Last data update: Sep 23, 2024. (Total: 47723 publications since 2009)
Records 1-30 (of 30 Records) |
Query Trace: Olson CK [original query] |
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Postmenopausal bleeding after coronavirus disease 2019 (COVID-19) vaccination: Vaccine Adverse Event Reporting System
Strid P , Abara WE , Clark E , Moro PL , Olson CK , Gee J . Obstet Gynecol 2024 We identified U.S. reports of postmenopausal bleeding in the VAERS (Vaccine Adverse Event Reporting System) between December 13, 2020, and December 13, 2021. Among 711,224 VAERS reports after coronavirus disease 2019 (COVID-19) vaccination, during our study period, we identified 554 presumptive postmenopausal bleeding reports; 434 were further classified as verified based on data abstracted from reports and medical records, when available. In the United States, by December 14, 2021, 58.8 million women aged 50 years or older had received at least one dose of a COVID-19 vaccine, corresponding to approximately seven verified VAERS postmenopausal bleeding reports per 1 million women aged 50 years or older who received a COVID-19 vaccine. Reports of postmenopausal bleeding after COVID-19 vaccination in VAERS were rare, and causes of postmenopausal bleeding based on medical record review were consistent with known causes of postmenopausal bleeding. |
Abnormal uterine bleeding diagnoses and care following COVID-19 vaccination
Brooks N , Irving SA , Kauffman TL , Vesco KK , Slaughter M , Smith N , Tepper NK , Olson CK , Weintraub ES , Naleway AL . Am J Obstet Gynecol 2024 BACKGROUND: There is evidence suggesting that COVID-19 vaccination may be associated with small, transitory effects on uterine bleeding, possibly including menstrual timing, flow, and duration, in some individuals. However, changes in health care seeking, diagnosis, and workup for abnormal uterine bleeding in the COVID-19 vaccine era are less clear. OBJECTIVES: To assess the impact of COVID-19 vaccination on incident abnormal uterine bleeding diagnosis and diagnostic evaluation in a large integrated health system. STUDY DESIGN: Using segmented regression, we assessed whether the availability of COVID-19 vaccines was associated with changes in monthly, population-based rates of incident abnormal uterine bleeding diagnoses compared to the pre-pandemic period in health system members ages 16-44 years who were not menopausal. We also compared clinical and demographic characteristics of patients diagnosed with incident abnormal uterine bleeding between December 2020 through October 13, 2021 by vaccination status (never vaccinated, vaccinated in the 60 days prior to diagnosis, vaccinated more than 60 days prior to diagnosis) and conducted detailed chart review of patients diagnosed with abnormal uterine bleeding within 1-60 days of COVID-19 vaccination in the same time period. RESULTS: In monthly populations ranging from 79,000 to 85,000 female health system members, incidence of abnormal uterine bleeding diagnosis per 100,000 person-days ranged from 8.97 to 19.19. There was no significant change in the level or trend in the incidence of abnormal uterine bleeding diagnoses between the pre-pandemic (January 2019-January 2020) and post-COVID-19 vaccine (December 2020-December 2021) periods. A comparison of clinical characteristics of 2,717 abnormal uterine bleeding cases by vaccination status suggested that abnormal bleeding among recently vaccinated patients was similar or less severe than abnormal bleeding among patients who had never been vaccinated patients or those vaccinated more than 60 days prior. There were also significant differences in age and race of patients with incident abnormal uterine bleeding diagnoses by vaccination status: never vaccinated patients were the youngest and those vaccinated more than 60 days prior were the oldest; the proportion of patients who were Black/African American was highest among never vaccinated patients, and the proportion of Asian patients was higher among vaccinated patients. Chart review of 114 confirmed post-vaccination abnormal uterine bleeding cases diagnosed from December 2020 through October 13, 2021 found that the most common symptoms reported were changes in timing, duration, and volume of bleeding. Approximately one-third of cases received no diagnostic workup; 57% had no etiology for the bleeding documented in the electronic health record. In 12% of cases, the patient mentioned or asked about a possible link between their bleeding and their recent COVID-19 vaccine. CONCLUSIONS: The availability of COVID-19 vaccination was not associated with a change in incidence of medically attended abnormal uterine bleeding in our population of over 79,000 female patients of reproductive age. Additionally, among 2,717 patients with abnormal uterine bleeding diagnoses in the period following COVID-19 vaccine availability, receipt of the vaccine was not associated with greater bleeding severity. |
CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description
Madni SA , Sharma AJ , Zauche LH , Waters AV , Nahabedian JF 3rd , Johnson T , Olson CK . Vaccine 2023 The U.S. Centers for Disease Control and Prevention (CDC) developed and implemented the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to monitor vaccine safety. Potential participants who received a COVID-19 vaccine in pregnancy or up to 30 days prior to their pregnancy-associated last menstrual period were eligible to participate in the registry, which monitored health outcomes of participants and their infants through phone interviews and review of available medical records. Data for select outcomes, including birth defects, were reviewed by clinicians. In certain cases, medical records were used to confirm and add detail to participant-reported health conditions. This paper serves as a description of CDC C19VPR protocol. We describe the development and implementation for each data collection aspect of the registry (i.e., participant phone interviews, clinical review, and medical record abstraction), data management, and strengths and limitations. We also describe the demographics and vaccinations received among eligible and enrolled participants. There were 123,609 potential participants 18-54 years of age identified from January 2021 through mid-June 2021; 23,339 were eligible and enrolled into the registry. Among these, 85.3 % consented to medical record review for themselves and/or their infants. Participants were majority non-Hispanic White (79.1 %), residents of urban areas (93.3 %), and 48.3 % were between 30 and 34 years of age. Most participants completed the primary series of vaccination by the end of pregnancy (89.7 %). Many participants were healthcare personnel (44.8 %), possibly due to the phased roll-out of the vaccination program. The registry continues to provide important information about the safety of COVID-19 vaccination among pregnant people, a population with higher risk of poor outcomes from COVID-19 who were not included in pre-authorization clinical trials. Lessons learned from the registry may guide development and implementation of future vaccine safety monitoring efforts for pregnant people and their infants. |
