Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
Records 1-23 (of 23 Records) |
Query Trace: Panagiotakopoulos L[original query] |
---|
CDC's new hepatitis C virus testing recommendations for perinatally exposed infants and children: A step towards hepatitis C elimination
Panagiotakopoulos L , Miele K , Cartwright EJ , Kamili S , Furukawa N , Woodworth K , Tong VT , Kim SY , Wester C , Sandul AL . J Womens Health (Larchmt) 2024 New U.S. Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing of perinatally exposed infants and children released in 2023 recommend a nucleic acid test (NAT) for detection of HCV ribonucleic acid (i.e., NAT for HCV RNA) at 2-6 months of age to facilitate early identification and linkage to care for children with perinatally acquired HCV infection. Untreated hepatitis C can lead to cirrhosis, liver cancer, and premature death and is caused by HCV, a blood-borne virus transmitted most often among adults through injection drug use in the United States. Perinatal exposure from a birth parent with HCV infection is the most frequent mode of HCV transmission among infants and children. New HCV infections have been increasing since 2010, with the highest rates of infection among people aged 20-39 years, leading to an increasing prevalence of HCV infection during pregnancy. In 2020, the CDC recommended one-time HCV screening for all adults aged 18 years and older and for all pregnant persons during each pregnancy. Detecting HCV infection during pregnancy is key for the identification of pregnant persons, linkage to care for postpartum treatment, and identification of infants with perinatal exposure for HCV testing. It was previously recommended that children who were exposed to HCV during pregnancy receive an antibody to HCV (anti-HCV) test at 18 months of age; however, most children were lost to follow-up before testing occurred, leaving children with perinatal infection undiagnosed. The new strategy of testing perinatally exposed children at age 2-6 months was found to be cost-effective in increasing the identification of infants who might develop chronic hepatitis C. This report describes the current perinatal HCV testing recommendations and how they advance national hepatitis C elimination efforts by improving the health of pregnant and postpartum people and their children. |
Frequency of children diagnosed with perinatal hepatitis C, United States, 2018-2020
Newton SM , Woodworth KR , Chang D , Sizemore L , Wingate H , Pinckney L , Osinski A , Orkis L , Reynolds BD , Carpentieri C , Halai UA , Lyu C , Longcore N , Thomas N , Wills A , Akosa A , Olsen EO , Panagiotakopoulos L , Thompson ND , Gilboa SM , Tong VT . Emerg Infect Dis 2024 30 (1) 202-204 We describe hepatitis C testing of 47 (2%) of 2,266 children diagnosed with perinatal hepatitis C who were exposed during 2018-2020 in 7 jurisdictions in the United States. Expected frequency of perinatal transmission is 5.8%, indicating only one third of the cases in this cohort were reported to public health authorities. |
CDC recommendations for hepatitis C testing among perinatally exposed infants and children - United States, 2023
Panagiotakopoulos L , Sandul AL , Conners EE , Foster MA , Nelson NP , Wester C . MMWR Recomm Rep 2023 72 (4) 1-21 The elimination of hepatitis C is a national priority (https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf). During 2010-2021, hepatitis C virus (HCV) acute and chronic infections (hereinafter referred to as HCV infections) increased in the United States, consequences of which include cirrhosis, liver cancer, and death. Rates of acute infections more than tripled among reproductive-aged persons during this time (from 0.8 to 2.5 per 100,000 population among persons aged 20-29 years and from 0.6 to 3.5 among persons aged 30-39 years). Because acute HCV infection can lead to chronic infection, this has resulted in increasing rates of HCV infections during pregnancy. Approximately 6%-7% of perinatally exposed (i.e., exposed during pregnancy or delivery) infants and children will acquire HCV infection. Curative direct-acting antiviral therapy is approved by the Food and Drug Administration for persons aged ≥3 years. However, many perinatally infected children are not tested or linked to care. In 2020, because of continued increases in HCV infections in the United States, CDC released universal screening recommendations for adults, which included recommendations for screening for pregnant persons during each pregnancy (Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults-United