--made by Merck
--immunizes against HPV types 6, 11, 16, and 18
--approved by FDA on June 8, 2006
--conventional aluminium salt adjuvant
--made by Glaxo-SmithKline Biologics
--immunizes against types 16 and 18
--filed for approval in Europe in March 2006
--Dec 17 2007 GSK said that it has received a complete response letter from the FDA & is working with the agency to gain approval
--different adjuvant "innovative AS04 adjuvant" which is an aluminium salt and monophosphoryl lipid A (MPL) an immunostimulant
--stronger immune response
GARDASIL immunizes against human papillomavirus (HPV) Types 6, 11, 16, and 18
CEVARIX immunizes against HPV 16 and 18
16 - accounts for 60% of cervical cancer
18 - accounts for another 10%
Types 6 and 11 cause 90% of genital warts cases.
wart causing strains don't cause cancer!
--highly contagious, many strains
--you can get more than one strain
--infection can spread even with proper condom use, although at a lower rate.
--Up to 80 per cent of sexually active women will be infected with a type of HPV at some point in their lives.
--HPV-positive status is linked with 'virtually 100%' of cervical cancers. However the vaccine makers recommend that women contniue to get pap smears because the vaccines "may not fully protect everyone and does not prevent all types of cervical cancer"
--Up to 80 per cent of sexually active women will be infected with a type of HPV at some point in their lives.
--Darren Brown, Indiana University, reported at the 2007 Interscience Conference on Antimicrobial Agents and Chemotherapy that Gardasil had 38% efficacy against 10 other HPV types responsible for >20% of cervical cancer cases.
--progesterone, including synthetic progesterone ie what's found in birth control pills, increases the gene expression of strains 16 and 18
HOW ITS GIVEN
3 injections over 6 months
THE MAKERS OF GARDASIL DON'T WANT YOU TO THINK
"Only a doctor or healthcare professional can decide if GARDASIL is right for you or your daughter. Ask about GARDASIL today."
WHO SHOULD GET VACCINATED
GARDASIL is for girls and women ages 9 to 26.
Anyone who doesn't already have all 4 covered forms of HPV.
GSK says it works on older women too
According to the Centers for Disease Control, the vaccine was tested in over 11,000 females (ages 9 to 26). These studies have shown no serious side effects. The most common side effect is soreness at the injection site. CDC, working with the FDA, will continue to monitor the safety of the vaccine after it is in general use.
COST OF VACCINE (GARDASIL)
--$120/dose, $360 total for the three required doses (price to doctors)
--$420 to $825 for a three-dose series (prices for patients)
--plus additional charges for each office visit to receive the shot.
--some docs aren't buying the vaccine because the cost is so high
--boosters may be needed. Testing has only been done up to 4-5 years.
--Merck, best known for blockbuster drugs such as Singulair for asthma and Zocor for cholesterol, posted revenues of $22.6 billion last year, stands to earn hundreds of millions of dollars annually on Gardasil, according to Wall Street estimates. ...Merck...has a powerful financial incentive to push for the mandate sooner rather than later. A rival drugmaker, GlaxoSmithKline, is pushing its own HPV vaccine through the approval process. Mandating the vaccine quickly would help Merck corner the market before then -- helping to explain the intensity of the company's marketing and lobbying campaign toward consumers, physicians and politicians.(Wall St Journal)
MANDATORY SHOTS AS COST CONTROL MECHANISM: Mandating the vaccine for girls entering school is given as a way of bringing down the cost of the vaccine. This approach has been taken with vaccines for mumps, measles, rubella, and hepatitis B (which is also sexually transmitted) so many state legislators have penned bills that do this. Almost all pieces of legislation currently pending in the states that would make the vaccine mandatory for school entrance have an "opt-out" policy.
A quick scan of the state by state legislation pertaining to the HPV vaccine reveals how controversial it is. Kentucky has halfway passed a mandatory vaccination law. Nevada passed a law requiring insurance companies to pay for it. New Mexico's legistlature passed a mandatory law, then the governor vetoed it. Texas had a mandate imposed by executive order of the governor that was later rescinded and the governor was revealed to be taking money from Merck. Very messy.
OPT OUT OPTION IN LAWS DRAWS UNDUE ATTENTION TO THOSE WHO TAKE IT?
Barbara Loe Fisher, spokesperson for the National Vaccine Information Center -- a group which provides information on the health risks of vaccines and urges parents to consider the option of not having their children vaccinated —argues that the medical establishment systematically harasses parents who choose the no-vaccine option for their kids.