Postmenopausal bleeding after COVID-19 vaccination
Kauffman TL , Irving SA , Brooks N , Vesco KK , Slaughter M , Smith N , Tepper NK , Olson CK , Weintraub ES , Naleway AL . Am J Obstet Gynecol 2023 230 (1) 71 e1-71 e14 BACKGROUND: There is a growing literature base regarding menstrual changes following COVID-19 vaccination among premenopausal people. However, relatively little is known about uterine bleeding in postmenopausal people following COVID-19 vaccination. OBJECTIVE: This study aimed to examine trends in incident postmenopausal bleeding diagnoses over time before and after COVID-19 vaccine introduction, and to describe cases of new-onset postmenopausal bleeding after COVID-19 vaccination. STUDY DESIGN: For postmenopausal bleeding incidence calculations, monthly population-level cohorts consisted of female Kaiser Permanente Northwest members aged ≥45 years. Those diagnosed with incident postmenopausal bleeding in the electronic medical record were included in monthly numerators. Members with preexisting postmenopausal bleeding or abnormal uterine bleeding, or who were at increased risk of bleeding due to other health conditions, were excluded from monthly calculations. We used segmented regression analysis to estimate changes in the incidence of postmenopausal bleeding diagnoses from 2018 through 2021 in Kaiser Permanente Northwest members meeting the inclusion criteria, stratified by COVID-19 vaccination status in 2021. In addition, we identified all members with ≥1 COVID-19 vaccination between December 14, 2020 and August 14, 2021, who had an incident postmenopausal bleeding diagnosis within 60 days of vaccination. COVID-19 vaccination, diagnostic procedures, and presumed bleeding etiology were assessed through chart review and described. A temporal scan statistic was run on all cases without clear bleeding etiology. RESULTS: In a population of 75,530 to 82,693 individuals per month, there was no statistically significant difference in the rate of incident postmenopausal bleeding diagnoses before and after COVID-19 vaccine introduction (P=.59). A total of 104 individuals had incident postmenopausal bleeding diagnosed within 60 days following COVID-19 vaccination; 76% of cases (79/104) were confirmed as postvaccination postmenopausal bleeding after chart review. Median time from vaccination to bleeding onset was 21 days (range: 2-54 days). Among the 56 postmenopausal bleeding cases with a provider-attributed etiology, the common causes of bleeding were uterine or cervical lesions (50% [28/56]), hormone replacement therapy (13% [7/56]), and proliferative endometrium (13% [7/56]). Among the 23 cases without a clear etiology, there was no statistically significant clustering of postmenopausal bleeding onset following vaccination. CONCLUSION: Within this integrated health system, introduction of COVID-19 vaccines was not associated with an increase in incident postmenopausal bleeding diagnoses. Diagnosis of postmenopausal bleeding in the 60 days following receipt of a COVID-19 vaccination was rare. |
Safety and effectiveness of maternal COVID-19 vaccines among pregnant people and infants
Fleming-Dutra KE , Zauche LH , Roper LE , Ellington SR , Olson CK , Sharma AJ , Woodworth KR , Tepper N , Havers F , Oliver SE , Twentyman E , Jatlaoui TC . Obstet Gynecol Clin North Am 2023 50 (2) 279-297 Evidence has consistently demonstrated that COVID-19 messenger RNA (mRNA) vaccines are safe when given during pregnancy. COVID-19 mRNA vaccines protect pregnant people and their infants who are too young to receive COVID-19 vaccines. Although generally protective, monovalent vaccine effectiveness was lower during SARS-CoV-2 Omicron variant predominance, in part due to changes in the Omicron spike protein. Bivalent vaccines, that combine ancestral strain and Omicron variant, may improve protection against Omicron variants. Everyone, including pregnant people, should stay up to date with recommended COVID-19 vaccines and bivalent booster, when eligible. |
The V-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response
Myers TR , Marquez PL , Gee JM , Hause AM , Panagiotakopoulos L , Zhang B , McCullum I , Licata C , Olson CK , Rahman S , Kennedy SB , Cardozo M , Patel CR , Maxwell L , Kallman JR , Shay DK , Shimabukuro TT . Vaccine 2023 41 (7) 1310-1318 The Centers for Disease Control and Prevention (CDC) developed and implemented the v-safe after vaccination health checker (v-safe) to monitor COVID-19 vaccine safety and as an active surveillance supplement to existing CDC vaccine safety monitoring programs. V-safe allows persons who received COVID-19 vaccines to report on post-vaccination experiences and how symptoms affected their health at daily, weekly, and monthly timepoints after vaccination. Text message reminders are sent linking to Internet-based health check-in surveys. Surveys include questions to identify v-safe participants who may be eligible to enroll in a separate pregnancy registry activity that evaluates maternal and infant outcomes in those pregnant at the time of vaccination or receiving vaccine in the periconception period. We describe the development of and enhancements to v-safe, data management, promotion and communication to vaccination sites and partners, publications, strengths and limitations, and implications for future systems. We also describe enrollment in v-safe over time and demographics of persons participating in v-safe during the first year of operation (December 14, 2020 - December 13, 2021). During this time, 9,342,582 persons submitted 131,543,087 v-safe surveys. The majority of participants were female (62.3 %) and non-Hispanic White (61.2 %); median age was 49.0 years. Most participants reported receiving an mRNA COVID-19 vaccine as their first recorded dose (95.0 %). V-safe contributed to CDC's vaccine safety assessments for FDA-authorized COVID-19 vaccines by enabling near real-time reporting of reactogenicity once the COVID-19 vaccination program began in the community, encouraging reports to the Vaccine Adverse Event Reporting System and facilitating enrollment in a large post-vaccination pregnancy registry. Given that v-safe is an integral component of the most comprehensive safety monitoring program in U.S. history, we believe that this approach has promise as a potential application for future pandemic response activities as well as rollout of novel vaccines in a non-pandemic context. |
Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to v-safe active surveillance, USA in December, 2020-January, 2022: an observational cohort study.
