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Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus Vaccine Refusal

Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus Vaccine Refusal Letters Conflict of Interest Disclosures: Dr Urbina has received personal fees from the Safety Concerns or Adverse Effects National Lipid Association. Dr de Ferranti has received personal fees from as the Main Reason for Human Papillomavirus UpToDate. No other disclosures were reported. Vaccine Refusal: National Immunization Survey– Funding/Support: This work was supported by grant R01HL141823 from the Teen, 2008 to 2019 National Institutes of Health (Drs Moran and de Ferranti). The i3C Consortium Vaccination against the human papillomavirus (HPV) is was supported by grant R01 HL121230 from the National Institutes of Health. The Bogalusa Heart Study was supported by grants SCOR-A/P60 HL15103, effective at preventing several squamous cell carcinomas, U01 HL038844, R01 HL002942, R01 HD032194, R01 AG016592, R01 yet the population-level uptake of the vaccine remains low HD069587, R01 ES021724, R01 AG062309, R03 HD047247, R03 HD062783, in the US. Several factors contribute to HPV vaccine hesi- R03 AG060619, R21/R33 AG057983, and RF1 AG041200 from the tancy and refusal; of note, safety concerns rank consistently National Institutes of Health and grants 13SDG14650068 and 0160261B 1,2 from the American Heart Association. The Minneapolis Childhood Cohort high as a reason for nonvaccination. The COVID-19 pan- Studies were supported by grants R01 HL19877, R01 HL34659, R01 HL52851, demic has brought to the forefront the fragility of public and R01 DK072124 from the National Institutes of Health; K23 HL04000 confidence in the safety of vaccines. Therefore, this study from the Vikings Children’s Fund; and a Department of Pediatrics Legacy examines safety concerns or adverse effects of the HPV vac- Grant. The National Heart, Lung, and Blood Institute Growth and Health Study was supported by grants N01-HC055025, U01 HL48941, R01 HL52911, cine as the main reason for nonvaccination over an 11-year R01 HL66430, and R21/R33 AG057983 from the National Institutes of Health. period. The Princeton Lipid Research Study was supported by grants N01-HV022914L, R01 HL33973, R01 GM28719, R01 HL62394, R21 DK085363, and R21/R33 AG057983 from the National Heart, Lung, and Blood Institute and grant Methods | Data for this study were derived from the National 9750129N from the American Heart Association. Immunization Survey–Teen (NIS-Teen), spanning from 2008 Role of the Funder/Sponsor: The funders had no role in the design and to 2019. The NIS-Teen is a population-based survey of par- conduct of the study; collection, management, analysis, and interpretation of ents or guardians of adolescents aged 13 to 17 years in their the data; preparation, review, or approval of the manuscript; and decision to household and of their primary care professionals. The meth- submit the manuscript for publication. odology used for the NIS-Teen has been described previously. Additional Contributions: We thank Brandon K. Bellows, PharmD, MS (Division The NIS-Teen was approved by the National Center for Health of General Medicine, Columbia University Irving Medical Center, New York, New York); Dhruv S. Kazi, MD, MSc, MS (Richard A. and Susan F. Smith Center Statistics research ethics review board. NIS-Teen data are dei- for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, dentified and publicly available; therefore, the secondary data Boston, Massachusetts); Alan R. Sinaiko, MD (Department of Pediatrics, School analysis conducted in this study was exempt from institu- of Medicine, University of Minnesota, Minneapolis); Terence Dwyer, MBBS, MD, MPH (Murdoch Children’s Research Institute, Melbourne, Australia); Lydia A. tional review board approval and informed consent in accor- Bazzano, MD, PhD (Department of Epidemiology, Tulane University School of dance with the Common Rule and University of Texas MD Public Health and Tropical Medicine, New Orleans, Louisiana); Trudy L. Burns, Anderson Cancer Center policy. MPH, PhD (Department of Epidemiology, College of Public Health, University of The primary outcome was reporting of safety concerns or Iowa, Iowa City); Stephen R. Daniels, MD, PhD (Department of Pediatrics, University of Colorado School of Medicine, Aurora); Nina Hutri-Kähönen, MD adverse effects as the main reason for intention to refuse HPV (Tampere Centre for Skills Training and Simulation, Tampere University, vaccination for adolescents by their parent or guardian. This Tampere, Finland); Markus Juonala, MD, PhD (Department of Medicine, outcome was derived as a response to the survey question, University of Turku, Turku, Finland); Ronald J. Prineas, MD, PhD (Division of Public Health Science, Wake Forest University, Winston-Salem, North “What is the MAIN reason teen will not receive HPV shots in Carolina); Olli T. Raitakari, MD, PhD (Centre for Population Health Research, the next 12 months?” among those who had not received any University of Turku and Turku University Hospital, Turku, Finland); Alison HPV vaccine and had no clear intention of receiving the vac- Venn, PhD (Menzies Institute for Medical Research, University of cine. Joinpoint software version 4.8.0.1 (National Cancer Tasmania, Hobart, Australia); and Julia Steinberger, MD, MS (Department of Pediatrics, School of Medicine, University of Minnesota), for their very helpful comments to the manuscript. None of the contributors were compensated for their work. Figure. Prevalence of Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus (HPV) Vaccine Refusal: National 1. Dai S, Fulton JE, Harrist RB, Grunbaum JA, Steffen LM, Labarthe DR. Blood Immunization Survey–Teen, 2008 to 2019 lipids in children: age-related patterns and association with body-fat indices: Project HeartBeat! Am J Prev Med. 2009;37(1)(suppl):S56-S64. doi:10.1016/j. amepre.2009.04.012 2. de Ferranti SD, Rodday AM, Mendelson MM, Wong JB, Leslie LK, Sheldrick RC. Prevalence of familial hypercholesterolemia in the 1999 to 2012 United States National Health and Nutrition Examination Surveys (NHANES). Circulation. 2016;133(11):1067-1072. doi:10.1161/CIRCULATIONAHA.115.018791 3. Dwyer T, Sun C, Magnussen CG, et al. Cohort profile: the International Childhood Cardiovascular Cohort (i3C) Consortium. Int J Epidemiol. 2013;42(1): 86-96. doi:10.1093/ije/dys004 15 4. Kuczmarski RJ, Ogden CL, Guo SS, et al. 2000 CDC growth charts for the United States: methods and development. Vital Health Stat 11. 2002;(246):1-190. 5. Gidding SS, Champagne MA, de Ferranti SD, et al; American Heart Association Atherosclerosis, Hypertension, and Obesity in Young Committee of Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and Council on Lifestyle and Cardiometabolic Health. The agenda for familial 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 hypercholesterolemia: a scientific statement from the American Heart Association. Circulation. 2015;132(22):2167-2192. doi:10.1161/CIR. Year 1074 JAMA Pediatrics October 2021 Volume 175, Number 10 (Reprinted) jamapediatrics.com HPV vaccine refusal, % Letters jamapediatrics.com (Reprinted) JAMA Pediatrics October 2021 Volume 175, Number 10 1075 Table. Prevalence of Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus (HPV) Vaccine Refusal by Sociodemographic Characteristics: National Immunization Survey–Teen, 2008 to % (95% CI) Characteristic 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 Total, No. (%; 95% 1973 (26.2; 2013 (23.4; 2169 (22.1; 2065 (19.3; 1542 (12.9; 1387 (12.6; 1085 (10.7; 1215 (9.9; 1939 (11.1; 1881 (11.1; 519 (9.1; 276 (5.3; CI) 24.3-28.2) 21.9-25.1) 20.8-23.5) 18.1-20.6) 12.0-13.9) 11.5-13.8) 9.7-11.8) 9.0-10.9) 10.3-11.8) 10.3-12.0) 8.1-10.3) 4.4-6.5) Sex Male 23.2 19.9 19.3 15.5 10.5 8.4 (7.2-9.8) 7.5 (6.4-8.7) 5.9 (5.1-6.8) 7.1 (6.4-7.9) 5.0 (4.4-5.6) NA NA (20.9-25.8) (18.0-21.9) (17.6-21.1) (14.1-16.9) (9.4-11.7) Female 30.0 27.4 25.7 24.3 16.4 18.7 15.6 16.8 18.6 22.7 9.1 5.3 (4.4-6.5) (27.1-33.2) (24.9-30.1) (23.7-27.8) (22.3-26.5) (14.9-18.1) (16.7-20.9) (13.7-17.7) (14.8-18.9) (17.1-20.2) (20.7-24.9) (8.1-10.3) Race/ethnicity Non-Hispanic 29.7 26.7 24.4 21.4 15.0 13.1 11.7 10.1 11.4 11.0 10.3 5.7 (4.5-7.2) White (27.4-32.2) (24.8-28.8) (22.9-25.9) (20.0-22.9) (13.8-16.2) (11.9-14.5) (10.5-13.1) (9.2-11.1) (10.6-12.3) (10.2-12.0) (8.9-11.8) Non-Hispanic 19.6 14.0 15.6 17.3 8.4 (6.2-11.3) 10.6 8.8 (6.4-11.8) 10.2 10.8 10.6 7.1 6.8 Black (14.7-25.7) (10.6-18.1) (11.9-20.3) (13.2-22.3) (7.7-14.5) (7.5-13.7) (8.7-13.4) (8.7-12.8) (5.0-10.2) (4.1-11.0) Hispanic 20.9 17.4 16.9 13.7 9.9 (7.9-12.4) 11.9 8.3 (6.0-11.5) 10.4 11.5 11.8 7.2 3.0 (1.6-5.5) (16.5-26.3) (13.9-21.5) (13.3-21.3) (10.9-17.1) (8.6-16.2) (7.7-13.9) (9.3-14.2) (8.8-15.6) (4.7-10.9) Multiple/other 21.4 25.8 23.6 17.2 9.6 (7.3-12.6) 12.6 10.1 7.4 7.7 (5.9-10.0) 10.9 7.2 3.7 (2.1-6.6) (17.1-26.6) (20.2-32.4) (19.4-28.4) (13.8-21.3) (8.6-18.1) (7.2-14.1) (4.3-12.3) (8.6-13.8) (4.3-11.8) Maternal education, y <12 13.7 11.8 8.3 (6.2-11.1) 7.7 (5.6-10.6) 6.7 (4.8-9.4) 5.8 (3.7-9.0) 9.6 (6.2-14.5) 4.4 (2.9-6.7) 10.9 8.3 (5.8-11.6) 9.8 3.7 (2.1-6.4) (9.5-19.4) (8.6-15.9) (8.1-14.6) (6.1-15.3) 12 21.4 21.2 18.7 16.5 9.2 (7.6-11.2) 11.4 10.4 9.7 9.4 (8.1-11.0) 10.7 8.3 5.5 (3.5-8.3) (17.6-25.8) (17.9-25.0) (15.6-22.3) (14.0-19.3) (9.1-14.2) (8.4-12.9) (7.6-12.2) (9.3-12.4) (6.3-10.8) >12, Non–college 30.4 25.3 23.7 20.9 14.9 14.8 11.3 11.5 11.9 12.2 9.6 5.4 (3.9-7.4) graduate (26.8-34.3) (22.5-28.3) (21.4-26.2) (18.8-23.2) (13.1-16.8) (12.6-17.3) (9.7-13.2) (9.9-13.4) (10.5-13.4) (10.4-14.2) (7.8-11.7) College graduate 28.3 25.5 25.5 22.1 14.7 12.9 10.7 10.0 11.5 11.3 9.3 5.7 (4.1-7.9) (25.5-31.2) (23.0-28.1) (23.5-27.6) (20.2-24.2) (13.2-16.3) (11.3-14.8) (9.1-12.5) (8.7-11.5) (10.4-12.7) (10.1-12.6) (7.7-11.1) Poverty status (family income) Below poverty 18.9 21.9 16.1 12.7 11.4 10.4 11.0 9.3 10.1 9.2 (7.0-12.0) 8.9 1.9 (1.0-3.7) level (13.0-26.6) (17.0-27.9) (12.2-20.9) (9.9-16.0) (9.1-14.2) (7.9-13.7) (8.2-14.7) (6.6-13.1) (8.1-12.6) (5.8-13.3) Above poverty 27.2 24.0 22.0 20.2 11.8 12.7 10.9 9.1 11.2 11.2 9.3 5.8 (4.4-7.5) level (<$75 000) (24.3-30.4) (21.6-26.6) (20.0-24.3) (18.2-22.4) (10.5-13.3) (10.9-14.7) (9.3-12.6) (7.9-10.5) (10.1-12.4) (10.1-12.4) (7.7-11.1) Above poverty 28.2 23.7 24.3 20.4 14.3 13.0 10.3 10.9 11.1 11.7 9.7 6.6 (4.7-9.2) level (>$75 000) (25.6-30.9) (21.5-26.0) (22.4-26.4) (18.8-22.2) (12.9-15.9) (11.4-14.8) (8.8-11.9) (9.6-12.3) (10.1-12.3) (10.4-13.1) (8.0-11.6) Abbreviation: NA, not applicable. American Indian, Alaska Native, Asian, Native Hawaiian, Pacific Islander, and those who selected more than one a race. HPV vaccination data for male children were not obtainable in 2008 and 2009 because of the absence of sex-neutral vaccination at this time. Poverty level is defined according to the US Centers for Disease Control and Prevention National Immunization b Survey–Teen based on family income and number of children (https://www.cdc.gov/vaccines/imz-managers/nis/ These categories were consolidated by the NIS Teen survey administrators after participants answered multiple downloads/NIS-TEEN-PUF19-CODEBOOK.pdf). open-ended questions regarding their race and ethnicity (https://www.cdc.gov/vaccines/imz-managers/nis/ downloads/NIS-Teen-Questionnaire-Q4-2019-508.pdf, 40-44). Race/ethnicity responses represented include Letters Institute) was used to evaluate safety concerns and adverse study is not without limitations, including low response rate effects over the study period. Weighted prevalence of safety and potential nonresponse bias. However, statistical adjust- concerns or adverse effects as the main reason for HPV non- ments, including standard weighting procedures, have been vaccination were estimated for the overall population and applied to account for such potential biases. by sociodemographic characteristics using R version 4.0.3 (The R Foundation). Tests were 2-tailed and significance was Onyema Greg Chido-Amajuoyi, MBBS, MPH set at P < .05. Rajesh Talluri, PhD Sahil S. Shete, BA Results | Self-reports of safety concerns or adverse effects as the Sanjay Shete, PhD main reason for HPV vaccine refusal increased over the study period. The prevalence increased from 5.3% (95% CI, 4.4-6.5) Author Affiliations: Department of Epidemiology, The University of Texas MD Anderson Cancer Center, Houston (Chido-Amajuoyi, S. Shete); Department of in 2008 to 12.9% (95% CI, 12.0-13.9) in 2015 with a slope of 0.9% Data Science, The University of Mississippi Medical Center, Jackson (Talluri); increase per year. However, the prevalence substantially in- Department of Psychology and Counseling, The University of Texas at Tyler creased from 12.9% (95% CI, 12.0-13.9) in 2015 to 26.2% (95% (S. S. Shete); Division of Cancer Prevention and Population Sciences, The CI, 24.3-28.2) in 2019 with a slope of 3.5% increase per year. University of Texas MD Anderson Cancer Center, Houston (S. Shete); Department of Biostatistics, The University of Texas MD Anderson Cancer The change in slope before and after 2015 was statistically sig- Center, Houston (S. Shete). nificant (0.9% vs 3.5%; difference, 2.6%; 95% CI, 0.7-4.6; Accepted for Publication: April 7, 2021. P = .03) (Figure). Throughout the study period, higher rates of Published Online: June 28, 2021. doi:10.1001/jamapediatrics.2021.1585 safety concerns or adverse effects as the main reason for non- Open Access: This is an open access article distributed under the terms of the CC- vaccination were reported by non-Hispanic White parents or BY License. © 2021 Chido-Amajuoyi OG et al. JAMA Pediatrics. guardians and by parents or guardians of teenaged girls (Table). Corresponding Author: Sanjay Shete, PhD, Division of Cancer Prevention and From 2008 to 2013, mothers who were college graduates had Population Sciences, The University of Texas MD Anderson Cancer Center, 1400 rates of reporting safety concerns or adverse effects compa- Pressler Dr, FCT4.6002, Houston, TX 77030 (sshete@mdanderson.org). rable with those among mothers with less than 12 years of edu- Author Contributions: Drs Talluri and Sanjay Shete had full access to all of the data in the study and take responsibility for the integrity of the data and the cation. However, from 2014 to 2019, there was a statistically accuracy of the data