Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-30 (of 33 Records) |
Query Trace: Hanson KE[original query] |
---|
Attitudes toward COVID-19 vaccines among pregnant and recently pregnant individuals
Williams JTB , Kurlandsky K , Breslin K , Durfee MJ , Stein A , Hurley L , Shoup JA , Reifler LM , Daley MF , Lewin BJ , Goddard K , Henninger ML , Nelson JC , Vazquez-Benitez G , Hanson KE , Fuller CC , Weintraub ES , McNeil MM , Hambidge SJ . JAMA Netw Open 2024 7 (4) e245479 IMPORTANCE: Pregnant people and infants are at high risk of severe COVID-19 outcomes. Understanding changes in attitudes toward COVID-19 vaccines among pregnant and recently pregnant people is important for public health messaging. OBJECTIVE: To assess attitudinal trends regarding COVID-19 vaccines by (1) vaccination status and (2) race, ethnicity, and language among samples of pregnant and recently pregnant Vaccine Safety Datalink (VSD) members from 2021 to 2023. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional surveye study included pregnant or recently pregnant members of the VSD, a collaboration of 13 health care systems and the US Centers for Disease Control and Prevention. Unvaccinated, non-Hispanic Black, and Spanish-speaking members were oversampled. Wave 1 took place from October 2021 to February 2022, and wave 2 took place from November 2022 to February 2023. Data were analyzed from May 2022 to September 2023. EXPOSURES: Self-reported or electronic health record (EHR)-derived race, ethnicity, and preferred language. MAIN OUTCOMES AND MEASURES: Self-reported vaccination status and attitudes toward monovalent (wave 1) or bivalent Omicron booster (wave 2) COVID-19 vaccines. Sample- and response-weighted analyses assessed attitudes by vaccination status and 3 race, ethnicity, and language groupings of interest. RESULTS: There were 1227 respondents; all identified as female, the mean (SD) age was 31.7 (5.6) years, 356 (29.0%) identified as Black race, 555 (45.2%) identified as Hispanic ethnicity, and 445 (36.3%) preferred the Spanish language. Response rates were 43.5% for wave 1 (652 of 1500 individuals sampled) and 39.5% for wave 2 (575 of 1456 individuals sampled). Respondents were more likely than nonrespondents to be White, non-Hispanic, and vaccinated per EHR. Overall, 76.8% (95% CI, 71.5%-82.2%) reported 1 or more COVID-19 vaccinations; Spanish-speaking Hispanic respondents had the highest weighted proportion of respondents with 1 or more vaccination. Weighted estimates of somewhat or strongly agreeing that COVID-19 vaccines are safe decreased from wave 1 to 2 for respondents who reported 1 or more vaccinations (76% vs 50%; χ21 = 7.8; P < .001), non-Hispanic White respondents (72% vs 43%; χ21 = 5.4; P = .02), and Spanish-speaking Hispanic respondents (76% vs 53%; χ21 = 22.8; P = .002). CONCLUSIONS AND RELEVANCE: Decreasing confidence in COVID-19 vaccine safety in a large, diverse pregnant and recently pregnant insured population is a public health concern. |
Simultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccines
Kenigsberg TA , Goddard K , Hanson KE , Lewis N , Klein N , Irving SA , Naleway AL , Crane B , Kauffman TL , Xu S , Daley MF , Hurley LP , Kaiser R , Jackson LA , Jazwa A , Weintraub ES . Vaccine 2023 41 (39) 5678-5682 The U.S. Food and Drug Administration authorized use of mRNA COVID-19 bivalent booster vaccines on August 31, 2022. Currently, CDC's clinical guidance states that COVID-19 and other vaccines may be administered simultaneously. At time of authorization and recommendations, limited data existed describing simultaneous administration of COVID-19 bivalent booster and other vaccines. We describe simultaneous influenza and mRNA COVID-19 bivalent booster vaccine administration between August 31-December 31, 2022, among persons aged ≥6 months in the Vaccine Safety Datalink (VSD) by COVID-19 bivalent booster vaccine type, influenza vaccine type, age group, sex, and race and ethnicity. Of 2,301,876 persons who received a COVID-19 bivalent booster vaccine, 737,992 (32.1%) received simultaneous influenza vaccine, majority were female (53.1%), aged ≥18 years (91.4%), and non-Hispanic White (55.7%). These findings can inform future VSD studies on simultaneous influenza and COVID-19 bivalent booster vaccine safety and coverage, which may have implications for immunization service delivery. |
COVID-19 booster dose reminder/recall for adolescents: Findings from a health-care system in Wisconsin
Alonge OD , Hanson KE , Eggebrecht M , Funk P , Christianson B , Williams CL , Belongia EA , McLean HQ . J Adolesc Health 2023 73 (5) 953-956 PURPOSE: This study assessed efficacy of one-time COVID-19 booster reminder/recall for booster eligible adolescents in a health-care system in Wisconsin. METHODS: COVID-19 booster eligible patients aged 12-17 years were randomized 1:1 to receive one reminder/recall message from the health-care system using the parent's preferred communication method (intervention) or no reminder/recall (usual care) in May 2022. RESULTS: Reminder/recall was sent to 2,146/4,296 (50%) adolescent patients. During the 90-day evaluation period following randomization, booster dose receipt was 2.0 percentage points (CI: 0.3%-3.7%) higher in the intervention (10.0%) versus usual care groups (8.0%). Among patients with ≥1 preventive visit during the evaluation period, uptake was 7.5 percentage points higher in the intervention (16.4%) versus usual care groups (8.9%). DISCUSSION: A single COVID-19 booster dose reminder/recall resulted in a small but statistically significant increase in booster dose receipt, though uptake overall was low. Additional strategies are needed to increase uptake. |
Changes in Transmission and Symptoms of SARS-CoV-2 in United States Households, April 2020-September 2022 (preprint)