“Your name goes on a state list,” Fisher told The Nation (in an article whose author was clearly biased in favor of mandatory HPV vaccination). “You get harassing phone calls from the CDC [the U.S. Centers for Disease Control] for your views on vaccines. Some families get thrown off health insurance plans, thrown out of their pediatricians’ offices, thrown out of public schools — or parents are put in a room and grilled by officials about the depth of their religious convictions on this.”"
(INGREDIENTS: NO MERCURY, THIMEROSAL-the mercury-containing ingredient, or LIVE VIRUS. We can presume it contains dead virus parts, because that's what a vaccine is. What are the other ingredients???)
The ingredients include “...inactive proteins from HPV Types 6, 11, 16, 18, amorphous aluminum, hydroxyphosphate sulfate, sodium chloride, L-histine, polysorbate 80, sodium borate, and water...”
Sodium borate (Borax) has been illegal as a food additive in the US for a while.
ON BORIC ACID:
Boric acid, sodium borate, and sodium perborate are estimated to have a lethal dose (LD50) from 0.1 to 0.5 g/kg in humans. These substances are toxic to all cells, and have a slow excretion rate through the kidneys. Kidney toxicity is the greatest, with liver fatty degeneration, cerebral edema, and gastroenteritis. A reassessment of boric acid/borax by the United States Environmental Protection Agency Office of Pesticide Programs found potential developmental toxicity (especially effects on the testes). Boric acid solutions used as an eye wash or on abraded skin are known to be especially toxic to infants, especially after repeated use because of its slow elimination rate.
--published: potential pain, fever, nausea, dizziness and itching after receiving the vaccine.
--77% of the adverse reactions reported are typical side effects to vaccinations
--more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.
(From the National Vaccine Information Center)
Greater Risk of GBS Reports When HPV Vaccine Is Given with Meningococcal and Other Vaccines, Washington, August 15, 2007
NVIC found that, as of May 31, there have been 2,227 Gardasil adverse events filed with VAERS, including 13 suspected or confirmed cases of GBS (two more GBS reports were made in June for a total of 15) and 239 cases of syncope (fainting with temporary loss of consciousness), many of which resulted in head injuries and fractures. Seven deaths have been reported after receipt of Gardasil. Nearly 10 percent of all Gardasil adverse event reports to VAERS (federal Vaccine Adverse Event Reporting System) involved avoidable medical errors.
RISK OF CO-ADMINISTRATION
A total of 1,930 reported Gardasil adverse events involved administration of Gardasil alone, and 135 adverse events involved co-administration of Gardasil with Menactra. NVIC’s comparative analysis of those two categories of VAERS reports indicates that when Gardasil was given simultaneously with Menactra rather than alone, there was a statistically significant increased risk of reported adverse events:
--respiratory problem reports increased by 114 percent
--cardiac problems reports increased by 118 percent
--neuromuscular and coordination problem reports increased by 234 percent
--convulsions, CNS problem reports increased by 301 percent
--injuries from falls after unconsciousness increased by 674 percent
--GBS reports increased by 1,130 percent.
CDC CONTINUES TO ENCOURAGE COADMINISTRATION ON ASSUMPTION OF SAFETY
On February 21, NVIC expressed concern about the safety of administering Gardasil simultaneously with other vaccines because the manufacturer (Merck), the FDA and the CDC had not provided evidence to the public that co-administration was safe. On March 12, the CDC published recommendations for Gardasil use in MMWR that acknowledged there is a lack of evidence that Gardasil can be safely administered with other vaccines, while encouraging physicians to co-administer Menactra and other vaccines with Gardasil based on assumption of safety.
GBS, GUILLAIN-BARRE SYNDROME
Guillain-Barré syndrome is a disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until the muscles cannot be used at all and the patient is almost totally paralyzed. In these cases, the disorder is life-threatening and is considered a medical emergency. The patient is often put on a respirator to assist with breathing. Most patients, however, recover from even the most severe cases of Guillain-Barré syndrome, although some continue to have some degree of weakness. Guillain-Barré syndrome is rare. Usually Guillain-Barré occurs a few days or weeks after the patient has had symptoms of a respiratory or gastrointestinal viral infection. Occasionally, surgery or vaccinations will trigger the syndrome. The disorder can develop over the course of hours or days, or it may take up to 3 to 4 weeks.
CERVICAL CANCER FACTOIDS
from: The American Cancer Society
--in 2007, about 11,150 cases of invasive cervical cancer will be diagnosed in the United States
--estimate that non-invasive cervical cancer (carcinoma in situ) is about 4 times more common than invasive cervical cancer.
--About 3,670 US women will die from CC during 2007
--CC was one of the most common causes of cancer death for American women BUT CC death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test. The death rate from cervical cancer continues to decline by nearly 4% a year.
