FDA Proposes Dangerous Vaccine Rule Change

by Barbara Loe Fisher

This past spring, the FDA took a hands-off approach to Merck’s admission that DNA from a lethal pig virus is contaminating doses of RotaTeq vaccine being swallowed by millions of newborn babies.1 Now the agency responsible for making sure pharmaceutical products do not hurt people is proposing a Rule Change to give one staff employee the sole authority to allow “exceptions or alternatives” when drug companies want to change vaccine ingredients, such as preservatives (like thimerosal) or adjuvants (like aluminum) or the amount of residual protein and antibiotics in vaccines.

The FDA’s proposed change to Requirements for Constituent Materials was quietly published in The Federal Register on March 30 and the deadline for public comment is only days away - on Monday, June 28. 2

The FDA is arguing that the rule change is necessary to “reduce burdens on industry” and to provide “greater flexibility and reduced regulatory requirements.” It gives one FDA staff Director the power to give drug companies the green light to “employ advances in science and technology as they become available” when companies want to make new vaccines really fast and get more bang for the buck.

If the proposed Rule Change is put into effect, a vaccine manufacturer could request a change in the content or amount of vaccine ingredients by simply writing a “brief statement describing the basis for the request and supporting data” as part of the original license application or for a pending or approved application. There is no information about how much scientific evidence the drug companies will have to submit to prove the new ingredients are safe; or whether the FDA’s Vaccine Advisory Committee will be able to review that evidence; or whether the American public will have a chance to comment before vaccine ingredients are changed.

This does not look like the transparency, public participation and collaboration in government that President Obama said he supports. 3 It removes the checks and balances necessary for good government.

Last year when federal health officials declared a pandemic H1N1 “swine flu” national emergency, drug companies put a full court press on the FDA to fast track licensure of highly reactive oil based squalene adjuvants 4 and the use of new technology, like insect cells, 5 to make pandemic influenza vaccines. During meetings of the FDA’s Vaccine Advisory Committee, the National Vaccine Information Center opposed both the quick licensure of squalene adjuvants, 6 which hyperstimulate the immune system and have been associated with autoimmunity, 7 8 9 10 and the use of insect cells, 11 which could be contaminated with insect viruses. 12 13 14

Neither technology was licensed by the FDA last year 15 16 but there are tens of thousands of doses of squalene that the federal government bought and is stored in warehouses waiting to be used. 17 If the proposed Rule Change goes into effect, will drug companies be able to put those doses of squalene in flu vaccines by getting only one FDA employee to say “yes?” This and other risks to health are waiting for the American people if drug companies can get quick approval from one person to raise the amount of mercury, 18 19 aluminum 20 21 22 23 or residual protein in vaccines, 24 25 which have been associated with chronic inflammation, brain and immune system damage. 26

This summer the American people are watching the horrifying consequences of inadequate federal regulation of the oil industry play out in the oil soaked Gulf coast. There are legitimate questions being asked about the cozy relationship and financial conflicts of interest between federal agency regulators and big oil companies partnering with the U.S. Government to generate billions of dollars for the U.S. Treasury. 27 Calls for an independent federal safety oversight agency to monitor offshore drilling are being made in congressional hearings.

NVIC has been calling for an independent vaccine safety oversight agency free from financial and ideological conflicts of interest 28 since Congress passed a law in 1997 allowing drug companies to pay the FDA to fast track licensure of new vaccines and drugs. 29 30 During the last decade, that fast track system has seen scores of risky drugs like Vioxx and reactive vaccines like Gardasil quickly licensed, only to be followed by tragic reports of deaths and injuries. 31 32

While federal health officials are spending millions of dollars of taxpayer money to persuade every American from infancy through the last year of life to take a flu shot every year, 33 and hundreds of new vaccines are now in clinical trials, 34 35 it is no time for the FDA to make it easier for drug companies to put whatever they want in vaccines. Giving absolute power to one FDA employee, who reports to unelected political appointees, who could be subjected to heavy pressure from Big Pharma lobbyists, is not the way to regulate vaccines for safety.

If you want to make your voice heard and tell the FDA Commissioner, President Obama and your elected congressional representatives in Washington, D.C. what you think about the proposed rule change making it easier for drug companies to put whatever potentially dangerous ingredients they want to in vaccines, take action now. Remember, you only have until this Monday, June 28 to take action.

It’s your health, Your family. Your choice. Help send a strong message to Washington that it is time for government to stop partnering with the pharmaceutical industry and RAISE the safety bar for drug companies enjoying congressionally mandated liability protection while making big profits from selling government mandated vaccines.

