December 1, 2017

Philippines Suspends Dengue Shots After Drug Firm’s Warning

The New York Times Reports:

MANILA — The Philippines suspended its school-based dengue immunization program on Friday after the French pharmaceutical giant Sanofi warned that its flagship vaccine, Dengvaxia, had been found to pose health risks in people not previously infected.

The suspension came after health experts expressed worries about Sanofi’s announcement this week.

The company said further clinical studies had revealed that, in those who had previously had dengue, the vaccine could prevent repeat infection. But for those who had not had dengue, and were vaccinated and later became infected, “more cases of severe disease could occur,” Sanofi said in the advisory.

With more than 740,000 elementary school students in the Philippines having already received Dengvaxia vaccinations, the government decided to halt the program for the time being.

The Philippine health secretary, Francisco Duque, said the program would be “on hold while review consultations are on the way.” He added that the government would seek help from medical experts outside the Philippines, including from the World Health Organization.

Dengue is the most widespread mosquito-borne disease in the world, with nearly 400 million people infected every year. There are four dengue viruses, or serotypes, and most people who are infected recover and become immune to the first serotype they had. In some cases, a later infection with a different serotype can lead to a severe hemorrhagic fever. About 25,000 people die every year from hemorrhagic fevers arising from the disease.

Mr. Duque said that, with an average of 200,000 people infected with dengue every year in the Philippines, vaccination was “essential.” He said that the Department of Health would be stepping up its monitoring efforts to ensure public safety and that the department’s legal division was studying what to do with the Sanofi contract and how to deal with the hundreds of thousands of children who may have been put at risk.

Mr. Duque said that government officials had been asked to coordinate with community health experts to identify and monitor the children. He said a post-vaccination surveillance program would last for five years.

“I hope that this development will not in any way affect the expanded program of immunization because there are countless number of lives that have been saved,” Mr. Duque said, adding that 7 billion Philippine pesos, or about $140 million, had been budgeted for all government vaccination programs for the year, up from 340 million pesos in 2006.

He would not say when the program was likely to be restarted or what steps would be necessary to allow resumption.

“We need to go back quite a long way to really put the facts together,” Mr. Duque said. “Until that is available, we can’t answer all your questions with definitive responses.”

He said the vaccines that were now in stock would not be allowed to be sold unless the labels were changed to reflect the latest advisory.

Photo

 
Sanofi, manufacturer of Dengvaxia, said the drug posed a risk to people who had not previously been infected. CreditNoel Celis/Agence France-Presse — Getty Images 

Sanofi representatives in Manila were not immediately available to comment on Friday.

The Philippines became the first country in Asia to approve the commercial sale of Dengvaxia, in December 2015. Dengvaxia is the first dengue vaccine developed by Sanofi.

Health advocates in the Philippines first raised the alarm over Dengvaxia when the government announced in April last year that it would be used in the school immunization program despite the fact that it was a relatively new drug with possible unknown effects. But the government continued, budgeting about $70 million for the program.

The government has defended its use of the vaccine, saying that the treatment had undergone extensive studies and stressing that it was approved for use by the World Health Organization. The first hint that there could be something wrong was in April last year, when an 11-year-old boy with congenital heart disease died after receiving a Dengvaxia shot, but the government worked to distance the drug from the death.

Nancy Binay, a legislator in the Philippine Senate, said she was alarmed at the drug’s potential impact on public health and urged the health authorities and Sanofi to “launch a nationwide medical advisory and information drive” to contact parents whose children had been given Dengvaxia.

The recently released Sanofi medical report was “deeply shocking and disturbing,” Senator Binay said.

She said it was “sad” that the health department ignored the warnings about the lack of patient safety and research integrity in the Dengvaxia tests. “Safety should always be the paramount concern when it comes to any immunization program,” she said.

Senator Binay called on the pharmaceutical giant to explain what it meant when it warned of “severe disease.”

“We don’t want the warning to the public to come too little, too late,” she said. “Obviously, there were shortfalls and gaps in the vaccine’s safety profile, and I believe Sanofi is morally and ethically obliged to inform the public what severe diseases came out in their clinical tests.”

Dr. Anthony Leachon, an independent director at PhilHealth, a government medical insurance body, said the Philippine medical community had expressed alarm at the government’s use of the vaccine.

He said that as early as last year medical experts had told the government that there was “lingering uncertainty” about the long-term effects of the vaccine, but that their concerns had apparently been ignored.