Mellis AM , Lauring AS , Talbot HK , McLean HQ , Morrissey KG , Stockwell MS , Bowman NM , Maldonado Y , Ellingson KD , Rao S , Biddle JE , Johnson S , Ogokeh C , Salvatore PP , Reed C , Smith-Jeffcoat SE , Meece JK , Hanson KE , Belongia EA , Bendall EE , Gilbert J , Olivo V , Merrill LS , McLaren SH , Sano E , Vargas CY , Saiman L , Silverio Francisco RA , Bullock A , Lin J , Govindarajan P , Goodman SH , Sarnquist CC , Lutrick K , Ledezma KI , Ramadan FA , Pryor K , Miiro FN , Asturias E , Dominguez S , Olson D , Izurieta HS , Chappell J , Lindsell C , Halasa N , Hart K , Zhu Y , Schmitz J , Rolfes MA , Grijalva CG . medRxiv 2023 19 Background: The natural history of SARS-CoV-2 infection and transmission dynamics may have changed as SARS-CoV-2 has evolved and population immunity has shifted. Method(s): Household contacts, enrolled from two multi-site case-ascertained household transmission studies (April 2020-April 2021 and September 2021-September 2022), were followed for 10-14 days after enrollment with daily collection of nasal swabs and/or saliva for SARS-CoV-2 testing and symptom diaries. SARS-CoV-2 virus lineage was determined by whole genome sequencing, with multiple imputation where sequences could not be recovered. Adjusted infection risks were estimated using modified Poisson regression. Finding(s): 858 primary cases with 1473 household contacts were examined. Among unvaccinated household contacts, the infection risk adjusted for presence of prior infection and age was 58% (95% confidence interval [CI]: 49-68%) in households currently exposed to pre-Delta lineages and 90% (95% CI: 74-100%) among those exposed to Omicron BA.5 (detected May - September 2022). The fraction of infected household contacts reporting any symptom was similarly high between pre-Delta (86%, 95% CI: 81-91%) and Omicron lineages (77%, 70-85%). Among Omicron BA.5-infected contacts, 48% (41-56%) reported fever, 63% (56-71%) cough, 22% (17-28%) shortness of breath, and 20% (15-27%) loss of/change in taste/smell. Interpretation(s): The risk of infection among household contacts exposed to SARS-CoV-2 is high and increasing with more recent SARS-CoV-2 lineages. This high infection risk highlights the importance of vaccination to prevent severe disease. Funding(s): Funded by the Centers for Disease Control and Prevention and the Food and Drug Administration. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
SARS-CoV-2 virus dynamics in recently infected people - data from a household transmission study (preprint)
Mellis AM , Meece JK , Halasa NB , Chappell JD , McLean HQ , Grijalva CG , Hanson KE , Zhu Y , Kim A , Deyoe J , Ivacic LC , Reed C , Talbot HK , Rolfes MA . medRxiv 2022 18 (10) 1699-1703 We used daily real-time reverse-transcription polymerase chain reaction (rRT-PCR) results from 67 cases of SARS-CoV-2 infection in a household transmission study to examine the trajectory of cycle threshold (Ct) values, an inverse correlate of viral RNA concentration, from nasal specimens collected between April 2020 and May 2021. Ct values varied over the course of infection, across RT-PCR platforms, and by participant age. Specimens collected from children and adolescents showed higher Ct values and adults aged >=50 years showed lower Ct values than adults aged 18-49 years. Ct values were lower on days when participants reported experiencing symptoms. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Guillain-Barre Syndrome after COVID-19 Vaccination in the Vaccine Safety Datalink (preprint)
Hanson KE , Goddard K , Lewis N , Fireman B , Myers TR , Bakshi N , Weintraub E , Donahue JG , Nelson JC , Xu S , Glanz JM , Williams JTB , Alpern JD , Klein NP . medRxiv 2021 05 Importance: Post-authorization monitoring of vaccines in a large population can detect rare adverse events not identified in clinical trials including Guillain-Barre syndrome (GBS). GBS has a background rate of 1-2 per 100,000 person-years. Objective(s): To 1) describe cases and incidence of GBS following COVID-19 vaccination, and 2) assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design(s): Interim analysis of surveillance data from the Vaccine Safety Datalink. Setting(s): Eight participating integrated healthcare systems in the United States. Participant(s): 10,158,003 individuals aged >=12 years. Exposures: Receipt of Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine. Main Outcomes and Measures: GBS with symptom onset in the 1-84 days after vaccination as confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared to the background rate, rate ratios (RRs) comparing GBS incidence in the 1-21 vs. 22-42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs. mRNA vaccination, using Poisson regression adjusted for age, sex, race/ethnicity, site, and calendar day. Result(s): From December 13, 2020 through November 13, 2021, 14,723,318 doses of COVID-19 vaccines were administered, including 467,126 Ad.26.COV2.S, 8,573,823 BNT162b2, and 5,682,369 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of confirmed cases of GBS per 100,000 person-years in the 1-21 days after Ad.26.COV2.S was 34.6 (95% confidence interval [CI]: 15.8-65.7), significantly higher than the background rate, and the adjusted RR in the 1-21 vs. 22-42 days following Ad.26.COV2.S was 6.03 (95% CI: 0.79-147.79). Thirty-four cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate of confirmed cases per 100,000 person-years in the 1-21 days after mRNA vaccines was 1.4 (95% CI: 0.7-2.5) and the adjusted RR in the 1-21 vs. 22-42 days following mRNA vaccines was 0.56 (95% CI: 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs. mRNA vaccines, the adjusted RR was 20.56 (95% CI: 6.94-64.66). Conclusions and Relevance: In this interim analysis of surveillance data of COVID-19 vaccines, the incidence of GBS was elevated after Ad.26.COV2.S. Surveillance is ongoing. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license. |
Household Transmission and Clinical Features of SARS-CoV-2 Infections by Age in 2 US Communities (preprint)
