Chapter 5

Lynette Luria and Gabriella Cardoza-Favarato, Human Papillomavirus (Treasure Island: Stat Pearls Publishing, 2022), Bookshelf ID: NBK448132.

Lynette Luria and Gabriella Cardoza-Favarato, Human Papillomavirus (Treasure Island: Stat Pearls Publishing, 2022), Bookshelf ID: NBK448132.

The American College of Obstetricians and Gynecologists, “Loop Electrosurgical Excision Procedure (LEEP),” updated February, 2022.

US Food and Drug Administration, “June 8, 2006 Approval Letter – Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant,” updated April 30, 2009.

BioSpace, “Merck & Co., Inc. Submits Biologics License Application To FDA For GARDASIL(R), The Company’s Investigational Vaccine For Cervical Cancer,” December 5, 2005.

US Food and Drug Administration, “Prescription Drug User Fee Amendments,” updated September 13, 2022.

US Food and Drug Administration, “Establishment of Prescription Drug User Fee Rates for Fiscal Year 2006,” Federal Register: The Daily Journal of the United States Government 70, no. 146 (2005): 44106-44109, Document Number: 05-15159.

“Gardasil,” US Food and Drug Administration, Current content as of Oct. 24, 2019, https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil. *Document available to download: Supporting Documents “Approval History, Letters, Reviews and Related Documents-Gardasil.”

European Medicines Agency, PROCOMVAX: Package Insert (West Point, PA: Merck & Co. Inc., 1999)

Sesilje B. Petersen and Christian Gluud, “Was Amorphous Aluminium Hydroxyphosphate Sulfate Adequately Evaluated Before Authorisation in Europe?” The BMJ: Evidence-Based Medicine 26, no. 6 (2021): 285-289, doi:10.1136/bmjebm-2020-111419.

US Food and Drug Administration, GARDASIL: Package Insert (Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 2006).

US Food and Drug Administration, GARDASIL 9: Package Insert (Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., updated 2016).

US Food and Drug Administration, GARDASIL 9: Package Insert (Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., updated 2016).

Trefis Team and Great Speculations, “Merck’s $3 Billion Drug Jumped to 4X Growth Over Previous Year,” Forbes, October 4, 2019.

US Food and Drug Administration, CERVAVIX: Package Insert (Triangle Park, NC: GlaxoSmithKline, 2009).

US Food and Drug Administration, CERVAVIX: Package Insert (Triangle Park, NC: GlaxoSmithKline, 2009).

US Food and Drug Administration, CERVAVIX: Package Insert (Triangle Park, NC: GlaxoSmithKline, 2009).

US Food and Drug Administration, CERVAVIX: Package Insert (Triangle Park, NC: GlaxoSmithKline, 2009).

US Food and Drug Administration, GARDASIL 9: Package Insert (Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., updated 2016).

US Food and Drug Administration, GARDASIL 9: Package Insert (Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., updated 2016).

US Food and Drug Administration, GARDASIL 9: Package Insert (Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., updated 2016).

Lucija Tomljenovic and Christopher A. Shaw, “Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety,” American Journal of Public Health 102, no. 9 (2012): e13, doi:10.2105/AJPH.2012.300837.

Lucija Tomljenovic and Christopher A. Shaw, “Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety,” American Journal of Public Health 102, no. 9 (2012): e13, doi:10.2105/AJPH.2012.300837.

Lucija Tomljenovic and Christopher A. Shaw, “Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety,” American Journal of Public Health 102, no. 9 (2012): e13, doi:10.2105/AJPH.2012.300837.

Yukari Yaju and Hiroe Tsubaki, “Safety Concerns with Human Papilloma Virus Immunization in Japan: Analysis and Evaluation of Nagoya City’s Surveillance Data for Adverse Events,” Japan Journal of Nursing Science 16, no.4 (2019): 433-449, doi:10.1111/jjns.12252.

Yukari Yaju and Hiroe Tsubaki, “Safety Concerns with Human Papilloma Virus Immunization in Japan: Analysis and Evaluation of Nagoya City’s Surveillance Data for Adverse Events,” Japan Journal of Nursing Science 16, no.4 (2019): 433-449, doi:10.1111/jjns.12252.

Yukari Yaju and Hiroe Tsubaki, “Safety Concerns with Human Papilloma Virus Immunization in Japan: Analysis and Evaluation of Nagoya City’s Surveillance Data for Adverse Events,” Japan Journal of Nursing Science 16, no.4 (2019): 433-449, doi:10.1111/jjns.12252.

Rotem Inbar et al., “Behavioral Abnormalities in Female Mice Following Administration of Aluminum Adjuvants and the Human Papillomavirus (HPV) Vaccine Gardasil,” Immunologic Research 65, (2017):136-149, doi:10.1007/s12026-016-8826-6.

Rotem Inbar et al., “Behavioral Abnormalities in Female Mice Following Administration of Aluminum Adjuvants and the Human Papillomavirus (HPV) Vaccine Gardasil,” Immunologic Research 65, (2017):136-149, doi:10.1007/s12026-016-8826-6.

Rotem Inbar et al., “Behavioral Abnormalities in Female Mice Following Administration of Aluminum Adjuvants and the Human Papillomavirus (HPV) Vaccine Gardasil,” Immunologic Research 65, (2017):136-149, doi:10.1007/s12026-016-8826-6.