a high prevalence of unvaccinated pregnant women. The proportion of unvaccinated women ranged from 57% to 75% within clusters as compared with 51% outside clusters. In covariate-adjusted analyses, residence in a cluster was associated with a 41% increase in the odds of being unvaccinated (odds ratio (OR) = 1.41, 95% confidence interval (CI): 1.36, 1.46). The odds of being unvaccinated were greater for Black women (OR = 1.58, 95% CI: 1.49, 1.69), Hispanic women (OR = 1.15, 95% CI: 1.05, 1.25), women with subsidized health insurance (OR = 1.18, 95% CI: 1.11, 1.24), women with fewer than 5 prenatal-care visits (OR = 1.85, 95% CI: 1.60, 2.16), and neighborhoods with a high deprivation index (fourth quartile vs. first: OR = 1.14, 95% CI: 1.07, 1.21). In conclusion, unvaccinated pregnant women were clustered geographically and by key sociodemographic factors. These findings suggest that interventions to increase influenza vaccine coverage among pregnant women are needed, particularly in vulnerable populations.


Asunto(s)
Vacunas contra la Influenza/uso terapéutico , Gripe Humana/prevención & control , Complicaciones Infecciosas del Embarazo/prevención & control , Atención Prenatal/estadística & datos numéricos , Cobertura de Vacunación/estadística & datos numéricos , Adulto , Afroamericanos/estadística & datos numéricos , California , Femenino , Geografía , Hispanoamericanos/estadística & datos numéricos , Humanos , Modelos Logísticos , Aceptación de la Atención de Salud/estadística & datos numéricos , Embarazo , Complicaciones Infecciosas del Embarazo/virología , Características de la Residencia , Análisis Espacial , Adulto Joven
11.
Ann Intern Med ; 173(4): 253-261, 2020 08 18.
Artículo en Inglés | MEDLINE | ID: mdl-32568572

RESUMEN

BACKGROUND: Subdeltoid bursitis has been reported as an adverse event after intramuscular vaccination in the deltoid muscle. Most published case reports involved influenza vaccine. OBJECTIVE: To estimate the risk for subdeltoid bursitis after influenza vaccination. DESIGN: Retrospective cohort study. SETTING: The Vaccine Safety Datalink, which contains health encounter data for 10.2 million members of 7 U.S. health care organizations. PATIENTS: Persons who received an inactivated influenza vaccine during the 2016-2017 influenza season. MEASUREMENTS: Potential incident cases were identified by searching administrative data for persons with a shoulder bursitis diagnostic code within 180 days after receiving an injectable influenza vaccine in the same arm. The date of reported bursitis symptom onset was abstracted from the medical record. A self-controlled risk interval analysis was used to calculate the incidence rate ratio of bursitis in a risk interval of 0 to 2 days after vaccination versus a control interval of 30 to 60 days, which represents the background rate. The attributable risk was also estimated. RESULTS: The cohort included 2 943 493 vaccinated persons. Sixteen cases of symptom onset in the risk interval and 51 cases of symptom onset in the control interval were identified. The median age of persons in the risk interval was 57.5 years (range, 24 to 98 years), and 69% were women. The incidence rate ratio was 3.24 (95% CI, 1.85 to 5.68). The attributable risk was 7.78 (CI, 2.19 to 13.38) additional cases of bursitis per 1 million persons vaccinated. LIMITATION: The results may not be generalizable to vaccinations done in other types of health care settings. CONCLUSION: Although an increased risk for bursitis after vaccination was present, the absolute risk was small. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.