analysis. Drs Chido-Amajuoyi and Talluri contributed significant increase in the reporting of safety concerns or ad- equally as co–first authors. verse effects as the main reason for HPV nonvaccination by Concept and design: Chido-Amajuoyi, Talluri, Sanjay Shete. mothers with college degrees compared with those with less Acquisition, analysis, or interpretation of data: All authors. Drafting of the manuscript: Chido-Amajuoyi, Talluri, Sahil S. Shete. than 12 years of education (eg, 28.3% [95% CI, 25.5-31.2] among Critical revision of the manuscript for important intellectual content: All authors. mothers with college degrees vs 13.7% [95% CI, 9.5-19.4] among Statistical analysis: Talluri. mothers with less than 12 years of education in 2019) (Table). Obtained funding: Sanjay Shete. Administrative, technical, or material support: Sanjay Shete. Supervision: Sanjay Shete. Discussion | Overall, study findings suggest that safety con- Conflict of Interest Disclosures: None reported. cerns or adverse effects as the main reason for refusing HPV Funding/Support: The study was funded by grant P30CA016672 from the vaccination increased over the years. This finding has several National Cancer Institute (Sanjay Shete), the Betty B. Marcus Chair in Cancer important implications. First, given that concerns about vac- Prevention (Sanjay Shete), the Duncan Family Institute for Cancer Prevention cine safety are critical for vaccine confidence, rising safety con- and Risk Assessment (Sanjay Shete), and grant RP170259 from the Cancer Prevention Research Institute of Texas (Sanjay Shete). cerns could negatively affect HPV vaccine uptake at the popu- Role of Funder/Sponsor: The funders had no role in the design and conduct of lation level. Considering recent evidence of slowing routine 5 the study; collection, management, analysis, and interpretation of the data; HPV vaccination uptake, addressing safety concerns about preparation, review, or approval of the manuscript; and decision to submit the vaccines should be of utmost public health importance. manuscript for publication. Second, the findings of this study suggest that disinforma- 1. Hanson KE, Koch B, Bonner K, McRee AL, Basta NE. National trends in tion campaigns aimed at hampering vaccine trust are thriving. parental human papillomavirus vaccination intentions and reasons for In the US, there has been a substantial rise of vaccine misinfor- hesitancy, 2010-2015. Clin Infect Dis. 2018;67(7):1018-1026. doi:10.1093/cid/ciy232 mation that has culminated in public mistrust in vaccines. The 2. Thompson EL, Rosen BL, Vamos CA, Kadono M, Daley EM. Human advent of social media and its exponential growth in popular- papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents? J Adolesc Health. 2017;61(3):288-293. doi:10.1016/j.jadohealth. ity have served as a catalyst for spreading misinformation to a 2017.05.015 wider audience within the general public. In some instances, 3. Verger P, Dubé E. Restoring confidence in vaccines in the COVID-19 era. misinformation has also been supported by influential public Expert Rev Vaccines. 2020;19(11):991-993. doi:10.1080/14760584.2020.1825945 and political figures. While our findings point to a need for wide- 4. National Center for Immunization and Respiratory Diseases. National spread dissemination of educational programs within the gen- Immunization Survey–Teen: a user’s guide for the 2016 public-use data file. eral population, it is also crucial that public health agencies Accessed May 20, 2021. https://www.cdc.gov/vaccines/imz-managers/nis/ downloads/NIS-TEEN-PUF16-DUG.pdf work with social media companies to develop campaigns to 5. Chido-Amajuoyi OG, Talluri R, Wonodi C, Shete S. Trends in HPV vaccination combat misinformation online. Lastly, physicians have a cru- initiation and completion within ages 9-12 years: 2008-2018. Pediatrics. Published cial frontline role to play in addressing vaccine hesitancy dur- online May 3, 2021. doi:10.1542/peds.2020-012765 ing parent-physician encounters. 6. Chido-Amajuoyi OG, Jackson I, Yu R, Shete S. Declining awareness of HPV Despite several strengths of our study, including using a and HPV vaccine within the general US population. Hum Vaccin Immunother. rigorously designed nationally representative sample, our 2021;17(2):420-427. doi:10.1080/21645515.2020.1783952 1076 JAMA Pediatrics October 2021 Volume 175, Number 10 (Reprinted) jamapediatrics.com http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Pediatrics American Medical Association

Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus Vaccine Refusal

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American Medical Association
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Copyright 2021 Chido-Amajuoyi OG et al. JAMA Pediatrics.
