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Posted: 5/27/2010 9:58:32 PM | with 9 comments


 

by Barbara Loe Fisher

In the past few months, the American public has been informed that two infant diarrhea vaccines – GlaxoSmithKline’s Rotarix and Merck’s RotaTeq – are contaminated with pig virus DNA. 1,2  But there’s a difference between the two vaccines: Rotarix contains parts of a pig virus that does not make pigs sick while Merck’s RotaTeq contains parts of a pig virus that kills baby pigs. 3,4,5

How many mothers know that, when Merck’s diarrhea vaccine is squirted into the mouths of their two month old babies, they are swallowing parts of a pig virus that suppresses the immune systems of baby pigs so badly, they waste away and can suffer respiratory, kidney, reproductive and brain damage before dying?  6,7,8

And how many doctors and nurses making babies swallow rotavirus vaccines know that?

And how many members of Congress, who are responsible for oversight of federal health agencies charged with ensuring vaccine safety, know that?

And how many mainstream media outlets are not covering this important story, a story that broke on March 22, 2010, when the FDA recommended temporary suspension of Rotarix vaccine because of contamination with parts of a non-lethal pig virus, only to withdraw the recommendation after a meeting on May 7th, when it was revealed that RotaTeq is contaminated with DNA from a pig virus that is lethal? 9

Why should we care about vaccines being contaminated with foreign DNA from deadly animal viruses?

Because it is a well known fact that DNA from animal viruses can infect human cells and change human DNA to cause disease in humans. 10, 11

Last fall public health officials declared an international pandemic emergency after a new pig-bird-human hybrid influenza virus was identified in Mexico and several people died. 12 Animal viruses can evolve to infect and make us sick  and there are no guarantees that won’t happen because doctors are pouring parts of a virus that kills baby pigs down the throats of two, four and six month old babies.

Scientists working in the labs of Merck and the FDA don’t know if pig virus DNA will infect human cells and change human DNA so that the babies given contaminated rotavirus vaccines - or their children – will someday suffer immune suppression that damages lungs, kidneys, brains and reproductive ability before they die just like the baby pigs are dying today.

I attended the May 7 FDA meeting and made two public comments on behalf of the National Vaccine Information Center. 13 At that meeting I heard GlaxoSmithKline officials pledge to clean up Rotarix but Merck did not show up to answer any questions or make any public pledges.

A lot of experts sitting around the table used words like “we believe” and “we don’t think” and “there is no evidence” when they defended the assumed safety of contaminated rotavirus vaccines. Nobody seemed to know exactly how the vaccines became contaminated or why the tests used by drug companies and the FDA did not detect the contamination before they were licensed and released. Nobody seemed to know if the pig virus DNA was infectious or not, but then, quickly almost everyone at the table agreed the contaminated rotavirus vaccines should still be given to babies. 14

THIS is science? This is the kind of science we are supposed to trust to keep us healthy?

Drug companies are racing to develop vaccines that use human, animal, insect, plant and even cancer cells for production. 15,16,17 Living cells can be contaminated with viral DNA that could evolve in humans to make us sick or kill us. 18

Is Big Pharma seeking big profits putting pressure on the FDA, CDC and politicians to allow them to keep parts of deadly animal viruses and other potentially harmful ingredients in vaccines? 19,20,21,22,23

I think that is exactly what is happening. The bigger question is: will the American public let the pharmaceutical industry and special interest groups taking money from drug companies get away with it?

If you want to take action in your community to raise awareness about why vaccines contaminated with animal virus DNA and other toxic ingredients should be cleaned up, 24,25  go to the websites of the National Vaccine Information Center at www.NVIC.org and www.Mercola.com
to learn more.

It’s your family. Your health. And your choice. If we don’t protect our health and choices today, we will lose both tomorrow.

TAKE ACTION NOW!

REFERENCES

1 FDA. Early Communication on Rotarix Vaccine. March 22, 2010.

2 FDA. Update on Recommendations for the Use of Rotavirus Vaccines. May 14, 2010.

3 FDA. May 7, 2010: Vaccines & Related Biological Products Advisory Committee Meeting Presentations: Dr. Gordon Allan: Porcine Circovirus.