Asunto(s)
Bursitis/etiología , Vacunas contra la Influenza/efectos adversos , Articulación del Hombro , Adulto , Anciano , Anciano de 80 o más Años , Bursitis/epidemiología , Músculo Deltoides , Femenino , Humanos , Incidencia , Vacunas contra la Influenza/administración & dosificación , Inyecciones Intramusculares/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Adulto Joven
12.
Hum Vaccin Immunother ; 16(12): 3098-3102, 2020 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-32401599

RESUMEN

Mumps outbreaks among previously vaccinated young adults raise concerns regarding waning vaccine immunity. This study identified, described and assessed the changing incidence of mumps cases following mumps-containing vaccination (MMR/MMRV) in a non-mumps outbreak setting. Potential cases between 1996 and 2018 were identified by the international classification of disease codes or by mumps laboratory test orders among Kaiser Permanente Northern California members. Medical charts were reviewed to confirm diagnoses, timing relative to vaccination and clinical characteristics. Among 474 potential cases, 257 (54.2%) were confirmed after chart review. A third of the cases were <10 years old at diagnosis and 48% were over 25 years. Most cases (92.2%) had parotitis and 5% of males had orchitis. Mumps rates decreased from 8.5 to 1.8/1,000,000 person-years as time since the second MMR/MMRV dose increased from <2 years to ≥10 years. Similarly, rates decreased from 16.3 to 3/1,000,000 person-years after at least 1 dose of MMR/MMRV. Mumps rates were higher among children aged ≤10 years compared with older age groups. In conclusion, in the context of a non-outbreak setting, this study suggests that waning of vaccine immunity to mumps appeared to have minimal clinical impact.


Asunto(s)
Vacuna contra el Sarampión-Parotiditis-Rubéola , Paperas , Anciano , Vacuna contra la Varicela , Niño , Brotes de Enfermedades , Humanos , Masculino , Vacuna contra el Sarampión-Parotiditis-Rubéola/uso terapéutico , Paperas/epidemiología , Paperas/prevención & control , Vacunas Combinadas , Adulto Joven
13.
Pediatr Infect Dis J ; 39(3): 247-253, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32032310

RESUMEN

BACKGROUND: Some findings from observational studies have suggested that recent receipt of live vaccines may be associated with decreased non-vaccine-targeted infection risk and mortality. Our objective was to estimate risk of non-vaccine-targeted infections based on most recent vaccine type (live vaccines only, inactivated vaccines only or both concurrently) received in US children 11-23 months of age. METHODS: We conducted a retrospective cohort study within the Vaccine Safety Datalink. We examined electronic health record and immunization data from children born in 2003-2013 who received 3 diphtheria-tetanus-acellular pertussis vaccines before their first birthday. We modeled vaccine type as a time-varying exposure and estimated risk of non-vaccine-targeted infections identified in emergency department and inpatient settings, adjusting for multiple confounders. RESULTS: Among 428,608 children, 48.9% were female, 4.9% had ≥1 immunization visit with live vaccines only and 10.3% had a non-vaccine-targeted infection. In males, lower risk of non-vaccine-targeted infections was observed following last receipt of live vaccines only or live and inactivated vaccines concurrently as compared with last receipt of inactivated vaccines only [live vaccines-only adjusted hazard ratio (aHR) = 0.83, 95% confidence interval (CI): 0.72-0.94; live and inactivated vaccines concurrently aHR: 0.91, 95% CI: 0.88-0.94]. Among females, last receipt of live and inactivated vaccines concurrently was significantly associated with non-vaccine-targeted infection risk (aHR = 0.94, 95% CI: 0.91-0.97 vs. last receipt of inactivated vaccines only). CONCLUSIONS: We observed modest associations between live vaccine receipt and non-vaccine-targeted infections. In this observational study, multiple factors, including healthcare-seeking behavior, may have influenced results.