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Abstract

Letters Conflict of Interest Disclosures: Dr Urbina has received personal fees from the Safety Concerns or Adverse Effects National Lipid Association. Dr de Ferranti has received personal fees from as the Main Reason for Human Papillomavirus UpToDate. No other disclosures were reported. Vaccine Refusal: National Immunization Survey– Funding/Support: This work was supported by grant R01HL141823 from the Teen, 2008 to 2019 National Institutes of Health (Drs Moran and de Ferranti). The i3C Consortium Vaccination against the human papillomavirus (HPV) is was supported by grant R01 HL121230 from the National Institutes of Health. The Bogalusa Heart Study was supported by grants SCOR-A/P60 HL15103, effective at preventing several squamous cell carcinomas, U01 HL038844, R01 HL002942, R01 HD032194, R01 AG016592, R01 yet the population-level uptake of the vaccine remains low HD069587, R01 ES021724, R01 AG062309, R03 HD047247, R03 HD062783, in the US. Several factors contribute to HPV vaccine hesi- R03 AG060619, R21/R33 AG057983, and RF1 AG041200 from the tancy and refusal; of note, safety concerns rank consistently National Institutes of Health and grants 13SDG14650068 and 0160261B 1,2 from the American Heart Association. The Minneapolis Childhood Cohort high as a reason for nonvaccination. The COVID-19 pan- Studies were supported by grants R01 HL19877, R01 HL34659, R01 HL52851, demic has brought to the forefront the fragility of public and R01 DK072124 from the National Institutes of Health; K23 HL04000 confidence in the safety of vaccines. Therefore, this study from the Vikings Children’s Fund; and a Department of Pediatrics Legacy examines safety concerns or adverse effects of the HPV vac- Grant. The National Heart, Lung, and Blood Institute Growth and Health Study was supported by grants N01-HC055025, U01 HL48941, R01 HL52911, cine as the main reason for nonvaccination over an 11-year R01 HL66430, and R21/R33 AG057983 from the National Institutes of Health. period. The Princeton Lipid Research Study was supported by grants N01-HV022914L, R01 HL33973, R01 GM28719, R01 HL62394, R21 DK085363, and R21/R33 AG057983 from the National Heart, Lung, and Blood Institute and grant Methods | Data for this study were derived from the National 9750129N from the American Heart Association. Immunization Survey–Teen (NIS-Teen), spanning from 2008 Role of the Funder/Sponsor: The funders had no role in the design and to 2019. The NIS-Teen is a population-based survey of par- conduct of the study; collection, management, analysis, and interpretation of ents or guardians of adolescents aged 13 to 17 years in their the data; preparation, review, or approval of the manuscript; and decision to household and of their primary care professionals. The meth- submit the manuscript for publication. odology used for the NIS-Teen has been described previously. Additional Contributions: We thank Brandon K. Bellows, PharmD, MS (Division The NIS-Teen was approved by the National Center for Health of General Medicine, Columbia University Irving Medical Center, New York, New York); Dhruv S. Kazi, MD, MSc, MS (Richard A. and Susan F. Smith Center Statistics research ethics review board. NIS-Teen data are dei- for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, dentified and publicly available; therefore, the secondary data Boston, Massachusetts); Alan R. Sinaiko, MD (Department of Pediatrics, School analysis conducted in this study was exempt from institu- of Medicine, University of Minnesota, Minneapolis); Terence Dwyer, MBBS, MD, MPH (Murdoch Children’s Research Institute, Melbourne, Australia); Lydia A. tional review board approval and informed consent in accor- Bazzano, MD, PhD (Department of Epidemiology, Tulane University School of dance with the Common Rule and University of Texas MD Public Health and Tropical Medicine, New Orleans, Louisiana); Trudy L. Burns, Anderson Cancer Center policy. MPH, PhD (Department of Epidemiology, College of Public Health, University of The primary outcome was reporting of safety concerns or Iowa, Iowa City); Stephen R. Daniels, MD, PhD (Department of Pediatrics, University of Colorado School of Medicine, Aurora); Nina Hutri-Kähönen, MD adverse effects as the main reason for intention to refuse HPV (Tampere Centre for Skills Training and Simulation, Tampere University, vaccination for adolescents by their parent or guardian. This Tampere, Finland); Markus Juonala, MD, PhD (Department of Medicine, outcome was derived as a response to the survey question, University of Turku, Turku, Finland); Ronald J. Prineas, MD, PhD (Division of Public Health