Although this information is accurate in a strictly literal sense, it is a misleading presentation of raw data that does not in itself establish a causal connection between Gardasil and the posited medical dangers. Thai Prime Minister Prayuth Chan-o-cha and members of his government were due to become the first people in the country to receive AstraZeneca's vaccine during a ceremony Friday morning. Find more COVID-19 testing locations on Maryland.gov. Beavis says that their findings demonstrate that parents are less concerned with the HPV vaccines relation to gender and sexual activity, and that public health campaigns should focus on persistent concerns about safety and necessity of the vaccine for both boys and girls in order to be responsive to parents true concerns. We have to be cautious about interpreting VAERS data and not make any causeeffect associations, she said. The U.S. Food and Drug Administration approved the vaccinebeginning at age 9in 2006 for females . 22 April 2009. There is no evidence yet that the AstraZeneca vaccine causes blood clots. Any other allegations about her lack of support for vaccinations is based on misinformation, disinformation and lies. The presence of a safety signal information about a new or known adverse reaction that requires investigation does not directly mean that a medicinal product or vaccine has caused the reported adverse reaction or event., Published studies are also reviewed, as relevant evidence is assessed in order to establish where a causal relationship exists between the vaccine and the reported event, she said. Since that licensing the "CDC and FDA have been closely monitoring the safety of the HPV vaccine" and found that: All serious reports for Gardasil have been carefully analyzed by medical experts. 3 May 2012. Human Papillomavirus (HPV) vaccine; Japan; Public health ethics; Vaccine policymaking. Latvia initially suspended the use of a specific batch of AstraZeneca's COVID-19 shot on March 9. Around three hours after Denmark's announcement,Norwegian officialssaid they would also suspend use of the AstraZeneca vaccine. Perhaps most telling are the revelations of Dr. Bernard Dalbergue, a former pharmaceutical industry physician with, Gardasil manufacturer Merck. Such was the response to the show that the Health Service Executive had to issue a statement on it to address the panic it induced. My 11-year-old great niece was a happy, healthy child until upon the recommendation of her pediatrician she received a Gardasil shot. The lives of countless young men and women count on us being guided by evidence rather than rhetoric. The recommended dosing schedule for the vaccine now involves two injections if the first is administered before age 15, or three injections if the first is administered after age 15. 2017 Sep;44(9):713-716. Yet evidence to date clearly indicates that abstinence programmes simply dont work, and that teens subjected to this approach begin sexual activity at the same stage as their peers worse again, teens educated in such ways tend to have more pregnancies than those receiving conventional sex education. Given the sheer volume of teens who have received the vaccine, it is a statistical certainty that some will develop a physical or psychosomatic illness after inoculation. "Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population," Ann Taylor, AstraZeneca's chief medical officer, said. The HPV vaccine protects against six different kinds of cancer (cervical, anal, back of the throat, penile, vaginal, and vulvar) that are caused by infection with the human papillomavirus, or HPV. None of these adverse events were found to be any more common after HPV vaccination than among the comparison groups. Indications: Indicated in girls and women 9 . In 2016 there were responses from 1,633 parents of girls and 2,255 parents of boys age 13-17. She bled from her mouth and nose; she was put into the Intensive Care Unit when the doctors feared that she would bleed on her brain and die. You can download a PDF version for your personal record. The vaccination can be started at age 9 years. Do not buy into the anti-vaccine trope about Gardasil - Japan did not ban it, but what the country did do was almost as appalling. Gardasil is a vaccine that protects young women from the strains of human papillomavirus (HPV) that cause 70% of cervical cancers. Manufacturer: Merck Sharp & Dohme Corp. Ireland has one of the highest cervical-cancer rates in western Europe,. The HPV - or human papilloma virus - vaccine, marketed as Gardasil, protects against cervical and other forms of cancer. She told CBS it is essentially useless. Gardasil is demonstrably safe and demonstrably effective in preventing cancer. But why is this the case? Masks are required inside all of our care facilities. As noted in a 2013 CDC follow-up announcement, 92% of those reports were classified as "non-serious," the other 8% generally encompassed symptoms such as "headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness," and adverse events reported to VAERS were "consistent with those identified during the vaccine's pre-licensure clinical trials." National Library of Medicine HPV can be transmitted by other means than sexual intercourse. In particular, claims that the HPV vaccine causes thrombosis and chronic fatigue are common , but have been comprehensively debunked. There was no common pattern to the deaths that would suggest that they were caused by the vaccine. They did note 2 cases of unusual neurological symptoms similar to Lou Gehrig's disease, and there was an increase in patients who had potentially