The debate has always been hot about the risk-benefit ratio of human papillomavirus (HPV) vaccines, ever since Merck’s Gardasil-4 vaccine was fast tracked to licensure by the U.S. Food and Drug Administration (FDA) in 2006 followed by persistent reports of young girls suffering serious health problems after vaccination.1 Now, new international investigations and reports of failure are hitting the headlines, prompting additional worries about severe reactions to HPV vaccines.
Europeans Launch Investigation Into HPV-Related Adverse Events
Three HPV vaccines are available both in the United States and the European Union. Merck and Co. makes two of them—Gardasil-4, the first FDA-approved HPV vaccine, and Gardasil-9, the newest licensed HPV vaccine—while GlaxoSmithKline Plc makes the third, Cervarix.
In July 2015, the European Medicines Agency (EMA) launched a probe to clarify the safety of the three HPV vaccines. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review available data with a focus on two conditions: complex regional pain syndrome (CRPS), which impacts the limbs, and postural orthostatic tachycardia syndrome (POTS) which increases heart rate abnormally and causes dizziness, fainting, chest pain, headache and weakness.
The PRAC has previously recorded reports of these conditions in female recipients of the HPV vaccines during routine safety monitoring, but Denmark requested a deeper investigation and for the PRAC to determine if there is a causal link between the incidents and the vaccines.2
A 2015 review published in Clinical Rheumatology describes a hypothesis for the development of CRPS and POTS following HPV vaccination.
“These are illnesses often difficult to diagnose that have overlapping clinical features,” suggesting that “small fiber neuropathy and dysautonomia could be the common underlying pathogenesis to the group of rare, but severe reactions that follow HPV vaccination.” The study author warned, “Clinicians should be aware of the possible association between HPV vaccination and the development of these difficult to diagnose painful dysautonomic syndromes.”3
While the EMA stressed that the review is not questioning if “the benefits of HPV vaccines outweigh their risks,” the results of the review could prompt the committee to recommend changes to product information.4
Japan has already taken an action against HPV vaccination. After recording 1,968 adverse reactions—358 events deemed as serious—since the country began offering Gardasil to girls, Japan’s Vaccine Adverse Reactions Review Committee announced in June 2013 that the HPV vaccine should not be recommended until safety concerns were addressed.5
U.S. Compensation Program Paid Some $6 Million to Victims
Between 2006, when Gardasil first received approval from the FDA, and August 14, 2015, there have been 36,855 Gardasil-4 adverse reactions reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS). Specifically, 16,327 (44%) were serious events categorized as “life threatening” or requiring an emergency room visit or hospitalization. There have been 6,914 Gardasil-4 adverse event reports where the patient “did not recover” and 1,145 reports that resulted in permanent disability. There have been 208 Gardasil-4 death reports made to VAERS.
Judicial Watch reported that the National Vaccine Injury Compensation Program (VICP) had awarded at least $5.9 million to 49 victims for claims that the HPV vaccine either caused injury or death (2 claims) as of March 2013. There are still nearly 100 claims pending and still others that were dismissed. Judicial Watch had requested these documents and information from the Department of Health and Human Services as part of the agency’s compliance with the Freedom of Information Act.
“This new information from the government shows that the serious safety concerns about the use of Gardasil have been well-founded,” Judicial Watch President Tom Fitton argued.
However, the FDA and U.S. government stands by the vaccine’s safety and continues to promote its use.6
U.S. Federal Claims About Reactions Still Unresolved
In November 2013, two Wisconsin sisters filed a federal claim against Merck claiming that Gardasil led their ovaries to stop producing eggs, leaving them infertile and forcing them into premature menopause. Though there is still no decision in the case, this case represents the first one to reach a hearing alleging that Gardasil causes infertility.7
Madelyne Meylor, who is now in her 20s, began her menstrual periods at age 13 and received her first HPV dose a few months later. Her periods became irregular and by the third HPV dose at age 15, her periods stopped. At age 16, she was diagnosed with premature ovarian failure.
