HPV type-specific trends in cervical precancers in the United States, 2008 to 2016.

Declines in cervical intraepithelial neoplasia grades 2 to 3 and adenocarcinoma in situ (CIN2+) observed among young women suggest impact from human papillomavirus (HPV) vaccination. To further evaluate vaccine impact including cross-protection and type replacement, we described high-risk (HR)-HPV type-specific cervical precancer incidence rates among women aged 20 to 39 years, 2008 to 2016. We analyzed cross-sectional population-based data on 18 344 cases of CIN2+ from a 5-site surveillance system. Diagnostic specimens were tested for individual HPV types, including 14 HR-HPV types (HPV16/18/31/33/35/39/45/51/52/56/58/59/66/68). We estimated age-specific annual HR-HPV type-specific CIN2+ incidence per 100 000 screened women for individual types, vaccine HR-HPV types (HPV16/18) and nonvaccine HR-HPV types (non-HPV16/18). We evaluated trends using average annual percent changes (AAPC) and 95% confidence intervals (CI), and estimated total declines by comparing 2015-2016 to 2008-2009 using incidence rate ratios. Among 20-24-year-olds, HPV16/18-CIN2+ declined from 2008 through 2016 (AAPC: -21.3%, 95% CI: -28.1%, -13.8%), whereas no trend was observed for non-HPV16/18-CIN2+ (AAPC: -1.8%, 95% CI: -8.1%, 4.9%). After 2010, CIN2+ among 20-24-year-olds was more often caused by nonvaccine vs vaccine HR-HPV types. No significant declining trends were observed in older age groups. In 2015-2016 compared with 2008-2009, HPV16-CIN2+ declined 78%, HPV18-CIN2+ 72% and HPV31-CIN2+ 51% among 20-24-year-olds; no increases were observed in type-specific CIN2+ incidence. Among 25-29-year-olds, HPV16-CIN2+ declined 18%; CIN2+ attributed to seven nonvaccine types increased significantly. No significant declines were observed in older groups. Significant declines in HPV16/18-CIN2+ in 20-24-year-olds and HPV16-CIN2+ in 25-29-year-olds corroborate impact of HPV vaccination. A declining trend in HPV31-CIN2+ is consistent with cross-protection from vaccination.

HPV prevalence among young adult women living with and without HIV in Botswana for future HPV vaccine impact monitoring.

INTRODUCTION: In 2015, Botswana introduced quadrivalent human papillomavirus (HPV) vaccine for girls aged 9-13 years. To establish a baseline HPV prevalence for future HPV vaccine impact monitoring, we evaluated HPV prevalences among the youngest unvaccinated women in Botswana and compared HPV prevalences among women living with HIV (WLHIV) and without HIV. METHODS: Women aged 18-22 years were recruited from the University of Botswana and HIV clinics in Gaborone from October 2019-January 2021. Demographic and behavioral characteristics were self-reported during structured interviews; HIV clinical characteristics were abstracted from medical charts. Self-collected vaginal swabs were tested for 28 HPV types using Seegene Anyplex II HPV28. We compared prevalence of any HPV, high risk (HR)-HPV, and quadrivalent HPV vaccine types (HPV6/11/16/18) among WLHIV and women without HIV and evaluated risk factors for prevalence of HR-HPV. RESULTS: A total of 306 WLHIV and 500 women without HIV were recruited. Compared to women without HIV, WLHIV were more likely to be sexually experienced (86.6% versus 74.4%) and have ≥ 3 lifetime sex partners (55.3% versus 27.8%). All HPV type prevalences were significantly higher among WLHIV compared to women without HIV, including prevalence of any HPV (82.7% versus 63.0%), HR-HPV (72.9% versus 53.8%), and quadrivalent vaccine HPV types (34.3% versus 21.0%). Among WLHIV, there were no differences between those perinatally and non-perinatally infected for HPV prevalences, number of HPV types detected, CD4 count, or viral load. CONCLUSIONS: Over one-third of WLHIV and nearly a quarter of those without HIV had vaccine-type HPV detected. This study supports need for the national HPV vaccination program in Botswana and provides important baseline data for future evaluation of impact of the program.

The Advisory Committee on Immunization Practices' Updated Interim Recommendation for Allocation of COVID-19 Vaccine - United States, December 2020.

