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FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

By Barbara Loe Fisher

Published November 17, 2015 in Infectious Diseases & Vaccines

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Following is a public comment made by Barbara Loe Fisher, NVIC Co-founder & President, at the Nov. 13, 2015 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy

Pregnancy Health Concerns Birth defects, chromosomal damage, premature birth, low birth weight, pregnancy complications and sudden infant death syndrome, not infectious diseases, are the leading causes of death for about 23,000 infants dying before their first birthday in the US every year, with half of those deaths occurring on the first day of life. ¹ ² Women getting pregnant and delivering babies in America today have more than twice the risk of dying during pregnancy, childbirth or within one year of giving birth than they did three decades ago, with heart failure, high blood pressure and stroke, diabetes, and blood clots being among the leading causes of death. ³ ⁴

In 2006, CDC officials directed doctors to give all pregnant women a flu shot ⁵ and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. ⁶ Prior to FDA licensure, influenza, diphtheria, tetanus and pertussis vaccines were not tested in or proven safe and effective for pregnant women in large clinical trials when given during every pregnancy either singly or simultaneously. ⁷ ⁸

Categorized by FDA as Pregnancy Category B and C biologicals ⁹ because it is not known whether the vaccines are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction, administering influenza and Tdap vaccines to pregnant women is an off-label use of these vaccines.¹⁰ ¹¹ ¹² It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it. ¹³

Tdap vaccine was licensed by FDA as a single dose pertussis booster shot in individuals over 10 or 11 years old, and pertussis containing vaccine injuries and deaths are the most compensated claim in the federal vaccine injury compensation program (VICP) for infants and children, while influenza vaccine-related injuries and deaths are the most compensated claim for adults. ¹⁴ And yet, in the absence of credible biological mechanism and epidemiologic evidence pre-licensure proving these vaccines are safe for all pregnant women, their fetuses and newborns, female health care workers are being fired for refusing to be injected with them while they are pregnant. ¹⁵

Epidemiology and Public Health This maternal vaccination policy is a violation of the precautionary principle to “first, do no harm,” ¹⁶ and it is of grave concern to women having babies in America, especially pregnant health care workers. When federal vaccine use recommendations are being turned into laws that punish Americans refusing to obey them with denial of a school education, medical care and employment, ¹⁷ ¹⁸ maintaining high FDA vaccine licensing standards is absolutely essential.

There have been no well designed prospective, long term case controlled studies enrolling large groups of American women who get influenza and Tdap vaccines during pregnancy and comparing their health and the viability of their fetuses and newborns to women who do not get vaccinated. There are no published studies to identify unresolved vaccine-induced inflammation in the brains and bodies of the fetus, mother and newborn; or to measure atypical changes in brain and immune function and chromosomal integrity, including evaluating the numbers of de novo mutations present before and occurring after vaccination.

Maternal vaccination policy has preceded vaccine safety science. Now, there are proposals on the table here in this Committee and in the 21^st Century Cures Act backed by FDA and industry to lower FDA licensing standards to ensure that vaccine Vaccine safety science is necessary policy can continue to precede vaccine safety science in the future. ¹⁹ Considerable discussion today about making a priori assumptions that complications and fetal death following maternal vaccination are only coincidentally and not causally related to vaccination ²⁰ is a big red flag for vaccine consumers in the absence of credible pathological evidence to conclusively determine what is and is not vaccine induced.

The National Vaccine Information Center is opposed to FDA retroactively licensing influenza and Tdap vaccines for use in pregnant women and fast tracking RSV ²¹ and group strep B ²² vaccines to licensure by using small clinical trials; adaptive trial designs; Baysian methods of data analysis; biomarkers and surrogate endpoint measures rather than actual clinical endpoints; or using clinical experience instead of good bench science and randomized controlled clinical trials with long term follow-up to prove effectiveness and safety.

The fact that vaccine manufacturers, regulators, policymakers and providers are completely shielded from civil liability for vaccine injuries and deaths ²³ makes it even more important for FDA standards for proof of vaccine safety and effectiveness to be very high, especially when licensing vaccines targeting pregnant women and their unborn babies.

References:

1 Mathews TJ, MacDorman MF, Thoma ME. Infant Mortality Statistics From the 2013 Period Linked Birth/InfantDeath Data Set . National Vital Statistics Reports 2015; 64(9).

2 Manning A. U.S. Top of List for First-Day Deaths in Rich Nations: More Babies Die on Their First Day of Life in the United States Than In Any Other Industrialized Country. National Geographic News May 8, 2013.

3 CDC. Pregnancy Mortality Surveillance System. Trends in Pregnancy-Related Deaths . Sept. 16, 2015.

4 Munz M. Why Are So Many US Women Dying During Childbirth? St. Louis Post Dispatch April 7, 2013.

5 Centers for Disease Control (CDC). Prevention and Control of Influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR July 28, 2006; 55(RR10): 1-42.

6 CDC. Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged Under 12 Months – ACIP, 2011. MMWR 2011; 60(41): 1424-1426.

7 Gruber MF. Maternal Immunization: US FDA Regulatory Considerations . Vaccine 2003; 21(24): 3487-3491.

8 Fisher BL, Wrangham TK. Public Comment to National Vaccine Advisory Committee (NVAC) Maternal Immunization Working Group (MIWG) on MIWG Recommendations on Maternal Immunization . Apr. 25, 2014.

