miércoles, 18 de diciembre de 2019

Human Papillomavirus (HPV) Vaccine | CDC

Human Papillomavirus (HPV) Vaccine | CDC



Human Papillomavirus (HPV) Vaccine Safety

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Safety Information

About HPV Infection

Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Most infections are asymptomatic and become undetectable, but some can be persistent and can progress to cancer in both women and men later in life. Learn more about HPV
There is a safe and effective HPV vaccine. CDC recommends HPV vaccination for all boys and girls at ages 11-12 to protect against HPV-related infections and cancers.
Some adults age 27 through 45 years who are not already vaccinated may decide to get HPV vaccine after speaking with their doctor about their risk for new HPV infections and the possible benefits of vaccination. HPV vaccination in this age range provides less benefit, as more people have already been exposed to HPV.
Vaccine Information Statements
Vaccine Information Statements (VISs) are information sheets produced by CDC that explain both the benefits and risks of a vaccine.
  • HPVHuman papillomavirus vaccine (Gardasil 9)

Available Vaccine and Package Insert

There is one licensed HPV vaccine available in the United States:
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was approved by FDA for use in 2014. The safety of Gardasil 9 was studied in clinical trials with more than 15,000 participants before it was licensed and continues to be monitored. Gardasil 9 protects against 9 types of cancer-causing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
CDC recommends that anyone starting the series before their 15th birthday receives two doses of HPV vaccine, with at least six months between the first and second dose. Adolescents who receive their two doses less than five months apart will require a third dose of HPV vaccine.Teens and young adults who start the series at ages 15 through 26 years still need three doses of HPV vaccine.  Also, three doses are recommended for people with certain immunocompromising conditions aged 9 through 26 years.
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Child and Adult Immunization Schedules
Get CDC’s official recommended immunization schedules for children, adolescents, and adults.

Manufacturer Package Insert

Gardasil 9 [PDF – 761 KB]external icon:
The Food and Drug Administration (FDA) approved this vaccine in 2014. It is approved for use in children at age 9.
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Common Side Effects

HPV vaccine is safe and effective at preventing HPV-related infections and cancers. Vaccines, like any medicine, can have side effects. Many people who get the HPV vaccine have no side effects at all. The most common side effects are usually mild, like a sore arm from the shot.
Important!
Severe allergic reactions following vaccination are rare, but can be life threatening.
Symptoms of a severe allergic reaction may include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.
If such reactions occur, seek immediate medical attention.
HPV Vaccine (Gardasil 9)
Common Side Effects 
  • Pain, redness, or swelling in the arm where the shot was given
  • Fever
  • Headache or feeling tired
  • Nausea
  • Muscle or joint pain
Who Should Not Get the HPV Vaccine
Tell your vaccine provider if the person getting the vaccine:
  • Has had an allergic reaction after a previous dose of HPV vaccine, or has any severe, life-threatening allergies.
  • Is pregnant.
In some cases, your healthcare provider may decide to postpone HPV vaccination to a future visit.
People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting HPV vaccine.
More Information
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A Closer Look at the Safety Data

Findings from many vaccine safety monitoring systems and more than 160 studies have shown that HPV vaccines have a favorable safety profile—the body of scientific evidence overwhelmingly supports their safety.
  • In November 2019, initial post-licensure safety monitoring of Gardasil 9 was published in Pediatrics. In two separate articles, analyses from the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) were presented. Both included multiple years of data, and did not identify any unexpected safety problems with Gardasil 9. These findings support the favorable safety profile that was established in pre-licensure clinical trials.
    • Analysis from VAERS: Researchers reviewed 7,244 reports submitted to the Vaccine Adverse Event Reporting System following HPV vaccination from December 2014 through December 2017. Of those reports, around 97% were classified as non-serious; around 3% were considered serious. The analysis did not detect any unexpected safety concerns.
    • Analysis from VSD: The Vaccine Safety Datalink conducted near-real time surveillance from October 2015 through October 2017, looking at 11 pre-specified adverse events. During this two-year time period, nearly 840,000 doses were administered to people aged 9-26 years at six VSD sites. No unexpected safety concerns were identified.
  • In 2014, before Gardasil 9 was licensed by the FDA, its safety was evaluated across seven studies. The safety findings from these pre-licensure studies show that Gardasil 9 has a similar safety profile to Gardasil, an earlier version of the vaccine. The main findings from these studies:
    • The most common side effect reported was pain, swelling, and redness in the arm where the shot was given.
    • These mild side effects may occur more often after Gardasil 9 vaccination than after Gardasil. Women and girls who received Gardasil 9 reported higher rates of swelling and redness where the shot was given than those who received Gardasil. Reports of swelling and redness also increased with each following dose for those receiving Gardasil 9.
  • In 2014, CDC published a report analyzing health events reported to VAERS following Gardasil vaccination from June 2006 through March 2014. About 92% of the Gardasil reports were classified as non-serious.
    The most common adverse events reported were:
    • Syncope (fainting)
    • Dizziness
    • Nausea
    • Headache
    • Fever
    • Injection site reactions (pain, swelling, and redness)
    Although rare, fainting was found to happen after HPV vaccination. In response, FDA changed Gardasil’s guidance for doctors to include information about preventing falls and injuries from fainting. CDC and the Advisory Committee on Immunization Practices included this guidance in the recommendations for HPV vaccination. Based on these recommendations, healthcare professionals should administer HPV vaccinations while the patient is seated or lying down.
    The patient should then remain seated and be observed for 15 minutes. CDC continues to remind doctors and nurses to observe this guidance and to share this information with all their patients.
  • In 2011, the Institute of Medicine (IOM) reviewed published and unpublished studies of the safety of eight vaccines, including HPV. The published report, Adverse Effects of Vaccines: Evidence and Causalityexternal icon, concluded:
    • Syncope (fainting) may be caused by injected vaccines, including HPV vaccines.
    Very rarely, any vaccine, including HPV vaccine, can cause anaphylaxis. Some people are allergic to certain ingredients in vaccines. As recommended by ACIP, people who experienced a severe allergic reaction (e.g., anaphylaxis) to a previous vaccine dose or to a vaccine component, including yeast, should not receive the HPV vaccine.
Which adverse events are considered “serious”?
By regulation, an adverse event is defined as seriousexternal icon if it involves any of the following outcomes:
  • death
  • a life-threatening adverse event
  • a persistent or significant disability or incapacity
  • a congenital anomaly or birth defect
  • hospitalization, or prolongation of existing hospitalization
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How CDC Monitors the Safety of HPV Vaccines

CDC and FDA monitor the safety of vaccines after they are approved. If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.
CDC uses three systems to monitor vaccine safety:
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