States, 2020. MMWR Recomm Rep 2020;69[No. RR-2]:1-17). This report introduces four new CDC recommendations: 1) HCV testing of all perinatally exposed infants with a nucleic acid test (NAT) for detection of HCV RNA at age 2-6 months; 2) consultation with a health care provider with expertise in pediatric hepatitis C management for all infants and children with detectable HCV RNA; 3) perinatally exposed infants and children with an undetectable HCV RNA result at or after age 2 months do not require further follow-up unless clinically warranted; and 4) a NAT for HCV RNA is recommended for perinatally exposed infants and children aged 7-17 months who previously have not been tested, and a hepatitis C virus antibody (anti-HCV) test followed by a reflex NAT for HCV RNA (when anti-HCV is reactive) is recommended for perinatally exposed children aged ≥18 months who previously have not been tested. Proper identification of perinatally infected children, referral to care, and curative treatment are critical to achieving the goal of hepatitis C elimination. |
Progress and unfinished business: Hepatitis B in the United States, 1980-2019
Bixler D , Roberts H , Panagiotakopoulos L , Nelson NP , Spradling PR , Teshale EH . Public Health Rep 2023 333549231175548 During 1990-2019, universal infant and childhood vaccination for hepatitis B resulted in a 99% decline in reported cases of acute hepatitis B among children, adolescents, and young adults aged <19 years in the United States; however, during 2010-2019, cases of acute hepatitis B plateaued or increased among adults aged ≥40 years. We conducted a topical review of surveillance strategies that will be critical to support the elimination of hepatitis B as a public health threat in the United States. In 2019, notifiable disease surveillance for acute hepatitis B showed continued transmission, especially among people who inject drugs and people with multiple sexual partners; rates were highest among people who were aged 30-59 years, non-Hispanic White, and living in rural areas. In contrast, newly reported cases of chronic hepatitis B (CHB) were highest among people who were aged 30-49 years, Asian or Pacific Islander, and living in urban areas. The National Health and Nutrition Examination Survey documented the highest CHB prevalence among non-US-born, non-Hispanic Asian people during 2013-2018; only one-third of people with CHB were aware of their infection. In the context of universal adult vaccination (2022) and screening (2023) recommendations for hepatitis B, better data are needed to support programmatic strategies to improve (1) vaccination rates among people with behaviors that put them at risk for transmission and (2) screening and linkage to care among non-US-born people. Surveillance for hepatitis B needs to be strengthened throughout the health care and public health systems. |
Cost-effectiveness of strategies to identify children with perinatally acquired hepatitis C infection
Hall EW , Panagiotakopoulos L , Wester C , Nelson N , Sandul AL . J Pediatr 2023 258 113409 OBJECTIVES: We aimed to determine the optimal testing strategy to identify children with perinatally acquired hepatitis C virus (HCV) infection. STUDY DESIGN: We used a decision-tree framework with a Markov disease progression model to conduct an economic analysis of four strategies, based on combinations of type and timing of test: Anti-HCV with reflex to HCV RNA at 18 months among children known to be perinatally exposed (ie, baseline comparison strategy); HCV RNA testing at 2-6 months among infants known to be perinatally exposed (Test Strategy 1); universal anti-HCV with reflex to HCV RNA at 18 months among all children (Test Strategy 2); universal HCV RNA testing at 2-6 months among all infants (Test Strategy 3). We estimated total cost, quality-adjusted life years (QALYs), and disease sequalae for each strategy. RESULTS: Each of the three alternative testing strategies resulted in an increased number of children tested and improved health outcomes. HCV RNA testing at 2-6 months (Test Strategy 1) was cost-saving and resulted in a population-level difference in cost of $469,671. The two universal testing strategies resulted in an increase in QALYs and an increase in total costs. CONCLUSIONS: Testing of perinatally exposed infants at age 2-6 months with a single HCV RNA test will reduce costs and improve health outcomes, preventing morbidity and mortality associated with complications from perinatal HCV infections. |