4 West KH, Bystrom JM et al. Myocarditis and abortion associated with intrauterine infection in sows with porcine circovirus 2. JVDI 1999 Nov; 11(6): 530-2.

5 Fenaux M, Opriessnig T et al. Immunogenicity and pathogenicity of chimeric infectious DNA clones of pathogenic procine circovirus type 2 (PCV2) and non-pathogenic PCV1 in weanling pigs. Journal of Virology 2003 Oct; 77(20): 11232-11243.

6 Chianini F, Majo N et al. Immunohistochemical characterization of PCV2 associate lesions in lymphoid and non-lymphoid and non-lymphoid tissues of pigs with natural postweaning multisystemic wasting syndrome (PMWS). Veterinary Immunology and Immunopathology 2003 July; 94(1-2): 63-75.

7 The Pig Site. Post-weaning multisystemic wasting syndrome (PMWS). Accessed May 25, 2010.

8 Correa AMR, Zlotowski P et al. Brain lesions in pigs affected with postweaning multisystemic wasting syndrome. JVDI 2007; 19(1): 109-112.

9 FDA. Video Webcast: May 7, 2010 VRPBAC Meeting.

10 Weiss RA. The Leeuwenhock Lecture 2001. Animal origins of human infectious disease. London School of Hygiene & Tropical Medicine. The Royal Society. March 8, 2001.

11 Science Daily. Evolutionary Surprise: Eight Percent of Human Genetic Material Comes From a Virus. Jan. 8, 2010.

12 Neumann G, Noda T, Kawaoka Y. Emergence and pandemic potential of swine origin H1N1 influenza viruses. Nature. June 18, 2009 Editor’s Summary: Swine Flu so far: the emergence of pandemic H1N1.

13 Fisher BL. Statements on Finding of PCV DNA Sequences in Rotavirus Vaccines and on Advanced Analytical Methods in the Characterization of Cell Substrates. May 7, 2010 Meeting of the Vaccines & Related Biological Products Advisory Committee.

14 See Reference # 9.

15 WHO. Initiative for Vaccine Research: Use of Cell Lines for the Production of Influenza Virus Vaccines: the Appraisal of Technical, Manufacturing and Regulatory Considerations. April 10, 2007.

16 FDA. Vaccines & Related Biological Products Advisory Committee. Safety & Effectiveness of Purified Recombinant Influenza Hemagglutinin Vaccine for the Prevention of Influenza (FluBlok). November 19, 2009.

17 FDA. Designer Cells as Substrates for the Manufacture of Viral Vaccines. 2001.

18 Medical News Today. Combined Viruses Cause More Deadly Disease in Pigs, Researchers Discover. Feb. 14, 2008. and see Reference # 10.

19 The Guardian (UK). GlaxoSmithKline swine flu sales boost profits. April 28, 2010.

20 Doherty D. Novartis Profit Rises on Pandemic Flu Vaccine Sales (Update 5). Bloomberg Businessweek. April 20, 2010.

21 Visiongain. Influenza Vaccine Market Outlook 2010-2020. Published December 2009.

22 Carlsen B. Adults Now Drive Growth of Vaccine Market. Genetic Engineering & Biotechnology News. June 1, 2008.

23 The Pharma Letter. Aventis says human vaccines business will maintain double digit growth. October 6, 2003.

24 FDA. Memorandum: Clinical Review of New Biologics License Application– RotaTeq (Description of the Product). Page 12. April 6, 2005.

25 FDA. Guidance for Industry:Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. February 2010.

ADDITIONAL RESOURCES:

June 1, 2010 Press Release: Vaccine Safety Critics Call for RotaTeq Vaccine Recall & Clean-Up

June 1, 2010 NVIC PSA (60 sec) on RotaTeq vaccine contamination

June 1, 2010 VIDEO INTERVIEW (30 min) with Dr. Joe Mercola and NVIC President Barbara Loe Fisher on RotaTeq Vaccine Contamination

NVIC Information on Rotavirus & Rotavirus Vaccine


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Posted: 5/27/2010 12:07:20 AM | with 5 comments

NVIC is alerting its Vaccine E-news subscribers and organizations of an important meeting of the National Vaccine Advisory Committee (NVAC) on June 2-3, 2010 and the need for public comment. The NVAC's Vaccine Safety Working Group (VSWG) is currently charged with reviewing the current federal vaccine safety system and developing a White Paper describing different options for what can be done to improve the system.