Science, Wake Forest University, Winston-Salem, North “What is the MAIN reason teen will not receive HPV shots in Carolina); Olli T. Raitakari, MD, PhD (Centre for Population Health Research, the next 12 months?” among those who had not received any University of Turku and Turku University Hospital, Turku, Finland); Alison HPV vaccine and had no clear intention of receiving the vac- Venn, PhD (Menzies Institute for Medical Research, University of cine. Joinpoint software version 4.8.0.1 (National Cancer Tasmania, Hobart, Australia); and Julia Steinberger, MD, MS (Department of Pediatrics, School of Medicine, University of Minnesota), for their very helpful comments to the manuscript. None of the contributors were compensated for their work. Figure. Prevalence of Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus (HPV) Vaccine Refusal: National 1. Dai S, Fulton JE, Harrist RB, Grunbaum JA, Steffen LM, Labarthe DR. Blood Immunization Survey–Teen, 2008 to 2019 lipids in children: age-related patterns and association with body-fat indices: Project HeartBeat! Am J Prev Med. 2009;37(1)(suppl):S56-S64. doi:10.1016/j. amepre.2009.04.012 2. de Ferranti SD, Rodday AM, Mendelson MM, Wong JB, Leslie LK, Sheldrick RC. Prevalence of familial hypercholesterolemia in the 1999 to 2012 United States National Health and Nutrition Examination Surveys (NHANES). Circulation. 2016;133(11):1067-1072. doi:10.1161/CIRCULATIONAHA.115.018791 3. Dwyer T, Sun C, Magnussen CG, et al. Cohort profile: the International Childhood Cardiovascular Cohort (i3C) Consortium. Int J Epidemiol. 2013;42(1): 86-96. doi:10.1093/ije/dys004 15 4. Kuczmarski RJ, Ogden CL, Guo SS, et al. 2000 CDC growth charts for the United States: methods and development. Vital Health Stat 11. 2002;(246):1-190. 5. Gidding SS, Champagne MA, de Ferranti SD, et al; American Heart Association Atherosclerosis, Hypertension, and Obesity in Young Committee of Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and Council on Lifestyle and Cardiometabolic Health. The agenda for familial 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 hypercholesterolemia: a scientific statement from the American Heart Association. Circulation. 2015;132(22):2167-2192. doi:10.1161/CIR. Year 1074 JAMA Pediatrics October 2021 Volume 175, Number 10 (Reprinted) jamapediatrics.com HPV vaccine refusal, % Letters jamapediatrics.com (Reprinted) JAMA Pediatrics October 2021 Volume 175, Number 10 1075 Table. Prevalence of Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus (HPV) Vaccine Refusal by Sociodemographic Characteristics: National Immunization Survey–Teen, 2008 to % (95% CI) Characteristic 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 Total, No. (%; 95% 1973 (26.2; 2013 (23.4; 2169 (22.1; 2065 (19.3; 1542 (12.9; 1387 (12.6; 1085 (10.7; 1215 (9.9; 1939 (11.1; 1881 (11.1; 519 (9.1; 276 (5.3; CI) 24.3-28.2) 21.9-25.1) 20.8-23.5) 18.1-20.6) 12.0-13.9) 11.5-13.8) 9.7-11.8) 9.0-10.9) 10.3-11.8) 10.3-12.0) 8.1-10.3) 4.4-6.5) Sex Male 23.2 19.9 19.3 15.5 10.5 8.4 (7.2-9.8) 7.5 (6.4-8.7) 5.9 (5.1-6.8) 7.1 (6.4-7.9) 5.0 (4.4-5.6) NA NA (20.9-25.8) (18.0-21.9) (17.6-21.1) (14.1-16.9) (9.4-11.7) Female 30.0 27.4 25.7 24.3 16.4 18.7 15.6 16.8 18.6 22.7 9.1 5.3 (4.4-6.5) (27.1-33.2) (24.9-30.1) (23.7-27.8) (22.3-26.5) (14.9-18.1) (16.7-20.9) (13.7-17.7) (14.8-18.9) (17.1-20.2) (20.7-24.9) (8.1-10.3) Race/ethnicity Non-Hispanic 29.7 26.7 24.4 21.4 15.0 13.1 11.7 10.1 11.4 11.0 10.3 5.7 (4.5-7.2) White (27.4-32.2) (24.8-28.8) (22.9-25.9) (20.0-22.9) (13.8-16.2) (11.9-14.5) (10.5-13.1) (9.2-11.1) (10.6-12.3) (10.2-12.0) (8.9-11.8) Non-Hispanic 19.6 14.0 15.6 17.3 8.4 (6.2-11.3) 10.6 8.8 (6.4-11.8) 10.2 10.8 10.6 7.1 6.8 Black (14.7-25.7) (10.6-18.1) (11.9-20.3) (13.2-22.3) (7.7-14.5) (7.5-13.7) (8.7-13.4) (8.7-12.8) (5.0-10.2) (4.1-11.0) Hispanic 20.9 17.4 16.9 13.7 9.9 (7.9-12.4) 11.9 8.3 (6.0-11.5) 10.4 11.5 11.8 7.2 3.0 (1.6-5.5) (16.5-26.3) (13.9-21.5) (13.3-21.3) (10.9-17.1) (8.6-16.2) (7.7-13.9) (9.3-14.2) (8.8-15.6) (4.7-10.9) Multiple/other 21.4 25.8 23.6 17.2 9.6 (7.3-12.6) 12.6 10.1 7.4 7.7 (5.9-10.0) 10.9 7.2 3.7 (2.1-6.6) (17.1-26.6) (20.2-32.4) (19.4-28.4) (13.8-21.3) (8.6-18.1) (7.2-14.1) (4.3-12.3) (8.6-13.8) (4.3-11.8) Maternal education, y <12 13.7 11.8 8.3 (6.2-11.1) 7.7 (5.6-10.6) 6.7 (4.8-9.4) 5.8 (3.7-9.0) 9.6 (6.2-14.5) 4.4 (2.9-6.7) 10.9 8.3 (5.8-11.6) 9.8 3.7 (2.1-6.4) (9.5-19.4) (8.6-15.9) (8.1-14.6) (6.1-15.3) 12 21.4 21.2 18.7 16.5 9.2 (7.6-11.2) 11.4 10.4 9.7 9.4 (8.1-11.0) 10.7 8.3 5.5 (3.5-8.3) (17.6-25.8) (17.9-25.0) (15.6-22.3) (14.0-19.3) (9.1-14.2) (8.4-12.9) (7.6-12.2) (9.3-12.4) (6.3-10.8) >12, Non–college 30.4 25.3 23.7 20.9 14.9 14.8 11.3 11.5 11.9 12.2 9.6 