McLean HQ , Grijalva CG , Hanson KE , Zhu YG , Deyoe JE , Meece JK , Halasa NB , Chappell JD , Mellis A , Reed C , Belongia EA , Talbot HK , Rolfes MA . medRxiv 2021 OBJECTIVES: Examine age differences in SARS-CoV-2 transmission risk from primary cases and infection risk among household contacts, and symptoms among those with SARS-CoV-2 infection. METHODS: People with SARS-CoV-2 infection in Nashville, Tennessee and central and western Wisconsin and their household contacts were followed daily for 14 days to ascertain symptoms and secondary transmission events. Households were enrolled between April 2020 and April 2021. Secondary infection risks (SIR) by age of the primary case and contacts were estimated using generalized estimating equations. RESULTS: The 226 primary cases were followed by 198 (49%) secondary SARS-CoV-2 infections among 404 household contacts. Age group-specific SIR among contacts ranged from 36% to 53%, with no differences by age. SIR was lower from primary cases aged 12-17 years than from primary cases 18-49 years (risk ratio [RR] 0.42; 95% confidence interval [CI] 0.19-0.91). SIR was 55% and 45%, respectively, among primary case-contact pairs in the same versus different age group (RR 1.47; 95% CI 0.98-2.22). SIR was highest among primary case-contacts pairs aged ≥65 years (76%) and 5-11 years (69%). Among secondary SARS-CoV-2 infections, 19% were asymptomatic; there was no difference in the frequency of asymptomatic infections by age group. CONCLUSIONS: Both children and adults can transmit and are susceptible to SARS-CoV-2 infection. SIR did not vary by age, but further research is needed to understand age-related differences in probability of transmission from primary cases by age. |
Safety of simultaneous vaccination with COVID-19 vaccines in the Vaccine Safety Datalink
Kenigsberg TA , Hanson KE , Klein NP , Zerbo O , Goddard K , Xu S , Yih WK , Irving SA , Hurley LP , Glanz JM , Kaiser R , Jackson LA , Weintraub ES . Vaccine 2023 INTRODUCTION: Safety data on simultaneous vaccination (SV) with primary series monovalent COVID-19 vaccines and other vaccines are limited. We describe SV with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged ≥5 years in the Vaccine Safety Datalink (VSD). METHODS: We utilized VSD's COVID-19 vaccine surveillance data from December 11, 2020-May 21, 2022. Analyses assessed frequency of SV. Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was ≥5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving SV and COVID-19 vaccinees receiving no SV in the 1-21 days following COVID-19 vaccine dose 1 and 1-42 days following dose 2 by SV type received ("All SV", "Influenza SV", "Non-influenza SV"). RESULTS: SV with COVID-19 vaccines was not common practice (dose 1: 0.7 % of 8,455,037 persons, dose 2: 0.3 % of 7,787,013 persons). The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive SV (6.5 vs. 6.8 per 10,000 persons). Statistically significant elevated RRs were observed for appendicitis (2.09; 95 % CI, 1.06-4.13) and convulsions/seizures (2.78; 95 % CI, 1.10-7.06) in the "All SV" group following dose 1, and for Bell's palsy (2.82; 95 % CI, 1.14-6.97) in the "Influenza SV" group following dose 2. CONCLUSION: Combined pre-specified health outcomes observed among persons who received SV with COVID-19 vaccine were rare and not statistically significantly different compared to persons who did not receive SV with COVID-19 vaccine. Statistically significant adjusted rate ratios were observed for some individual outcomes, but the number of outcomes was small and there was no adjustment for multiple testing. |
Safety of COVID-19 mRNA vaccination among young children in the Vaccine Safety Datalink
Goddard K , Donahue JG , Lewis N , Hanson KE , Weintraub ES , Fireman B , Klein NP . Pediatrics 2023 152 (1) We previously assessed safety of monovalent messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines using weekly surveillance monitoring known as rapid cycle analysis (RCA) among individuals aged 5 years and older, identifying an increased risk for myocarditis and pericarditis in younger males, particularly following dose 2 of the primary series.1,–3 Information regarding COVID-19 vaccine safety among children under age 5 is limited.4 Here we report RCA safety surveillance of mRNA COVID-19 vaccines administered in this youngest age group within the Vaccine Safety Datalink (VSD). |
Interim estimates of 2022-23 seasonal influenza vaccine effectiveness - Wisconsin, October 2022-February 2023
McLean HQ , Petrie JG , Hanson KE , Meece JK , Rolfes MA , Sylvester GC , Neumann G , Kawaoka Y , Belongia EA . MMWR Morb Mortal Wkly Rep 2023 72 (8) 201-205 In the United States, 2022-23 influenza activity began earlier than usual, increasing in October 2022, and has been associated with high rates of hospitalizations among children* (1). Influenza A(H3N2) represented most influenza viruses detected and subtyped during this period, but A(H1N1)pdm09 viruses cocirculated as well. Most viruses characterized were in the same genetic subclade as and antigenically similar to the viruses included in the 2022-23 Northern Hemisphere influenza vaccine (1,2). Effectiveness of influenza vaccine varies by season, influenza virus subtype, and antigenic match with circulating viruses. This interim report used data from two concurrent studies conducted at Marshfield Clinic Health System (MCHS) in Wisconsin during October 23, 2022-February 10, 2023, to estimate influenza vaccine effectiveness (VE). Overall, VE was 54% against medically attended outpatient acute respiratory illness (ARI) associated with laboratory-confirmed influenza A among patients aged 6 months-64 years. In a community cohort of children and adolescents aged <18 years, VE was 71% against symptomatic laboratory-confirmed influenza A virus infection. These interim analyses indicate that influenza vaccination substantially reduced the risk for medically attended influenza among persons aged <65 years and for symptomatic influenza in children and adolescents. Annual influenza vaccination is the best strategy for preventing influenza and its complications. CDC recommends that health care providers continue to administer annual influenza vaccine to persons aged ≥6 months as long as influenza viruses are circulating (2). |