Wong KK , Heilig CM , Hause A , Myers TR , Olson CK , Gee J , Marquez P , Strid P , Shay DK . Lancet Digit Health 2022 4 (9) e667-e675 BACKGROUND: Anecdotal reports of menstrual irregularities after receiving COVID-19 vaccines have been observed in post-authorisation and post-licensure monitoring. We aimed to identify and classify reports of menstrual irregularities and vaginal bleeding after COVID-19 vaccination submitted to a voluntary active surveillance system. METHODS: This observational cohort study included recipients of a COVID-19 vaccine who were aged 18 years and older and reported their health experiences to v-safe, a voluntary smartphone-based active surveillance system for monitoring COVID-19 vaccine safety in the USA, from Dec 14, 2020, to Jan 9, 2022. Responses to survey questions on reactions after vaccination were extracted, and a pre-trained natural language inference model was used to identify and classify free-text comments related to menstruation and vaginal bleeding in response to an open-ended prompt about any symptoms at intervals after vaccination. Related responses were further categorised into themes of timing, severity, perimenopausal and postmenopausal bleeding, resumption of menses, and other responses. We examined associations between symptom theme and respondent characteristics, including vaccine type and dose number received, solicited local and systemic reactions reported, and health care sought. FINDINGS: 63 815 respondents reported on menstrual irregularities or vaginal bleeding, which included 62 679 female respondents (1·0% of 5 975 363 female respondents aged ≥18 years). Common themes identified included timing of menstruation (70 981 [83·6%] responses) and severity of menstrual symptoms (56 890 [67·0%] responses). Other themes included menopausal bleeding (3439 [4·0%] responses) and resumption of menses (2378 [2·8%] responses). Respondents submitting reports related to menopausal bleeding were more likely to seek health care than were those submitting reports related to other menstruation and vaginal bleeding themes. INTERPRETATION: Reports of heterogeneous symptoms related to menstruation or vaginal bleeding after COVID-19 vaccination are being submitted to v-safe, although this study is unable to characterise the relationship of these symptoms to COVID-19 vaccination. Methods that leverage pretrained models to interpret and classify unsolicited signs and symptoms in free-text reports offer promise in the initial evaluation of unexpected adverse events potentially associated with use of newly authorised or licensed vaccines. FUNDING: Centers for Disease Control and Prevention. |
Safety of mRNA COVID-19 vaccines during pregnancy.
Ellington S , Olson CK . Lancet Infect Dis 2022 22 (11) 1514-1515 Pregnant people with COVID-19 are at increased risk of severe illness and death compared with non-pregnant females of reproductive age (aged 15–49 years).1 Additionally, COVID-19 during pregnancy is associated with increased risk for adverse pregnancy outcomes, such as preterm birth and stillbirth.1 When mRNA COVID-19 vaccines first became available in December, 2020, safety data in pregnancy were limited because pregnant people were excluded from pre-authorisation clinical trials.2 Lack of data and safety concerns contributed to initially low uptake among pregnant people, which continues to be lower than uptake among non-pregnant females of reproductive age.3 To address this issue, public health researchers from across the globe have been assessing the safety and effectiveness of COVID-19 vaccines during pregnancy. |
Safety of Booster Doses of Coronavirus Disease 2019 (COVID-19) Vaccine in Pregnancy in the Vaccine Adverse Event Reporting System.
Moro PL , Olson CK , Zhang B , Marquez P , Strid P . Obstet Gynecol 2022 140 (3) 421-427 OBJECTIVE: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant people who received a booster dose of mRNA coronavirus disease 2019 (COVID-19) vaccine. METHODS: We searched VAERS for U.S. reports of adverse events in pregnant people who received a booster dose of an mRNA COVID-19 vaccine from September 22, 2021, to March 24, 2022. Clinicians reviewed reports and available medical records. RESULTS: The Vaccine Adverse Event Reporting System received 323 reports of adverse events in pregnant people who received a booster dose of COVID-19 vaccine; 178 (55.1%) after BNT162b2 from Pfizer-BioNTech and 145 (44.9%) after mRNA-1273 from Moderna. Seventy-two (22.3%) reports were coded as serious. One neonatal death was reported, but no maternal deaths occurred. Pregnancy-specific outcomes included 56 (17.3%) spontaneous abortions (before 20 weeks of gestation), eight (2.5%) episodes of vaginal bleeding, five (1.5%) stillbirths (at or after 20 weeks of gestation), four (1.2%) episodes of preeclampsia, and two (0.6%) preterm deliveries. Reporting rates for stillbirth and preterm delivery were below background rates. Ten instances of adverse events in neonates were reported, which included two reports of birth defects. Non-pregnancy-specific adverse events (n=207; 64.1%) were mostly systemic (eg, headache, fatigue) and local reactions and occurred in proportions comparable with those seen in pregnant people who received the primary COVID-19 vaccination series and reported to VAERS during the same period. CONCLUSION: Review of reports after a booster dose of mRNA COVID-19 vaccine in pregnant people in VAERS found their safety profile was comparable with that of published reports after primary COVID-19 vaccination in pregnant people. |
Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 - October 2021.