Asunto(s)
Enfermedades Transmisibles/epidemiología , Enfermedades Transmisibles/etiología , Vacunas Atenuadas/efectos adversos , Vacunas de Productos Inactivados/efectos adversos , Factores de Edad , Susceptibilidad a Enfermedades , Femenino , Humanos , Esquemas de Inmunización , Incidencia , Lactante , Masculino , Modelos de Riesgos Proporcionales , Vigilancia en Salud Pública , Estudios Retrospectivos , Medición de Riesgo , Estados Unidos/epidemiología , Vacunación , Vacunas Atenuadas/administración & dosificación , Vacunas Atenuadas/inmunología , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/inmunología
14.
PLoS One ; 15(2): e0229279, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32101582

RESUMEN

There is concern that influenza vaccine effectiveness (VE) may be attenuated by passage in eggs during manufacture. We compared quadrivalent cell-culture vaccine with egg-based vaccines, most of which were trivalent, against influenza A and B during 2017-2018 when A(H3N2) and B/Yamagata (present only in quadrivalent vaccines) predominated. We retrospectively examined risk of PCR-confirmed influenza A and B in members of Kaiser Permanente Northern California aged 4-64 years. We estimated the relative VE (rVE) of cell-culture vaccine versus egg-based vaccines, and the absolute VE (aVE) of each vaccine comparing vaccinated to unvaccinated individuals. Analyses used Cox regression with a calendar timeline, stratified by birth year, and adjusted for demographics, co-morbidities and utilization. One-third (1,016,965/3,053,248) of the population was vaccinated; 932,545 (91.7% of vaccinees) received egg-based and 84,420 (8.3%) received cell-culture vaccines. The rVE against influenza A was 8.0% (95% CI: -10, 23); aVE was 31.7% (CI: 18.7, 42.6) for cell-culture and 20.1% (CI: 14.5, 25.4) for egg-based vaccines. The rVE against influenza B was 39.6% (CI: 27.9, 49.3); aVE was 40.9% (CI: 30, 50.1) for cell-culture and 9.7% (CI 3.5, 15.6) for egg-based trivalent vaccines. Inclusion of the B/Yamagata lineage in the quadrivalent cell-based vaccine provided better protection against influenza B but vaccine effectiveness against influenza A was low for both the cell-culture vaccine and the egg-based vaccines. Improving influenza vaccines requires ongoing comparative vaccine effectiveness monitoring.


Asunto(s)
Huevos , Virus de la Influenza A/inmunología , Vacunas contra la Influenza/administración & dosificación , Gripe Humana/prevención & control , Vacunación/estadística & datos numéricos , Vacunas de Productos Inactivados/administración & dosificación , Adolescente , Adulto , California/epidemiología , Niño , Preescolar , Femenino , Estudios de Seguimiento , Humanos , Virus de la Influenza A/aislamiento & purificación , Gripe Humana/epidemiología , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Estaciones del Año , Factores de Tiempo , Adulto Joven
15.
Vaccine ; 38(10): 2326-2332, 2020 02 28.
Artículo en Inglés | MEDLINE | ID: mdl-32033850

RESUMEN

OBJECTIVE: Despite recommendations by professional organizations that all pregnant women receive inactivated influenza vaccine, safety concerns remain a barrier. Our objective was to assess the effect of trivalent influenza vaccines (IIV3) during pregnancy on parent report 6-month infant development. METHODS: We conducted a multi-site prospective birth cohort study during the 2010-2011 influenza season and followed pregnant women and their newborns through 6 months of age. Information on IIV3 during pregnancy was ascertained from the EHR and self-report. The Ages and Stages Questionnaire-3 (ASQ-3) was completed by the mother to assess 6-month infant neurodevelopment in five domains (communication, gross motor, fine motor, problem-solving, and personal adaptive skills). Scores for each domain above the cut-off point indicating typical development were categorized as "on schedule" while scores in the zones indicating the need for either monitoring or further assessment were categorized as "not on schedule". Multivariable logistic regression was conducted. RESULTS: Of the 1225 infant-mother pairs, 65% received IIV3 during pregnancy. In bivariate analysis, infants of women who received IIV3 during pregnancy were moderately-less likely to need monitoring or further assessment in the personal social domain compared with infants of unvaccinated women (10.0% vs. 14.1%, p = 0.033; crude OR (cOR): 0.68(95%CI:0.48,0.97)). However, after controlling for potential confounders, the findings were no longer statistically significant (aOR:0.72,95%CI: 0.49,1.06,p = 0.46). No significant unadjusted or adjusted associations emerged in any other ASQ-3 domain. CONCLUSION: There was no significant association between IIV3 exposure during pregnancy and 6-month infant development. Studies of IIV3 during pregnancy to assess longer-term developmental outcomes are indicated.