Safety of measles, mumps, and rubella vaccine in adolescents and adults in the vaccine safety Datalink
Hanson KE , Marin M , Daley MF , Groom HC , Jackson LA , Sy LS , Klein NP , DeSilva MB , Panagiotakopoulos L , Weintraub E , Belongia EA , McLean HQ . Vaccine X 2023 13 100268 Background: Measles, mumps, and rubella vaccine (MMR) is routinely administered to children; however, adolescents and adults may receive MMR for various reasons. Safety studies in adolescents and adults are limited. We report on safety of MMR in this age group in the Vaccine Safety Datalink. Methods: We included adolescents (aged 9–17 years) and adults (aged ≥ 18 years) who received ≥ 1 dose of MMR from January 1, 2010–December 31, 2018. Pre-specified outcomes were identified by diagnosis codes. Clinically serious outcomes included anaphylaxis, encephalitis/myelitis, Guillain-Barré syndrome, immune thrombocytopenia, meningitis, and seizure. Non-serious outcomes were allergic reaction, arthropathy, fever, injection site reaction, lymphadenopathy, non-specific reaction, parotitis, rash, and syncope. All serious outcomes underwent medical record review. Outcome-specific incidence was calculated in pre-defined post-vaccination windows. A self-controlled risk interval design was used to determine the relative risk of each outcome in a risk window after vaccination compared to a more distal control window. Results: During the study period, 276,327 MMR doses were administered to adolescents and adults. Mean age of vaccinees was 34.8 years; 65.8 % were female; 53.2 % of doses were administered simultaneously with ≥ 1 other vaccine. Serious outcomes were rare, with incidence ≤ 6 per 100,000 doses for each outcome assessed, and none had a significant elevation in incidence during the risk window compared to the control window. Incidence of non-serious outcomes per 100,000 doses ranged from 3.4 for parotitis to 263.0 for arthropathy. Other common outcomes included injection site reaction and rash (157.0 and 112.9 per 100,000 doses, respectively). Significantly more outcomes were observed during the risk window compared to the control window for all non-serious outcomes except parotitis. Some variability was observed by sex and age group. Conclusion: Serious outcomes after MMR are rare in adolescents and adults, but vaccinees should be counseled regarding anticipated local and systemic non-serious adverse events. © 2023 The Author(s) |
Extended surveillance to assess safety of 9-valent human papillomavirus vaccine
Sundaram ME , Kieke BA , Hanson KE , Belongia EA , Weintraub ES , Daley MF , Hechter RC , Klein NP , Lewis EM , Naleway AL , Nelson JC , Donahue JG . Hum Vaccin Immunother 2022 18 (7) 2159215 The safety of 9-valent HPV vaccine (9vHPV) has been established with regard to common and uncommon adverse events. However, investigation of rare and severe adverse events requires extended study periods to capture rare outcomes. This observational cohort study investigated the occurrence of three rare and serious adverse events following 9-valent human papillomavirus (9vHPV) vaccination compared to other vaccinations, in US individuals 9-26 years old, using electronic health record data from the Vaccine Safety Datalink (VSD). We searched for occurrences of Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and stroke following 9vHPV vaccination from October 4, 2015, through January 2, 2021. We compared the risks of GBS, CIDP, and stroke following 9vHPV vaccination to risks of those outcomes following comparator vaccines commonly given to this age group (Td, Tdap, MenACWY, hepatitis A, and varicella vaccines) from January 1, 2007, through January 2, 2021. We observed 1.2 cases of stroke, 0.3 cases of GBS, and 0.1 cases of CIDP per 100,000 doses of 9vHPV vaccine. After observing more than 1.8 million doses of 9vHPV, we identified no statistically significant increase in risks associated with 9vHPV vaccination for any of these adverse events, either combined or stratified by age (9-17 years of age vs. 18-26 years of age) and sex (males vs. females). Our findings provide additional evidence supporting 9vHPV vaccine safety, over longer time frames and for more serious and rare adverse events. |
Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United States.
Goddard K , Hanson KE , Lewis N , Weintraub E , Fireman B , Klein NP . Ann Intern Med 2022 175 (12) 1169-1771 Background: Vaccine safety monitoring systems worldwide have reported cases of myocarditis/pericarditis after mRNA-based COVID-19 vaccines (Pfizer-BioNTech and Moderna), especially among younger male persons 0 to 7 days after they received dose 2 (1, 2). Less is known about the incidence of myocarditis/pericarditis after booster doses. | | Objective: To estimate the incidence of myocarditis/pericarditis during days 0 to 7 after mRNA vaccination by age, sex, dose number, and product. | | Methods: The Vaccine Safety Datalink (VSD) is a collaborative of 8 integrated health care delivery systems with comprehensive medical records that has conducted active, population-based surveillance of prespecified outcomes after COVID-19 vaccination since December 2020 (1, 3). We identified all potential cases of myocarditis/pericarditis in emergency department and inpatient settings 1 to 98 days after vaccination, using myocarditis/pericarditis–specific ICD-10 codes, among 5- to 39-year-old persons (Table). We validated cases through review of medical records with physician adjudication and classified according to the Centers for Disease Control and Prevention case definition (1). |
Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination.