“Evidence from manufacturer’s trials shows that there may be a paradoxical increase in the incidence of severe dengue beginning a few years after children are vaccinated, and possibly continuing for the rest of their lives,” Dr. Leachon said.

The clinical trials on the dengue vaccine were designed specifically to assess this “and sadly, this danger has been confirmed,” he said.

“Many parents, teachers and health care workers claim they were never fully informed about the benefits and potential side effects of the vaccine,” Dr. Leachon added.

Nov. 28, 2017

Scientists from University of Keele, and King’s College of London Report on “Aluminium in brain tissue in autism.”

Scientists from University of Keele, and King’s College of London Report on “Aluminium in brain tissue in autism.”
 
For the first time, scientists report on aluminum in brain tissue from donors who died with a diagnosis of Autism Spectrum Disorder. They have measured aluminum in brain tissue in autism and identified the location of aluminum in these tissues.
 
These findings are troubling, since many vaccines contain aluminum (Al) adjuvants – typically Al hydroxide and/or Al phosphate nano particles.
 
“These are some of the highest values for aluminium in human brain tissue yet recorded and one has to question why, for example, the aluminium content of the occipital lobe of a 15 year old boy would be 8.74 (11.59) μg/g dry wt.?” – Mold Matthew, Umar Dorcas, King Andrew, Exley Christopher. Aluminium in brain tissue in autism. Journal of Trace Elements in Medicine and Biologyhttps://doi.org/10.1016/j.jtemb.2017.11.012.

Article in press, available online 26 November 2017.  (Note: Articles in Press are accepted, peer reviewed articles that are not yet assigned to volumes/issues, but are citable using DOI.)

“The research does not infer that Al is a cause of autism, “said Exley, who also authored Human Exposure to Aluminum. “But these very high concentrations of a neurotoxin in brain tissue are not going to be benign and will contribute to neurodegeneration in affected tissues.” Read more at :  The Children’s Medical Safety Research Institute
 
Article in press, available online 26 November 2017.  (Note: Articles in Press are accepted, peer reviewed articles that are not yet assigned to volumes/issues, but are citable using DOI.)

Full accepted manuscript: keele-kings-Aluminium in brain tissue in autism

 

-Jennifer Stella

After All These Years, FDA is Still “Asleep at the Switch”

By Lyn Redwood, RN, MSN, Executive Director

Background: Peter Patriarca, an FDA employee, admitted back in 1999, in a confidential e-mail obtained through FOIA, that, “… the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex.  The calculations done by FDA are not complex. I’m not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been “asleep at the switch” re: thimerosal until now”. 

Since 1999, an entire generation of children both in the US and internationally has continued to be exposed to thimerosal – and it is time for this to stop.  Nobody should be exposed to a known neurotoxin.

An Ongoing Saga: On March 30th of this year, Robert F. Kennedy, Jr., and the World Mercury Project team met with the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) Dr. Peter Marks, M.D., Ph.D. and his colleagues to discuss the agency’s ongoing refusal to ban thimerosal, a mercury-based preservative, from vaccines in the United States. CBER is the division of the FDA responsible for approving and monitoring the safety of all biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.

At the meeting, we presented a large amount of research showing the toxicity of thimerosal in humans, animals and cellular models, including at levels similar to those resulting from vaccine exposures.  We expressed our alarm regarding the total lack of adequate safety testing of thimerosal prior to licensure, especially given its current use in vaccines approved for infants and pregnant women and its worldwide use in millions of vaccines given to children, particularly in developing countries.  Dr. Marks promised to look over the studies and seriously consider our concerns.

Here is the correspondence that followed:

April 24, 2017: Lyn Redwood Letter to Peter Marks, FDA [PDF]

July 11, 2017: Peter Marks Letter to Lyn Redwood [PDF]

November 13, 2017: Lyn Redwood Letter to Peter Marks, FDA [PDF][Article]

One FDA Hand Doesn’t Know What the Other FDA Hand is Doing

It seems ludicrous for one arm of the FDA, the Center for Drug Evaluation and Research (CDER), which regulates over-the-counter products to find that thimerosal and other mercury products are not generally recognized as safe and effective (GRASE) while CBER allows their widespread use in over 120 vaccines and other prescription products. In 1998, FDA issued final rules banning thimerosal and mercury product use in over-the-counter products.  Our goal at World Mercury Project is to extend that ban to all use of mercury in medical products both in the United States and worldwide.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the World Mercury Project. Your donation will help to support us in our efforts.

Autoimmune disease: Better studies needed.

For those with rheumatoid arthritis (RA) in the family: Researchers from three different universities in China, representing the fields of rheumatology, immunology, endocrinology and epidemiology, recently performed a meta-analysis . They found an increased risk of lupus and an increased risk RA – after vaccination. Autoimmunity Reviews, July, 2017: http://www.sciencedirect.com/science/article/pii/S1568997217301349?via%3Dihub

The Vaccine Safety Project – Presentation

Robert F. Kennedy, Jr.’s  comprehensive PowerPoint presentation and companion video reviews the process of vaccine approvals, recommendations, post-marketing safety monitoring and concludes with necessary recommendations for improving vaccine safety and protecting our children from vaccine injuries. We hope this presentation will be used by parents and vaccine safety advocates as a tool to educate local policy makers, state and federal legislators and public health officials who need to know the facts about our federal vaccine programs, vaccine safety and the Vaccine Injury Compensation Program.

View the video here.

View the powerpoint here.

Source: World Mercury Project.

Citizens for informed consent file petition for hearing on vaccine evidence

Vermont citizens for informed consent
(1) File petition for hearing on vaccine evidence
(2) Send notice to US DHHS 

Reference documents:
(1) http://www.vaxchoicevt.com/wp-content/uploads/2017/10/Press-release-Oct-12-2017-3.htm; and
(2) http://icandecide.com/white-papers/ICAN-HHS-Notice.pdf

News Reports:

Physicians for Informed Consent Publishes Scientific Findings on the MMR Vaccine

FOR IMMEDIATE RELEASE: October 10, 2017

Contact: [email protected]

Physicians for Informed Consent Publishes Scientific Finding on the MMR Vaccine
It has Not Been Proven that the MMR Vaccine is Safer than Measles for U.S. Children

CLICK HERE to read, download, and print the measles educational materials:

Los Angeles, Calif. — The California-based nonprofit organization, Physicians for Informed Consent (PIC), has announced the release of new educational materials to help pediatricians and parents assess the risks of measles compared to risks of the measles-containing vaccine (MMR). The educational materials were developed to provide a user-friendly educational tool from data compiled by the Centers for Disease Control and Prevention (CDC) and the National Center for Health Statistics. “Many people don’t realize that the risk of dying or suffering permanent injury from measles in the United States was very small, even before the measles vaccine was introduced in 1963,” said Dr. Shira Miller, PIC founder and president. “Therefore, vaccine safety studies must show that the risk of dying or suffering permanent injury from the MMR vaccine is even smaller.”

In the late 1950s and early 1960s, right before the measles mass vaccination program was introduced, the chance of dying from measles was 1 in 10,000 or 0.01%. However, the public is generally unaware of this figure, as the CDC publishes case-fatality rates based on the number of reported cases only. Since it is estimated that nearly 90% of measles cases are benign and therefore not reported to the CDC, the widely publicized rate is 10 times higher than what is actually found in the general population.

PIC’s measles educational materials, which include the Disease Information Statement (DIS) and Vaccine Risk Statement (VRS), provide data on total measles cases (both reported and unreported to the CDC) and available information on MMR risks. This allows for a more informed risk/benefit calculation. The documents, which have undergone peer-review and scrutiny by multiple clinical and statistics experts, are now available for public distribution.

“When determining whether any medication is safe, the standard is the risk of the disease one is trying to treat or prevent,” said Dr. Miller. “With vaccines, one must follow the same procedure to determine a safety standard. Through our educational materials, we show that it has not been proven that the risk of death or permanent injury from the MMR vaccine is less than that from measles. This is an important factor in both personal and public health decision-making.”

Physicians for Informed Consent is an independent 501(c)(3) nonprofit educational organization dedicated to safeguarding informed consent in vaccination. To read and download the Measles DIS and VRS, visit physiciansforinformedconsent.org/measles.

####

CLICK HERE to read, download, and print the measles educational materials:

October 6, 2017: Without liability – should there be mandates in the first place?

Don’t forget, you still have the religious exemption – you don’t need a letter from your pastor or from your rabbi or wherever, if you claim that you, that your religion doesn’t allow you vaccinate, then that gets you out of it.” 
– Vermont Governor Peter Shumlin,  May 18, 2015

 


This fall marks the second school year in which Vermont’s parents are being blocked from filing “philosophical objections” to Vermont’s ever-expanding mandatory vaccine schedule. Vermont parents with vaccine concerns, who are not “fully vaccinating on schedule,” must now sign a religious exemption form and “attest to holding religious beliefs opposed to immunizations.” The form requires them to acknowledge they have reviewed “evidence-based educational material provided by the Vermont Department of Health.”

This “evidence-based” material is devoid of adequate scientific references to support its claims and does not fulfill Vermont law, which requires that the information include, “information about the risk of adverse reactions.” Instead, the material reads like a pharmaceutical advertisement, minus the required warnings.

The facts show that vaccines do come with risks of “adverse reactions.” That is why we are petitioning for an administrative hearing at the health department.

The facts:

Thanks to an act of Congress that went into effect in 1988, drug companies and vaccine doctors face no liability for harm their vaccines may cause: As long as their products are properly labeled and accompanied by adequate warning.

No liability – but the warnings are thereVaccine manufacturers (pharmaceutical companies) provide consumer product warnings inside “package inserts” for each vaccine. In the US, the FDA regulates the contents of these “package inserts” and lists them here. These are the prescribing information leaflets that come with the product to the doctor or health department office.

From these FDA regulated package inserts, one can plainly see that there is evidence of severe, life threatening side effects or, in some cases the risks have not been evaluated, for every vaccine approved by the CDC and required by the Vermont Department of Health.

Excerpts from package inserts

(Read more here)

  • “Deaths have been reported following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.” – Merck, ProQuad Package Insert, 2017.
  • “Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.” – Merck MMR II Package Insert, 2017.
  • “Deaths have been reported in temporal association with the administration of IPV.”  – Sanofi-Pasteur Ipol Package Insert, 2017.
  • “Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.” – Sanofi-Pasteur Ipol Package Insert, 2017.

Check the facts for yourself

Here is a compilation of the latest testing and links to the prescribing information (package inserts), including adverse reaction warnings, for each and every vaccine.
– See also: Introduction to Vaccine Safety Science & Policy in the United States, a white-paper from the Informed Consent Action Network.

The Vermont Department of Health website prominently says, ”

“Parents should be able to make informed decisions based on accurate information.”

We agree. There is no excuse for failing to warn consumers and parents.

That is why Vermont has always protected the right to moral (philosophical) and religious “exemptions” to mandatory vaccine policies.
Without liability, should there be mandate in the first place?

October 1, 2017: Mercury & State of Vermont Flu Vaccine Clinics

Here’s What You Need to Know: Some Shots Will Contain 25 micrograms of mercury.

On May 18th, Vermont Public Radio listeners heard:  

You are not going to get the multi dose if you get vaccinated in Vermont.”

But just 4.5 months later, the State announced flu vaccination clinics for Vermont State Employees & Retirees. They will include shots that have 25 micrograms of mercury per dose.

Question: “Does this vaccine have the mercury-based preservative called thimerosal?”

Answer (see FAQ):

“Yes. Multi-dose vials have a small amount of thimerasol to prevent contamination and growth of potentially harmful bacteria. We will have a limited supply of thimerasol preservative-free vaccine available upon request for anyone who is allergic, pregnant or breastfeeding.”

Note: “Thimerosal dissociates in the body to ethyl mercury. The evidence for its reproductive toxicity includes severe mental retardation or malformations in human offspring who were poisoned when their mothers were exposed to ethyl mercury or thimerosal while pregnant, studies in animals demonstrating developmental toxicity after exposure to either ethyl mercury or thimerosal, and data showing interconversion to other forms of mercury that also clearly cause reproductive toxicity. The evidence for PMA comes from numerous findings of developmental toxicity in laboratory animals and interconversion data.” – State of California, Office of Environmental Health Hazard Assessment, in response to pharma attempt to delist thimerosal…

Voices for Choice asked for clarification from the Vermont Department of Health on this policy.
Read the email exchange:

Letter to VDH 9/12/2017 – http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VCVCSept12-2017.pdf

Letter to VDH 9/12/2017 – http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VCVCSept14-2017.pdf

Letter from VDH 9/14/2017 – http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VTDOHSept14-2017.pdf

Letter to VDH 9/14/2017 – http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VCVCSept-14-2017-2.pdf

For more information about how to fight mercury poisoning from vaccines, please visit: www.worldmercuryproject.org