FDA Expands the Market for Gardasil Vaccine Use

FDA Expands the Market for Gardasil Vaccine Use

Story Highlights

  • Merck’s new Gardasil 9 human papillomavirus vaccine has now been approved for use in men and women to age 45.
  • Expanded routine administration of Gardasil 9 in older people may raise cervical cancer risks for some adult women who are actively infected with HPV.
  • The American Cancer Society does not expect Gardasil 9 to provide much protection to older adults.

On October 5, 2018, the U.S. Food and Drug Administration (FDA) approved the use of Merck & Co.’s Gardasil 9 human papillomavirus (HPV) vaccine for men and women between the ages of 27 and 45 years old. As its name implies, Gardasil 9 includes nine strains of HPV, replacing the original 4-strain Gardasil released in 2006.1

Prior to the FDA’s recent decision to expand the market for Gardasil 9, Gardasil vaccine has been controversial since the four-strain version was fast tracked to licensure in 2006 using questionable study designs for both pre-licensure and post-marketing studies. There have been allegations that Gardasil’s effectiveness has been overstated with premature reports of cancer prevention and that public health officials and medical trade groups have minimized serious side effects.2 Expanding the age range to include marketing of the vaccine to older adults is raising concerns about the vaccine’s safety and effectiveness profile for women and men in this new age group.

Questionable and Increased Risk

The stated rationale for expanding the use indications for Gardasil 9 to include older adults is to help prevent HPV-related diseases and cancers in a broader age range,” according to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.1 However, FDA’s approval of Gardasil 9 for use in women between 27 and 45 years of age was based on results of studies of the original 4-strain Gardasil conducted more than a decade ago. The vaccine’s safety and effectiveness in men of that age group were only inferred from the data on women and younger men, again primarily using Gardasil 4, not Gardasil 9, although FDA officials state that “the vaccines are manufactured similarly and cover four of the same HPV types.”1

Of increased concern for older females receiving Gardasil 9, is the fact that the vaccine does not treat a current HPV infection, which is usually asymptomatic and, if a female receives the vaccine while infected, it may actually increase her risk of developing cervical cancer.3 This increased cervical cancer risk was disclosed by Merck prior to the vaccine’s licensure in 2006 yet there are no official recommendations calling for HPV testing prior to vaccination to screen females for active infections.4

Prior or Current HPV Infection Affects Response to Gardasil Vaccine

HPV infection is so common, that most everyone who has been sexually active is likely to be infected at some point, although infections clear naturally without complications within two years in over 90 percent of cases.5 The risk of chronic infection with HPV, which can increase the risk for HPV-related cancers, is higher for those who smoke, have multiple sexual partners, long term oral contraceptive use, multiple births, weakened immune system, chronic inflammation or have other high risk factors.6 

One of the concerns in vaccinating women between 27 and 45 is that there is a much higher chance that they have been exposed to HPV prior to being vaccinated or are actively infected at the time of vaccination before natural clearance of the infection from the body takes place. Older women who have recently ended a long-term monogamous relationship, for example, may be at greater risk of being actively infected at the time of vaccination, thus reducing the potential benefit of the vaccine.

According to the American Cancer Society, not only is HPV vaccination “unlikely to provide much, if any, benefit as people get older,”7 but most insurance companies do not cover the vaccine cost for men and women in that age group. This will result in out-of-pocket costs that can range from $216 to $445 per dose of Gardasil.8

In addition, the risk of HPV infection reportedly declines after age 39, whether because of decreases in natural antibody levels or “different cumulative sexual practices in older women.”9 Patient history can be used a valuable gauge of risk: The chance of infection with HPV types 16, and/or 18, the most common cancer-causing strains, is 24 percent in women over 30 whose paps smear test results have always been normal. By comparison, for women between the ages of 30 and 39, with a history of abnormal pap smear tests that include a history of high-grade dysplasia, the chances of infection with one or both strains increases to 55 percent.9

There is continuing uncertainty about the safety and effectiveness of Gardasil 9 and new well designed studies are needed that also include older adults now being recommended to receive the vaccine. In the meantime, regular check-ups and pap screening remains the cornerstone of HPV-related cancer prevention in women.