dangerous blood clots, although 90% of those patients had a risk factor for those clots, such as taking birth control pills, that might explain the increase. These included safety concerns (cited by 23 percent of non-vaccinating parents in 2010 versus 22 percent in 2016), lack of necessity (21 percent versus 20 percent), knowledge (14 percent versus 13 percent) and physician recommendation (9 percent versus 10 percent). CDC recommends that 11- to 12-year-olds receive two doses of HPV vaccine 6 to 12 months apart. The majority of reports we have received have been consistent with the expected pattern of adverse effects for the vaccine, as described in the currently approved product information, a spokeswoman said. HPV infection can cause cervical, vaginal, and vulvar cancers in women and penile cancer in men. The girls were administered the Human Papilloma Virus (HPV) vaccine in three rounds that year under the supervision of state health department officials. Gardasil has also been linked to a myriad of long-term side effects associated with induced-autoimmune diseases, including such dangers as fibromyalgia, dysautonomia, premature ovarian failure, chronic fatigue syndrome, and chronic regional pain syndrome. The last strategy for re-dissemination of HPV vaccination in Japan while still under the suspension of the governmental recommendation. Credit: Johns Hopkins Medicine. As the CDC stated in its 2009 article on "Reports of Health Concerns Following HPV Vaccination," before the Gardasil HPV vaccine was licensed it was studied in five clinical trials involving over 21,000 girls and women of ages 9 through 26. These physicians may also be more likely to broach the subject with parents, and recommend the vaccine, if they themselves better understand that relatively few parents avoid vaccinating due to concerns over sexual activity. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low. The study looked at data from 2015 to 2018, Dr. Vanderpool noted, well before the COVID-19 pandemic and rising hesitancy around COVID-19 vaccines. Ireland has one of the highest cervical-cancer rates in western Europe, with 90 deaths a year, but uptake of the vaccine has plummeted following opposition from a number of groups. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection-site reactions, the Health Products Regulatory Authority said. Unauthorized use of these marks is strictly prohibited. In peer-reviewed articles published in important, high impact journals, she has given strong, but scientifically qualified, endorsements to HPV vaccines. The findings highlight an urgent need for doctors and public health leaders to address these concerns with parents, according to the scientists who led the study. However, numerous instances of serious adverse reactions were widely reported in the media, resulting in the Ministry of Health, Labor, and Welfare (MHLW) suspending the official recommendation of the HPV vaccine on June 14, 2013. A week of IVIG treatments were unsuccessful, and she was discharged. David Robert Grimes Over 90% of cervical cancers are caused by HPV. Please enable it to take advantage of the complete set of features! "Allergic Reactions to Gardasil Uncommon: Study." Such skewed coverage also triggers a chorus of populist politicians to chime in with equally vacuous additions. Frequently Asked Questions About HPV Vaccine Safety. Encouraging HPV Vaccination via an Evolutionary Theoretical Approach: A Randomized Controlled Study in Japan. Additionally, certain strains can cause changes in DNA that encourage the formation of cancers in both males and females. The batch consisted of 1 million doses that were distributed among 17 EU countries, according to the EMA. For boys, the top reasons cited by parents for not vaccinating in 2010 all decreased over time. Although such a report would be literally true, it would not establish any causal connection between the flu vaccine and the adverse medical symptom of a throbbing, painful hand.). This slightly twisted assumption is flatly contradicted by the data it operates on a strange, moralistic consequences of sex principle, a mantra that abstinence trumps pragmatism. You have to look at this finding and the vaccine uptake [rates] together. According to recent data, there has been a steady increase in HPV vaccination rates. In addition to thoughts and beliefs about a topic, peoples behavior is also influenced by the things they see their friends and family and important people in their community recommending or doing for themselves, she added. She suggests that doctors who commonly administer the HPV vaccine, including family practice physicians, obstetricians/gynecologists and pediatricians, should focus on the fact that the HPV vaccine has enormous potential to prevent cancers and has a strong safety profile from over a decade of vaccine administration. The New York Times. But the facts are she has not said anything of the sort about Gardasil and Cervarix. Believe it or not, Gardasil is still being promoted in America as safe, effective and vital for ages 9 to 26. Some people will die after any vaccination, not because vaccines cause death but because people, even babies and adolescents, die with terrible regularity. There have also been some reports describing persisting/chronic fatigue, generally with multiple other symptoms (eg, headache, malaise, drowsiness, nausea, gastrointestinal upset, joint swelling, flu-like illness, menstrual disorders) following vaccination.. Sadly, it is still used in 100 countries, including this great United States of America. Federal government websites