5.4 (3.9-7.4) graduate (26.8-34.3) (22.5-28.3) (21.4-26.2) (18.8-23.2) (13.1-16.8) (12.6-17.3) (9.7-13.2) (9.9-13.4) (10.5-13.4) (10.4-14.2) (7.8-11.7) College graduate 28.3 25.5 25.5 22.1 14.7 12.9 10.7 10.0 11.5 11.3 9.3 5.7 (4.1-7.9) (25.5-31.2) (23.0-28.1) (23.5-27.6) (20.2-24.2) (13.2-16.3) (11.3-14.8) (9.1-12.5) (8.7-11.5) (10.4-12.7) (10.1-12.6) (7.7-11.1) Poverty status (family income) Below poverty 18.9 21.9 16.1 12.7 11.4 10.4 11.0 9.3 10.1 9.2 (7.0-12.0) 8.9 1.9 (1.0-3.7) level (13.0-26.6) (17.0-27.9) (12.2-20.9) (9.9-16.0) (9.1-14.2) (7.9-13.7) (8.2-14.7) (6.6-13.1) (8.1-12.6) (5.8-13.3) Above poverty 27.2 24.0 22.0 20.2 11.8 12.7 10.9 9.1 11.2 11.2 9.3 5.8 (4.4-7.5) level (<$75 000) (24.3-30.4) (21.6-26.6) (20.0-24.3) (18.2-22.4) (10.5-13.3) (10.9-14.7) (9.3-12.6) (7.9-10.5) (10.1-12.4) (10.1-12.4) (7.7-11.1) Above poverty 28.2 23.7 24.3 20.4 14.3 13.0 10.3 10.9 11.1 11.7 9.7 6.6 (4.7-9.2) level (>$75 000) (25.6-30.9) (21.5-26.0) (22.4-26.4) (18.8-22.2) (12.9-15.9) (11.4-14.8) (8.8-11.9) (9.6-12.3) (10.1-12.3) (10.4-13.1) (8.0-11.6) Abbreviation: NA, not applicable. American Indian, Alaska Native, Asian, Native Hawaiian, Pacific Islander, and those who selected more than one a race. HPV vaccination data for male children were not obtainable in 2008 and 2009 because of the absence of sex-neutral vaccination at this time. Poverty level is defined according to the US Centers for Disease Control and Prevention National Immunization b Survey–Teen based on family income and number of children (https://www.cdc.gov/vaccines/imz-managers/nis/ These categories were consolidated by the NIS Teen survey administrators after participants answered multiple downloads/NIS-TEEN-PUF19-CODEBOOK.pdf). open-ended questions regarding their race and ethnicity (https://www.cdc.gov/vaccines/imz-managers/nis/ downloads/NIS-Teen-Questionnaire-Q4-2019-508.pdf, 40-44). Race/ethnicity responses represented include Letters Institute) was used to evaluate safety concerns and adverse study is not without limitations, including low response rate effects over the study period. Weighted prevalence of safety and potential nonresponse bias. However, statistical adjust- concerns or adverse effects as the main reason for HPV non- ments, including standard weighting procedures, have been vaccination were estimated for the overall population and applied to account for such potential biases. by sociodemographic characteristics using R version 4.0.3 (The R Foundation). Tests were 2-tailed and significance was Onyema Greg Chido-Amajuoyi, MBBS, MPH set at P < .05. Rajesh Talluri, PhD Sahil S. Shete, BA Results | Self-reports of safety concerns or adverse effects as the Sanjay Shete, PhD main reason for HPV vaccine refusal increased over the study period. The prevalence increased from 5.3% (95% CI, 4.4-6.5) Author Affiliations: Department of Epidemiology, The University of Texas MD Anderson Cancer Center, Houston (Chido-Amajuoyi, S. Shete); Department of in 2008 to 12.9% (95% CI, 12.0-13.9) in 2015 with a slope of 0.9% Data Science, The University of Mississippi Medical Center, Jackson (Talluri); increase per year. However, the prevalence substantially in- Department of Psychology and Counseling, The University of Texas at Tyler creased from 12.9% (95% CI, 12.0-13.9) in 2015 to 26.2% (95% (S. S. Shete); Division of Cancer Prevention and Population Sciences, The CI, 24.3-28.2) in 2019 with a slope of 3.5% increase per year. University of Texas MD Anderson Cancer Center, Houston (S. Shete); Department of Biostatistics, The University of Texas MD Anderson Cancer The change in slope before and after 2015 was statistically sig- Center, Houston (S. Shete). nificant (0.9% vs 3.5%; difference, 2.6%; 95% CI, 0.7-4.6; Accepted for Publication: April 7, 2021. P = .03) (Figure). Throughout the study period, higher rates of Published Online: June 28, 2021. doi:10.1001/jamapediatrics.2021.1585 safety concerns or adverse effects as the main reason for non- Open Access: This is an open access article distributed under the terms of the CC- vaccination were reported by non-Hispanic White parents or BY License. © 2021 Chido-Amajuoyi OG et al. JAMA Pediatrics. guardians and by parents or guardians of teenaged girls (Table). Corresponding Author: Sanjay Shete, PhD, Division of Cancer Prevention and From 2008 to 2013, mothers who were college graduates had Population Sciences, The University of Texas MD Anderson Cancer Center, 1400 rates of reporting safety concerns or adverse effects compa- Pressler Dr, FCT4.6002, Houston, TX 77030 (sshete@mdanderson.org). rable with those among mothers with less than 12 years of edu- Author Contributions: Drs Talluri and Sanjay