Olivia Meylor, who is also now in her 20s, received the three HPV doses before having her first period at age 15. At age 16, she was diagnosed with premature ovarian failure. Both women tested negative for genetic predispositions to the condition.8
There has also been a question as to the link between HPV vaccines and infertility. Infertility affected 10.9% of women aged 15 to 44 years in the United States from 2006 through 2010.9
According to Sanevax, a non-profit group providing independent monitoring of HPV vaccine safety, there has been a recent, substantial increase in reports of infertility in the U.S. with a 790% increase in the annual average of fertility problems beginning in 2007, shortly after HPV vaccines were introduced.10
Further, according to the VAERS databases, nearly 90% of infertility cases reported as a vaccine side effect were attributed to the HPV vaccines. There has also been a 276% increase in the number of “abortion/stillbirth” adverse events related to vaccines since 2006.11
Merck said its post-licensure reports of Gardasil effects and clinical trial evidence do not support a causal link between the vaccine and premature ovarian insufficiency.12
However, according to Merck’s package insert for Gardasil, the vaccine has not been evaluated for impairment of fertility in humans, only in female rates. These pre-clinical studies showed no effects on fertility.13
References:
1 NVIC. Merck’s Gardasil Vaccine Not Proven Safe for Little Girls. June 27, 2006.
2 European Medicines Agency. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines. Press Release July 13, 2015.
3 Martinez-Lavin M. Hypothesis: Human papillomavirus vaccination syndrome—small fiber neuropathy and dysautonomia could be its underlying pathogenesis. Clinical Rheumatology 2015;34:7:1165-69.
4 See Footnote #1.
5 Judicial Watch. Japan Halts HPV Shot for Girls over Safety Issues. The Judicial Watch Blog Corruption Chronicles Oct. 1, 2013.
6 Judicial Watch. JW Investigates HPV Injury Compensation Program. Press Release Mar. 20, 2013.
7 Wahlberg D. Still no ruling in Mount Horeb sisters’ HPV vaccine injury claim. Wisconsin State Journal Oct. 20, 2014.
8 Wahlberg D. Sisters’ HPV Vaccine injury claim heads to federal court. Wisconsin State Journal Nov. 7, 2013.
9 Centers for Disease Control and Prevention. Infertility. Updated Oct. 30, 2013.
10 Erickson N. How closely does the CDC monitor HPV vaccine safety? News Blog. SaneVax Inc. Jan. 5, 2014.
11 Erickson N. Chart on Abortion/Stillbirth from article How closely does the CDC monitor HPV vaccine safety? News Blog. SaneVax Inc. Jan. 5, 2014.
12 See Footnote #3.
13 U.S. Food and Drug Administration. Package Insert–Gardasil. Vaccines, Blood & Biologics. Updated Nov. 13, 2013.
5 Responses
Isn’t it about time for someone to check the vaccines for “accidental” contamination with HCG?
After being in a wheelchair for 4 months this year, being severely sick and not attending school for 7 months, my daughter has recovered from her adverse reaction to the HPV vaccination. Long term homeopathic medicine, naturopathy, acupuncture, bowen technique and meditation and the pure will to get better and prove the doctors wrong, were what worked – Western medicine tried to tell me my daughter had a psychological sickness!!!! All I can say is- thank god for the European Medicines Agency and the doctors at Frederiksberg hospital in Denmark for pushing for this investigation!
We have a 12 months old little guy who have just made the transition from solution to dairy and
we have started presenting him table food.
INEFFICACY OF THE HPV VACCINE SEEN BY DOCTOR OF DEEP PERÚ
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 May 2013 Vaccine Adverse Event Reporting Syntem (VAERS) published that the vaccines against the HPV caused only in Unites States 138 muertes and 30020 adverse events; 947 disabled: 12 males, 924 females and 11sex unknown; 4050 advers graves: 106 males, 3883 females and 57 unknown sex; 527 abnormal PAP smears, 214 dysplasia cervical and cervical cancer 214. Vaccine Adverse Event Reporting System secure that only the !% to 10% are denounced https://dub104.mail.live.com/default.aspx#n=1521802 http://holyhormones.com/vaccinations/hpv-vaccine/hpv-vaccine-adverse-eve…
http://therefusers.com/?s=cervarix
The Vaccine efects advers reactions (VAERS) ensures that only complaint between 1% to 10% of the adverse effects produced by this evil vaccine;this figures shown are calculated according to the statements of the VAERS: to 10%.
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 ensures that the 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: [email protected]
THE ENIGMATIC HUMAN PAPILLOMA VIRUS
There are identified 234 types of human papillomavirus (HPV); they are divided in low and high risk; the high risk factor HPV are suspicious to originate the uterine cervical carcinoma (UCC); the low risk the mayority, produce benigns lesions; to day exist world collective psicosis about the HPV by the full advertising to the manufacturer to introduce the vaccine against the HPV in the market.
There are not researchers; stadistic, epidemiologc, citologic, histologic, colposcopic and clinic to demostrate that this vaccine prevent the pollution with HPV nor the HPV produce the cervical cancer
HPV infection not only is adquired for the coitus; we are contaminated since after born, are widespread in the world; they life in the environment and blood for reduced time; they are ubiquitous; by immunology are determined that have the affinity by our skin and the mucous membrane of the genital, upper respiratory and digestive tracts; anus, of the mouth, gum, lips, in the amniotic fluid, ruber glove, biopsy forceps, specula, underwear, towels, on the floor, the toilet seat, gyms, lockers rooms of swimming in general in the fomites;: are considered as commensals; the domestic and wild animals too are contaminated.
In average have the viruses 3% to 93% of the men; between 23-26 years of women have the more high frequency and 40% of children have this virus and the 10% of women without sex have the HPV; the pregnants of the first quarter 40%, of the third quarter 60% and in the postpartum 17% have the HPV. Not all person in the world are contaminated;.in average 10% of persons that are leving in development countries and 15% in underdevelpment are polluted with this viruses; they lack to the cellular structure; they have not the proper metabolism; they request a cell to life, is the parasitic of the cell; they are considered the basic structure of life.The frequency and types of the HPV vary according to the region, geography, age, cultural, social, economic and religious factors; the HPV do not distribuited to iqual in the world; in USA: the more frequecy is PVH 16 , Africa HPV 45 , Central and South America PVH 39-59, Canada HPV 31, Spain HPVs 6-16-51- 53: The HPV is increased in the second time of the menstrual cycles and in women who use hormonal anticonception and decrease in the first time of the cycles and do not use hormonal anticonception; the proportion of the HPV too is diferent over the world: Africa Subsahariana 24%, east of Europe 21.4% , Latin America 16.1%, Thailand 8%, New Mexico both sexo 9%, white no hispanic 13.7% , hispanic 9.7% and natives 6.6% , Argentina 16.6% , South Corea 10.4% and so on; a metanalysis in women with normal PAP 11.7%.The HPV life in the cervix of the uterine without produced disturbance: are latent, subclinical in minority case as warts, condylomata flat or inverted ; The HPV are capricious, ubiquitous and enigmatics, appears and disappears from the body of the person, the highest incidence are in women aged 20 to 26 years disappear with the age, may persist throughout life without causing any disturbance, in 80% of women who have HPV in your cervix disappear before the twelve months, by action of the immune system.
There are not any investigation that scienrtifically proof that the HPV cause the uterine cervical carcinoma (UCC) it is only suspicious. In the development of the UCC are implicate others cofactors being the first and foremost the sexual act; the coitus is the factor scientifically demostrated that produce the UCC; Mix in 130, 000 nuns do not found not any UCC, followed by fasctor suspísous: tobacco, alcohol, HPV, herpes simplex virus 2, age of first intercourse, number of partners, cofactor man, economic factors, more frequent in women of low economic status , multiparity, circumcision, immune system disorders, hormonal contraception, environment and others.
In 1974 zur Hausen hypothesized that HPV was the agent that cause the UCC and other researchers reported the same idea, but HPV does not fulfill the five Koch’s postulates, which is accepted as dogma in the scientific medical to be considered as the cause of cervical cancer; the HPV in UCC are found by immunological methods in only 90%, that can consider as that the HPV is present or is a immunology residue; the HPV natural or native do not found.in UCC
The presence of HPV is not sufficient for the development the UCC, require the company of several exogenous and endogenous cofactors.
Our understanding of the relationship of HPV with the cofactors are still poor and the role of cofactors in the development of cervical malignancy are nebulous. Scientifically can ensures that HPV does not cause cervical carcinoma and HPV vaccine does not prevent less prevents cervical carcinoma, must have further research on the HPV and other cofactors.
Dr. Godfrey Arauzo
Huancayo PERU
E mail: godo.ara @ gmail.com