Gardasil 9 components (HPV)

Gardasil 9 is a sterile suspension for intramuscular administration. Gardasil 9 components are:

  • Human Papillomavirus Type 6 L1 protein
    Human Papillomavirus Type 11 L1 protein
    Human Papillomavirus Type 16 L1 protein
    Human Papillomavirus Type 18 L1 protein
    Human Papillomavirus Type 31 L1 protein
    Human Papillomavirus Type 33 L1 protein
    Human Papillomavirus Type 45 L1 protein
    Human Papillomavirus Type 52 L1 protein
    Human Papillomavirus Type 58 L1 protein

Each 0.5-mL dose of the vaccine also contains:

  • Amorphous aluminium hydroxyphosphate sulfate as adjuvant
  • Sodium chloride
  • L-histidine
  • Polysorbate 80,
  • Sodium borate,
  • Yeast protein
  • Water for injection

The product does not contain a preservative or antibiotics.

GARDASIL 9, Human Papillomavirus 9-valent Vaccine (polyvalent like e.g. Pediarix), recombinant, is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The L1 proteins are produced by separate fermentations using recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process
involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates.

The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed
aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS).

The 9-valent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer.

Source:
https://www.fda.gov/media/90064/download
https://www.ema.europa.eu/en/documents/product-information/gardasil-9-epar-product-information_en.pdf

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