Moro PL , Olson CK , Clark E , Marquez P , Strid P , Ellington S , Zhang B , Mba-Jonas A , Alimchandani M , Cragan J , Moore C . Vaccine 2022 40 (24) 3389-3394 BACKGROUND: Pregnant persons are at increased risk of severe illness from COVID-19 infection, including intensive care unit admission, mechanical ventilation, and death compared with non-pregnant persons of reproductive age. Limited data are available on the safety of COVID-19 vaccines administered during and around the time of pregnancy. OBJECTIVE: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant persons who received a COVID-19 vaccine to assess for potential vaccine safety problems. METHODS: We searched VAERS for US reports of adverse events (AEs) in pregnant persons who received a COVID-19 vaccine from 12/14/2020-10/31/2021. Clinicians reviewed reports and available medical records. Crude reporting rates for selected AEs were calculated, and disproportional reporting was assessed using data mining methods. RESULTS: VAERS received 3,462 reports of AEs in pregnant persons who received a COVID-19 vaccine; 1,831 (52.9%) after BNT162b2, 1,350 (38.9%) after mRNA-1273, and 275 (7.9%) after Ad26.COV2.S. Eight maternal deaths and 12 neonatal deaths were reported. Six-hundred twenty-one (17.9%) reports were serious. Pregnancy-specific outcomes included: 878 spontaneous abortions (<20 weeks), 101 episodes of vaginal bleeding, 76 preterm deliveries (<37 weeks), 62 stillbirths (≥20 weeks), and 33 outcomes with birth defects. Crude reporting rates for preterm deliveries and stillbirths, as well as maternal and neonatal mortality rates were below background rates from published sources. No disproportional reporting for any AE was observed. CONCLUSIONS: Review of reports to VAERS following COVID-19 vaccines in pregnant persons did not identify any concerning patterns of maternal or infant-fetal outcomes. |
Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth - Eight Integrated Health Care Organizations, United States, December 15, 2020-July 22, 2021.
Lipkind HS , Vazquez-Benitez G , DeSilva M , Vesco KK , Ackerman-Banks C , Zhu J , Boyce TG , Daley MF , Fuller CC , Getahun D , Irving SA , Jackson LA , Williams JTB , Zerbo O , McNeil MM , Olson CK , Weintraub E , Kharbanda EO . MMWR Morb Mortal Wkly Rep 2022 71 (1) 26-30 COVID-19 vaccines are recommended during pregnancy to prevent severe maternal morbidity and adverse birth outcomes; however, vaccination coverage among pregnant women has been low (1). Concerns among pregnant women regarding vaccine safety are a persistent barrier to vaccine acceptance during pregnancy. Previous studies of maternal COVID-19 vaccination and birth outcomes have been limited by small sample size (2) or lack of an unvaccinated comparison group (3). In this retrospective cohort study of live births from eight Vaccine Safety Datalink (VSD) health care organizations, risks for preterm birth (<37 weeks' gestation) and small-for-gestational-age (SGA) at birth (birthweight <10th percentile for gestational age) after COVID-19 vaccination (receipt of ≥1 COVID-19 vaccine doses) during pregnancy were evaluated. Risks for preterm and SGA at birth among vaccinated and unvaccinated pregnant women were compared, accounting for time-dependent vaccine exposures and propensity to be vaccinated. Single-gestation pregnancies with estimated start or last menstrual period during May 17-October 24, 2020, were eligible for inclusion. Among 46,079 pregnant women with live births and gestational age available, 10,064 (21.8%) received ≥1 COVID-19 vaccine doses during pregnancy and during December 15, 2020-July 22, 2021; nearly all (9,892; 98.3%) were vaccinated during the second or third trimester. COVID-19 vaccination during pregnancy was not associated with preterm birth (adjusted hazard ratio [aHR] = 0.91; 95% CI = 0.82-1.01). Among 40,627 live births with birthweight available, COVID-19 vaccination in pregnancy was not associated with SGA at birth (aHR = 0.95; 95% CI = 0.87-1.03). Results consistently showed no increased risk when stratified by mRNA COVID-19 vaccine dose, or by second or third trimester vaccination, compared with risk among unvaccinated pregnant women. Because of the small number of first-trimester exposures, aHRs for first-trimester vaccination could not be calculated. These data add to the evidence supporting the safety of COVID-19 vaccination during pregnancy. To reduce the risk for severe COVID-19-associated illness, CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future (4). |
Monitoring the safety of COVID-19 vaccines in pregnancy in the US.
Moro PL , Panagiotakopoulos L , Oduyebo T , Olson CK , Myers T . Hum Vaccin Immunother 2021 17 (12) 1-9 Pregnant persons are at increased risk of severe illness from COVID-19. The first COVID-19 vaccines in the U.S. were authorized for emergency use in December 2020 and pregnant persons were eligible and could get vaccinated despite scarce safety data in this population. To monitor the safety of COVID-19 vaccination during pregnancy, four surveillance systems are used by the Centers for Disease Control and Prevention (CDC). The Vaccine Adverse Event Reporting System is a national, passive system that captures reports of potential adverse events. V-safe is a novel, active system that uses text messaging and web-based surveys to provide health check-ins after vaccination; and enrolls eligible v-safe participants in the v-safe pregnancy registry. The Vaccine Safety Datalink is a collaboration between the CDC and nine integrated health care organizations which performs near-real time surveillance and traditional epidemiologic studies on pregnant vaccine recipients. The CDC is committed to timely and comprehensive monitoring of COVID-19 vaccine safety in pregnancy. |
Receipt of mRNA Covid-19 Vaccines and Risk of Spontaneous Abortion.
Zauche LH , Wallace B , Smoots AN , Olson CK , Oduyebo T , Kim SY , Petersen EE , Ju J , Beauregard J , Wilcox AJ , Rose CE , Meaney-Delman DM , Ellington SR . N Engl J Med 2021 385 (16) 1533-1535 Pregnant persons are at risk for severe coronavirus disease 2019 (Covid-19), and infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy is associated with increased risks of preterm birth and other adverse maternal and neonatal outcomes.1 Although spontaneous abortion (pregnancy loss occurring at less than 20 weeks of gestation) is a common pregnancy outcome affecting 11 to 22% of recognized pregnancies (see Table S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org),2-4 data to inform estimates of the risk of spontaneous abortion after receipt of an mRNA Covid-19 vaccine either before conception (30 days before the first day of the last menstrual period through 14 days after) or during pregnancy are limited. |
U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines.
