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Human Papillomavirus (HPV) Vaccine

ACIP Rec  VIS  WHO module
  • EMA concludes that complex regional pain syndrome (CRPS) or postural orthostatic tachycardia syndrome (POTS) are not caused by HPV vaccines  (11-20-2015).  link to EMA statement and information
  • Gardasil 9 has been approved by the US FDA for protection of females (age 9-26 years) and males (age 9-15 years) against 9 HPV types.  Previous vaccines protected against types 6, 11, 16 and; Merck's latest vaccine protects agains 5 additional HPV types (31, 33, 45, 52 and 58).   Gardasil 9 should be available in February 2015.  (12-10-14).  link to FDA press release | package insert
  • Use of HPV4 in males. Recommendations on Use of Quadrivalent HPV in Males - ACIP, 2011 Source: MMWR;60(50);1705-8 [Link] (12-23-11)
  • The US FDA has approved Gardasil for use in males aged 9-26 years [Oct 16, 2009] link to FDA press release
  • The US FDA has approved a new HPV vaccine, Cervarix, for use in females aged 10-25 years [Oct 16, 2009] link to FDA press release 
  • In a September 2009 meeting, an FDA advisory committee voted on the following issues:
    • to recommend Gardasil to boys 9-26 years of age in the same 3-dose schedule recommended for girls
    • [link to more info]
    • that Cervarix, a vaccine against 2 strains of HPV, is safe and effective
    • [link to more info]
  • HPV vaccine has a low risk of serious allergic reactions
    Most vaccines are associated with a low risk of serious allergic reactions, including anaphylaxis.
    • Preliminary data from the United States suggest that the risk with HPV vaccine is about one per million doses, similar to the rates for other vaccines.
      Halsey NA.  The human papillomavirus vaccine and risk of anaphylaxis.  CMAJ 2008;179(6):509-10.  link to CMAJ
    • A preliminary study from Australia that the rate may be somewhat higher in that population, but there are several unanswered questions about the study. Allergy testing failed to identify the potential allergen in all affected persons who were tested and none of them reacted to the vaccine in skin testing.
      Brotherton JML et al.  Anaphylaxis following quadrivalent human papillomavirus vaccination.  CMAJ 2008;179(6):525-33.  link to CMAJ
    • The CISA network published guidelines for the investigation of patients with apparent allergic reactions following vaccines.
      Wood RA et al. An Algorithm for Treatment of Patients With Hypersensitivity Reactions After Vaccines.  Pediatrics 2008;122(3):e771-7. link to abstract
  • Two vaccines to protect against human papilloma viruses (HPV) have been developed.  The first to be licensed, Gardasil, produced by Merck protects against four HPV types including the two types most commonly associated with cervical cancer (types 16 and 18) and the two types that cause most genital warts (types 6 and 11). An application has been submitted by Glaxo SmithKline for another HPV vaccine and licensure is expected either later in 2008 or early 2009.

Both of these vaccines have been shown to be highly efficacious for protection against persistent infections with the serotypes that are in the vaccines.  The most common side effects have been local pain and fainting. Rare allergic reactions have been reported as well.

Links to more information:


This page was last updated on December 29, 2016

2016 Institute for Vaccine Safety