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sex, STDs, vaccines

How safe is the HPV vaccine? New data available.

CDC/James Gathany

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.

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Discussion

36 thoughts on “How safe is the HPV vaccine? New data available.

  1. I have yet to meet a medical doctor who wouldn’t give the vaccine to his own daughter. Both of mine are vaccinated. However, it’s not offered to boys as a rule, yet men are just as likely to get infected.

    I get the impression from your post that you think boys should also be vaccinated. Can I add my +1 to that?

    Posted by anarchic_teapot | June 18, 2011, 12:00 pm
  2. Thanks for posting this Jen,

    I have just finished writing two CME lessons on HPV and immunization. When looking through all the research and talking to three Canadian Key Opinion Leaders (KOLs) on this topic I am amazed by the controversy.

    Actually I wrote a brief blog on the topic called “I just don’t get it!” on my site at http://www.commpharm.com/?p=64 What I am amazed is that I could go to a patient and say “take this pill 3 times, it has minimal side effects and it will prevent cancer” and most would take it, even line up for it and would hail it as the miracle pil. The two HPV vaccines do the same thing but apparently cancer prevention through immunization is controversial.

    The vaccines work and prevent cervical dysplasia and cervical cancer. But what really drives me crazy is the psychological ramifications of an abnormal Pap, HPV infection or the emotional stress of having to undergo further evaluation like colposcopy is rarely discussed. The data shows that these results can destroy a woman’s self-confidence and can grossly impact her current, past and future relationships.

    I know that vaccines are safe and it is time that all clinicians and public health push consistent messaging to protect our loved ones and the community.

    Thanks for taking the time to post this information,

    Mike

    Posted by Mike Boivin | June 19, 2011, 8:56 pm
  3. I’m trying to work out which article you’re referring to, Jen.

    The only HPV-related articles I could find in Lancet recently were:

    1. Brotherton JML, Fridman M, May CL, Chappell G, Saville AM, Gertig DM. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet 2011;377(9783):2085-2092 PMID: 21684381. (http://linkinghub.elsevier.com/retrieve/pii/S0140673611605515).

    2. Lacey CJN, Garnett GP. Promising control of genital warts: but is elimination possible? The Lancet Infectious Diseases 2011;11(1):4-6. (http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2810%2970297-8/fulltext).

    3. Saraiya M, Hariri S. HPV vaccine effect: is the glass half full or half empty? Lancet 2011;377(9783):2057-2058. (http://www.sciencedirect.com/science/article/pii/S0140673611606508).

    I’m not sure it’s any of these. I didn’t see anything in Lancet ID, either; I’ve also looked at the “In Press” articles.

    I have recently been corresponding with an antivaccine, anti-Gardasil lobby group, and have posted about the experience at http://peterenglish.blogspot.com/2011/07/debating-with-anti-vaccine-lobbyists.html

    Posted by Peter M B English | July 6, 2011, 1:31 pm
  4. Regarding Gardasil, it is stated in the package insert that it has not been tested for carcinogenic properties.

    Gardasil may cause cancer in another way too, by the process of “replacement”. This is a normal phenomenon in virology where virus strains which are removed are always replaced by new ones.

    It is unknown (also to the manufacturers, Merck) if the new strains will be more carcinogenic than the ones which have been removed.

    In other words, Gardasil may actually increase the risk of cancer.

    Posted by Mindano Iha | July 6, 2011, 2:17 pm
    • What you are saying makes no sense. If you understood virology and oncogenes you would know the HPV vaccine cannot be carcinogeneic. And if you read the article in the Lancet from June (the Australian study) you will see a reduction in high grade lesions (pre cancers) in young women.

      Posted by Dr. Jen Gunter | July 7, 2011, 6:29 am
    • Dear, Yes definetly Gardasil may actually increase the risk of cacer!!! your statement has total sense, is as saying that Gardasil will prevent Cancer!
      irrelevant sarcasm appart, Gardasil is an ANTI -HPV vaccine, not an anti-cancer vaccine. if the HPV strains stopped by gardasil actually increases the ocurrance of natural ocurring cancer is considered a surrogate outcome of the vaccine. Main outcome is protection efficacy against HPV strains.
      True, no research results are out YET about viral natural replacement, as long term natural studies are needed to observe changes, if any. that means that for example a non vaccinal HPV strain, like HPV- 33, that causes lets say 5% of High grade lesions and subsequently cancer, may take the 70% gap left by HPV vaccinal strains 16 and 18. Definetly incidence of Cancer caused by non vaccinal strains will become more evident in a vaccinated population, the real question is with time, will the general incidence of Cancer related to HPV decrase, will this non vaccinal strains keep an stable 5-10% , lets say 100 cases per year or will it fill the gap and become the normal lets say 1000 cases per year that where normally caused by Vaccinal strains? thats the worst case scenario… but then again it will be counteract with a second generation vaccine, even if right now both gardasil and cervarix have proven good cross protection.
      Saying that something may cause an INCREASE, is not only allarming but illogical.