Asunto(s)
Desarrollo Infantil , Vacunas contra la Influenza/administración & dosificación , Gripe Humana , Adulto , Femenino , Humanos , Lactante , Recién Nacido , Vacunas contra la Influenza/efectos adversos , Gripe Humana/prevención & control , Masculino , Embarazo , Complicaciones Infecciosas del Embarazo/prevención & control , Nacimiento Prematuro , Estudios Prospectivos , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/efectos adversos
16.
Hum Vaccin Immunother ; 16(4): 875-880, 2020 04 02.
Artículo en Inglés | MEDLINE | ID: mdl-31584845

RESUMEN

We evaluated whether parental clinical conditions were associated with fever after a first dose of measles-containing vaccine (MCV) in the child in a cohort study including 244,125 children born in Kaiser Permanente Northern California between 2009 and 2016 who received MCV between ages 1 and 2 years. Each child was linked with his/her mother and father when possible. Parental clinical conditions present before and after their child's birth were identified. We defined fever in the children as clinic and emergency department visits with a fever code 7-10 days after a first dose of MCV ("MCV-associated fever"). We evaluated parental clinical conditions associated with MCV-associated fever using multivariate logistic regression analyses. After adjusting for multiple factors, including healthcare utilization, maternal fever [odds ratio (OR) = 1.19, 95% confidence interval (CI) 1.06-1.32], fever after MCV (OR = 5.90, 95% CI 1.35-25.78), respiratory infections (OR = 1.20, 95% CI 1.10-1.31), migraine (OR = 1.14, 95% CI 1.05-1.24), syncope (OR 1.14, 95% CI 1.01-1.27), and essential thrombocythemia (OR = 1.93, 95% CI 1.15-3.25) were significantly associated with MCV-associated fever. Paternal respiratory infections (OR = 1.15, 95% CI 1.05-1.27), fever associated with respiratory infections (OR = 1.47, 95% CI 1.23-1.76), and vitiligo (OR = 1.63, 95% CI 1.06-2.53) were significantly associated with MCV-associated fever. Parental clinical conditions, specifically fever alone and fever associated with respiratory infection, are associated with fever in their child 7-10 days after MCV.


Asunto(s)
Vacuna contra el Sarampión-Parotiditis-Rubéola , Sarampión , Vacuna contra la Varicela , Niño , Preescolar , Estudios de Cohortes , Femenino , Humanos , Lactante , Masculino , Factores de Riesgo , Vacunas Combinadas
17.
Biol Psychiatry ; 86(4): 255-264, 2019 08 15.
Artículo en Inglés | MEDLINE | ID: mdl-31279535

RESUMEN

BACKGROUND: The identification of an early biomarker for autism spectrum disorder (ASD) would improve the determination of risk, leading to earlier diagnosis and, potentially, earlier intervention and improved outcomes. METHODS: Data were generated from the Early Markers for Autism study, a population-based case-control study of prenatal and neonatal biomarkers of ASD. Newborn bloodspots of children with ASD (n = 370), children with developmental delay (n = 140), and general population (GP) controls (n = 378) were analyzed for 42 different immune markers using a Luminex multiplex platform. Comparisons of immune marker concentrations between groups were examined using logistic regression and partial least squares discriminant analysis. RESULTS: Children with ASD had significantly increased neonatal levels of interleukin-6 (IL-6) and IL-8 compared with GP controls. An increase in IL-8 was especially significant in the ASD group with early onset compared with the GP group, with an adjusted odds ratio of 1.97 (95% confidence interval, 1.39-2.83; p = .00014). In addition, children with ASD had significantly elevated levels of eotaxin-1, interferon-γ, and IL-12p70 relative to children with developmental delay. We observed no significant differences in levels of immune markers between the developmental delay and GP groups. CONCLUSIONS: Elevated levels of some inflammatory markers in newborn bloodspots indicated a higher degree of immune activation at birth in children who were subsequently diagnosed with ASD. The data from this exploratory study suggest that with further expansion, the development of neonatal bloodspot testing for cytokine/chemokine levels might lead to the identification of biomarkers that provide an accurate assessment of ASD risk at birth.