Gubernot D , Jazwa A , Niu M , Baumblatt J , Gee J , Moro P , Duffy J , Harrington T , McNeil MM , Broder K , Su J , Kamidani S , Olson CK , Panagiotakopoulos L , Shimabukuro T , Forshee R , Anderson S , Bennett S . Vaccine 2021 39 (28) 3666-3677 The Coronavirus Disease 2019 (COVID-19) pandemic has had a devastating impact on global health, and has resulted in an unprecedented, international collaborative effort to develop vaccines to control the outbreak, protect human lives, and avoid further social and economic disruption. Mass vaccination campaigns are underway in multiple countries and are expected worldwide once more vaccine becomes available. Some early candidate vaccines use novel platforms, such as mRNA encapsulated in lipid nanoparticles, and relatively new platforms, such as replication-deficient viral vectors. While these new vaccine platforms hold promise, limited safety data in humans are available. Serious health outcomes linked to vaccinations are rare, and some outcomes may occur incidentally in the vaccinated population. Knowledge of background incidence rates of these medical conditions is a critical component of vaccine safety monitoring to aid in the assessment of adverse events temporally associated with vaccination and to put these events into context with what would be expected due to chance alone. A list of 22 potential adverse events of special interest (AESI), including neurologic, autoimmune, and cardiovascular disorders, was compiled by subject matter experts at the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. The most recently available U.S. background rates for these medical conditions, overall and by age, sex, and race/ethnicity (when available), were sourced from reported statistics (data published by medical panels/ associations or federal government reports), and literature reviews in PubMed. This review provides estimates of background incidence rates for medical conditions that may be monitored or studied as AESI during safety surveillance and research for COVID-19 vaccines and other new vaccines. |
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.
Shimabukuro TT , Kim SY , Myers TR , Moro PL , Oduyebo T , Panagiotakopoulos L , Marquez PL , Olson CK , Liu R , Chang KT , Ellington SR , Burkel VK , Smoots AN , Green CJ , Licata C , Zhang BC , Alimchandani M , Mba-Jonas A , Martin SW , Gee JM , Meaney-Delman DM . N Engl J Med 2021 384 (24) 2273-2282 BACKGROUND: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. METHODS: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. RESULTS: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). CONCLUSIONS: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. |
U-shaped pillows and sleep-related infant deaths, United States, 2004-2015
Cottengim C , Parks SE , Erck Lambert AB , Dykstra HK , Shaw E , Johnston E , Olson CK , Shapiro-Mendoza CK . Matern Child Health J 2019 24 (2) 222-228 OBJECTIVES: To describe infant deaths where a u-shaped pillow was under or around an infant and to describe cases classified as Explained Suffocation. METHODS: We examined demographics and circumstances of 141 infant deaths during 2004-2015 in the US National Fatality Review Case Reporting System with u-shaped pillows in the sleep environment. RESULTS: Most infants were < 6 months old (92%), male (58%), non-Hispanic White (53%), and of the nine explained suffocation deaths, four occurred when the u-shaped pillow obstructed the infant's airway; five occurred when the infant rolled off the pillow and their airway was obstructed by another object. CONCLUSIONS FOR PRACTICE: Although infrequent, infant deaths with u-shaped pillows have occurred. Health care providers may include discussion of the importance of caregivers following infant product packaging precautions and warning labels for commonly used consumer products, such as u-shaped pillows in their advice to caregivers. |
Receipt of breast milk by gestational age - United States, 2017
Chiang KV , Sharma AJ , Nelson JM , Olson CK , Perrine CG . MMWR Morb Mortal Wkly Rep 2019 68 (22) 489-493 Breast milk is the optimal source of infant nutrition. For the nearly one in 10 infants born prematurely in the United States annually (1), breast milk is especially beneficial, helping prevent sepsis and necrotizing enterocolitis and promoting neurologic development (2). National estimates of newborn feeding practices by gestational age have not been available previously. CDC analyzed 2017 birth certificate data from 48 states and the District of Columbia (3,194,873; 82.7% of all births) to describe receipt of breast milk among extremely preterm (20-27 weeks), early preterm (28-33 weeks), late preterm (34-36 weeks), and term (>/=37 weeks) infants with further stratification by maternal and infant characteristics. The prevalence of infants receiving any breast milk was 83.9% overall and varied by gestational age, with 71.3% of extremely preterm infants, 76.0% of early preterm infants, 77.3% of late preterm infants, and 84.6% of term infants receiving any breast milk. Disparities in receipt of breast milk by several sociodemographic factors, including maternal race/ethnicity, were noted across gestational age groups. These estimates suggest that many infants, particularly infants at high risk for medical complications, might not be receiving breast milk. Efforts are needed to increase the implementation of existing evidence-based policies and practices that support breast milk feeding, particularly for medically fragile infants (2,3). |
Making the case: The importance of using 10 key preconception indicators in understanding the health of women of reproductive age
Kroelinger CD , Okoroh EM , Boulet SL , Olson CK , Robbins CL . J Womens Health (Larchmt) 2018 27 (6) 739-743 In 2006, the Preconception Care (PCC) Work Group and the Select Panel on PCC published 10 recommendations promoting preconception health (PCH) and healthcare for women of reproductive age. In the years following the recommendations, much research focused on specific PCH behaviors, clinical provision of care, and care financing, but no comprehensive, well-defined set of indicators was identified. In 2011, seven states developed a set of 45 PCH indicators; however, to date, no one publication has assessed the usefulness of all 45 indicators in addressing PCH. This report makes the case for reducing the original 45 indicators to a condensed set of 10 for national and state reporting by describing the use of the 45 indicators to date, describing development of evaluation criteria for narrowing the number of indicators, and identifying gaps in indicator development for provision of PCC. Using the condensed set, states can set priorities, revise and develop programs and policies, implement system changes, and better allocate resources to support interventions to improve the health of women of reproductive age during the preconception and interconception periods. |
The National Network of State Perinatal Quality Collaboratives: A growing movement to improve maternal and infant health