Goddard K , Lewis N , Fireman B , Weintraub E , Shimabukuro T , Zerbo O , Boyce TG , Oster ME , Hanson KE , Donahue JG , Ross P , Naleway A , Nelson JC , Lewin B , Glanz JM , Williams JTB , Kharbanda EO , Katherine Yih W , Klein NP . Vaccine 2022 40 (35) 5153-5159 BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. |
Human papillomavirus vaccine beliefs and practice characteristics in rural and urban adolescent care providers
Goessl CL , Christianson B , Hanson KE , Polter EJ , Olson SC , Boyce TG , Dunn D , Williams CL , Belongia EA , McLean HQ , VanWormer JJ . BMC Public Health 2022 22 (1) 1322 BACKGROUND: The human papillomavirus (HPV) vaccine is recommended for all adolescents age 11-12 years. HPV vaccine coverage remains suboptimal in the United States though, particularly in rural areas. We surveyed adolescent immunization providers in two Midwestern states to assess rural vs. urban differences in HPV vaccine resources, practices, and attitudes. METHODS: A cross-sectional survey was sent to all licensed adolescent care providers in a subset of urban and rural counties in Minnesota and Wisconsin during 2019. Multivariable regression was used to identify attitudes and practices that differentiated rural vs. urban providers. RESULTS: There were 437 survey respondents (31% rural). Significantly fewer rural providers had evening/weekend adolescent vaccination appointments available (adjusted odds ratio (aOR) = 0.21 [95% confidence interval (CI): 0.12, 0.36]), had prior experience with adolescent vaccine quality improvement projects (aOR = 0.52 [95% CI: 0.28, 0.98]), and routinely recommended HPV vaccine during urgent/acute care visits (aOR = 0.37 [95% CI: 0.18, 0.79]). Significantly more rural providers had standing orders to administer all recommended adolescent vaccines (aOR = 2.81 [95% CI: 1.61, 4.91]) and reported giving HPV vaccine information to their patients/families before it is due (aOR = 3.10 [95% CI: 1.68, 5.71]). CONCLUSIONS: Rural vs. urban differences in provider practices were mixed in that rural providers do not implement some practices that may promote HPV vaccination, but do implement other practices that promote HPV vaccination. It remains unclear how the observed differences would affect HPV vaccine attitudes or adolescent vaccination decisions for parents in rural areas. |
Factors associated with human papillomavirus and meningococcal vaccination among adolescents living in rural and urban areas
Boyce TG , Christianson B , Hanson KE , Dunn D , Polter E , VanWormer JJ , Williams CL , Belongia EA , McLean HQ . Vaccine X 2022 11 100180 BACKGROUND: Studies have shown that adolescent vaccination rates with human papillomavirus (HPV) and quadrivalent meningococcal conjugate (MenACWY) vaccines are lower in rural areas of the U.S. than in urban areas. We sought to determine factors associated with vaccine acceptance in these two settings. METHODS: We conducted a cross-sectional survey of 536 parents or guardians of teens age 13 through 15 years in select rural and urban counties of Minnesota and Wisconsin. We collected information on demographic variables, receipt of adolescent vaccines, and attitudes toward HPV vaccine in particular. Multivariable logistic regression models were used to assess associations between covariates and outcomes of interest (HPV vaccine receipt and MenACWY receipt). RESULTS: Of the 536 respondents, 267 (50%) resided in a rural county. Most respondents were female (78%) and non-Hispanic White (88%). About half (52%) of teens of the surveyed parents received the three vaccines recommended specifically for adolescents: 90% received tetanus-diphtheria-acellular pertussis (Tdap), 84% received MenACWY, and 60% received one or more doses of HPV vaccine. Rural and urban parents surveyed differed on several covariates relating to teen's health services, parent's demographics, and household characteristics. Parent's perception of the importance that their healthcare providers placed on vaccination with HPV and MenACWY were independently associated with receipt of each of those vaccines (odds ratio [OR] 6.37, 95% confidence interval [CI] 2.90-13.96 and OR 2.15, 95% CI 1.07-4.31, respectively). Parents of vaccinated teens were less likely to report concerns about potential harm from the HPV vaccine or having heard stories about health problems caused by the HPV vaccine. CONCLUSION: Teen receipt of HPV vaccine and MenACWY appears to be influenced by parents' perception of vaccine importance, provider recommendations, and concerns regarding potential harm from the HPV vaccine. Continued education of providers and parents of the importance of adolescent vaccinations is warranted. |
Safety of COVID-19 Vaccination in US Children Ages 5-11 Years.
Hause AM , Shay DK , Klein NP , Abara WE , Baggs J , Cortese MM , Fireman B , Gee J , Glanz JM , Goddard K , Hanson KE , Hugueley B , Kenigsberg T , Kharbanda EO , Lewin B , Lewis N , Marquez P , Myers T , Naleway A , Nelson JC , Su JR , Thompson D , Olubajo B , Oster ME , Weintraub ES , Williams JTB , Yousaf AR , Zerbo O , Zhang B , Shimabukuro TT . Pediatrics 2022 150 (2) BACKGROUND AND OBJECTIVES: Limited post-authorization safety data for BNT-162b2 COVID-19 vaccination among children ages 5-11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the US COVID-19 vaccination program in this age group. METHODS: We analyzed data from 3 US safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system co-managed by CDC and FDA; and the Vaccine Safety Datalink (VSD), an active surveillance system that monitors electronic health records for prespecified events, including myocarditis. RESULTS: Among 48,795 children ages 5-11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7,578 adverse event reports; 97% were non-serious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in males after dose 2 (reporting rate 2.2 per million doses). In VSD, no safety signals were detected in weekly sequential monitoring after administration of 726,820 doses. CONCLUSIONS: Safety findings for BNT-162b2 vaccine from 3 US monitoring systems in children ages 5-11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12-15 years. |
SARS-CoV-2 virus dynamics in recently infected people - data from a household transmission study.