Click here to watch the video

1 Fisher, BL. Vaccine Contamination: A Threat to Human Health. NVIC Vaccine E-News. May 27, 2010.
2 DHHS. Food & Drug Administration. Proposed Rule Revision of Requirements for Constituent Materials. Federal Register. March 30, 2010 (Vo. 75, No.60)
3 The White House. Memo from President Barack Obama to Heads of Executive Departments & Agencies on Transparency and Open Government. January 21, 2009.
4 FDA. Centers for Biologics Evaluation & Research (CBER). Regulatory Consideration Regarding the Use of Novel Influenza A (H1N1) Virus Vaccines. Transcript of July 23, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC).
5 FDA. CBER. Safety & Efffectiveness of Purified Recombinant Influenza Hemagglutinin Vaccine for the Prevention of Influenza. Transcript of November 19, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC).
6 Fisher BL. NVIC. Public Comment on Fast Tracking of Unlicensed Adjuvants for H1N1 Pandemic Influenza Vaccine. July 23, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee. Also see Reference #4, pages 161-162.
7 Kuroda Y, Nacionales DC et al. Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine. Biomedicine & Pharmacotherapy 58 (2004) 325-337.
8 Carlson BC, Jansson AM et al. The Endogenous Adjuvant Squalene Can Induce a Chronic T-cell-Mediated Arthritis in Rats. American Journal of Pathology2000; 156: 2057-2065.
9 Asa PB, Cao Y, Garry RF. Antibodies to Squalene in Gulf War Syndrome. Experimental & Molecular Pathology 2000; 68, 55-64.
10 Petrovsky N, Heinzel S et al. New Age Vaccine Adjuvants: Friend or Foe? International BioPharm. August 2, 2007.
11 Fisher BL. NVIC. Public Comment on Use of Insect Cells for Influenza Vaccine Production. November 19, 2009 Meeting of the FDA Vaccines & Related Biological Products Advisory Committee. Also see Reference #5, pages 119-121.
12 Becker AL. Momentum builds for cell culture flu vaccines. Center for Infectious Disease Research & Policy (CIDRAP). June 27, 2005.
13 Khan AS. Cell Substrates for Viral Vaccines: A Regulatory Update. FDA Centers for Biologics, Evaluation & Research (CBER). New Cells for New Vaccines IV: October 14, 2009. Pages 16-19.
14 Cummins J, Ho MW. Dangers of HPV Vaccine Production in Plants, Microbes and Viruses. Institute of Science in Society. July 1, 2009.
15 Miller, T. US Passes on Unlicensed H1N1 Boosters Despite Shortage. PBS NewsHour. November 9, 2009.
16 Randall T. Flu Shot Made from Caterpillars Fails Safety Vote (Update 3). Bloomberg News. November 19, 2009.
17 Ehart W. Pandemic’s workshop: Making Policy, making money, making vaccine. The Washington Times. December 7, 2009.
18 SafeMinds. Summary of Science Demonstrating the Harmful Nature of Mercury in Vaccines. Accessed June 21, 2010.
19 Egan W. FDA Statement: Additives in Childhood Vaccines. House Committee onGovernment Reform. July 18, 2000.
20 Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle. Brain, Vol 124, No. 9, 1821-1831.
21 Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue. Pharmacol.Toxico;70: 278-280.
22 Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of betamyloid protein. Brain Res. Bull. 55, 211-217.
23 Sahin G. et al. 1994. Determination of aluminum levels in the kidney, liver and brain of mice treated with aluminum hydroxide. Biol. Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.
24 Gandy A. Report of Motor Neuron Disease After HPV Vaccine. ALS TherapyDevelopment Institute. October 28, 2009.
26 Orbach H. Vaccines and Autoimmune Diseases of the Adult. DiscoveryMedicine. February 4, 2010.
27 Efstathiou J. Oil-Spill Agency Fetches $13 Billion Amid “Cozy” Ties (Update 4). May 11, 2010. Bloomberg Business Week.
28 NVIC. Public Engagement Group Reviews U.S. Vaccine Safety System. NVIC E-News. April 16, 2010.
30 Find Law. The FDA Modernization Act of 1997 (Summary). February 22, 1999.
31 Burst S, Muhtadie L, Walters J. Dangerous Medicine: Blind Faith (What happens when drugs, science & money mix). The Hamilton Spectator. June 27, 2005.
32 NVIC. Gardasil: The Damage Continues. Gardasil & HPV Infection Information.
33 Stobbe M. Panel recommends flu shots for nearly every American. Associated Press.February 25, 2010.
34 Rosenthal KS, Zimmerman DH. Vaccines: All things considered. Clin VaccineImmunol. 2006 August; 13(8): 821-829
35 NIH. Vaccine Clinical Trials. Accessed June 21, 2010.


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.


Click here to watch the video


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.


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