References:

1 Food and Drug Administration (press release). FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. FDA.gov Oct. 5, 2018.
2 Raines K, Fisher BL. Mass HPV Vaccination Plan for the U.S. The Vaccine Reaction. Nov. 14, 2018.
3
Mercola J. HPV Vaccine Risks You Should Know About. Mercola.com 2018.
4 
Gardasil™ HPV Quadrivalent Vaccine. VRBPAC Background Document. May 18, 2006.
5 
Mercola J. HPV Vaccine Can Make You Susceptible to More Serious Strains of HPV. Mercola.com May 5, 2015.
6 
National Vaccine Information Center. Human Papillomavirus (HPV) and HPV Vaccine Quick Facts. NVIC.org 2018
7 HPV Vaccines, What is HPV? American Cancer Society Oct. 8, 2018.
8 
Gardasil 9. Good RX. C 2018.
9 
Gunter J. HPV vaccine over age 26 – is it worth it? Dr. Jen Gunter. May 19, 2015.

8 Responses to "FDA Expands the Market for Gardasil Vaccine Use"

  1. Mike   November 23, 2018 at 9:02 am

    Too scary. Why don’t more see the truth?

    Reply
  2. Mary   November 23, 2018 at 12:00 pm

    I read that Gardasil 9 has even more aluminum than the older version. Maybe they want it to look like it is doing more, but is it truly useful or just more toxic?

    Reply
  3. JD   November 23, 2018 at 9:28 pm

    as long as Gardasil has less flavors than breakfast cereals and sports drinks, we will remain dead. WHY the gov covers for the drug co’s is simply the bribes.
    Robert F. Kennedy and others have given speeches that Big Pig Pharma bribes more than twice as much as oil & gas ever did.
    In 2013, CDC insiders came out that they’d know since 2001 vaccines caused brain-damage autism. (& modern vaccines are filled with unregulated industrial chemicals and other waste matters AND NOT TESTED FOR SAFETY)
    Nothing has been done; nothing has been changed; the gov “captured” Agencies and “souled-out” “Representatives” continue t count their money faster than vaccine deaths and injuries.
    YOU are not “represented.”

    Reply
  4. Carol Jackson   November 26, 2018 at 5:35 pm

    FDA insanity in action.

    Reply
  5. Don   December 20, 2018 at 11:55 am

    FAKE DRUG ADMINISTRATION And FAKE DRUG PUSHERS Like MERK ECT. Must Be ABOLISHED From Our REPUBLIC!

    Reply
  6. Virginia Newcomb   December 20, 2018 at 12:23 pm

    Sad that our government is tied up with big pharma!! More money for bit pharma and more harm for people!

    Reply
  7. Mimi Hughes   December 20, 2018 at 1:45 pm

    This could potentially stop women from getting regular checkups and Pap smears thinking they are safe- have you researched the potential side effects including death (reputed bt CDC) – no wonder banned in some countries! The vaccine has never been tested on children under 15 years old and yet are given to nine year olds