Screening and testing for hepatitis B virus infection: CDC recommendations - United States, 2023
Conners EE , Panagiotakopoulos L , Hofmeister MG , Spradling PR , Hagan LM , Harris AM , Rogers-Brown JS , Wester C , Nelson NP . MMWR Recomm Rep 2023 72 (1) 1-25 Chronic hepatitis B virus (HBV) infection can lead to substantial morbidity and mortality. Although treatment is not considered curative, antiviral treatment, monitoring, and liver cancer surveillance can reduce morbidity and mortality. Effective vaccines to prevent hepatitis B are available. This report updates and expands CDC's previously published Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection (MMWR Recomm Rep 2008;57[No. RR-8]) regarding screening for HBV infection in the United States. New recommendations include hepatitis B screening using three laboratory tests at least once during a lifetime for adults aged ≥18 years. The report also expands risk-based testing recommendations to include the following populations, activities, exposures, or conditions associated with increased risk for HBV infection: persons incarcerated or formerly incarcerated in a jail, prison, or other detention setting; persons with a history of sexually transmitted infections or multiple sex partners; and persons with a history of hepatitis C virus infection. In addition, to provide increased access to testing, anyone who requests HBV testing should receive it, regardless of disclosure of risk, because many persons might be reluctant to disclose stigmatizing risks. |
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) |
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. |
Timing of positive hepatitis C virus test results during and 1 year before pregnancy
Woodworth KR , Newton SM , Olsen EO , Tannis A , Sizemore L , Wingate H , Orkis L , Reynolds B , Longcore N , Thomas N , Bocour A , Wills A , Kim SY , Panagiotakopoulos L , Wester C , Delman Meaney D , Gilboa SM , Tong VT . Obstet Gynecol 2022 140 (6) 997-999 The incidence of hepatitis C virus (HCV) infection in reproductive-aged adults quadrupled during the past decade. Hepatitis C can progress to advanced liver disease and be transmitted perinatally. Highly effective curative hepatitis C treatment is available but is not recommended in pregnancy. Using the Surveillance for Emerging Threats to Mothers and Babies Network, we describe timing of positive RNA testing among pregnant people with HCV (HCV RNA detected during or within one year prior to pregnancy). Four US jurisdictions reported 1161 pregnancies during 2018-2021 among people with hepatitis C: 75.9% were multiparous; and 21.4% had their first peri-pregnancy HCV RNA detected prior to pregnancy, indicating potential missed treatment opportunities to improve maternal health and prevent perinatal transmission. |
Kawasaki disease following the 13-valent pneumococcal conjugate vaccine and rotavirus vaccines
Kamidani S , Panagiotakopoulos L , Licata C , Daley MF , Yih WK , Zerbo O , Tseng HF , DeSilva MB , Nelson JC , Groom HC , Williams JTB , Hambidge SJ , Donahue JG , Belay ED , Weintraub ES . Pediatrics 2022 150 (6) BACKGROUND: Temporal associations between Kawasaki disease (KD) and childhood vaccines have been reported. Limited data on KD following 13-valent pneumococcal conjugate (PCV13) and rotavirus vaccines are available. METHODS: We conducted a self-controlled risk interval study using Vaccine Safety Datalink electronic health record data to investigate the risk of KD following PCV13 and rotavirus vaccines in children <2 years of age who were born from 2006 to 2017. All hospitalized KD cases identified by International Classification of Diseases diagnosis codes that fell within predefined risk (days 1-28 postvaccination) and control (days 29-56 for doses 1 and 2, and days 43-70 for doses 3 and 4) intervals were confirmed by manual chart review. RESULTS: During the study period, 655 cases of KD were identified by International Classification of Diseases codes. Of these, 97 chart-confirmed cases were within risk or control intervals. In analyses, the age-adjusted relative risk for KD following any dose of PCV13 was 0.75 (95% confidence interval, 0.47-1.21). Similarly, the age-adjusted relative risk for KD following any dose of rotavirus vaccine was 0.66 (95% CI, 0.40-1.09). Overall, there was no evidence of an elevated risk of KD following PCV13 or rotavirus vaccines by dose. In addition, no statistically significant temporal clustering of KD cases was identified during days 1 to 70 postvaccination. CONCLUSIONS: PCV13 and rotavirus vaccination were not associated with an increased risk of KD in children <2 years of age. Our findings provide additional evidence for the overall safety of PCV13 and rotavirus vaccines. |