The White Paper will describe criteria for an ideal system, such as characterization of the safety profile of vaccines in a timely manner, reducing adverse events whenever possible, and maintaining and improving public confidence in vaccine safety. Different options for improving effectiveness, accountability and transparency will be discussed, including whether changes in the infrastructure and governance are needed.

The White Paper will be sent to the Secretary for the Department of Health and Human Services (DHHS) for action.

NVIC is on record supporting an independent vaccine safety oversight agency housed within the federal government that reports directly to the President with responsibility for vaccine safety research, vaccine risk evaluation and vaccine safety monitoring systems, such as VAERS. The independent agency should be free from conflicts of interest, including responsibility for making recommendations for or promoting vaccine use or evaluating legal claims related to vaccine-associated injuries. The new agency would value science-based policymaking, personalized medicine, informed consent, transparency in government and responsive public engagement.

Two members of NVIC's team serve on the VSWG. Tawny Buck, NVIC's Director of Government Relations, is a voting member of NVAC and co-chair of the VSWG. Dr. Vicky Debold, NVIC's Director of Research & Patient Safety, is a VSWG member. Ms. Buck is the only consumer representative on the NVAC.  Though written comment deadlines specific to this meeting passed yesterday, this work continues beyond the June meeting and the National Vaccine Program Office (NVPO) has advised NVIC that public comments submitted after the deadline will be forwarded to the committee. 

Public comment is urgently needed to reinforce the consumer voices on the Committee. It is important that NVAC receive many public comments during this critical June 2-3 to evaluate whether or not there should be independent oversight of vaccine safety activities. 

The June 2-3 meeting will be held in Washington, DC. at the Hubert H. Humphrey Building - Room 800, 200 Independence Ave S.W. from 9-5 PM EST and 9-3 PM EST. Meetings of the NVAC are open to the public and pre-registration is required to physically attend and/or comment and the agenda has been posted. 

If you want to provide written comments, please send them to nvpo@hhs.gov. The meeting will also be broadcast via webinar if you cannot attend the meeting in DC. You must register for each day's webinar separately. Click on each day to register for the webinar - Register for June 2 Webinar, Register for June 3 Webinar. The NVPO has also notified NVIC that teleconference lines provided for this meeting will be opened for public comment during public comment sessions identified in the agenda.  No prior written comment need be submitted for oral comments made by teleconference.

NVIC has been representing consumers on vaccine advisory committees since 1988 and in public engagement initiatives since 2002. It is vitally important that government hear from the public on important issues like improving the vaccine safety infrastructure. We encourage you to participate by making your voice heard and will update our readers on other public engagement opportunities regarding this process as more information becomes available from NVPO.  


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Posted: 5/20/2010 2:48:07 PM | with 7 comments

PRESS RELEASE
For Immediate Release

Washington, D.C., June 1, 2010 - The National Vaccine Information Center (NVIC) joins with holistic health pioneer Dr. Joseph Mercola in calling for Merck to voluntarily recall its live rotavirus vaccine - RotaTeq - which is contaminated with parts of a lethal virus that infects pigs - porcine circovirus 2 (PCV2) - and publicly pledge to clean-up the vaccine.

On May 7th, GlaxoSmithKline (GSK) publicly pledged to re-formulate its rotavirus vaccine, Rotarix, by removing DNA from a non-lethal pig virus (PCV1). RotaTeq is contaminated with DNA from both PCV1 and PCV2. PCV2 is an aggressive virus that causes immune suppression, wasting disease and death in baby pigs.

“Responsible corporations voluntarily recall contaminated foods and drugs that could possibly compromise safety,” said NVIC Co-Founder & President Barbara Loe Fisher. “When RotaTeq is squirted into the mouths of babies, how many doctors or parents know those babies are swallowing DNA from a virus that can injure and kill baby pigs?”