The first vaccines for prevention of coronavirus disease 2019 (COVID-19) in the United States were authorized for emergency use by the Food and Drug Administration (FDA) (1) and recommended by the Advisory Committee on Immunization Practices (ACIP) in December 2020.* However, demand for COVID-19 vaccines is expected to exceed supply during the first months of the national COVID-19 vaccination program. ACIP advises CDC on population groups and circumstances for vaccine use.† On December 1, ACIP recommended that 1) health care personnel§ and 2) residents of long-term care facilities¶ be offered COVID-19 vaccination first, in Phase 1a of the vaccination program (2). On December 20, 2020, ACIP recommended that in Phase 1b, vaccine should be offered to persons aged ≥75 years and frontline essential workers (non-health care workers), and that in Phase 1c, persons aged 65-74 years, persons aged 16-64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b should be offered vaccine.** These recommendations for phased allocation provide guidance for federal, state, and local jurisdictions while vaccine supply is limited. In its deliberations, ACIP considered scientific evidence regarding COVID-19 epidemiology, ethical principles, and vaccination program implementation considerations. ACIP's recommendations for COVID-19 vaccine allocation are interim and might be updated based on changes in conditions of FDA Emergency Use Authorization, FDA authorization for new COVID-19 vaccines, changes in vaccine supply, or changes in COVID-19 epidemiology.

Assessment of Neonatal Abstinence Syndrome Surveillance - Pennsylvania, 2019.

The incidence of neonatal abstinence syndrome (NAS), a withdrawal syndrome associated with prenatal opioid or other substance exposure (1), has increased as part of the U.S. opioid crisis (2). No national NAS surveillance system exists (3), and data about the accuracy of state-based surveillance are limited (4,5). In February 2018, the Pennsylvania Department of Health began surveillance for opioid-related NAS in birthing facilities and pediatric hospitals* (6). In March 2019, CDC helped the Pennsylvania Department of Health assess the accuracy of this reporting system at five Pennsylvania hospitals. Medical records of 445 infants who possibly had NAS were abstracted; these infants had either been reported by hospital providers as having NAS or assigned an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) hospital discharge code potentially related to NAS.† Among these 445 infants, 241 were confirmed as having NAS. Pennsylvania's NAS surveillance identified 191 (sensitivity = 79%) of the confirmed cases. The proportion of infants with confirmed NAS who were assigned the ICD-10-CM code for neonatal withdrawal symptoms from maternal use of drugs of addiction (P96.1) was similar among infants reported to surveillance (71%) and those who were not (78%; p = 0.30). Infants with confirmed NAS who were not assigned code P96.1 typically had less severe signs and symptoms. Accurate NAS surveillance, which is necessary to monitor changes and regional differences in incidence and assist with planning for needed services, includes and is strengthened by a combination of diagnosis code assessment and focused medical record review.

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020.

On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 µg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.

The Advisory Committee on Immunization Practices' Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020.

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic that has disrupted all sectors of society. Less than 1 year after the SARS-CoV-2 genome was first sequenced, an application* for Emergency Use Authorization for a candidate vaccine has been filed with the Food and Drug Administration (FDA). However, even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program. The Advisory Committee on Immunization Practices (ACIP) advises CDC on population groups and circumstances for vaccine use.† ACIP convened on December 1, 2020, in advance of the completion of FDA's review of the Emergency Use Authorization application, to provide interim guidance to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both 1) health care personnel§ and 2) residents of long-term care facilities (LTCFs)¶ be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a**).†† In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles.§§ The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization.

The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020.

To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure (1). ACIP's recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine's safety and efficacy as well as consideration of other factors, including implementation (2). Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility: 1) maximize benefits and minimize harms; 2) promote justice; 3) mitigate health inequities; and 4) promote transparency. These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020.

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 µg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.§ The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP's interim recommendation for allocating initial supplies of COVID-19 vaccines (2). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.

Estimated Number of Cases of High-Grade Cervical Lesions Diagnosed Among Women - United States, 2008 and 2016.