Hepatitis C virus testing during pregnancy after universal screening recommendations
Kaufman HW , Osinubi A , Meyer WA3rd , Khan M , Huang X , Panagiotakopoulos L , Thompson WW , Nelson N , Wester C . Obstet Gynecol 2022 140 (1) 99-101 The study evaluates the effect of the 2020 Centers for Disease Control and Prevention and U.S. Preventive Services Task Force recommendations on hepatitis C virus (HCV) screening among pregnant persons nationally and by health insurance type. The study included 5,048,428 pregnant persons aged 15-44 years with either Medicaid or commercial health insurance who had obstetric panel testing performed by Quest Diagnostics, January 2011-June 2021. Antibody screening for HCV infection increased before and accelerated after the updated recommendations in early 2020. Disparities in HCV testing by health insurance status were substantial over the entire study period. Despite substantial progress in the proportion of pregnant persons screened for HCV infection, current testing rates fall short of universal recommendations. |
COVID-19 vaccines in children and adolescents
Maldonado YA , O'Leary ST , Ardura MI , Banerjee R , Bryant KA , Campbell JD , Caserta MT , John CC , Gerber JS , Kourtis AP , Ratner AJ , Romero JR , Shah SS , Zangwill KM , Kimberlin DW , Barnett ED , Lynfield R , Sawyer MH , Bernstein HH , Cohn AC , Farizo KM , Halasa NB , Kafer LM , Kim D , LpezMedina E , Moore D , Panagiotakopoulos L , Sauv L , Silverman NS , Starke JR , Tomashek KM , Frantz JM , CommitteeonInfectious Diseases . Pediatrics 2022 149 (1) Vaccines are safe and effective in protecting individuals and populations against infectious diseases. New vaccines are evaluated by a long-standing, rigorous, and transparent process through the US Food and Drug Administration and the Centers for Disease Control and Prevention (CDC), by which safety and efficacy data are reviewed before authorization and recommendation. |
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. |
Measles in the 21st century: Progress toward achieving and sustaining elimination
Gastañaduy PA , Goodson JL , Panagiotakopoulos L , Rota PA , Orenstein WA , Patel M . J Infect Dis 2021 224 S420-s428 The global measles vaccination program has been extraordinarily successful in reducing measles-related disease and deaths worldwide. Eradication of measles is feasible because of several key attributes, including humans as the only reservoir for the virus, broad access to diagnostic tools that can rapidly detect measles-infectious persons, and availability of highly safe and effective measles-containing vaccines (MCVs). All 6 World Health Organization (WHO) regions have established measles elimination goals. Globally, during 2000-2018, measles incidence decreased by 66% (from 145 to 49 cases per million population) and deaths decreased by 73% (from 535 600 to 142 300), drastically reducing global disease burden. Routine immunization with MCV has been the cornerstone for the control and prevention of measles. Two doses of MCV are 97% effective in preventing measles, qualifying MCV as one of the most effective vaccines ever developed. Mild adverse events occur in <20% of recipients and serious adverse events are extremely rare. The economic benefits of measles vaccination are highlighted by an overall return on investment of 58 times the cost of the vaccine, supply chains, and vaccination. Because measles is one of the most contagious human diseases, maintenance of high (≥95%) 2-dose MCV coverage is crucial for controlling the spread of measles and successfully reaching measles elimination; however, the plateauing of global MCV coverage for nearly a decade and the global measles resurgence during 2018-2019 demonstrate that much work remains. Global commitments to increase community access to and demand for immunizations, strengthen national and regional partnerships for building public health infrastructure, and implement innovations that can overcome access barriers and enhance vaccine confidence, are essential to achieve a world free of measles. |
Vaccine Safety Datalink infrastructure enhancements for evaluating the safety of maternal vaccination
