1,400
Views
0
CrossRef citations to date
0
Altmetric
Original Research

Post-marketing surveillance for the safety of the 9-valent human papillomavirus vaccine: a retrospective real-world study in China

, , , , , , , & show all
Pages 696-703 | Received 11 Apr 2023, Accepted 19 Jul 2023, Published online: 27 Jul 2023

References

  • Kocarnik JM, Compton K, Dean FE, et al. Cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life years for 29 cancer groups from 2010 to 2019: a systematic analysis for the Global Burden of Disease study 2019. JAMA Oncol. 2022 Mar 1;8(3):420–444. doi: 10.1001/jamaoncol.2021.6987
  • Singh D, Vignat J, Lorenzoni V, et al. Global estimates of incidence and mortality of cervical cancer in 2020: a baseline analysis of the WHO global cervical cancer elimination initiative. Lancet Glob Health. 2023 Feb;11(2):e197–e206.
  • AG BL, S B, M M, et al. Human papillomavirus and related diseases in China. summary report 22 October 2021. https://hpvcentre.net/statistics/reports/CHN.pdf
  • Olsson SE, Restrepo JA, Reina JC, et al. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: interim analysis after 8 years of follow-up. Papillomavirus Res. 2020 Dec;10:100203.
  • Moreira ED Jr., Block SL, Ferris D, et al. Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials. Pediatrics. 2016 Aug;138(2). doi: 10.1542/peds.2015-4387
  • Moreira ED, Giuliano AR, de Hoon J, et al. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396–403.
  • Kharbanda EO, Vazquez-Benitez G, DeSilva MB, et al. Association of inadvertent 9-valent human papillomavirus vaccine in pregnancy with spontaneous abortion and adverse birth outcomes. JAMA Netw Open. 2021 Apr 1;4(4):e214340.
  • Yih WK, Kulldorff M, Dashevsky I, et al. A broad safety assessment of the 9-valent human papillomavirus vaccine. Am J Epidemiol. 2021 Jul 1;190(7):1253–1259.
  • Donahue JG, Kieke BA, Lewis EM, et al. Near real-time surveillance to assess the safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019 Dec;144(6). doi: 10.1542/peds.2019-1808
  • Di Lorenzo A, Berardi P, Martinelli A, et al. Real-life safety profile of the 9-valent HPV vaccine based on data from the Puglia region of southern Italy. Vaccines (Basel). 2022 Mar 10;10(3):419.
  • Landazabal CS, Moro PL, Lewis P, et al. Safety of 9-valent human papillomavirus vaccine administration among pregnant women: adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), 2014-2017. Vaccine. 2019 Feb 21;37(9):1229–1234.
  • Hansen J, Yee A, Lewis N, et al. Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Vaccine. 2023 Mar 10;41(11):1819–1825.
  • Shimabukuro TT, Su JR, Marquez PL, et al. Safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019 Dec;144(6). doi: 10.1542/peds.2019-1791
  • Liu Z, Zhang L, Yang Y, et al. Active surveillance of adverse events following human papillomavirus vaccination: feasibility pilot study based on the regional health care information platform in the city of Ningbo, China. J Med Internet Res. 2020 Jun 1;22(6): e17446. 10.2196/17446
  • Sun Y, Zhang L, Li N, et al. No association between enterovirus 71 (EV71) vaccination and risk of febrile seizures: a population-based near real-time surveillance study. Expert Rev Vaccines. 2022 Jan;21(1):125–134.
  • Genovese C, V LAF, Squeri A, et al. HPV vaccine and autoimmune diseases: systematic review and meta-analysis of the literature. J Prev Med Hyg. 2018 Sep;59(3):E194–E199.
  • Office of Maternal and Child Health Surveillance of Department of Maternal and Child Health Services of National Health and Family Planning Commission. The Chinese National Maternal And Child Health Surveillance Manual 2013. http://www.mchscn.cn/National-22/450.html
  • Arnheim-Dahlström L, Pasternak B, Svanström H, et al. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013 Oct 9;347(oct09 4):f5906.
  • Teng W, Shan Z, Teng X, et al. Effect of iodine intake on thyroid diseases in China. N Engl J Med. 2006 Jun 29;354(26):2783–2793. doi: 10.1056/NEJMoa054022
  • Weng J, Zhou Z, Guo L, et al. Incidence of type 1 diabetes in China, 2010-13: population based study. BMJ. 2018 Jan 3;360:j5295.
  • Li R, Sun J, Ren LM, et al. Epidemiology of eight common rheumatic diseases in China: a large-scale cross-sectional survey in Beijing. Rheumatology (Oxford). 2012 Apr;51(4):721–729.
  • Zou YF, Feng CC, Zhu JM, et al. Prevalence of systemic lupus erythematosus and risk factors in rural areas of Anhui Province. Rheumatol Int. 2014 Mar;34(3):347–356.
  • Xu L, Chen L, Wang S, et al. Urban prevalence of multiple sclerosis in China: a population-based study in six provinces. Eur J Neurol. 2021 May;28(5):1636–1644.
  • Woung LC, Lin CH, Tsai CY, et al. Optic neuritis among national health insurance enrollees in Taiwan, 2000-2004. Neuroepidemiology. 2007;29(3–4):250–254. doi: 10.1159/000112858
  • Hwang DK, Chou YJ, Pu CY, et al. Epidemiology of uveitis among the Chinese population in Taiwan: a population-based study. Ophthalmol. 2012 Nov;119(11):2371–2376. doi: 10.1016/j.ophtha.2012.05.026g
  • Cheng YF, Xirasagar S, Liu TC, et al. Ten-year trends in the incidence of microtia: a nationwide population-based study from Taiwan. Eur Arch Otorhinolaryngol. 2021 Nov;278(11):4315–4319. doi: 10.1007/s00405-021-07014-x
  • Harris J, Kallen B, Robert E. The epidemiology of anotia and microtia. J Med Genet. 1996 Oct;33(10):809–813. doi: 10.1136/jmg.33.10.809
  • Zhou Y, Mao X, Zhou H, et al. Birth defects data from population-based birth defects surveillance system in a district of southern Jiangsu, China, 2014-2018. Front Public Health. 2020;8:378.