      Posted by Jhon | July 27, 2011, 10:13 am
  5. I’m concerned about a few things here. Firstly what level of cancer precursors are they addressing, severe, mild etc and the fact that most cancer precursors go away on there own are not addressed. Secondly ‘However, long-term efficacy and safety needs to be addressed in future trials.’ is very disconcerting. Also they tested 15 to 44yr olds who were not very sexually active and recommend this vaccine to much younger girls. As well the placebo is a concern since ‘All trials used placebo as the comparator except for two in which all or part of the control group received hepatitis A vaccine [16], or placebo plus hepatitis B vaccine’ If ‘Approximately 90% of participants in each trial had normal cytology at enrollment.’ then how does this show that this prevents cancer as they were not at risk? Another concern ‘However, there was significant heterogeneity among pooled studies’ Adverse events were only recorded for 15-30 days post vaccination, why not longer? Another question, will these side effects be discussed with patients prior to vaccination ‘Serious AE reported included abnormal pregnancy outcomes, blood and lymphatic system disorder, hepatobiliary disorder, immune system disorder, cardiac and vascular disorder, gastrointestinal disorder, musculoskeletal and connective tissue disorder, nervous system disorder, psychiatric disorder, renal and urinary disorder, reproductive system and breast disorder, respiratory, thoracic and mediastinal disorder, skin and subcutaneous tissue disorder, neoplasm, infection and infestation, injury, poisoning and procedural complications.’ Also this ‘The added benefit of cross-protection may result in further reductions in incidence of cervical cancer and precancerous lesions following vaccination.’ May result and yet it is being advertised as an anti cancer vaccine. This is very misleading to the public.

    Posted by Nicole DaSilva | July 6, 2011, 6:49 pm
    • Side effects listed in vaccine inserts generally have little if anything to do with prospective studies. They are a particular medicolegal document that is rather unique to the US. If you read the package insert for Tylenol you will see it contains many potentially serious adverse events. However, the meta analysis of 44,000 girls tell us there were n serious adverse events. For there to be cause and effect between a vaccine and an injury, there needs to be be some sign during the first 30 days.

      One would expect the participants to have normal cytology at enrollment as these studies are recruiting HPV naive women. That is the whole point of the studies and the vaccine – to prevent HPV, not treat active disease.

      Every woman who has sex is at risk for HPV.

      The studies look at all the cancer precursors and at the end of the day several abnormalities (severe dysplasia), mild dysplasia, and warts are less common among vaccine recipients.

      The answers are all there in the articles.

      Posted by Dr. Jen Gunter | July 7, 2011, 6:34 am
  6. But vaccine status was not recorded in the Brotherton study. So how can you say the vaccine was responsible for any decline?

    Posted by Candace | July 8, 2011, 3:39 am
  7. thanks very much for your info here. i have been considering the vaccine for a few years, but was waiting on better data, specifically long-term studies (which i know are still not possible, which bothers me). it does, however, still bother me a LOT that the HPV vaccine is just “not for” boys, which is complete fucking bullshit (sorry, was hoping to keep this PG, but arbitrary gender favoritism infuriates me). so. yeah. all in all, i had better get on with it, since i’m zeroing in on 27.

    Posted by a name | July 24, 2011, 7:40 am
  8. Jen you should probably publish also some info on male uses of gardasil from GIULIANO et.al and the proven protection against anal cancer two, also its possible relation to oropharyngeal cancer, genital warts caused by HPV 6-11. theres some new safety data too thats also in MEN. if you want i can send you the articles, all of them brend new. we must not forget that over 90million doses have been distributed worldwide and no serious adverse related to the vaccine have been observe, only mild adverse events related to puncture site might be related but thats the case with any vaccine. i think 90 million is quite a number to realise if something is safe or not?
    Brotherton study is quite nice as it shows real life results of effectiveness.