Mellis AM , Meece JK , Halasa NB , Chappell JD , McLean HQ , Grijalva CG , Hanson KE , Zhu Y , Kim A , Deyoe J , Ivacic LC , Reed C , Talbot HK , Rolfes MA . J Infect Dis 2022 226 (10) 1699-1703 We used daily real-time reverse-transcription polymerase chain reaction (rRT-PCR) results from 67 cases of SARS-CoV-2 infection in a household transmission study, conducted April 2020--May 2021, to examine the trajectory of cycle threshold (Ct) values, an inverse correlate of viral RNA concentration. Ct values varied across RT-PCR platforms and by participant age. Specimens collected from children and adolescents had higher Ct values and adults aged ≥50 years showed lower Ct values than adults aged 18-49 years. Ct values were lower on days when participants reported experiencing symptoms, with the lowest Ct value occurring 2-6 days after symptom onset. |
Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink.
Hanson KE , Goddard K , Lewis N , Fireman B , Myers TR , Bakshi N , Weintraub E , Donahue JG , Nelson JC , Xu S , Glanz JM , Williams JTB , Alpern JD , Klein NP . JAMA Netw Open 2022 5 (4) e228879 IMPORTANCE: Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as Guillain-Barré syndrome (GBS), which has a background rate of 1 to 2 per 100 000 person-years. OBJECTIVE: To describe cases and incidence of GBS following COVID-19 vaccination and assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used surveillance data from the Vaccine Safety Datalink at 8 participating integrated health care systems in the United States. There were 10 158 003 participants aged at least 12 years. Data analysis was performed from November 2021 to February 2022. EXPOSURES: Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine, including mRNA vaccine doses 1 and 2, December 13, 2020, to November 13, 2021. MAIN OUTCOMES AND MEASURES: GBS with symptom onset in the 1 to 84 days after vaccination, confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared with the background rate, rate ratios (RRs) comparing GBS incidence in the 1 to 21 vs 22 to 42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs mRNA vaccination, using Poisson regression adjusted for age, sex, race and ethnicity, site, and calendar day. RESULTS: From December 13, 2020, through November 13, 2021, 15 120 073 doses of COVID-19 vaccines were administered to 7 894 989 individuals (mean [SE] age, 46.5 [0.02] years; 8 138 318 doses received [53.8%] by female individuals; 3 671 199 doses received [24.3%] by Hispanic or Latino individuals, 2 215 064 doses received [14.7%] by Asian individuals, 6 266 424 doses received [41.4%] by White individuals), including 483 053 Ad.26.COV2.S doses, 8 806 595 BNT162b2 doses, and 5 830 425 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of GBS per 100 000 person-years in the 1 to 21 days after Ad.26.COV2.S was 32.4 (95% CI, 14.8-61.5), significantly higher than the background rate, and the adjusted RR in the 1 to 21 vs 22 to 42 days following Ad.26.COV2.S was 6.03 (95% CI, 0.79-147.79). Thirty-six cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate per 100 000 person-years in the 1 to 21 days after mRNA vaccines was 1.3 (95% CI, 0.7-2.4) and the adjusted RR in the 1 to 21 vs 22 to 42 days following mRNA vaccines was 0.56 (95% CI, 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs mRNA vaccines, the adjusted RR was 20.56 (95% CI, 6.94-64.66). CONCLUSIONS AND RELEVANCE: In this cohort study of COVID-19 vaccines, the incidence of GBS was elevated after receiving the Ad.26.COV2.S vaccine. Surveillance is ongoing. |
Dashboard development for near real-time visualization of COVID-19 vaccine safety surveillance data in the vaccine safety datalink.
Kenigsberg TA , Hause AM , McNeil MM , Nelson JC , AnnShoup J , Goddard K , Lou Y , Hanson KE , Glenn SC , Weintraub E . Vaccine 2022 40 (22) 3064-3071 The Vaccine Safety Datalink (VSD) conducts active surveillance and vaccine safety research studies. Since the start of the U.S. COVID-19 vaccination program, the VSD has conducted near real-time safety surveillance of COVID-19 vaccines using Rapid Cycle Analysis. VSD investigators developed an internal dashboard to facilitate visualization and rapid reviews of large weekly automated vaccine safety surveillance data. Dashboard development and maintenance was informed by vaccine surveillance data users and vaccine safety partners. Key metrics include population demographics, vaccine uptake, pre-specified safety outcomes, sequential analyses results, and descriptive data on potential vaccine safety signals. Dashboard visualizations are used to provide situational awareness on dynamic vaccination coverage and the status of multiple safety analyses conducted among the VSD population. This report describes the development and implementation of the internal VSD COVID-19 Vaccine Dashboard, including metrics used to develop the dashboard, which may have application across various other public health settings. |
Household Transmission and Clinical Features of SARS-CoV-2 Infections.