Henderson ZT , Ernst K , Simpson KR , Berns SD , Suchdev DB , Main E , McCaffrey M , Lee K , Rouse TB , Olson CK . J Womens Health (Larchmt) 2018 27 (2) 123-127 State Perinatal Quality Collaboratives (PQCs) are networks of multidisciplinary teams working to improve maternal and infant health outcomes. To address the shared needs across state PQCs and enable collaboration, Centers for Disease Control and Prevention, in partnership with March of Dimes and perinatal quality improvement experts from across the country, supported the development and launch of the National Network of PQCs National Network of Perinatal Quality Collaboratives (NNPQC). This process included assessing the status of PQCs in this country and identifying the needs and resources that would be most useful to support PQC development. National representatives from 48 states gathered for the first meeting of the NNPQC to share best practices for making measurable improvements in maternal and infant health. The number of state PQCs has grown considerably over the past decade, with an active PQC or a PQC in development in almost every state. However, PQCs have some common challenges that need to be addressed. After its successful launch, the NNPQC is positioned to ensure that every state PQC has access to key tools and resources that build capacity to actively improve maternal and infant health outcomes and healthcare quality. |
Vital signs: Trends and disparities in infant safe sleep practices - United States, 2009-2015
Bombard JM , Kortsmit K , Warner L , Shapiro-Mendoza CK , Cox S , Kroelinger CD , Parks SE , Dee DL , D'Angelo DV , Smith RA , Burley K , Morrow B , Olson CK , Shulman HB , Harrison L , Cottengim C , Barfield WD . MMWR Morb Mortal Wkly Rep 2018 67 (1) 39-46 INTRODUCTION: There have been dramatic improvements in reducing infant sleep-related deaths since the 1990s, when recommendations were introduced to place infants on their backs for sleep. However, there are still approximately 3,500 sleep-related deaths among infants each year in the United States, including those from sudden infant death syndrome, accidental suffocation and strangulation in bed, and unknown causes. Unsafe sleep practices, including placing infants in a nonsupine (on side or on stomach) sleep position, bed sharing, and using soft bedding in the sleep environment (e.g., blankets, pillows, and soft objects) are modifiable risk factors for sleep-related infant deaths. |
Achieving appropriate gestational weight gain: The role of healthcare provider advice
Deputy NP , Sharma AJ , Kim SY , Olson CK . J Womens Health (Larchmt) 2018 27 (5) 552-560 BACKGROUND: The Institute of Medicine (IOM) revised gestational weight gain recommendations in 2009. We examined associations between healthcare provider advice about gestational weight gain and inadequate or excessive weight gain, stratified by prepregnancy body mass index category. MATERIALS AND METHODS: We analyzed cross-sectional data from women delivering full-term (37-42 weeks of gestation), singleton infants from four states that participated in the 2010-2011 Pregnancy Risk Assessment Monitoring System (unweighted n = 7125). Women reported the weight gain range (start and end values) advised by their healthcare provider; advice was categorized as follows: starting below recommendations, starting and ending within recommendations (IOM consistent), ending above recommendations, not remembered, or not received. We examined associations between healthcare provider advice and inadequate or excessive, compared with appropriate, gestational weight gain using adjusted prevalence ratios (aPR) and 95% confidence intervals (CIs). RESULTS: Overall, 26.3% of women reported receiving IOM-consistent healthcare provider advice; 26.0% received no advice. Compared with IOM-consistent advice, advice below recommendations was associated with higher likelihood of inadequate weight gain among underweight (aPR 2.22, CI 1.29-3.82) and normal weight women (aPR 1.57, CI 1.23-2.02); advice above recommendations was associated with higher likelihood of excessive weight gain among all but underweight women (aPR range 1.36, CI 1.08-1.72 to aPR 1.42, CI 1.19-1.71). Not remembering or not receiving advice was associated with both inadequate and excessive weight gain. CONCLUSIONS: Few women reported receiving IOM-consistent advice; not receiving IOM-consistent advice put women at-risk for weight gain outside recommendations. Strategies that raise awareness of IOM recommendations and address barriers to providing advice are needed. |
Prolonged detection of Zika virus RNA in pregnant women
Meaney-Delman D , Oduyebo T , Polen KN , White JL , Bingham AM , Slavinski SA , Heberlein-Larson L , St George K , Rakeman JL , Hills S , Olson CK , Adamski A , Culver Barlow L , Lee EH , Likos AM , Munoz JL , Petersen EE , Dufort EM , Dean AB , Cortese MM , Santiago GA , Bhatnagar J , Powers AM , Zaki S , Petersen LR , Jamieson DJ , Honein MA . Obstet Gynecol 2016 128 (4) 724-730 OBJECTIVE: Zika virus infection during pregnancy is a cause of microcephaly and other fetal brain abnormalities. Reports indicate that the duration of detectable viral RNA in serum after symptom onset is brief. In a recent case report involving a severely affected fetus, Zika virus RNA was detected in maternal serum 10 weeks after symptom onset, longer than the duration of RNA detection in serum previously reported. This report summarizes the clinical and laboratory characteristics of pregnant women with prolonged detection of Zika virus RNA in serum that were reported to the U.S. Zika Pregnancy Registry. METHODS: Data were obtained from the U.S. Zika Pregnancy Registry, an enhanced surveillance system of pregnant women with laboratory evidence of confirmed or possible Zika virus infection. For this case series, we defined prolonged detection of Zika virus RNA as Zika virus RNA detection in serum by real-time reverse transcription-polymerase chain reaction (RT-PCR) 14 or more days after symptom onset or, for women not reporting signs or symptoms consistent with Zika virus disease (asymptomatic), 21 or more days after last possible exposure to Zika virus. RESULTS: Prolonged Zika virus RNA detection in serum was identified in four symptomatic pregnant women up to 46 days after symptom onset and in one asymptomatic pregnant woman 53 days postexposure. Among the five pregnancies, one pregnancy had evidence of fetal Zika virus infection confirmed by histopathologic examination of fetal tissue, three pregnancies resulted in live births of apparently healthy neonates with no reported abnormalities, and one pregnancy is ongoing. CONCLUSION: Zika virus RNA was detected in the serum of five pregnant women beyond the previously estimated timeframe. Additional real-time RT-PCR testing of pregnant women might provide more data about prolonged detection of Zika virus RNA and the possible diagnostic, epidemiologic, and clinical implications for pregnant women. |