Shete had full access to all of the data in the study and take responsibility for the integrity of the data and the cation. However, from 2014 to 2019, there was a statistically accuracy of the data analysis. Drs Chido-Amajuoyi and Talluri contributed significant increase in the reporting of safety concerns or ad- equally as co–first authors. verse effects as the main reason for HPV nonvaccination by Concept and design: Chido-Amajuoyi, Talluri, Sanjay Shete. mothers with college degrees compared with those with less Acquisition, analysis, or interpretation of data: All authors. Drafting of the manuscript: Chido-Amajuoyi, Talluri, Sahil S. Shete. than 12 years of education (eg, 28.3% [95% CI, 25.5-31.2] among Critical revision of the manuscript for important intellectual content: All authors. mothers with college degrees vs 13.7% [95% CI, 9.5-19.4] among Statistical analysis: Talluri. mothers with less than 12 years of education in 2019) (Table). Obtained funding: Sanjay Shete. Administrative, technical, or material support: Sanjay Shete. Supervision: Sanjay Shete. Discussion | Overall, study findings suggest that safety con- Conflict of Interest Disclosures: None reported. cerns or adverse effects as the main reason for refusing HPV Funding/Support: The study was funded by grant P30CA016672 from the vaccination increased over the years. This finding has several National Cancer Institute (Sanjay Shete), the Betty B. Marcus Chair in Cancer important implications. First, given that concerns about vac- Prevention (Sanjay Shete), the Duncan Family Institute for Cancer Prevention cine safety are critical for vaccine confidence, rising safety con- and Risk Assessment (Sanjay Shete), and grant RP170259 from the Cancer Prevention Research Institute of Texas (Sanjay Shete). cerns could negatively affect HPV vaccine uptake at the popu- Role of Funder/Sponsor: The funders had no role in the design and conduct of lation level. Considering recent evidence of slowing routine 5 the study; collection, management, analysis, and interpretation of the data; HPV vaccination uptake, addressing safety concerns about preparation, review, or approval of the manuscript; and decision to submit the vaccines should be of utmost public health importance. manuscript for publication. Second, the findings of this study suggest that disinforma- 1. Hanson KE, Koch B, Bonner K, McRee AL, Basta NE. National trends in tion campaigns aimed at hampering vaccine trust are thriving. parental human papillomavirus vaccination intentions and reasons for In the US, there has been a substantial rise of vaccine misinfor- hesitancy, 2010-2015. Clin Infect Dis. 2018;67(7):1018-1026. doi:10.1093/cid/ciy232 mation that has culminated in public mistrust in vaccines. The 2. Thompson EL, Rosen BL, Vamos CA, Kadono M, Daley EM. Human advent of social media and its exponential growth in popular- papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents? J Adolesc Health. 2017;61(3):288-293. doi:10.1016/j.jadohealth. ity have served as a catalyst for spreading misinformation to a 2017.05.015 wider audience within the general public. In some instances, 3. Verger P, Dubé E. Restoring confidence in vaccines in the COVID-19 era. misinformation has also been supported by influential public Expert Rev Vaccines. 2020;19(11):991-993. doi:10.1080/14760584.2020.1825945 and political figures. While our findings point to a need for wide- 4. National Center for Immunization and Respiratory Diseases. National spread dissemination of educational programs within the gen- Immunization Survey–Teen: a user’s guide for the 2016 public-use data file. eral population, it is also crucial that public health agencies Accessed May 20, 2021. https://www.cdc.gov/vaccines/imz-managers/nis/ downloads/NIS-TEEN-PUF16-DUG.pdf work with social media companies to develop campaigns to 5. Chido-Amajuoyi OG, Talluri R, Wonodi C, Shete S. Trends in HPV vaccination combat misinformation online. Lastly, physicians have a cru- initiation and completion within ages 9-12 years: 2008-2018. Pediatrics. Published cial frontline role to play in addressing vaccine hesitancy dur- online May 3, 2021. doi:10.1542/peds.2020-012765 ing parent-physician encounters. 6. Chido-Amajuoyi OG, Jackson I, Yu R, Shete S. Declining awareness of HPV Despite several strengths of our study, including using a and HPV vaccine within the general US population. Hum Vaccin Immunother. rigorously designed nationally representative sample, our 2021;17(2):420-427. doi:10.1080/21645515.2020.1783952 1076 JAMA Pediatrics October 2021 Volume 175, Number 10 (Reprinted) jamapediatrics.com

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