McLean HQ , Grijalva CG , Hanson KE , Zhu Y , Deyoe JE , Meece JK , Halasa NB , Chappell JD , Mellis AM , Reed C , Belongia EA , Talbot HK , Rolfes MA . Pediatrics 2022 149 (3) OBJECTIVES: Examine age differences in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission risk from primary cases and infection risk among household contacts and symptoms among those with SARS-CoV-2 infection. METHODS: People with SARS-CoV-2 infection in Nashville, Tennessee and central and western Wisconsin and their household contacts were followed daily for 14 days to ascertain symptoms and secondary transmission events. Households were enrolled between April 2020 and April 2021. Secondary infection risks (SIR) by age of the primary case and contacts were estimated using generalized estimating equations. RESULTS: The 226 primary cases were followed by 198 (49%) secondary SARS-CoV-2 infections among 404 household contacts. Age group-specific SIR among contacts ranged from 36% to 53%, with no differences by age. SIR was lower in primary cases age 12 to 17 years than from primary cases 18 to 49 years (risk ratio [RR] 0.42; 95% confidence interval [CI] 0.19-0.91). SIR was 55% and 45%, respectively, among primary case-contact pairs in the same versus different age group (RR 1.47; 95% CI 0.98-2.22). SIR was highest among primary case-contact pairs age ≥65 years (76%) and 5 to 11 years (69%). Among secondary SARS-CoV-2 infections, 19% were asymptomatic; there was no difference in the frequency of asymptomatic infections by age group. CONCLUSIONS: Both children and adults can transmit and are susceptible to SARS-CoV-2 infection. SIR did not vary by age, but further research is needed to understand age-related differences in probability of transmission from primary cases by age. |
Surveillance for Adverse Events After COVID-19 mRNA Vaccination.
Klein NP , Lewis N , Goddard K , Fireman B , Zerbo O , Hanson KE , Donahue JG , Kharbanda EO , Naleway A , Nelson JC , Xu S , Yih WK , Glanz JM , Williams JTB , Hambidge SJ , Lewin BJ , Shimabukuro TT , DeStefano F , Weintraub ES . JAMA 2021 326 (14) 1390-1399 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. |
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.
Rosenblum HG , Hadler SC , Moulia D , Shimabukuro TT , Su JR , Tepper NK , Ess KC , Woo EJ , Mba-Jonas A , Alimchandani M , Nair N , Klein NP , Hanson KE , Markowitz LE , Wharton M , McNally VV , Romero JR , Talbot HK , Lee GM , Daley MF , Mbaeyi SA , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (32) 1094-1099 In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public. |
Recognition of Diagnostic Gaps for Laboratory Diagnosis of Fungal Diseases: Expert Opinion from the Fungal Diagnostics Laboratories Consortium (FDLC)
Zhang SX , Babady NE , Hanson KE , Harrington AT , Larkin PMK , Leal SM Jr , Luethy PM , Martin IW , Pancholi P , Procop GW , Riedel S , Seyedmousavi S , Sullivan KV , Walsh TJ , Lockhart SR . J Clin Microbiol 2021 59 (7) e0178420 Fungal infections are a rising threat to our immunocompromised patient population, as well as other nonimmunocompromised patients with various medical conditions. However, little progress has been made in the past decade to improve fungal diagnostics. To jointly address this diagnostic challenge, the Fungal Diagnostics Laboratory Consortium (FDLC) was recently created. The FDLC consists of 26 laboratories from the United States and Canada that routinely provide fungal diagnostic services for patient care. A survey of fungal diagnostic capacity among the 26 members of the FDLC was recently completed, identifying the following diagnostic gaps: lack of molecular detection of mucormycosis; lack of an optimal diagnostic algorithm incorporating fungal biomarkers and molecular tools for early and accurate diagnosis of Pneumocystis pneumonia, aspergillosis, candidemia, and endemic mycoses; lack of a standardized molecular approach to identify fungal pathogens directly in formalin-fixed paraffin-embedded tissues; lack of robust databases to enhance mold identification with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry; suboptimal diagnostic approaches for mold blood cultures, tissue culture processing for Mucorales, and fungal respiratory cultures for cystic fibrosis patients; inadequate capacity for fungal point-of-care testing to detect and identify new, emerging or underrecognized, rare, or uncommon fungal pathogens; and performance of antifungal susceptibility testing. In this commentary, the FDLC delineates the most pressing unmet diagnostic needs and provides expert opinion on how to fulfill them. Most importantly, the FDLC provides a robust laboratory network to tackle these diagnostic gaps and ultimately to improve and enhance the clinical laboratory's capability to rapidly and accurately diagnose fungal infections. |
Implications of Shortened Quarantine Among Household Contacts of Index Patients with Confirmed SARS-CoV-2 Infection - Tennessee and Wisconsin, April-September 2020.
Rolfes MA , Grijalva CG , Zhu Y , McLean HQ , Hanson KE , Belongia EA , Halasa NB , Kim A , Meece J , Reed C , Talbot HK , Fry AM . MMWR Morb Mortal Wkly Rep 2021 69 (5152) 1633-1637 To prevent further transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), CDC currently recommends that persons who have been in close contact with someone with SARS-CoV-2 infection should quarantine (stay away from other persons) for 14 days after the last known contact.* However, quarantine might be difficult to maintain for a prolonged period. A shorter quarantine might improve compliance, and CDC recommends two options to reduce the duration of quarantine for close contacts without symptoms, based on local circumstances and availability of testing: 1) quarantine can end on day 10 without a test or 2) quarantine can end on day 7 after receiving a negative test result.(†) However, shorter quarantine might permit ongoing disease transmission from persons who develop symptoms or become infectious near the end of the recommended 14-day period. Interim data from an ongoing study of household transmission of SARS-CoV-2 were analyzed to understand the proportion of household contacts that had detectable virus after a shortened quarantine period. Persons who were household contacts of index patients completed a daily symptom diary and self-collected respiratory specimens for 14 days. Specimens were tested for SARS-CoV-2 using reverse transcription-polymerase chain reaction (RT-PCR). Among 185 household contacts enrolled, 109 (59%) had detectable SARS-CoV-2 at any time; 76% (83/109) of test results were positive within 7 days, and 86% (94 of 109) were positive within 10 days after the index patient's illness onset date. Among household contacts who received negative SARS-CoV-2 test results and were asymptomatic through day 7, there was an 81% chance (95% confidence interval [CI] = 67%-90%) of remaining asymptomatic and receiving negative RT-PCR test results through day 14; this increased to 93% (95% CI = 78%-98%) for household members who were asymptomatic with negative RT-PCR test results through day 10. Although SARS-CoV-2 quarantine periods shorter than 14 days might be easier to adhere to, there is a potential for onward transmission from household contacts released before day 14. |
Transmission of SARS-COV-2 Infections in Households - Tennessee and Wisconsin, April-September 2020.