--tends to occur in midlife. Half of women diagnosed with this cancer are between the ages of 35 and 55. Rare in women younger than 20.
--many older women do not realize that the risk of developing cervical cancer is still present as they age. Slightly over 20% of women with cervical cancer are diagnosed when they are over 65
--occurs most often in Hispanic women; the rate is over twice that in non-Hispanic white women.
--African-American women develop this cancer about 50% more often than non-Hispanic white women.
--5-year relative survival rate for the earliest stage of invasive cervical cancer is 92%.
--overall (all stages combined) 5-year survival rate for cervical cancer is about 72%.
--5-year survival rate refers to the percentage of patients who live at least 5 years after their cancer is diagnosed. Many people live much longer than 5 years. Five-year relative survival rates exclude patients dying of other diseases.
--5-year survival rates are based on patients diagnosed and initially treated more than 5 years ago
**Info on 2007 State Legislation concerning mandating the HPV vaccine:
ARGUMENTS AGAINST MANDATORY VACCINATION OF GIRLS:
--risks associated with vaccine (potential pain, fever, nausea, dizziness and itching, paralysis, Bells Palsy, Guillain-Barre Syndrome, seizures)
--Safe sex or celibacy can prevent transmission of HPV 100%
--pap smears work: CC was one of the most common causes of cancer death for American women BUT CC death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test. The death rate from cervical cancer continues to decline by nearly 4% a year.
--HPV is not contagious like measles: Human papillomavirus is not a highly infectious airborne disease, which is the paradigm for the exercise of compulsory vaccination. There is no immediate risk of rapid transmission of HPV in schools, as is the case, for example, with measles.
--it's unfair: The ACIP probably recommended routine vaccination for girls only because the data are limited to that sex. However, if compulsory powers were justified on classic public health grounds, the same arguments could and should apply to vaccination of boys. While less is known about HPV prevalence in men, some studies have shown that men can have at least as high a prevalence of HPV infection as women,19 and they are just as likely to transmit the infection to their partners. Issues of fairness arise if young girls are compelled to submit to a new vaccine as a condition of receiving publicly funded education, when boys are not.
--it's rare: the overall prevalence of HPV types associated with cervical cancer is relatively low (3.4%)(Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the United States. JAMA. 2007;297:813-819.)
--public outrage: Legislation to make HPV vaccine mandatory has undermined public confidence and created a backlash among parents. There is nothing more important to the success of public health policies than to ensure community acceptability.
--state liability: How would vaccine recipients would be compensated if they incurred serious adverse effects in the future as a result of a vaccine that the state required. By making the vaccine mandatory, the state would complicate tort claims, with some courts holding that the manufacturer had no (or reduced) responsibility for consumer harms. Ethically, if the state mandates an intervention, it should also provide a compensation system, for example, through the no-fault National Vaccine Injury Compensation Program.
--some communities may view the vaccine as condoning early sexual activity. One site said "There is no evidence to support the claim that vaccinating young people against HPV will increase sexual promiscuity" however I don't think anyone has studied this yet and I think they will find that when youth feel safe from pregnancies & disease they are more likely to partake of the goods.
--causality of virus not proven, only correlation
JUSTIFICATION FOR MANDATORY VACCINATION OF GIRLS:
--among the most expensive of all vaccines, so making it mandatory and getting the state to pay is the only way to get the poor covered, incidence is highest among Hispanics who are unlikely to get it on their own
--The primary justification for HPV vaccination is to protect women from long-term risks (not immediately necessary to prevent harm to others)
--public health: reduction in the worldwide incidence of HPV
Merck lobbies lawmakers to get the vaccine made mandatory, Washington Post: http://www.bcbs.com/news/national/drugmaker-assists-in-pushing-for-mandate-for-hpv-vaccination.html
6th June 2006 - The global health nonprofit PATH today launched a five-year effort to make sure that new cervical cancer vaccines—the first vaccines developed and approved just for women’s health—reach women in the developing world. A quarter-million women, most of them from the world’s poorest countries, die of cervical cancer each year.
With a $27.8 million grant from the Bill & Melinda Gates Foundation, PATH will conduct program research in India, Peru, Uganda, and Vietnam to gather the evidence countries need to make informed decisions about how to introduce the vaccine.
SOME SITES USED HERE
JAMA on mandatory: http://jama.ama-assn.org/cgi/content/full/297/17/1921
To report a vaccine reaction, go to https://www.nvic.org/report/reaction.htm
MMWR = Morbidity and Mortality Weekly Report: http://www.cdc.gov/MMWR/index.html