Asunto(s)
Trastorno del Espectro Autista/sangre , Trastorno del Espectro Autista/diagnóstico , Quimiocinas/sangre , Citocinas/sangre , Diagnóstico Precoz , Biomarcadores/sangre , California , Estudios de Casos y Controles , Discapacidades del Desarrollo/sangre , Femenino , Humanos , Recién Nacido , Modelos Logísticos , Masculino , Factores de Riesgo
18.
Autism Res ; 12(10): 1551-1561, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31317667

RESUMEN

Maternal infection and fever during pregnancy have been implicated in the etiology of autism spectrum disorder (ASD); however, studies have not been able to separate the effects of fever itself from the impact of a specific infectious organism on the developing brain. We utilized data from the Study to Explore Early Development (SEED), a case-control study among 2- to 5-year-old children born between 2003 and 2006 in the United States, to explore a possible association between maternal infection and fever during pregnancy and risk of ASD and other developmental disorders (DDs). Three groups of children were included: children with ASD (N = 606) and children with DDs (N = 856), ascertained from clinical and educational sources, and children from the general population (N = 796), randomly sampled from state birth records. Information about infection and fever during pregnancy was obtained from a telephone interview with the mother shortly after study enrollment and maternal prenatal and labor/delivery medical records. ASD and DD status was determined by an in-person standardized developmental assessment of the child at 3-5 years of age. After adjustment for covariates, maternal infection anytime during pregnancy was not associated with ASD or DDs. However, second trimester infection accompanied by fever elevated risk for ASD approximately twofold (aOR = 2.19, 95% confidence interval 1.14-4.23). These findings of an association between maternal infection with fever in the second trimester and increased risk of ASD in the offspring suggest that the inflammatory response to the infectious agent may be etiologically relevant. Autism Res 2019, 12: 1551-1561. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Using data from a large multisite study in the United States-the Study to Explore Early Development-we found that women who had an infection during the second trimester of pregnancy accompanied by a fever are more likely to have children with ASD. These findings suggest the possibility that only more severe infections accompanied by a robust inflammatory response increase the risk of ASD.


Asunto(s)
Trastorno del Espectro Autista/epidemiología , Fiebre/epidemiología , Infecciones/epidemiología , Madres , Complicaciones del Embarazo/epidemiología , Adulto , Estudios de Casos y Controles , Preescolar , Comorbilidad , Femenino , Humanos , Masculino , Embarazo , Segundo Trimestre del Embarazo , Factores de Riesgo , Estados Unidos/epidemiología , Adulto Joven
19.
Pediatrics ; 144(1)2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31182549