Grijalva CG , Rolfes MA , Zhu Y , McLean HQ , Hanson KE , Belongia EA , Halasa NB , Kim A , Reed C , Fry AM , Talbot HK . MMWR Morb Mortal Wkly Rep 2020 69 (44) 1631-1634 Improved understanding of transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), within households could aid control measures. However, few studies have systematically characterized the transmission of SARS-CoV-2 in U.S. households (1). Previously reported transmission rates vary widely, and data on transmission rates from children are limited. To assess household transmission, a case-ascertained study was conducted in Nashville, Tennessee, and Marshfield, Wisconsin, commencing in April 2020. In this study, index patients were defined as the first household members with COVID-19-compatible symptoms who received a positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test result, and who lived with at least one other household member. After enrollment, index patients and household members were trained remotely by study staff members to complete symptom diaries and obtain self-collected specimens, nasal swabs only or nasal swabs and saliva samples, daily for 14 days. For this analysis, specimens from the first 7 days were tested for SARS-CoV-2 using CDC RT-PCR protocols.(†) A total of 191 enrolled household contacts of 101 index patients reported having no symptoms on the day of the associated index patient's illness onset, and among these 191 contacts, 102 had SARS-CoV-2 detected in either nasal or saliva specimens during follow-up, for a secondary infection rate of 53% (95% confidence interval [CI] = 46%-60%). Among fourteen households in which the index patient was aged <18 years, the secondary infection rate from index patients aged <12 years was 53% (95% CI = 31%-74%) and from index patients aged 12-17 years was 38% (95% CI = 23%-56%). Approximately 75% of secondary infections were identified within 5 days of the index patient's illness onset, and substantial transmission occurred whether the index patient was an adult or a child. Because household transmission of SARS-CoV-2 is common and can occur rapidly after the index patient's illness onset, persons should self-isolate immediately at the onset of COVID-like symptoms, at the time of testing as a result of a high risk exposure, or at the time of a positive test result, whichever comes first. Concurrent to isolation, all members of the household should wear a mask when in shared spaces in the household.(§). |
Survey of influenza vaccine knowledge, attitudes, and beliefs among pregnant women in the 2016-17 season
King JP , Hanson KE , Donahue JG , Glanz JM , Klein NP , Naleway AL , DeStefano F , Weintraub E , Belongia EA . Vaccine 2020 38 (9) 2202-2208 OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. |
Near real-time surveillance to assess the safety of the 9-valent human papillomavirus vaccine
Donahue JG , Kieke BA , Lewis EM , Weintraub ES , Hanson KE , McClure DL , Vickers ER , Gee J , Daley MF , DeStefano F , Hechter RC , Jackson LA , Klein NP , Naleway AL , Nelson JC , Belongia EA . Pediatrics 2019 144 (6) BACKGROUND AND OBJECTIVES: Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink. METHODS: Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses. RESULTS: During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events. CONCLUSIONS: After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified. |
Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15
Donahue JG , Kieke BA , King JP , Mascola MA , Shimabukuro TT , DeStefano F , Hanson KE , McClure DL , Olaiya O , Glanz JM , Hechter RC , Irving SA , Jackson LA , Klein NP , Naleway AL , Weintraub ES , Belongia EA . Vaccine 2019 37 (44) 6673-6681 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 >56days before the SAB date. RESULTS: Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28day 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 1-28day 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. |
Sociodemographic and clinical correlates of human papillomavirus vaccine attitudes and receipt among Wisconsin adolescents
Hanson KE , McLean HQ , Belongia EA , Stokley S , McNeil MM , Gee J , VanWormer JJ . Papillomavirus Res 2019 8 100168 Few studies have assessed adolescent human papillomavirus (HPV) vaccine attitudes and whether they are associated with vaccination uptake. This study characterized HPV vaccine attitudes among male and female adolescents, identified factors associated with attitude changes, and examined associations between attitudes and vaccination receipt. Surveys were administered to adolescents aged 15-16 years who had not completed the HPV vaccine series. A modified version of the Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) was employed to assess barriers, harms, ineffectiveness, and uncertainties scores. Surveys were available from 108 participants; 63% were male and 33% had initiated the HPV vaccine series at baseline. CHIAS scores significantly decreased (i.e., became more favorable) between baseline and follow up for barriers (p=0.01) and uncertainties (p<0.01). At least one sociodemographic/clinical factor was associated with changes in each score. Attitude changes were not associated with receipt of HPV vaccine, although adolescents with higher baseline harms scores were significantly less likely to receive an HPV vaccine dose (OR=0.67). Adolescents' HPV vaccine attitudes slightly improved over a one year period during which an intervention was implemented. More research is needed to learn how parent and adolescent HPV vaccine attitudes form, and how best to address concerns about vaccine harms. |
- Page last reviewed:Feb 1, 2024
- Page last updated:May 06, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure