Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus Vaccine Refusal: National Immunization Survey–Teen, 2008 to 2019 | Adolescent Medicine | JAMA Pediatrics | JAMA Network
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Figure.  Prevalence of Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus (HPV) Vaccine Refusal: National Immunization Survey–Teen, 2008 to 2019
Prevalence of Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus (HPV) Vaccine Refusal: National Immunization Survey–Teen, 2008 to 2019
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 2019
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 2019
1.
Hanson  KE, Koch  B, Bonner  K, McRee  AL, Basta  NE.  National trends in parental human papillomavirus vaccination intentions and reasons for hesitancy, 2010-2015.   Clin Infect Dis. 2018;67(7):1018-1026. doi:10.1093/cid/ciy232PubMedGoogle ScholarCrossref
2.
Thompson  EL, Rosen  BL, Vamos  CA, Kadono  M, Daley  EM.  Human papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents?   J Adolesc Health. 2017;61(3):288-293. doi:10.1016/j.jadohealth.2017.05.015PubMedGoogle ScholarCrossref
3.
Verger  P, Dubé  E.  Restoring confidence in vaccines in the COVID-19 era.   Expert Rev Vaccines. 2020;19(11):991-993. doi:10.1080/14760584.2020.1825945PubMedGoogle ScholarCrossref
4.
National Center for Immunization and Respiratory Diseases. National Immunization Survey–Teen: a user’s guide for the 2016 public-use data file. Accessed May 20, 2021. https://www.cdc.gov/vaccines/imz-managers/nis/downloads/NIS-TEEN-PUF16-DUG.pdf
5.
Chido-Amajuoyi  OG, Talluri  R, Wonodi  C, Shete  S.  Trends in HPV vaccination initiation and completion within ages 9-12 years: 2008-2018.   Pediatrics. Published online May 3, 2021. doi:10.1542/peds.2020-012765PubMedGoogle Scholar
6.
Chido-Amajuoyi  OG, Jackson  I, Yu  R, Shete  S.  Declining awareness of HPV and HPV vaccine within the general US population.   Hum Vaccin Immunother. 2021;17(2):420-427. doi:10.1080/21645515.2020.1783952PubMedGoogle ScholarCrossref
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    1 Comment for this article
    EXPAND ALL
    Vaccine safety confidence: it’s time to redesign the system
    Eileen Natuzzi, MD, MPH | Retired surgeon and epidemiologist
    Thank you for this study on vaccine safety concerns and HPV vaccines.
    In the paper the authors listed measures that could enhance trust in vaccines. Redesigning, upgrading and relocating our vaccine safety surveillance system could do a great deal to increase confidence. At present the system is archaic, understaffed, underfunded, unresponsive and leads from behind when compared with the EU. It does little to instill confidence. It should be moved from the FDA and CDC and redeveloped within a multidisciplinary public private partnership that is free of manufacturer influence and serves the people.
    Vaccines are one of the
    greatest public health tools we have but we fail to study, improve development of and understand them thru the lens of safety. It’s time for a safety upgrade.
    CONFLICT OF INTEREST: None Reported
    READ MORE
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    Research Letter
    June 28, 2021

    Safety Concerns or Adverse Effects as the Main Reason for Human Papillomavirus Vaccine Refusal: National Immunization Survey–Teen, 2008 to 2019

    Author Affiliations
    • 1Department of Epidemiology, The University of Texas MD Anderson Cancer Center, Houston
    • 2Department of Data Science, The University of Mississippi Medical Center, Jackson
    • 3Department of Psychology and Counseling, The University of Texas at Tyler
    • 4Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston
    • 5Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston
    JAMA Pediatr. Published online June 28, 2021. doi:10.1001/jamapediatrics.2021.1585

    Vaccination against the human papillomavirus (HPV) is effective at preventing several squamous cell carcinomas, yet the population-level uptake of the vaccine remains low in the US. Several factors contribute to HPV vaccine hesitancy and refusal; of note, safety concerns rank consistently high as a reason for nonvaccination.1,2 The COVID-19 pandemic has brought to the forefront the fragility of public confidence in the safety of vaccines.3 Therefore, this study examines safety concerns or adverse effects of the HPV vaccine as the main reason for nonvaccination over an 11-year period.

    Methods

    Data for this study were derived from the National Immunization Survey–Teen (NIS-Teen), spanning from 2008 to 2019. The NIS-Teen is a population-based survey of parents or guardians of adolescents aged 13 to 17 years in their household and of their primary care professionals. The methodology used for the NIS-Teen has been described previously.4 The NIS-Teen was approved by the National Center for Health Statistics research ethics review board. NIS-Teen data are deidentified and publicly available; therefore, the secondary data analysis conducted in this study was exempt from institutional review board approval and informed consent in accordance with the Common Rule and University of Texas MD Anderson Cancer Center policy.

    The primary outcome was reporting of safety concerns or adverse effects as the main reason for intention to refuse HPV vaccination for adolescents by their parent or guardian. This outcome was derived as a response to the survey question, “What is the MAIN reason teen will not receive HPV shots in the next 12 months?” among those who had not received any HPV vaccine and had no clear intention of receiving the vaccine. Joinpoint software version 4.8.0.1 (National Cancer Institute) was used to evaluate safety concerns and adverse effects over the study period. Weighted prevalence of safety concerns or adverse effects as the main reason for HPV nonvaccination were estimated for the overall population and by sociodemographic characteristics using R version 4.0.3 (The R Foundation). Tests were 2-tailed and significance was set at P < .05.

    Results

    Self-reports of safety concerns or adverse effects as the main reason for HPV vaccine refusal increased over the study period. The prevalence increased from 5.3% (95% CI, 4.4-6.5) in 2008 to 12.9% (95% CI, 12.0-13.9) in 2015 with a slope of 0.9% increase per year. However, the prevalence substantially increased from 12.9% (95% CI, 12.0-13.9) in 2015 to 26.2% (95% CI, 24.3-28.2) in 2019 with a slope of 3.5% increase per year. The change in slope before and after 2015 was statistically significant (0.9% vs 3.5%; difference, 2.6%; 95% CI, 0.7-4.6; P = .03) (Figure). Throughout the study period, higher rates of safety concerns or adverse effects as the main reason for nonvaccination were reported by non-Hispanic White parents or guardians and by parents or guardians of teenaged girls (Table). From 2008 to 2013, mothers who were college graduates had rates of reporting safety concerns or adverse effects comparable with those among mothers with less than 12 years of education. However, from 2014 to 2019, there was a statistically significant increase in the reporting of safety concerns or adverse effects as the main reason for HPV nonvaccination by mothers with college degrees compared with those with less than 12 years of education (eg, 28.3% [95% CI, 25.5-31.2] among mothers with college degrees vs 13.7% [95% CI, 9.5-19.4] among mothers with less than 12 years of education in 2019) (Table).

    Discussion

    Overall, study findings suggest that safety concerns or adverse effects as the main reason for refusing HPV vaccination increased over the years. This finding has several important implications. First, given that concerns about vaccine safety are critical for vaccine confidence, rising safety concerns could negatively affect HPV vaccine uptake at the population level. Considering recent evidence of slowing routine HPV vaccination uptake,5 addressing safety concerns about vaccines should be of utmost public health importance.

    Second, the findings of this study suggest that disinformation campaigns aimed at hampering vaccine trust are thriving. In the US, there has been a substantial rise of vaccine misinformation that has culminated in public mistrust in vaccines. The advent of social media and its exponential growth in popularity have served as a catalyst for spreading misinformation to a wider audience within the general public. In some instances, misinformation has also been supported by influential public and political figures. While our findings point to a need for widespread dissemination of educational programs within the general population,6 it is also crucial that public health agencies work with social media companies to develop campaigns to combat misinformation online. Lastly, physicians have a crucial frontline role to play in addressing vaccine hesitancy during parent-physician encounters.

    Despite several strengths of our study, including using a rigorously designed nationally representative sample, our study is not without limitations, including low response rate and potential nonresponse bias. However, statistical adjustments, including standard weighting procedures, have been applied to account for such potential biases.

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    Article Information

    Accepted for Publication: April 7, 2021.

    Published Online: June 28, 2021. doi:10.1001/jamapediatrics.2021.1585

    Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Chido-Amajuoyi OG et al. JAMA Pediatrics.

    Corresponding Author: Sanjay Shete, PhD, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, 1400 Pressler Dr, FCT4.6002, Houston, TX 77030 (sshete@mdanderson.org).

    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 accuracy of the data analysis. Drs Chido-Amajuoyi and Talluri contributed equally as co–first authors.

    Concept and design: Chido-Amajuoyi, Talluri, Sanjay Shete.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: Chido-Amajuoyi, Talluri, Sahil S. Shete.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Talluri.

    Obtained funding: Sanjay Shete.

    Administrative, technical, or material support: Sanjay Shete.

    Supervision: Sanjay Shete.

    Conflict of Interest Disclosures: None reported.

    Funding/Support: The study was funded by grant P30CA016672 from the National Cancer Institute (Sanjay Shete), the Betty B. Marcus Chair in Cancer Prevention (Sanjay Shete), the Duncan Family Institute for Cancer Prevention and Risk Assessment (Sanjay Shete), and grant RP170259 from the Cancer Prevention Research Institute of Texas (Sanjay Shete).

    Role of Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    References
    1.
    Hanson  KE, Koch  B, Bonner  K, McRee  AL, Basta  NE.  National trends in parental human papillomavirus vaccination intentions and reasons for hesitancy, 2010-2015.   Clin Infect Dis. 2018;67(7):1018-1026. doi:10.1093/cid/ciy232PubMedGoogle ScholarCrossref
    2.
    Thompson  EL, Rosen  BL, Vamos  CA, Kadono  M, Daley  EM.  Human papillomavirus vaccination: what are the reasons for nonvaccination among US adolescents?   J Adolesc Health. 2017;61(3):288-293. doi:10.1016/j.jadohealth.2017.05.015PubMedGoogle ScholarCrossref
    3.
    Verger  P, Dubé  E.  Restoring confidence in vaccines in the COVID-19 era.   Expert Rev Vaccines. 2020;19(11):991-993. doi:10.1080/14760584.2020.1825945PubMedGoogle ScholarCrossref
    4.
    National Center for Immunization and Respiratory Diseases. National Immunization Survey–Teen: a user’s guide for the 2016 public-use data file. Accessed May 20, 2021. https://www.cdc.gov/vaccines/imz-managers/nis/downloads/NIS-TEEN-PUF16-DUG.pdf
    5.
    Chido-Amajuoyi  OG, Talluri  R, Wonodi  C, Shete  S.  Trends in HPV vaccination initiation and completion within ages 9-12 years: 2008-2018.   Pediatrics. Published online May 3, 2021. doi:10.1542/peds.2020-012765PubMedGoogle Scholar
    6.
    Chido-Amajuoyi  OG, Jackson  I, Yu  R, Shete  S.  Declining awareness of HPV and HPV vaccine within the general US population.   Hum Vaccin Immunother. 2021;17(2):420-427. doi:10.1080/21645515.2020.1783952PubMedGoogle ScholarCrossref
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