Naleway AL , Crane B , Irving SA , Bachman D , Vesco KK , Daley MF , Getahun D , Glenn SC , Hambidge SJ , Jackson LA , Klein NP , McCarthy NL , McClure DL , Panagiotakopoulos L , Panozzo CA , Vazquez-Benitez G , Weintraub ES , Zerbo O , Kharbanda EO . Ther Adv Drug Saf 2021 12 20420986211021233 Background: Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data. Methods: We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time. Results: Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births. Conclusion: The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies. Plain Language Summary: Improving identification of pregnancies in the Vaccine Safety Datalink electronic medical record databases to allow for better and faster monitoring of vaccination safety during pregnancy Introduction: It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child. Methods: The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements, we manually reviewed medical records and compared the results with the algorithm. We also developed a new algorithm, the Dynamic Pregnancy Algorithm (DPA), to identify women earlier in pregnancy, allowing us to conduct more timely vaccine safety assessments. Results: The new version of the PEA identified 2,485,410 pregnancies in the VSD database. The enhanced algorithm more precisely estimated the beginning of pregnancies, especially those that did not result in live births, due to the new sources of gestational age data. Conclusion: Our new algorithm, the DPA, was successful at identifying pregnancies earlier in gestation than the PEA. The enhanced PEA and the new DPA will allow us to better evaluate the safety of current and future vaccinations administered during or around the time of pregnancy. © The Author(s), 2021. |
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. |
Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes
Kharbanda EO , Vazquez-Benitez G , DeSilva MB , Naleway AL , Klein NP , Hechter RC , Glanz JM , Donahue JG , Jackson LA , Sheth SS , Greenberg V , Panagiotakopoulos L , Mba-Jonas A , Lipkind HS . JAMA Netw Open 2021 4 (4) e214340 IMPORTANCE: The 9-valent human papillomavirus (9vHPV) vaccine is recommended for individuals through age 26 years and may be administered to women up to age 45 years. Data on 9vHPV vaccine exposures during pregnancy are limited. OBJECTIVE: To evaluate the associations between 9vHPV vaccine exposures during pregnancy or peripregnancy and selected pregnancy and birth outcomes (spontaneous abortion [SAB], preterm birth, small-for-gestational age [SGA] birth, and major structural birth defect). DESIGN, SETTING, AND PARTICIPANTS: This cohort study analyzed data from 7 participating health systems in the Vaccine Safety Datalink. The cohort comprised pregnancies among girls and women aged 12 to 28 years that ended between October 26, 2015, and November 15, 2018. Singleton pregnancies that ended in a live birth, stillbirth, or SAB were included. EXPOSURES: Vaccine exposure windows were distal (9vHPV or 4vHPV vaccine administered from 22 to 16 weeks before last menstrual period [LMP]), peripregnancy (9vHPV vaccine administered from 42 days before LMP until LMP), and during pregnancy (9vHPV vaccine administered from LMP to 19 completed weeks' gestation). Primary comparisons were (1) girls and women with 9vHPV vaccine exposures during pregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, (2) girls and women with vaccine exposures peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, and (3) girls and women with 9vHPV vaccine exposures during pregnancy or peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposure. MAIN OUTCOMES AND MEASURES: Spontaneous abortions were confirmed based on medical record review and adjudication. Preterm and SGA births were identified from electronic health record and birth data. Major structural birth defects were based on diagnostic codes using a validated algorithm. Inverse probability weighting was used to balance the covariates. Time-dependent covariate Cox proportional hazards regression models and Poisson regression were used to estimate the associations between 9vHPV vaccine exposures and pregnancy and birth outcomes. RESULTS: The final cohort included 1493 pregnancies among girls and women with a mean (SD) maternal age of 23.9 (2.9) years. Of these pregnancies, 445 (29.8%) had exposures to the 9vHPV vaccine during pregnancy, 496 (33.2%) had exposures to the 9vHPV vaccine peripregnancy, and 552 (37.0%) had 4vHPV or 9vHPV distal vaccine exposures. The 9vHPV vaccine administered during pregnancy was not associated with increased risk for SAB (hazard ratio, 1.12; 95% CI, 0.66-1.93) compared with distal vaccine exposures. Findings were similar for 9vHPV vaccine exposures peripregnancy (relative risk [RR], 0.72; 95% CI, 0.42-1.24). Among live births (n = 1409), 9vHPV vaccine exposures during pregnancy were not associated with increased risks for preterm birth (RR, 0.73; 95% CI, 0.44-1.20) or SGA birth (RR, 1.31; 95% CI, 0.78-2.20). Results were similar regarding the association between 9vHPV vaccine exposures peripregnancy and preterm birth (RR, 0.72; 95% CI, 0.45-1.17) and SGA birth (RR, 1.10; 95% CI, 0.65-1.88). Birth defects were rare in all exposure groups, occurring in about 1% of live births with available infant data. CONCLUSIONS AND RELEVANCE: This study found that 9vHPV vaccine exposures during or around the time of pregnancy were uncommon and not associated with SABs or selected adverse birth outcomes. These findings can inform counseling for inadvertent 9vHPV vaccine exposures. |
Evaluating the association of stillbirths after maternal vaccination in the Vaccine Safety Datalink
Panagiotakopoulos L , McCarthy NL , Tepper NK , Kharbanda EO , Lipkind HS , Vazquez-Benitez G , McClure DL , Greenberg V , Getahun D , Glanz JM , Naleway AL , Klein NP , Nelson JC , Weintraub ES . Obstet Gynecol 2020 136 (6) 1086-1094 OBJECTIVE: To evaluate whether the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinations in pregnancy are associated with increased risk of stillbirth. METHODS: We performed a case-control study in the Vaccine Safety Datalink that was matched 1:4 on site, month, and year of last menstrual period, comparing the odds of vaccination in pregnancies that ended in stillbirth (defined as fetal loss at or after 20 weeks of gestation) compared with those that ended in live birth from January 1, 2012, to September 30, 2015. We included patients with singleton pregnancies that ended in stillbirth or live birth who had at least one prenatal care visit, pregnancy dating information, and continuous health plan enrollment for the duration of pregnancy. Medical records for all stillbirths were reviewed. We were statistically powered to detect an odds ratio (OR) of 1.37 when evaluating the association between influenza or Tdap vaccination and stillbirth. We also examined stillbirth rates in pregnant patients aged 14-49 years in the Vaccine Safety Datalink between 2007 and 2015. RESULTS: In our matched analysis of 795 confirmed stillbirths in the case group and 3,180 live births in the control group, there was no significant association between influenza vaccination during pregnancy and stillbirth (343/795 [43.1%] stillbirths in the case group vs 1,407/3,180 [44.3%] live births in the control group, OR 0.94, adjusted OR 0.95, 95% CI 0.79-1.14, P=.54) and no significant association between Tdap vaccination during pregnancy and stillbirth (184/795 [23.1%] stillbirths in the case group vs 746/3,180 [23.5%] live births in the control group, OR 0.97, aOR 0.96, 95% CI 0.76-1.28, P=.91). From 2007 to 2015, the stillbirth rate in the Vaccine Safety Datalink was 5.2 per 1,000 live births and stillbirths. CONCLUSION: No association was found between vaccination during pregnancy and the odds of stillbirth. These findings support the safety of ACIP recommendations for vaccination during pregnancy. |
SARS-CoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics - Eight U.S. Health Care Centers, March 1-May 30, 2020.
Panagiotakopoulos L , Myers TR , Gee J , Lipkind HS , Kharbanda EO , Ryan DS , Williams JTB , Naleway AL , Klein NP , Hambidge SJ , Jacobsen SJ , Glanz JM , Jackson LA , Shimabukuro TT , Weintraub ES . MMWR Morb Mortal Wkly Rep 2020 69 (38) 1355-1359 Pregnant women might be at increased risk for severe coronavirus disease 2019 (COVID-19), possibly related to changes in their immune system and respiratory physiology* (1). Further, adverse birth outcomes, such as preterm delivery and stillbirth, might be more common among pregnant women infected with SARS-CoV-2, the virus that causes COVID-19 (2,3). Information about SARS-CoV-2 infection during pregnancy is rapidly growing; however, data on reasons for hospital admission, pregnancy-specific characteristics, and birth outcomes among pregnant women hospitalized with SARS-CoV-2 infections are limited. During March 1-May 30, 2020, as part of Vaccine Safety Datalink (VSD)(†) surveillance of COVID-19 hospitalizations, 105 hospitalized pregnant women with SARS-CoV-2 infection were identified, including 62 (59%) hospitalized for obstetric reasons (i.e., labor and delivery or another pregnancy-related indication) and 43 (41%) hospitalized for COVID-19 illness without an obstetric reason. Overall, 50 (81%) of 62 pregnant women with SARS-CoV-2 infection who were admitted for obstetric reasons were asymptomatic. Among 43 pregnant women hospitalized for COVID-19, 13 (30%) required intensive care unit (ICU) admission, six (14%) required mechanical ventilation, and one died from COVID-19. Prepregnancy obesity was more common (44%) among pregnant women hospitalized for COVID-19 than that among asymptomatic pregnant women hospitalized for obstetric reasons (31%). Likewise, the rate of gestational diabetes (26%) among pregnant women hospitalized for COVID-19 was higher than it was among women hospitalized for obstetric reasons (8%). Preterm delivery occurred in 15% of pregnancies among 93 women who delivered, and stillbirths (fetal death at ≥20 weeks' gestation) occurred in 3%. Antenatal counseling emphasizing preventive measures (e.g., use of masks, frequent hand washing, and social distancing) might help prevent COVID-19 among pregnant women,(§) especially those with prepregnancy obesity and gestational diabetes, which might reduce adverse pregnancy outcomes. |
Adverse outcomes in pregnant women hospitalized with respiratory syncytial virus infection: A case-series
Hause AM , Panagiotakopoulos L , Weintraub E , Sy LS , Glenn SC , Tseng HF , McNeil MM . Clin Infect Dis 2020 72 (1) 138-140 We identified 10 women hospitalized with RSV infection during pregnancy. Diagnoses included pneumonia/atelectasis (five), respiratory failure (two), and sepsis (two). Six had obstetrical complications during hospitalization, including one induced preterm birth. One required intensive care unit admission and mechanical ventilation. Four infants had complications at birth. |
Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink study
Groom HC , Smith N , Irving SA , Koppolu P , Vazquez-Benitez G , Kharbanda EO , Daley MF , Donahue JG , Getahun D , Jackson LA , Klein NP , McCarthy NL , Nordin JD , Panagiotakopoulos L , Naleway AL . Vaccine 2019 37 (44) 6648-6655 INTRODUCTION: Infection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A vaccine (HepA) is recommended for anyone at increased risk for contracting hepatitis A, including women at risk who are also pregnant. Limited data are available on the safety of maternal HepA vaccination. OBJECTIVES: Assess the frequency of maternal HepA receipt and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes. METHODS: A retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live births from 2004 through 2015 was included. Pregnancies with HepA exposure were compared to those with other vaccine exposures, and to those with no vaccine exposures. Risk factors for contracting hepatitis A were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were evaluated according to maternal HepA exposure status. Adjusted odds ratio (OR) were used to describe the association. RESULTS: Among 666,233 pregnancies in the study period, HepA was administered at a rate of 1.7 per 1000 (n=1140), most commonly within the first six weeks of pregnancy. Less than 3% of those exposed to HepA during pregnancy had an ICD-confirmed risk factor. There were no significant associations between HepA exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, and low birthweight. There was a statistically significant association between HepA exposure during pregnancy and small-for-gestational age (SGA) infants (aOR 1.32, [95% CI 1.09, 1.60], p=0.004). CONCLUSIONS: The rate of maternal HepA vaccination was low and rarely due to documented risk factors for vaccination. HepA vaccination during pregnancy was not associated with an increased risk for a range of adverse events examined among pregnancies resulting in live births, but an identified association between maternal HepA and SGA infant outcomes, while likely due to unmeasured confounding, warrants further exploration. |
Estimation of the incidence of Guillain-Barre syndrome during pregnancy in the United States
Myers TR , McCarthy NL , Panagiotakopoulos L , Omer SB . Open Forum Infect Dis 2019 6 (3) ofz071 Guillain-Barré syndrome (GBS) is an adverse event of interest after vaccination, yet few data are available for background rates during pregnancy. We confirmed 2 cases of incident GBS and estimated an incidence of 2.8 confirmed GBS cases per million person-years (95% confidence interval, 0.5-9.3), indicating rare occurrence. Our findings will help inform safety assessments of Zika vaccines in pregnant populations. |
- Page last reviewed:Feb 1, 2024
- Page last updated:Apr 29, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure