How long was gardasil tested

After seven years of design and testing, the first human trials for the vaccine, named Gardasil, were completed. Since then, two further vaccines have been approved: a bivalent vaccine called Cervarix approved in that prevents two HPV types HPV16 and 18 and a nonavalent vaccine called Gardasil 9 in that protects against nine HPV types HPV 6, 11, 16, 18, 31, 33, 45, 52, and As of October , countries worldwide vaccinate against HPV as part of their regular vaccine schedule.

Jun 18, The history of the HPV vaccine. Recent Posts See All. The initial decline in males was likely due to herd effects, as routine vaccination of boys was recommended in Cervical Precancers.

Studies from Other Countries. Decreases in prevalence of vaccine-type HPV infections, anogenital warts, and cervical precancers external icon also have been observed in more than 14 countries with HPV vaccination programs, including Australia, Scotland, and others. HPV Vaccine Safety.

Safety of the 9-valent human papillomavirus vaccine. Published ahead of print. Near real-time surveillance to assess the safety of the 9-valent human papillomavirus vaccine. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.

Br J Clin Pharmacol. Drug Saf. No increased risk of Guillain-Barre syndrome after human papilloma virus vaccine: A self-controlled case-series study in England. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study.

Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. Expert Rev Vaccines. Quadrivalent human papillomavirus vaccination in boys and risk of autoimmune diseases, neurological diseases and venous thromboembolism. Int J Epidemiol. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. Risk of autoimmune diseases and human papilloma virus HPV vaccines: Six years of case-referent surveillance.

It is approved for females aged 9 to 45 years and males 9 to 26 years. The trials did not seek to prove that the vaccine prevents cervical cancer. This is because it would not have been ethical to allow cervical cancer to develop in the group who did not receive the vaccine in the trials the placebo or control group. These abnormalities are a proven pre-cursor to cervical cancer. For ethical reasons, younger girls were not included in the trials as they would have been required to have regular Pap tests now known as Cervical Screening Tests , which would have been inappropriate given their age.

Younger boys were also excluded from the trials. Instead, studies compared the body's immune response to the vaccine between younger and older girls, and younger and older boys. It was determined those younger girls and boys who received the vaccine in these studies:. These laws, however, provided parents with the option of declining the vaccine for their daughters. The early adverse reaction reports included seven deaths following receipt of Gardasil.

Additionally, an early NVIC analysis of VAERS data found a significantly greater risk of severe adverse events including Guillain-Barre Syndrome, respiratory and cardiac problems, central nervous system problems, convulsions, coordination and neuromuscular problems when Gardasil was administered along with another vaccine, Menectra, a meningococcal vaccine routinely administered to adolescents.

No pre-licensure clinical trials evaluated safety when Gardasil was administered along with other vaccines targeted for use in teenagers. At the time their report was published, 8, adverse reactions following Gardasil vaccination had been reported to VAERS, including 18 deaths. Reported side effects included blood clots, Guillain-Barre Syndrome GBS , growth of warts, dizziness, nausea, convulsions, and headaches. The report also highlighted reports of miscarriages noting that Gardasil was not studied in pregnant women and evaluated as to whether it could cause fetal harm.

Reports of serious reactions and deaths following HPV vaccination were also appearing in the media. These reports included seizures, paralysis, collapse, Guillain-Barre Syndrome as well as unexplained deaths. The article provides the reporting rates for syncope, local site reactions, dizziness, nausea, headache, hypersensitivity reactions, urticarial, venous thromboembolic events, autoimmune disorders and Guillain-Barre Syndrome, anaphylaxis, pancreatitis, transverse myelitis, motor neuron disease and death.

The authors concluded that the rates of these events, except for syncope and venous thromboembolic events, were no different than background rates. Merck continued to push for expanded use of its Gardasil vaccine and on October 16, , the FDA approved Gardasil for use in boys and young men ages nine to twenty-six for the prevention of genital warts associated with HPV types 6 and 11, even though the vaccine had been studied in only about 3, males.

Merck also submitted a request to the FDA for Gardasil to be approved in women between the ages of 27 and 45, but the FDA declined this request August due to a lack of data supporting substantial benefit for this population. In October Cervarix, 78 a bivalent recombinant vaccine manufactured by GlaxoSmithKline targeting HPV types 16 and 18, received FDA approval for use in girls ages 10 through 25 years of age for the prevention of CIN grades 1, 2 and higher, adenocarcinoma in situ, and cervical cancer.

In pre-clinical trials, the safety of Cervarix was assessed by comparing it to a licensed vaccine that is assumed to be safe - Hepatitis A which contained up to mcg of Aluminum Hydroxide AL 0H 3. Severe adverse reactions following HPV vaccination continued to be reported in the United States and abroad. The program discussed the benefits and risks of vaccination and interviewed two mothers who reported sudden serious health issues that followed their daughters HPV vaccinations.

While mainstream media in the U. Despite numerous reports from around the world of serious side effects and death following HPV vaccination, in most cases, government health agencies continue to actively promote HPV vaccine use and contend that the vaccine is effective and is not linked to any serious side effects or death.

As a result, Merck increased the number of types of HPV from four to nine and on December 10, , its 9-valent recombinant vaccine Gardasil 9 received FDA approval for use in females ages 9 through 26 years of age, for the prevention of genital warts associated with HPV Types 6 and 11 and for the prevention of anal, cervical, vaginal, and vulvar cancers associated with HPV Types 16, 18, 31, 33, 45, 52, and As previously noted for Gardasil, pre-licensure studies of Gardasil 9 did not use true placebos as controls and instead, tended to compare Gardasil 9 to Gardasil.

Gardasil 9 was recommended by the ACIP in males between the age of 13 and 21 even though the FDA had yet to approval its use in males over 15 years of age. The 3-dose vaccine schedule continued to be recommended for individuals receiving the first HPV dose after the age The ACIP stated that the dosing changes were based on evidence that the immune response in persons between the age of 9 and 14 after two doses of HPV vaccine was significant enough to produce adequate long lasting antibodies against HPV types present within the vaccine.

A published report on HPV vaccination rates in adolescents completed by the insurance company Blue Cross Blue Shield found that, in , only 34 percent of teenagers had received their first dose of HPV vaccine by the age of This study also found that only 9 percent of adolescents had completed the series prior to the age of An additional survey of over parents whose children had not received the HPV vaccine reported that over half of the parents were not planning to have their child receive HPV vaccination and 60 percent of these parents cited vaccine safety concerns as the reason they decided to decline HPV vaccination for their child.

In June the FDA granted Merck a priority review of its application to expand Gardasil 9 use in both males and females 27 to 45 years of age. A decision is expected in October of For females over 21 years of age, HPV vaccination does not replace the need for routine Pap smear testing to detect abnormal cells that can cause cervical cancer especially considering that cervical cancer can be caused by HPV types not included in the vaccine.

This information is for educational purposes only and is not intended as medical advice. A papillomavirus DNA from a cervical carcinoma and its prevalence in cancer biopsy samples from different geographic regions. A new type of papillomavirus DNA, its presence in genital cancer biopsies and in cell lines derived from cervical cancer.