A study evaluating the efficacy of the HPV vaccine (also called the cervical cancer vaccine) was just published in the Lancet. In a nutshell, when young girls are vaccinated against HPV, the virus that causes cervical cancer, the number of serious cancer precursors in girls 17 and younger dropped by 50%. Wow. This is important because serious cancer precursors (called dysplasia) lead to sometimes painful biopsies and treatments. And if these pre-cancers are not treated, for many women they can lead to cancer.
But how safe is the vaccine? With any treatment, you have to balance the risk benefit ratio. There is much HPV vaccine mythology. On blogs, message boards and Twitter feeds you read whisperings of serious side effects and worse. Even physicians get on board. In the wee hours of June 15th, Dr. Jay Gordon and I had a healthy vaccine debate and he reported on his concerns that more than 50 girls have died from the vaccine. He’s wrong.
The HPV vaccines (there are two) are actually incredibly safe (and now we know they are incredibly effective). To talk responsibly about vaccine safety (or the safety of any medication) you need facts. So here they are.
As of February 14, 2011 there were a total of 53 HPV vaccine associated deaths reported to VAERS (Vaccine Adverse Event Reporting System). This means the deaths were temporally related to receiving the vaccine, not cause and effect. At total of 33 of the deaths were confirmed and 20 were unconfirmed (meaning there was no information provided about the death so no investigation was possible). After analysis not one of the 33 confirmed deaths were found to be related to the vaccine. Meaning no cause and effect.
There have been reports of blood clots. Now that these have been analyzed, it is clear the blood clots were not vaccine related. Many girls who get the HPV vaccine when they are a little older start the birth control pill at the same time. The pills raises the risk of blood clots (some more than others). Other girls who developed blood clots had other risk factors, like obesity.
But ultimately the problem with VAERS and vaccine safety is that the data isn’t clean. Reporting happens after the fact and can suffer from under reporting or inaccuracies, as anyone can report and you don’t need any kind of proof.
Fortunately, a GREAT study was published this year giving us the information that we need. It is an analysis of seven studies looking at the HPV vaccine and includes data from over 44,000 girls. These seven studies followed girls who received the vaccine in real-time (prospective studies), so if an adverse event occurred it would be captured. In the studies, the girls kept daily vaccination report cards and recorded their symptoms within 15-30 days of injection. In addition, information was solicited by the investigators. These studies also include control populations, which is very important. The studies in this meta analysis represent the cleanest kind of data and this is the information that we should be giving to girls (and boys) and parents about HPV vaccine safety:
There were no deaths in the more than 44,000 participants and there was no statistically significant difference between serious adverse events among the girls who got the HPV vaccine and those who received the placebo. Fainting and headache occurred equally in both groups, so it’s the needle people, not the vaccine.
So in summary, more than 44,000 girls received the HPV vaccine in a highly monitored, placebo controlled setting. There were no deaths and the risk of serious adverse events was the same in the vaccine and the placebo group. Young girls faint from needles, not because of any hidden toxin in the HPV vaccine.
The HPV vaccine is safe. It’s effective. End of discussion.