“No company marketing a product found to be contaminated should be given a free pass,” said Dr. Joseph Mercola. “It is always dangerous to assume safety. Vaccines contaminated with viral DNA that could evolve and infect humans cannot and should not be assumed to be safe,” said Dr. Mercola.

The FDA recommended in March that doctors temporarily suspend use of GSK’s Rotarix vaccine after an independent lab using new technology detected PCV1 DNA in the rotavirus vaccine given to infants 2 to 6 months of age. At a special FDA advisory committee meeting on May 7, NVIC called on the FDA to legally require manufacturers to adhere to regulations for testing of vaccines before and after licensure for contamination and also require stricter labeling standards to fully inform consumers about any foreign DNA content that remains in vaccines.

On May 14, the FDA withdrew its suspension of Rotarix vaccine recommendation and pronounced both vaccines safe, even though both remain contaminated and safety data on PCV2 contamination of RotaTeq was not evaluated by the FDA advisory committee.

NVIC and Mercola.com defend informed consent to vaccination and support public access to vaccines that meet high standards for proof of safety and effectiveness. “Rotavirus vaccine is not required for daycare or school entry,” said Fisher. “The American Academy of Pediatrics and doctors should be informing parents they have a choice and that one rotavirus vaccine is contaminated with DNA from a lethal pig virus while the other is not.”

Dr. Mercola pointed to the recent voluntary recall of medicines for children that were contaminated with unidentified “particles,” as well as past voluntary recalls of contaminated food products. “Why should for-profit vaccine corporations which, unlike other industries, are shielded from liability by our government, be different from any other company selling a product in the U.S.? The American consumer has a right to demand that the products they use are pure and free from contamination,” he said.

About Us: The National Vaccine Information Center is a non-profit organization founded in 1982 to prevent vaccine injuries and deaths through public education and defend the informed consent ethic. Mercola.com is the most visited natural health website in the world.

TAKE ACTION NOW!

ADDITIONAL RESOURCES:

June 1, 2010 NVIC PSA (60 sec) on RotaTeq vaccine contamination

June 1, 2010 VIDEO COMMENTARY: Vaccine Contamination: A Threat to Human Health

June 1, 2010 VIDEO INTERVIEW (30 min) with Dr. Joe Mercola and NVIC President Barbara Loe Fisher on RotaTeq Vaccine Contamination.

NVIC Information on Rotavirus & Rotavirus Vaccine


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Posted: 5/9/2010 8:05:42 PM | with 1 comments

Washington, D.C. May 10, 2010 – During a special meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) held May 7th to discuss new information on contamination of rotavirus vaccines with DNA from two pig viruses, the National Vaccine Information Center (NVIC) called for the FDA to raise legal vaccine safety testing and labeling standards.

“The contamination of rotavirus vaccines with animal virus DNA that was not detected pre or post-licensure is an important wake up call for industry and government,” said NVIC Co-Founder and President Barbara Loe Fisher. ”Parents being told by federal officials to give their babies Rotarix and RotaTeq vaccine expect those vaccines and others to be free from adventitious agent contamination.”

NVIC called on the FDA to legally require vaccine manufacturers to adhere to binding regulations rather than offering companies non-binding recommendations and to immediately:

  • Recommend use of RotaTeq vaccine be suspended until Merck can guarantee it is free of PCV1 and PCV2 and other adventitious agents;
  • Institute stronger legal requirements for proof that vaccine cell substrates and other animal products used for production of seed stocks are free from adventitious agent contamination and that vaccines remain clean before being released; and
  • Institute stricter labeling standards to fully and clearly inform the public using vaccines about residual adventitious agent content of all vaccines.

NVIC’s Director of Research & Patient Safety, Vicky Debold, PhD, RN, who is also the consumer member of the FDA vaccine advisory committee, urged the FDA to continue to adhere to the precautionary principle and be transparent in its process whenever contaminants are detected in vaccines. “The public has a right to know whatever you learn,” she said.


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