Update: interim guidance for health care providers caring for women of reproductive age with possible Zika virus exposure - United States, 2016
Petersen EE , Polen KN , Meaney-Delman D , Ellington SR , Oduyebo T , Cohn A , Oster AM , Russell K , Kawwass JF , Karwowski MP , Powers AM , Bertolli J , Brooks JT , Kissin D , Villanueva J , Munoz-Jordan J , Kuehnert M , Olson CK , Honein MA , Rivera M , Jamieson DJ , Rasmussen SA . MMWR Morb Mortal Wkly Rep 2016 65 (12) 315-322 CDC has updated its interim guidance for U.S. health care providers caring for women of reproductive age with possible Zika virus exposure (1) to include recommendations on counseling women and men with possible Zika virus exposure who are interested in conceiving. This guidance is based on limited available data on persistence of Zika virus RNA in blood and semen (2-5). Women who have Zika virus disease* should wait at least 8 weeks after symptom onset to attempt conception, and men with Zika virus disease should wait at least 6 months after symptom onset to attempt conception. Women and men with possible exposure to Zika virus but without clinical illness consistent with Zika virus disease should wait at least 8 weeks after exposure to attempt conception. Possible exposure to Zika virus is defined as travel to or residence in an area of active Zika virus transmission (http://www.cdc.gov/zika/geo/active-countries.html), or sex (vaginal intercourse, anal intercourse, or fellatio) without a condom with a man who traveled to or resided in an area of active transmission. Women and men who reside in areas of active Zika virus transmission should talk with their health care provider about attempting conception. This guidance also provides updated recommendations on testing of pregnant women with possible Zika virus exposure. These recommendations will be updated when additional data become available. |
Preventing transmission of Zika virus in labor and delivery settings through implementation of standard precautions - United States, 2016
Olson CK , Iwamoto M , Perkins KM , Polen KN , Hageman J , Meaney-Delman D , Igbinosa II , Khan S , Honein MA , Bell M , Rasmussen SA , Jamieson DJ . MMWR Morb Mortal Wkly Rep 2016 65 (11) 290-292 Zika virus transmission was detected in the Region of the Americas (Americas) in Brazil in May 2015, and as of March 21, 2016, local mosquito-borne transmission of Zika virus had been reported in 32 countries and territories in the Americas, including Puerto Rico and the U.S. Virgin Islands.* Most persons infected with Zika virus have a mild illness or are asymptomatic. However, increasing evidence supports a link between Zika virus infection during pregnancy and adverse pregnancy and birth outcomes (1), and a possible association between recent Zika virus infection and Guillain-Barre syndrome has been reported (2). Although Zika virus is primarily transmitted through the bite of Aedes species of mosquitoes, sexual transmission also has been documented (3). Zika virus RNA has been detected in a number of body fluids, including blood, urine, saliva, and amniotic fluid (3-5), and whereas transmission associated with occupational exposure to these body fluids is theoretically possible, it has not been documented. Although there are no reports of transmission of Zika virus from infected patients to health care personnel or other patients, minimizing exposures to body fluids is important to reduce the possibility of such transmission. CDC recommends Standard Precautions in all health care settings to protect both health care personnel and patients from infection with Zika virus as well as from blood-borne pathogens (e.g., human immunodeficiency virus [HIV] and hepatitis C virus [HCV]) (6). Because of the potential for exposure to large volumes of body fluids during the labor and delivery process and the sometimes unpredictable and fast-paced nature of obstetrical care, the use of Standard Precautions in these settings is essential to prevent possible transmission of Zika virus from patients to health care personnel. |
Syphilis among U.S.-bound refugees, 2009-2013
Nyangoma EN , Olson CK , Painter JA , Posey DL , Stauffer WM , Naughton M , Zhou W , Kamb M , Benoit SR . J Immigr Minor Health 2016 19 (4) 835-842 U.S. immigration regulations require clinical and serologic screening for syphilis for all U.S.-bound refugees 15 years of age and older. We reviewed syphilis screening results for all U.S.-bound refugees from January 1, 2009 through December 31, 2013. We calculated age-adjusted prevalence by region and nationality and assessed factors associated with syphilis seropositivity using multivariable log binomial regression models. Among 233,446 refugees, we identified 874 syphilis cases (373 cases per 100,000 refugees). The highest overall age-adjusted prevalence rates of syphilis seropositivity were observed among refugees from Africa (1340 cases per 100,000), followed by East Asia and the Pacific (397 cases per 100,000). In most regions, male sex, increasing age, and living in non-refugee camp settings were associated with syphilis seropositivity. Future analysis of test results, stage of infection, and treatment delivery overseas is warranted in order to determine the extent of transmission risk and benefits of the screening program. |
Cost-effectiveness of screening and treating foreign-born students for tuberculosis before entering the United States
Wingate LT , Coleman MS , Posey DL , Zhou W , Olson CK , Maskery B , Cetron MS , Painter JA . PLoS One 2015 10 (4) e0124116 INTRODUCTION: The Centers for Disease Control and Prevention is considering implementation of overseas medical screening of student-visa applicants to reduce the numbers of active tuberculosis cases entering the United States. OBJECTIVE: To evaluate the costs, cases averted, and cost-effectiveness of screening for, and treating, tuberculosis in United States-bound students from countries with varying tuberculosis prevalence. METHODS: Costs and benefits were evaluated from two perspectives, combined and United States only. The combined perspective totaled overseas and United States costs and benefits from a societal perspective. The United States only perspective was a domestic measure of costs and benefits. A decision tree was developed to determine the cost-effectiveness of tuberculosis screening and treatment from the combined perspective. RESULTS: From the United States only perspective, overseas screening programs of Chinese and Indian students would prevent the importation of 157 tuberculosis cases annually, and result in $2.7 million in savings. From the combined perspective, screening programs for Chinese students would cost more than $2.8 million annually and screening programs for Indian students nearly $440,000 annually. From the combined perspective, the incremental cost for each tuberculosis case averted by screening Chinese and Indian students was $22,187 and $15,063, respectively. Implementing screening programs for German students would prevent no cases in most years, and would result in increased costs both overseas and in the United States. The domestic costs would occur because public health departments would need to follow up on students identified overseas as having an elevated risk of tuberculosis. CONCLUSIONS: Tuberculosis screening and treatment programs for students seeking long term visas to attend United States schools would reduce the number of tuberculosis cases imported. Implementing screening in high-incidence countries could save the United States millions of dollars annually; however there would be increased costs incurred overseas for students and their families. |
Measles outbreak associated with adopted children from China - Missouri, Minnesota, and Washington, July 2013
Nyangoma EN , Olson CK , Benoit SR , Bos J , Debolt C , Kay M , Rietberg K , Tasslimi A , Baker D , Feng X , Lippold S , Blumensaadt S , Schembri C , Vang A , Burke H , Wallace G , Zhou W . MMWR Morb Mortal Wkly Rep 2014 63 (14) 301-4 On July 5, 2013, CDC was notified of two cases of laboratory-confirmed measles in recently adopted children from an orphanage in Henan Province, China. To find potentially exposed persons, CDC collaborated with state and local health departments, the children's adoption agency, and airlines that carried the adoptees. Two additional measles cases were identified, one in a family member of an adoptee and one in a third adopted child from China. To prevent further importation of measles, CDC worked with health officials in China, including "panel physicians" contracted by the U.S. Department of State to conduct the overseas medical examinations required for all immigrants and refugees bound for the United States. The following measures were recommended: 1) all adoptees examined at panel physician facilities should be screened for fever and rash illness, 2) measles immunity should be ensured among all adoptees from Henan Province who are scheduled for imminent departure to the United States, and 3) all children at the orphanage in Henan Province should be evaluated for measles. This report summarizes the results of the outbreak investigation and underscores the importance of timely routine vaccination for all international adoptees. |
Implementation of new TB screening requirements for U.S.-bound immigrants and refugees - 2007-2014
Posey DL , Naughton MP , Willacy EA , Russell M , Olson CK , Godwin CM , McSpadden PS , White ZA , Comans TW , Ortega LS , Guterbock M , Weinberg MS , Cetron MS . MMWR Morb Mortal Wkly Rep 2014 63 (11) 234-6 For more than two decades, as the number of tuberculosis (TB) cases overall in the United States has declined, the proportion of cases among foreign-born persons has increased. In 2013, the percentage of TB cases among those born outside the country was 64.6%. To address this trend, CDC has developed strategies to identify and treat TB in U.S.-bound immigrants and refugees overseas. Each year, approximately 450,000 persons are admitted to the United States on an immigrant visa, and 50,000-70,000 are admitted as refugees. Applicants for either an immigrant visa or refugee status are required to undergo a medical examination overseas before being allowed to travel to the United States. CDC is the federal agency with regulatory oversight of the overseas medical examination, and panel physicians appointed by the U.S. Department of State perform the examinations in accordance with Technical Instructions (TI) provided by CDC's Division of Global Migration and Quarantine (DGMQ). Beginning in 1991, the algorithm for TB TI relied on chest radiographs for applicants aged ≥15 years, followed by sputum smears for those with findings suggestive of TB; no additional diagnostics were used. In 2007, CDC issued enhanced standards for TB diagnosis and treatment, including the addition of sputum cultures (which are more sensitive than smears) as a diagnostic tool and treatment delivered as directly observed therapy (DOT). This report summarizes worldwide implementation of the new screening requirements since 2007. In 2012, the year for which the most recent data are available, 60% of the TB cases diagnosed were in persons with smear-negative, but culture-positive, test results. The results demonstrate that rigorous diagnostic and treatment programs can be implemented in areas with high TB incidence overseas. |
Examining the use of oral rehydration salts and other oral rehydration therapy for childhood diarrhea in Kenya
Blum LS , Oria PA , Olson CK , Breiman RF , Ram PK . Am J Trop Med Hyg 2011 85 (6) 1126-33 Reductions in the use of oral rehydration therapy (ORT) in sub-Saharan Africa highlight the need to examine caregiver perceptions of ORT during diarrheal episodes. Qualitative research involving group discussions with childcare providers and in-depth interviews with 45 caregivers of children < 5 years of age who had experienced diarrhea was conducted in one rural and urban site in Kenya during July-December 2007. Diarrhea was considered a dangerous condition that can kill young children. Caregivers preferred to treat diarrhea with Western drugs believed to be more effective in stopping diarrhea than ORT. Inconsistent recommendations from health workers regarding use of oral rehydration solution (ORS) caused confusion about when ORS is appropriate and whether it requires a medical prescription. In the rural community, causal explanations about diarrhea, beliefs in herbal remedies, cost, and distance to health facilities presented additional barriers to ORS use. Health communication is needed to clarify the function of ORT in preventing dehydration. |
Community case management of childhood diarrhea in a setting with declining use of oral rehydration therapy: findings from cross-sectional studies among primary household caregivers, Kenya, 2007
Olson CK , Blum LS , Patel KN , Oria PA , Feikin DR , Laserson KF , Wamae AW , Bartlett AV , Breiman RF , Ram PK . Am J Trop Med Hyg 2011 85 (6) 1134-1140 We sought to determine factors associated with appropriate diarrhea case management in Kenya. We conducted a cross-sectional survey of caregivers of children < 5 years of age with diarrhea in rural Asembo and urban Kibera. In Asembo, 61% of respondents provided oral rehydration therapy (ORT), 45% oral rehydration solution (ORS), and 64% continued feeding. In Kibera, 75% provided ORT, 43% ORS, and 46% continued feeding. Seeking care at a health facility, risk perception regarding death from diarrhea, and treating a child with oral medications were associated with ORT and ORS use. Availability of oral medication was negatively associated. A minority of caregivers reported that ORS is available in nearby shops. In Kenya, household case management of diarrhea remains inadequate for a substantial proportion of children. Health workers have a critical role in empowering caregivers regarding early treatment with ORT and continued feeding. Increasing community ORS availability is essential to improving diarrhea management. |
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