often end in .gov or .mil. It's true that there have been 24,000 reports of adverse events with Gardasil. A new study of survey data finds that only a minority of parents choose not to immunize their children against the sexually transmitted, Study outlines top reasons parents choose not to immunize their children against #HPV, . Nor is the vaccine, which has been given to more than 10 million people, likely responsible for those deaths. Vaccines (Basel). Tradename: GARDASIL 9. You have permission to edit this article. The Italian health authority announced Monday that it had extended a local ban of AstraZeneca's vaccine in the Piedmont region to become a national one, local media first reported. The CDC, in conjunction with the Food and Drug Administration (FDA), operates a program known as the Vaccine Adverse Event Reporting System (VAERS). Those of us in science outreach were left in the unenviable position of having to counter an emotive narrative in an attempt to neutralise some of the damage done by such vapid reporting. Herper, Matthew. In the case of permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title; e.g., Despite Proven Safety of HPV Vaccines, More Parents Have Concerns was originally published by the National Cancer Institute., January 12, 2023, The Nation. Following is an outline of countries that have restricted or suspended use of COVID-19 vaccines from AstraZeneca and Johnson & Johnson, after Europe confirmed possible links to rare blood. And yes, it's true that there have been 106 deaths reported after Gardasil vaccination. STN: 125508. Everyone else must pay out of pocket. Frequently Asked Questions About HPV Vaccine Safety (CDC). The announcement came just six days after it had been approved by the country's regulators. That article grossly misrepresents what Dr. Harper actually said. Whether this is borne of genuine ignorance or cynical vote-chasing we can only speculate, but it risks adding to the public perception there is some genuine debate over the safety and efficacy of the vaccine when this is resoundingly not the case. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Gardasil is a vaccine intended for girls and young women between the ages 9 to 26 to protect against human papillomavirus (HPV), a virus which is currently linked to an estimated 70% of known cervical cancer cases. There was only one pan-European study involving four countries: France, the UK, Germany, and Italy. This site needs JavaScript to work properly. Dr. Diane Harper is one of the leading researchers in biomedical science, an individual who has spent her life studying vaccines. doi: 10.1172/JCI146956. The authority's view, based on reviews by the European Medicines Agency, was that the benefits of HPV vaccines continue to outweigh their risks, she said. Our suspicion is that the rising safety concerns are probably being driven by [the] use of social media and people trying to find vaccine information online, said the studys lead researcher, Kalyani Sonawane, Ph.D., of UTHealth School of Public Health in Houston, Texas. We all want the same thing.. 19 August 2009. Gardasil has been banned in Japan. Very few have searched on websites where renowned doctors and medical journals question everything about Gardasil. Photograph: Voisin/Phanie/Rex/Shutterstock. Anti-vaccine sites also perpetuate the falsehood that Gardasil has been banned in Japan . In December, Irish broadcaster TV3 ran an investigation, featuring Regrets assertions prominently. "Gardasil Researcher Speaks Out." Kirby alleges that her daughter suffered horrendous adverse effects after being given the vaccine, and Regret claim that upwards of 140 girls are suffering severe non-specific reactions to the vaccination, from fainting spells to fits. The Latvian health authorities said in a statement that the pause was due to reports of blood clots in people immunized with AstraZeneca's COVID-19 vaccine in other European countries. 30 June 2006. And there is no way to tell if a particular side effect is linked to the vaccine. The case for the safety of the HPV vaccine is buttressed by swathes of clinical evidence and years of data, whereas the opposing side is comprised of anecdotes, emotive appeals and easily debunked assertions. Spanish Minister of Health Carolina Darias said Monday that Spain would also suspend the use of the AstraZeneca vaccine for at least 15 days due to concerns about possible side effects. NCI has funded 11 research projects to explore the influence local organizations have on community members with HPV vaccine hesitancy. The VAERS program collects and analyzes reports on adverse events following immunizations in order to help track the safety and efficacy of various vaccines. They found that for girls, the top four reasons parents gave for not vaccinating stayed relatively stable between 2010 and 2016. Here Is How We Know Gardasil Has Not Killed 100 People." Highlights include Bangladesh, where almost 98% of people believe that vaccines are both safe and effective. Despite the complicity of media outlets in spreading poorly researched or misleading stories, blame for this seems to be curiously evanescent. government site. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. The health ministry said the decision was based on information it had received about possible side effects and the EMA's ongoing investigation. You cant tell people theyre wrong if you actually want them to hear alternative information. Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive . Broadly speaking, opposition can be separated into two distinct categories, the first of which expresses itself as moral concern. Our Standards: The Thomson Reuters Trust Principles. Moral opposition to HPV vaccination is clearest in America, primarily voiced by religious conservatives, whose arguments pivot around sex rather than efficacy, advocating abstinence in lieu of vaccination. | Jill Filipovic, Original reporting and incisive analysis, direct from the Guardian every morning, uman papillomavirus (HPV) has long haunted humankind; almost all sexually active adults carry some of HPVs 170 strains. The https:// ensures that you are connecting to the His statement did not mention the blood clots or name any countries. migraines, severe headaches, persistent gastrointestinal discomfort, widespread pain of a Her pediatrician filed a report with the Centers for Disease Control and Prevention about the effects Gardasil had on her; her doctor recommended that she not get the second dose. Cyprus announced Monday that it would temporarily postpone vaccinations until the EMA had concluded its investigation. But there are also trouble spots, including France, where 1 in 3 people disagree that vaccines are safe, and Ukraine, where only about half of the population thinks that vaccines work. People who received their first dose of AstraZeneca's vaccine would have to wait for their second dose during the suspension, the authority said. These included lack of necessity (24 percent versus 22 percent), physician recommendation (22 percent versus 17 percent), knowledge (16 percent versus 14 percent), childs lack of sexual activity (16 percent versus 9 percent) and gender (13 percent versus 2 percent). The German government announced Monday that it was suspending the use of AstraZeneca's vaccine as a "precaution" and on the advice of Germany's national vaccine regulator, the Paul Ehrlich Institute, which called for further investigation of the cases, the Associated Press reported. Gardasil has been studied in clinical trials of more than 30,000 people; Cervarix, the competitor vaccine, has run a similar gantlet. GARDASIL 9. See here for a complete list of exchanges and delays. Adverse events in the HPV vaccinated population were compared to another appropriate population (such as adolescents vaccinated with vaccines other than HPV) and included Guillain-Barr syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope (fainting), allergic reactions, and a potentially life-threatening allergic reaction called anaphylaxis. And on Sunday, the Dutch said there had been six new reports of clotting and thrombocytopenia low platelet count in adults under 50 in Denmark and Norway over that weekend. The two companies' respective vaccines the former's Cervarix and the latter's Gardasil were widely marketed as the best available prophylactic, or preventive, for cervical cancer. HPV vaccines protect against certain cancers caused by human papillomavirus (HPV) infection. Studies have shown that while individuals trust medical professionals for health information, a growing number are turning to the internet for first and second opinions about HPV, HPV vaccines, and HPV-associated cancer, they continued. Gardasil is useless and costs a fortune!". 2020 Nov 17;8(4):691. doi: 10.3390/vaccines8040691. This propensity to sensationalism over informed reporting is one that crops up with each new or rehashed panic story. Reports of allergic-type reactions, including skin rashes, urticaria and flushing, have also been received, including isolated reports of more severe hypersensitivity-type reactions. Despite the paucity of evidence for damaging effects from Gardasil, there have been a number of legal challenges mounted against it, most recently in December 2015 by Fiona Kirby, who is being supported by Irish group Reactions and Effects of Gardasil Resulting in Extreme Trauma (Regret). It is also irresponsible: we need only cast our minds back to the damage done by baseless scare stories reported about the MMR vaccine to be reminded of this fact. Scroll down for the full list. And based on the data available, it is unlikely (though not impossible) that even those deaths were caused by the vaccine. What is the evidence? The majority of these infections resolve without symptoms. NIS-Teen collects information from a nationally representative sample of parents about their childrens vaccine usage, with vaccine rates verified with information collected from each childs physician. Some of this is based on simple misunderstandings, but a significant proportion is down to the success anti-vaccine campaigners have in sharing their claims online and across social media. "I think its really telling.. The .gov means its official. Reports of serious health issues after HPV vaccination were consistently rarearound 1.8 per 100,000 HPV vaccine doses, or 0.0018%. The safety and the efficacy of the vaccine has been reaffirmed by numerous independent investigations, including a 2015 report based on data from over a million individuals which concluded the vaccine had a favourable safety profile. "FDA Approves Expanded Uses for Gardasil." Dr. Harper has expressed concerns such as how long protection from vaccines such as Gardasil will last (which is not a safety issue, but rather an issue of whether the expected results of an HPV immunization program will justify the financial costs), and whether the marketing of Gardasil might lead some women to avoid taking other STD-preventing precautions, but she has never said that Gardasil "doesn't work," "wasn't tested," or was "dangerous," as explained in great detail at the Skeptical Raptor blog: In a 2012 peer-reviewed article about Cervarix, Dr. Harper states that "Cervarix is an excellent choice for both screened and unscreened populations due to its long-lasting protection, its broad protection for at least five oncogenic HPV types, the potential to use only one-dose for the same level of protection, and its safety." Copyright 2019 Elsevier B.V. All rights reserved. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. Bulgaria said Friday it was pausing use of the AstraZeneca vaccine. Its health authority said there had been six new reports of clotting and thrombocytopenia low platelet count in adults under 50 in Denmark and Norway after receiving the AstraZeneca vaccine. The Latvian health authorities announced Monday that it would go further, pressing pause on the entire AstraZeneca vaccine rollout as an "additional precaution" for two weeks. If you doubt their good intentions, theyre not going to hear you out, regardless of how sparse the evidence is for their beliefs, she said. 12 September 2008. It's absolutely clear that these are for the most part not side effects from Gardasil. Corrected human papillomavirus vaccination rates for each birth fiscal year in Japan. The HPV vaccine has been a political lightening rod in Japan, where claims of side effects prompted the government to halt active recommendation of the shots in June 2013. Gardasil (quadrivalent human papillomavirus [HPV] [types 6, 11, 16, and 18] recombinant vaccine, Merck & Co., Inc., Whitehouse Station, In 2006, the U.S. Food and Drug Administration (FDA) approved the first vaccine for prevention of cervical cancer based on the molecular biology of the disease. I predict that Gardasil will become the greatest medical scandal of all time because at some point in time, the evidence will add up to prove that this vaccine has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers. She has the academic training and research credibility at a level that if she said "Gardasil is dangerous," many of us would stand up and begin to wonder. "Vaccine Can Save Vast Number of Lives, Says Cancer Specialist." It didn't specifically say whether these were the same as the two incidents reported in Austria. When autocomplete results are available use up and down arrows to review and enter to select. Human papillomavirus (HPV) has long haunted humankind; almost all sexually active adults carry some of HPVs 170 strains. Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant. Almost 650 girls in Ireland reported requiring medical intervention or treatment after receiving the HPV vaccine, according to data collected by the States medicines watchdog. The alert said that there were four new reports of serious rare clotting events, including some complicated by low platelet counts, in adults under 65 after receiving the AstraZeneca vaccine. Next year, the World Health Assembly will discuss a Draft Global Strategy for the elimination of cervical cancer as a public health issue, presented for approval, which will provide countries with targets and strategic actions for countries in their efforts. It added that if it permanently suspended AstraZeneca's vaccine, it would push back its vaccination plan by about four weeks. sharing sensitive information, make sure youre on a federal Foreign travelers, including family members, friends, and business relations, are being kept off U.S. soil due to the air travel vaccine mandate, which remains for . Tradename: Gardasil Manufacturer: Merck & Co., Inc Indications: Prevention of vulvar and vaginal cancer Vaccination in females 9 through 26 years of age for prevention of the following diseases. The European Commission then decided that the vaccines could continue to be marketed. Cervical cancer is a cancer that originates in the cervix, which connects the uterus to the vagina. Consequently, the arguments for the suspension of the HPV vaccine recommendation are not ethically appropriate. And research has shown that parents who are exposed to misinformation about HPV vaccines on social media are less likely to vaccinate their children. CBS News. The next month she had chemo treatments 10 hours of infusion each time. Sadly, scaremongering anecdotes without scientific evidence all too frequently masquerade unchallenged as public interest stories, and the Gardasil controversy is no exception. It then said Monday it had reversed the decision and administer the first doses of AstraZeneca's vaccine Tuesday. The Japanese government could not immediately be reached for comment on the Lancet report. According to CDC and FDA, VAERS data can only be used to find unusual patterns that should be evaluated in additional studies. The most common serious side effects of HPV vaccination are dizziness and fainting. What Causes Immunotherapys Heart-Related Side Effects? It would continue administering both Pfizer-BioNTech and Moderna's COVID-19 vaccines, it said. Portugal suspended use of AstraZeneca's vaccine Monday. This material may not be reproduced without permission. Today 6 months after her vaccination, her blood platelets have gone from a low of 100,000 to 132,000 (150,000 to 400,000 is normal). Up to 80 percent of sexually active Americans will be infected with HPV at some point during their lives, according to the American Sexual Health Association. Over 90% of cervical cancers are caused by HPV. It's normal for these reports to pour in for safe vaccines. Accessibility But from 2015 to 2018, the study showed, the percentage of parents who declined the HPV vaccine for their kids due to safety concerns nearly doubled. The HPV vaccine can protect against nine cancer-causing strains of HPV.