    Posted by Jhon | July 27, 2011, 10:21 am
  9. The truth is out there! follow the truth about gardasil safety! hahahaha, appart from joking, for anyone interested this is the real, official truth reported by the CDC and the FDA using all registered VAERS about gardasil real safety in the USA, updated to june 2011!
    this is the link: http://www.cdc.gov/vaccinesafety/Vaccines/HPV/gardasil.html
    thats to show that the real truth is out there ! it explains clearly VAERS, how it works, and the studied relation between the reported adverse events around Gardasil.
    hope it is of some help for the real truth seekers!

    Posted by Jhon | July 28, 2011, 12:45 pm
  10. Finding this information is truly disturbing. TOO many Doctors that call themselves professionals are pushing a dangerous vaccine. It is well know and the data is out there oh how many thousands of girls are severly sick, having daily seizures for yrs after this shot. Fainting after a vaccine is not due to your childs fear of needles. Research the ingredients in Gardasil Polysorbate 80 (tween80) is a sterilizing agent, sodium borate which is boric acid- main ing in Roach killer and also aluminum at 225 mcg. Find out all you can about aluminum toxcity and then ask yourself if you should shot up your child with three doses i n 6 months. My daughter almost died from this shot but she is not the only one. If you want the truth go to truthaboutgardasil.org. look up lets talk about gardasil site. Get ALL your facts!! This vaccine is effective for only 5 years, protects against 4 HPV viruses. try googling gardasil in the UK, go to utube and look for gardasil videos. Protect your kids, It is happening, kids are dying and disabled so know your facts before you decide. Alot of mothers wish they did- Fast-tracking a vaccine is one red-flag, a vaccine for cervical cancer, now being offered to boys is another red flag, Doctors telling you theat the injured are just a bunch of liars is a huge red flag.

    Posted by samantha | July 29, 2011, 5:44 pm
  11. I’m not at all sure what JHON is trying to say, but s/he does mention virus type replacement.

    It’s not clear that this will be of any signficance with HPV, as you can already be co-infected with several virus types.

    It’s true that when we used a 7-valent vaccine against 7 serotypes of pneumococcus we started to see other serotypes appearing that weren’t a problem previously, because there was a space available, where the vaccine- preventable types used to be.

    But as you can already be co-infected with several types of HPV this is unlikely to be a problem.

    Furthermore, we know which types of HPV vaccine are most oncogenic, and they are the two types in the vaccine. This relates to the likelihood of chronic (long-term) infection: these two types are also the types least likely to be cleared.

    I’m not sure if JHON was arguing that type-replacement could mean replacement of vaccine types with more oncogenic types – but for the reasons I’ve described, this is not something to be concerned about.

    Posted by Peter English | July 30, 2011, 3:46 pm
  12. I’ll have to read this whole article more in depth plus all the comments but I was under the belief that hpv was pretty much something you get stuck with for life? http://wartrolandhpv.blogspot.com/

    Posted by simon ealing | September 14, 2011, 4:57 pm
  13. the issue of vaccinating boys is interesting. obviously, a boy doesn’t have a cervix, so you’d be looking for other benefits. These include: benefits to the individual boys – prevention of genital warts (if you use Gardasil); prevention of head & neck, penile, anal, & maybe other cancers; & wider benefits from herd immunity.

    Posted by peter english | September 15, 2011, 8:48 am
  14. Thank you Dr. Gunter – sorry that so many of the anti-Gardasil brigade has popped in to offer their crazy conspiracy theories.

    Posted by Lawrence | January 4, 2012, 11:19 am
  15. Is Dr. Gunter getting paid from FDA,vaccine manufacturers or someone else to promote its safety? Who knows :)

    Posted by Matt | July 14, 2012, 8:54 am
  16. “Any medical professional who believes that it is justified to inject any type of neurotoxin into any person to prevent any disease is completely misguided, misinformed, deluded and ignorant of any logic regarding human health.”
    Dr. Dave Mihalovic, vaccine specialist

    Posted by Megan Kerkhoff | March 10, 2013, 2:02 pm
    • There is no neurotoxin in vaccines. Perhaps you should read the ingredients first?

      You naturopathic doctor that you quote has never published any papers listed in PubMed. Can you direct me to his published, peer-reviewed research?

      Posted by Dr. Jen Gunter | March 10, 2013, 2:10 pm

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