COMMENTARY

Ten Years of Safe Protection From Cancer: The HPV Vaccine

Sandra Adamson Fryhofer, MD

Disclosures

July 08, 2016

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Happy 10th birthday, HPV vaccine!

Hello. I'm Dr Sandra Fryhofer. This edition of Medicine Matters highlights the 10-year anniversary of the human papillomavirus (HPV) vaccine licensing. The first cervical cancer vaccine was licensed by the US Food and Drug Administration (FDA) in June 2006. The Advisory Committee on Immunization Practices (ACIP) met in June 2006 and voted in favor of a three-dose HPV vaccine series for all females ages 9 through 26. From that moment on, we had a new weapon in the fight against cervical cancer.

Now, 10 years later, more than 80 million doses of HPV vaccine have been given in the United States. But what about the vaccine's safety? Each HPV vaccine was closely studied in clinical trials to make sure that it was safe. At least 29,000 males and females were studied in clinical trials for the four-valent vaccine. More than 15,000 were studied in clinical trials for the nine-valent version. Even post-licensure, the Centers for Disease Control and Prevention (CDC) continues to monitor for safety in three different ways:

  • The Vaccine Adverse Event Reporting System (VAERS);

  • The Vaccine Safety Datalink (VSD); and

  • The Clinical Immunization Safety Assessment Network (CISA).

Any adverse events reported are investigated and followed up carefully. Vaccine safety monitoring is discussed at just about every ACIP meeting.

These are shots, given with a needle. And shots hurt. In VAERS, pain, redness, and swelling in the arm where the shot was given are frequently reported. The other most frequently reported adverse effects include fainting, dizziness, headache, and nausea. Guidance to doctors has been updated to include information about preventing falls and injuries from fainting after HPV vaccination. (See the package insert.)

Sometimes bad things can happen to good people. And if an adverse event happens to someone who has received a vaccination, it does not necessarily mean that the vaccine is to blame. That's why CDC looks for signals or patterns and compares these patterns to what is expected for the general population.

With respect to HPV vaccination, CDC has found no link to ovarian failure and no link to Guillain-Barré syndrome. The European Medicines Agency found no link between HPV vaccines and postural orthostatic tachycardia syndrome (POTS) and also found no causal link between HPV vaccination and complex regional pain syndrome (CRPS), a rare condition characterized by persistent pain. VAERS reviewed similar reports and also found no safety concerns.

Check out this CDC website for more details.

In summary, CDC, FDA, and other organizations have confirmed that the HPV vaccine has an excellent safety record. So, happy birthday, HPV vaccine! Thank you for 10 years of cancer protection. We wish you many more!

For Medicine Matters, I'm Dr Sandra Fryhofer.

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