Safety of the 9-Valent Human Papillomavirus Vaccine

Shimabukuro, Tom T.; Su, John R.; Marquez, Paige; Mba‐Jonas, Adamma; Araña, Jorge E.; Cano, Maria

doi:10.1542/peds.2019-1791

Cited by 51 publications

(42 citation statements)

References 46 publications

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“…Since the launch of this product in Japan in May 2019, there have been a total of four cases involving interstitial lung disease (including two cases for which a causal relationship to the drug could not be ruled out). In addition, there has been one patient death reported to date, but again, a causal relationship between the drug and death subsequent to the patient's interstitial lung disease could not be ruled out [1].…”

Section: Interstitial Lung Disease Risk With Prostate Cancer Medsmentioning

confidence: 99%

“…Treatment with statins does not appear to be associated with memory or cognitive disorders in elderly patients, according to findings of the Sydney Memory and Aging Study published in the Journal of the American College of Cardiology (JACC) [1]. This prospective study investigated the effects of statins (atorvastatin, pravastatin or simvastatin) on memory and global cognition over a 6-year period in 1037 community-dwelling patients in Australia who were 70-90 years of age, and the effects of statins on brain volume over a 2-year period in a subgroup of 526 patients.…”

Section: Statins Not Associated With Memory or Cognitive Declinementioning

confidence: 99%

“…The first study investigated 7244 postlicensure surveillance reports to the US FDA's Vaccine Adverse Event Reporting System (VAERS) from December 2014 until December 2017 [1]. Most reports were submitted by the vaccine manufacturer (64.2%), with 26.8% of reports submitted by healthcare providers.…”

Section: Reports To Vaersmentioning

confidence: 99%

“…Angiotensin receptor blockers (ARBs) appear to increase the risk of suicide in elderly patients compared with ACE inhibitors (ACEIs), according to findings of a Canadian case-control study published in JAMA Network Open [1]. Data from administrative claims databases in Ontario (1995-2015) were used to investigate death by suicide during treatment with ARBs or ACEIs in patients 66 years of age and over.…”

Section: Angiotensin Receptor Antagonists Increase Risk Of Suicidementioning

confidence: 99%

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2019

Pharm Med

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The US Food and Drug Administration (FDA) is introducing electronic submission of safety reports for investigational new drug (IND) applications through the FDA's Adverse Event Reporting System (FAERS). The FDA has released new draft guidance on the process as well as supporting technical specification documents. The changes will enable the FDA to review pre-and post-marketing safety data within in the same system, with the same data standard. Publication of the draft guidance and technical documents should assist drug manufacturers in beginning preparations for when final draft guidance is issued and becomes effective. IND safety reports will be submitted in a reporting format that is consistent with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B guidelines. The FDA will shortly announce when sponsors can begin voluntary submissions of IND safety reports to FAERS. "The FDA highly encourages sponsors of all INDs, both commercial and noncommercial, to begin submitting IND safety reports to FAERS voluntarily as soon as the new submission process is available," said Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research (CDER). IND safety reporting via FAERS will be voluntary until 2 years after the final guidance has been issued, after which it will become mandatory for commercial INDs. The FDA has created a separate submission path to FAERS for IND safety report submissions; they will remain designated as investigational and will not be publicly available. US Food and Drug Administration. Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts. 29 Oct 2019. https ://www.fda.gov/news-event s/press-annou nceme nts/digit al-submi ssion-adver se-event-repor ts-inves tigat ional-new-drug-appli catio ns-refle cts-fdas-ongoi ng. Accessed 11 Dec 2019.

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Section: Interstitial Lung Disease Risk With Prostate Cancer Medsmentioning

confidence: 99%

Section: Statins Not Associated With Memory or Cognitive Declinementioning

confidence: 99%

Section: Reports To Vaersmentioning

confidence: 99%

Section: Angiotensin Receptor Antagonists Increase Risk Of Suicidementioning

confidence: 99%

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2019

Pharm Med

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“…A massive retrospective study recently verified the high degree of safety associated with the nanovalent HPV vaccine. 15 Pubic lice can be treated with permethrin 1% cream rinse applied to the affected areas and washed off after 10 minutes or with malathion 0.5% lotion applied to the affected areas and washed off after 8-12 hours. Scabies can be treated with permethrin 5% cream applied to all areas of the body from the neck down and washed off after 8-14 hours.…”

Section: Therapeutic Pearlsmentioning

confidence: 99%

Dermatologists' Management Approach to Sexually Transmitted Disease

Rosén

2020

J of Skin

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Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States

et al. 2021

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Key Points Question Does public sentiment of human papillomavirus (HPV) vaccine safety align with spontaneous HPV vaccine adverse event reporting data? Findings This cross-sectional analysis of the 2015 to 2018 National Immunization Survey indicates a 79.9% increase in the proportion of parents who refused the HPV vaccine for their adolescents due to safety concerns. In contrast, estimates from the national vaccine safety surveillance system found that the HPV vaccine adverse event reporting rate per 100 000 doses distributed decreased from 44.7 in 2015 to 29.4 in 2018. Meaning These findings suggest an urgent need to combat safety concerns about the HPV vaccine in the US.

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Safety of the 9-Valent Human Papillomavirus Vaccine

Cited by 51 publications

References 46 publications

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Forum

Dermatologists' Management Approach to Sexually Transmitted Disease

Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States

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