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TGA Laboratories testing report: Gardasil 9 Human Papillomavirus (HPV) vaccine monitoring

3 March 2020

Introduction

Human papillomaviruses (HPVs) are small, non-enveloped DNA viruses. There are many types of HPV, and many do not cause problems, with infections caused by these types usually clearing up within a few months. However, a small proportion of infections with certain types of HPV can persist and progress to cervical cancer.

HPV infection rates vary greatly between geographic regions and population groups, but it is estimated that historically around 90% of the general population will be infected with HPV at some point in their lives.[1] The National HPV Vaccination Program, which commenced in 2007, has been credited with dramatically reducing the incidence of HPV infection and disease in Australia. From 2007 to the end of 2015, there has been a more than 90% reduction in genital warts.[2] High grade cervical abnormalities have also declined, with detection rates declining between 2006 and 2014 by 62 per cent in women aged 20 years or younger, and 35 per cent in women aged 20–24 years.[3]

GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant, 30, 40, 60, 40, 20, 20, 20, 20, 20 micrograms/0.5 mL, suspension for injection, syringe (AUST R 224092) is a recombinant HPV vaccine that is used to immunise against the most common cervical cancer-causing types of HPV. The vaccine is produced using a biotechnology process where a copy of the virus DNA sequence is inserted into yeast cells to allow the cells to produce only the specific major protein of interest. Once purified, the virus protein self-assembles to form virus-like particles (VLPs) in the final vaccine product. When the vaccine is given, the VLPs look like the native virus to the immune system but they are unable to cause any infection.

From 2007 to 2017, the Australian immunisation programs used GARDASIL quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine 20,40,40,20 micrograms/0.5 mL sterile liquid syringe (AUST R 124410). This vaccine was replaced with Gardasil 9 from 2018.

To monitor the quality compliance and batch to batch consistency of Gardasil 9 being supplied in Australia a testing project was performed by TGA Laboratories. This project was initiated as part of routine surveillance testing of the quality of the vaccine and not in response to any specific safety concerns.

Testing

Fifteen samples of GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) were tested by Enzyme Linked Immunosorbent Assay (ELISA) for the amount of the active components of the four most common HPV antigen genotypes (type 6, 11, 16 and 18) which is also a measure of the products potency. The results were assessed against the approved specifications for the product and the internationally recognised standard of the European Pharmacopoeia (monograph for Human papillomavirus vaccine (rDNA) # 2441).

Product Name Sponsor Test performed Results Doses released
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

215,770
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

78,939
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

69,680
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

60,165
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

162,344
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

108,290
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

85,243
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

258,610
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

79,718
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

2,210
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

162,582
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

224,380
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

76,144
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

235,140
GARDASIL 9 Human Papillomavirus 9-valent Vaccine (Aust R 224092) Merck Sharp & Dohme (Australia) Pty Ltd Potency/content by ELISA

PASS
Meets quality standards

150,233

Outcomes

All samples were found to be of acceptable quality for the test applied, complying with the approved specifications and the European Pharmacopoeia monograph for Human papillomavirus vaccine (rDNA). The samples tested represent just over 1.9 million doses supplied in Australia since the product launch and all batches released up to January 2020. The testing also indicates that the manufacturing control strategy in place is working to deliver a consistent product of the expected level of quality.

In addition to the described laboratory testing, the TGA Laboratories has assessed the manufacturing and/or cold chain records of a total of 42 shipments of Gardasil 9 as part of the ongoing vaccine batch release program which assesses the quality of all vaccine batches before they are supplied in Australia.

The TGA published a report in 2015 reviewing the safety profile of Gardasil. That report is available on the TGA website at Gardasil (quadrivalent human papillomavirus vaccine), update 2.


Footnotes


Version history
Version Description of change Author Effective date
V1.0 Original publication TGA Laboratories November 2019
V2.0 Updated to add further test results TGA Laboratories March 2020