Safety and Effectiveness of HPV Vaccine

Each year, there are approximately 32,100 HPV-related cancers in the United States. HPV vaccination can prevent approximately 90% of these cancers. 

Yet, some parents still have concerns about the safety and effectiveness of HPV vaccine. But parent should also consider that there is a rigorous testing and approval process for all vaccines. Additionally, there’s a continued effort to monitor vaccines after approval by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). 

To ensure vaccine safety, there are different phases of the testing process.   

• Pre-clinical Phase: The vaccines must be tested in the lab, which can take several years. The FDA uses data from these exploratory trials to determine if the vaccine can be tested on people. 
• Phase I: If the FDA permits it, it is tested on a small number of volunteers (10-30) to ensure safety.
• Phase II: The vaccine is administered to approximately 25-100 volunteers to continue monitoring for safety and effectiveness.
• Phase III: Thousands of volunteers receive the vaccine. The data is reviewed at pre-determined intervals. Once a vaccine is approved and recommended, safety continues to be monitored for the lifespan of the vaccine. According to the CDC, "Over 120 million doses have been administered since the vaccines were licensed, and the data continue to show the vaccine is safe and effective." HPV vaccine cannot cause an HPV infection or cancer because the vaccine is comprised of an HPV-like particle (protein), not the HPV virus.  Additionally, HPV vaccine contains no preservatives, no antibiotics, no thimerosal and no mercury. 

The FDA approved Gardasil 9 vaccine for the prevention of HPV-related cancers. 

We encourage parents to seek the science about vaccines, recognize and evaluate opinions and be aware of misinformation. Moreover, it is important to remember that one vaccine can prevent up to six types of HPV-related cancers. Talk to your healthcare providers about the safety and effectiveness of HPV vaccine or visit Eliminating HPV-Related Cancers.