Human papillomavirus (HPV) causes approximately 30,000 cancers in the United States annually (1). HPV vaccination was introduced in 2006 to prevent HPV-associated cancers and diseases (1). Cervical cancer is the most common HPV-associated cancer in women (1). Whereas HPV-associated cancers typically take decades to develop, screen-detected high-grade cervical lesions (cervical intraepithelial neoplasia grades 2 [CIN2], 3 [CIN3], and adenocarcinoma in situ, collectively CIN2+) develop within a few years after infection and have been used to monitor HPV vaccine impact (1-3). CDC analyzed data from the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT), a population-based CIN2+ surveillance system, to describe rates of CIN2+ among women aged ≥18 years during 2008-2016. Age-specific rates were applied to U.S. population data to estimate the total number of CIN2+ cases diagnosed in the United States in 2008* and in 2016. From 2008 to 2016, the rate of CIN2+ per 100,000 women declined significantly in women aged 18-19 years and 20-24 years and increased significantly in women aged 40-64 years. In the United States in 2008, an estimated 216,000 (95% confidence interval [CI] = 194,000-241,000) CIN2+ cases were diagnosed, 55% of which were in women aged 18-29 years; in 2016, an estimated 196,000 (95% CI = 176,000-221,000) CIN2+ cases were diagnosed, 36% of which were in women aged 18-29 years. During 2008 and 2016, an estimated 76% of CIN2+ cases were attributable to HPV types targeted by the vaccine currently used in the United States. These estimates of CIN2+ cases likely reflect changes in CIN2+ detection resulting from updated cervical cancer screening and management recommendations, as well as primary prevention through HPV vaccination. Increasing coverage of HPV vaccination in females at the routine age of 11 or 12 years and catch-up vaccination through age 26 years will contribute to further reduction in cervical precancers.

Human papillomavirus vaccination coverage among men who have sex with men-National HIV Behavioral Surveillance, United States, 2017.

Men who have sex with men (MSM) are at high risk for infections and diseases caused by human papillomavirus (HPV), many of which are vaccine-preventable. In the United States, routine HPV vaccination has been recommended for adolescent males since 2011. This analysis evaluated self-reported receipt of ≥ 1 HPV vaccine dose by age group and HIV status among adult MSM using 2017 data from National HIV Behavioral Surveillance (NHBS) and compared the proportion vaccinated to prior years. Among 10,381 MSM aged ≥ 18 years, 17.9% of MSM overall and 28.4% of MSM living with HIV reported any HPV vaccination. Among 2,482 MSM aged 18-26 years, 32.8% overall and 51.3% living with HIV reported HPV vaccination. Since 2011, the proportion of MSM aged 18-26 years reporting HPV vaccination has increased over six-fold. As vaccinated adolescents age into young adults, coverage will continue to increase overall, including among MSM.

Declines in Vaccine-Type Human Papillomavirus Prevalence in Females Across Racial/Ethnic Groups: Data From a National Survey.

PURPOSE: To monitor human papillomavirus (HPV) vaccine impact in the U.S., we evaluated quadrivalent vaccine (4vHPV)-type prevalence among females aged 14-34 years in the prevaccine (2003-2006) and vaccine (2013-2016) eras overall and by race/ethnicity in the National Health and Nutrition Examination Survey. METHODS: We analyzed HPV DNA prevalence in self-collected cervicovaginal specimens, demographic characteristics, sexual behavior, and self-reported/parent-reported vaccination status. We compared prevaccine to vaccine era 4vHPV-type prevalence, using unadjusted and adjusted prevalence ratios (PR and aPR) and 95% confidence intervals (CIs). PRs were calculated by race/ethnicity (non-Hispanic white [NHW], non-Hispanic black [NHB], and Mexican American [MA]). Overall aPRs were adjusted for race/ethnicity, lifetime sex partners, and poverty. RESULTS: Overall, 4,674 females had HPV typing results; 3,915 reported NHW, NHB, or MA race/ethnicity. Vaccination coverage of ≥1 dose was 53.9% among 14- to 19-year-olds (NHW 52.6%, NHB 58.1%, and MA 59.5%) and 51.5% among 20- to 24-year-olds (NHW 58.8%, NHB 45.0%, MA 33.8%). Among 14- to 19-year-olds, 4vHPV-type prevalence decreased overall (11.5% to 1.8%; aPR = .14 [CI: .08-.24]) and in NHW (PR = .14 [CI: .06-.29]), NHB (PR = .26 [CI: .12-.54]), and MA (PR = .13 [CI: .03-.53]). In 20- to 24-year-olds, 4vHPV-type prevalence decreased overall (18.5% to 5.3%; aPR = .29 [CI: .15-.56]) and in NHW (PR = .27 [CI: .11-.67]) and NHB (PR = .38 [CI: .18-.80]). No significant declines were observed in older age groups. CONCLUSIONS: Within 10 years of vaccine introduction, 4vHPV-type prevalence declined 86% among 14- to 19-year-olds, with declines observed in NHW, NHB, and MA females, and 71% among 20- to 24-year-olds, with declines in NHW and NHB females. These extraordinary declines should lead to substantial reductions in HPV-associated cancers.