RESUMEN

OBJECTIVES: To determine pertussis risk by diphtheria-tetanus-acellular pertussis (DTaP) vaccination status and time since last DTaP dose. METHODS: Children born at Kaiser Permanente Northern California between 1999 and 2016 were followed from 3 months of age until they tested positive for pertussis; disenrolled from Kaiser Permanente Northern California; received the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed vaccine; turned 11 years of age, or the end of the study period. DTaP vaccination status was categorized on the basis of the number of doses received in relation to the number of doses expected according to the Advisory Committee on Immunization Practice-recommended ages. RESULTS: Among 469 982 children ages 3 months to 11 years, we identified 738 pertussis cases. A total of 99 cases were unvaccinated, 36 were undervaccinated, 515 were fully vaccinated, and 88 were fully vaccinated plus 1 dose. Pertussis risk was 13 times higher among unvaccinated (adjusted hazard ratio [aHR] = 13.53; 95% confidence interval [CI] 10.64-17.21) compared with fully vaccinated children and 1.9 times higher (aHR = 1.86; 95% CI 1.32-2.63) among undervaccinated children. Among vaccinated children ages 19 to <84 months, pertussis risk was 5 times higher (aHR = 5.04; 95% CI 1.84-13.80) ≥3 years vs <1 year after vaccination. Among children ages 84 to 132 months, risk was 2 times higher (aHR = 2.32; 95% CI 0.97-5.59) ≥6 years vs <3 years after vaccination. CONCLUSIONS: Undervaccinated and especially unvaccinated children were at greater risk of pertussis. However, most pertussis cases occurred among children age-appropriately vaccinated who were further away from their last DTaP dose, suggesting that suboptimal vaccine effectiveness played a major role in recent pertussis epidemics.


Asunto(s)
Vacunas contra Difteria, Tétanos y Tos Ferina Acelular , Tos Ferina/prevención & control , California/epidemiología , Niño , Preescolar , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Femenino , Estudios de Seguimiento , Humanos , Esquemas de Inmunización , Lactante , Masculino , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Tiempo , Cobertura de Vacunación , Tos Ferina/epidemiología
20.
Autism Res ; 12(1): 123-135, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-30095240

RESUMEN

Numerous studies have reported immune system disturbances in individuals with autism and their family members; however, there is considerable variability in findings with respect to the specific immune conditions involved, their timing, and the family members affected and little understanding of variation by autism subphenotype. Using data from the Study to Explore Early Development (SEED), a multi-site case-control study of children born 2003-2006 in the United States, we examined the role of family history of autoimmune diseases, asthma, and allergies in autism spectrum disorder (ASD) as well as other developmental disorders (DD). We investigated maternal immune conditions during the pregnancy period, as well as lifetime history of these conditions in several family members (mother, father, siblings, and study child). Logistic regression analyses included 663 children with ASD, 984 children with DD, and 915 controls ascertained from the general population (POP). Maternal history of eczema/psoriasis and asthma was associated with a 20%-40% increased odds of both ASD and DD. Risk estimates varied by specific ASD subphenotypes in association with these exposures. In addition, children with ASD were more likely to have a history of psoriasis/eczema or allergies than POP controls. No association was observed for paternal history or family history of these immune conditions for either ASD or DD. These data support a link between maternal and child immune conditions and adverse neurodevelopmental outcomes, and further suggest that associations may differ by ASD phenotype of the child. Autism Research 2019, 12: 123-135. © 2018 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Using data from a large multi-site study in the US-the Study to Explore Early Development-we found that women with a history of eczema/psoriasis and asthma are more likely to have children with ASD or DD. In addition, children with ASD are more likely to have a history of psoriasis/eczema or allergies than typically developing children. These data support a link between maternal and child immune conditions and adverse neurodevelopmental outcomes.


Asunto(s)
Trastorno del Espectro Autista/epidemiología , Trastorno del Espectro Autista/fisiopatología , Desarrollo Infantil/fisiología , Salud de la Familia/estadística & datos numéricos , Enfermedades del Sistema Inmune/epidemiología , Enfermedades del Sistema Inmune/fisiopatología , Trastorno del Espectro Autista/inmunología , Estudios de Casos y Controles , Preescolar , Comorbilidad , Discapacidades del Desarrollo/epidemiología , Discapacidades del Desarrollo/inmunología , Discapacidades del Desarrollo/fisiopatología , Femenino , Humanos , Enfermedades del Sistema Inmune/inmunología , Masculino , Embarazo , Estados Unidos/epidemiología
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