    Reply
  8. Godofredo   March 9, 2019 at 5:59 pm

    INEFFICACY OF THE HPV VACCINE SEEN BY DOCTOR OF DEEP PERÚ
    Dr. Godfrey Arauzo
    From its inception until the appearance of uterine cervical carcinoma (UCC) takes a average of 25-30 years; the research of this vaccine have begun in 2000. It is evident that the scientific efficacy of this new vaccine will be determined the years 2025 – 2030.
    HPV not causes definitely the (CCU); at the onset of this disease involves multiple risk factors, including the suspected HPV, but scientifically is proven by epidemiology and statistics that the sex is what generates this disease. Nix in 100.000 nuns found not any UCC.
    http://www.portalesmedicos.com/publicaciones/articles/1832/1/Epidemiolog.,.
    There are not scientific researchs; stadistic, epidemiologic, citologic, histologic, colpocopic and clinic to demostrate that the HPV produce the cervical cance, are publishing. whitout scierntific sustentance.
    To accept that a virus or a bacteria causes a infection disease must unfailingly fulfill the five Koch’s postulate
    http://www.xatakaciencia.com/salud/los-postulados-de-koch
    1 – The agent must be present in every case of the disease and absent from healthy.
    2 – The agent must not appear in other diseases.
    3 – The agent to be isolated in pure culture from disease lesions.
    4 – The agent of causing disease in a susceptible animal being inoculated.
    5 – The agent must again be isolated lesions in experimental animals.
    http://es.scribd.com/doc/44558220/MICROBIOLOGIA-1
    Consequently, HPV not fulfill not any principle of Koch’s postulates. by not meeting this postulate, that is accepted as dogma in medicine, scientifically we must be ensure that the HPV is not the causative agent to the UCC..
    Until November 2018 Vaccine Adverse Event Reporting Syntem (VAERS) published that the vaccines against the HPV caused only in Unites States 458 deaths and 60714 adverse events; only the !% to 10% are denounced projecting to 100 % then was produced 4580 dearhs and 607140 adver events ( VAERS Nov 2018) http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccio
    http://www.pop.org/content/merck-researcher-admits-gardasil-guards-again
    Dr. Harper, who contributed to the development of the vaccine by Merck, reports that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
    http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gard
    The vaccine was approved to give girls uncontaminated with HPV, (Dr. Howenstinc If
    he women are vaccinated with HPV contaminated, have the possibility to acquire a 44.6% CCU
    http://www.newswithviews.com / Howenstine/james170.htm.
    Merck did not disclose that the vaccine was transgenic, the Sane Vax has discovered, which is transgenic because it has been found that the vaccine is contaminated with DNA recombinant vaccine Gardasil (DNArPVH) and has raised its concerns to the president of the FDA Margaret Hamburg. The FDA replied that the vaccine will not cause any damage transgenic
    http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-re
    http://bolsonweb.com.ar/diariobolson/detalle.php?id_noticia=26075
    A vaccinated child was ill with rheumatoid arthritis, which is an autoimmune disease. 24 hours after vaccination and found that the aluminum adhered to DNArPVH, two years after vaccination and in autopsy 6 months after death in a New Zeland girl Jazmine Renata which had recibed this deadly vaccines
    http://www.mecfsforums.com/index.php?topic=9331.0
    Management time to get market approval of a drug the FDA is at least three years, it is a drug for cancer 15 years, but the authorization Merck had only six months and the European Medicines Agency (EMA in English) only 9 months: To introduce the vaccine are using the marketing of fear
    http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-http://mujeresenaccion.over-blog.es/article-vph-la-vacuna -of-marketing-of-fear-67210961.ht
    HPV is ubiquitous; lives in wild and domestic animals, pollute us from birth, is on the doorknobs, on towels, on nails, on fomites, in gloves and specula of gynecologists,. sexual intercourse is not the only means of contamination.
    http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/invest
    HPV also lives in the 400 nm outermost of our skin and mucous membranes. ,
    If it live in our skin, our immune system produces cellular and humoral immunity is acquired or that our body is self vaccinatinge by PVHs living on our skin and mucous ..
    http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
    The PVHs is not distributed uniformly worldwide. It has been found that in Canada HPV 18 only reaches 3%; is more often HPV 31, in my country Peru no studies have determined that HPV types predominate; Gardasil contains 225 mcg. aluminum and Cervarix 500 mcg, that produce the Alzheimer, Parkinson and autism, produce too neurotoxic and immune system disorders (Blaylock 2012) and polisorbato 80, a powerful contraceptive, that in experimental animals produces sterility, atrophy of the testicles and disturbance organic and funtional of the organs of the reproduction; is carcinogenic and mutagenic; also contains sodium borate considered poison unused in medicinal preparations (NLM)
    http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
    Have been discovered to date 200 types of HPV; HPV is not infectious, contagious; the intercourse is not only that the persons is contaminated
    http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
    On 22-11-2010 FDA approved Gardasil for males aged 9 to 26 to prevent warts and cancer to the anus, is overkill
    http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-re
    http://salud.aollatino.com/2011/02/02/aprueba-fda-nueva-indicacion-vacun
    For the reasons from deep Peru Huancayo, I believe that this vaccine is a fraud?, a robbery?, a swindle?, a rough joke?, a crime?, a shame?, a scam?
    The HPV is not scientifically proved for the moment that produce the UCC its effectiveness shall be verified just the years of 2025-2030.
    Dr. Godofredo Arauzo
    E mail: godo.ara@gmail.com

    Reply

Leave a Reply

Your email address will not be published.