Trends in Human Papillomavirus Vaccine Types 16 and 18 in Cervical Precancers, 2008-2014.

BACKGROUND: The impact of human papillomavirus (HPV) vaccination has been observed in the United States through declining cervical precancer incidence in young women. To further evaluate vaccine impact, we described trends in HPV vaccine types 16/18 in cervical precancers, 2008-2014. METHODS: We analyzed data from a 5-site, population-based surveillance system. Archived specimens from women age 18-39 years diagnosed with cervical intraepithelial neoplasia grades 2-3 or adenocarcinoma in situ (CIN2+) were tested for 37 HPV types. We described the proportion and estimated number of cases of CIN2+ by HPV-type groups over time. Trends in HPV16/18-positive CIN2+ were examined, overall and by vaccination status, age, histologic grade, and race/ethnicity, using Cochrane-Armitage tests. RESULTS: In 10,206 cases, the proportion and estimated number of cases of HPV16/18-positive CIN2+ declined from 52.7% (1,235 cases) in 2008 to 44.1% (819 cases) in 2014 (P < 0.001). Declining trends in the proportion of HPV16/18-positive CIN2+ were observed among vaccinated (55.2%-33.3%, P < 0.001) and unvaccinated (51.0%-47.3%, P = 0.03) women; ages 18-20 (48.7%-18.8%, P = 0.02), 21-24 (53.8%-44.0%, P < 0.001), 25-29 (56.9%-42.4%, P < 0.001), and 30-34 (49.8%-45.8%, P = 0.04) years; CIN2 (40.8%-29.9%, P < 0.001) and CIN2/3 (61.8%-46.2%, P < 0.001); non-Hispanic white (59.5%-47.9%, P < 0.001) and non-Hispanic black (40.7%-26.5%, P < 0.001). CONCLUSIONS: From 2008-2014, the proportion of HPV16/18-positive CIN2+ declined, with the greatest declines in vaccinated women; declines in unvaccinated women suggest herd protection. IMPACT: The declining proportion of HPV16/18-positive CIN2+ provides additional evidence of vaccine impact in the United States.

Financial burdens and mental health needs in families of children with congenital heart disease.

OBJECTIVE: To examine the financial burdens and mental health needs of families of children with special healthcare needs (CSHCN) with congenital heart disease (CHD). METHODS: Data from the 2009-2010 National Survey of Children with Special Health Care Needs (NS-CSHCN) were used to examine parent-reported financial burdens (out-of-pocket expenses, financial problems, employment impact, caregiving hours) and family members' need for mental health services in families of CSHCN with CHD. Multivariable logistic regression was used to compare financial burdens and family members' need for mental health services among CSHCN with and without CHD. Among CSHCN with CHD, multivariable logistic regression, stratified by age (0-5 and 6-17 years), was used to assess characteristics associated with the outcomes. RESULTS: Overall, families of 89.1% of CSHCN with CHD experienced at least one financial burden and 14.9% needed mental health services due to the child's condition. Compared with CSHCN without CHD, those with CHD had families with a higher prevalence of all financial burdens (adjusted prevalence ratio [aPR] range: 1.4-1.8) and similar family member need for mental health services (aPR = 1.3, 95% CI [1.0, 1.6]). Across both age groups, insurance type, activity limitations, and comorbidities were significantly associated with financial burdens and/or family members' need for mental health services. CONCLUSIONS: CSHCN with CHD, compared with those without CHD, lived in families with more financial burdens. Interventions that reduce financial burdens and improve mental health of family members are needed, especially among CSHCN with CHD who are uninsured and have comorbidities or activity limitations.