Is the HPV Vaccine Safe?

How do we know the HPV vaccine is safe?

Speaker 1: Dr. Offit, how do we know the HPV vaccine is safe?

Paul Offit, MD: The human papillomavirus vaccine was first actually licensed and then recommended for people in the United States beginning in 2006. Ever since then, for the 16 years since then, people have asked the question, is it safe? How do we know that it's safe? So, at the time that that recommendation was made, did we know enough to say that the vaccine should be used?

So, what did we know?

We knew that the vaccine had been tested in 30,000 people. We knew that it had been tested for over about a seven-year period. We also knew that at least in those studies that the vaccine, although it could cause pain or redness at the site of injection, didn't cause any other problems.

We also knew that at the time about 30,000 people could get cancer caused by HPV. About 5,000 would die every year from HPV. We knew that about a two-thirds of those cancers occurred in women and one-third in men, typically cervical cancers or head and neck or anal and genital cancers. And we also knew that the technology used to make that vaccine, so-called recombinant DNA technology, had been used actually for the hepatitis B vaccine for decades.

So, we had all of that information. Was that enough to say let's move forward? So, the issue I think with vaccines or with any medical product is never when you know everything, it's when you know enough. And we decided at the time that we did know enough.

The FDA and the Centers for Disease Control and Prevention decided that we knew enough to move forward, and that was a good decision because if you look at places, for example, that have very high rates of vaccine-induced immunity from HPV, like Australia for example, they've had a dramatic reduction in the number of cases of cancer and the number of deaths from those cancers that were caused by HPV.

So, we know that the vaccine now is safe because it's been out there now for about a decade and a half. And I think people can feel comfortable getting it because a choice not to get an HPV vaccine is a choice to take the very real risk of getting cancer.