9 Drugs.com. FDA Pregnancy Categories. October 2013.

10 NVIC.org . Influenza Vaccine Package Inserts (2015-2016): Important Information from Manufacturers . NVIC 2013.

11 Sanofi Pasteur. Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Full Prescribing Information . Use in Specific Populations: 8.1 Pregnancy Category C. Sanofi Pasteur April 2013.

12 Glaxo-Smith Kline. BOOSTRIX (Tetanus Toxoid, Reducated Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Full Prescribing Information . Specific Populations: 8.1 Pregnancy Category B.

13 Fisher BL. Vaccination During Pregnancy: Is It Safe? NVIC Newsletter Nov. 9, 2013.

14 Health Resources Services Administration (HRSA). Vaccine Injury Compensation Program Data & Statistics.

15 CBS News. Pregnant nurse fired for refusing flu shot. Dec. 28, 2013.

16 Science & Environmental Health Network (SEHN). The Wingspread Statement on the Precautionary Principle. SEHN January 1998.

17 Fisher BL.Women, Vaccines & Bodily Integrity. NVIC Newsletter Jan. 24, 2013.

18 Richardson D. The Fallout from California SB277 – What Happens Next? NVIC Newsletter Aug. 5, 2015.

19 Fisher BL. Here Comes the 21^st Century Cures Act: Say Goodbye to Vaccine Safety Science . NVIC Newsletter July 21, 2015.

20 FDA. Nov. 13, 2015 VRBPAC Meeting Agenda and FDA Briefing Document: Clinical Development and Requirements for Licensure of Vaccines Intended for Use During Pregnancy to Prevent Disease in the Infant .

21 Fierce Vaccines. Novavax (Nvax) Receives FDA Fast-Track Designation for RSV F Vaccine Candidate . Dec. 4, 2014.

22 Edwards MS, Gonik B. Preventing the broad spectrum of perinatal morbidity and mortality through group B streptococcal vaccination . Vaccine 2013; 31 (Supple 4).

23 Fisher BL. Vaccine Injury Compensation: Government’s Broken Social Contract with Parents. NVIC Newsletter Nov. 2, 2015.

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22 Responses to "FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women"

That such a well documented and clear argument can be either ignored or argued away points to the moral vacuum that exists in the FDA and their corporate enablers. The loss of basic morality is evidenced by the necessity to remind regulators of "do no harm", a basic Oath of medicine, long lost to its derivative, "do no harm to the bottom line". The mix of pharmaceuticals and medicine-for-profit is toxic and its legacy of destruction will someday be viewed as the crime it most certainly is.

The real science is not being done to prove these vaccines are safe and now you want to make it even easier to allow these vaccines to be given to pregnant women. Look at the rise of problems in our children today. Could it be the increased number of vaccines that they are forced to take. Compare the health of vaccinated vs unvaccinated children. Don't allow the vaccine industry to keep increasing the number of vaccines that the government is making mandatory and allowing the vaccine industry to not be liable for any problems these vaccines can cause. What is their incentive other than profit to make sure these vaccines are safe and effective? DO THE REAL SCIENCE FIRST AND QUIT HELPING THE VACCINE INDUSTRY MAKE MORE PROFITS WITH NO LIABILITY.

There is no "real science" because it has always been corrupted by big money/grants. If the many attempts at killing humans in the womb doesn't work, there exist many other methods to diminish population post-birth. The agenda is nothing if not persistent, dogged, and ruthless.

Our investigational products and drugs and vaccines are considered "innocent until proven guilty" or "safe unless proven otherwise". There are plenty of adverse events in trials and in post marketing experience. But our medical community has be brainwashed into thinking show me the evidence that this xxxxx (side effect or adverse effect) is related. The time when doing less and allowing the body's natural resources to fight this out is gone. But we ARE at the brink of a paradigm shift. Even as all this is happening, there is clear and undeniable evidence on the gut microbiome and how our therapies, lifestyle, industrialized food and pollution have altered that microbiome. It becomes clearer to even conventional medicine that we can only reverse disease and restore health as we re-balance our bodies and our planet. Regardles off the corporate-political-power hold on our current medical paradigm, these truths are bubbling to the surface and soon will explode. I see this insanity as the storm before that shift. Those in power are desparately clinging to their paradigm. I hope we don't take down the entire planet before this is realized (perhaps we already have).

"Fast track" means "We're shoving it down your throats, whether it's legal or not, whether it's harmful or not, or whether you want it or not - we just don't give a damn!"

I always think of Janine Roberts in regard to the VRBPAC, particularly, "THE HEALTH AUTHORITIES IGNORE THE RECOMMENDATIONS OF THEIR TOP VACCINE SAFETY EXPERTS THAT NO VACCINES SHOULD BE MADE USING FERTILIZED EGGS FOR RISK OF AVIAN VIRUSES" (from The Vaccine Papers). What is going on today is nothing new, and is nothing short of a crime against humanity, perpetrated by our government against its own people purely in the name of profit. A special prosecutor should be appointed to investigate DHHS.

What needs to be addressed is the root cause of infant mortalities which are found in less than nutritious foods laced with many trace toxins combined with poor life style choices. Measuring each pregnant mother's nutrient levels and supplementing accordingly would do wonders. When the IOM denies the need for pregnant mothers need for extra Vitamin D during gestation speaks volumes about the lack of understanding in our medical community of what needs to be addressed to reduce our shameful 6.6 rate of infant mortalities plus the number of infants that acquire autism and other diseases after birth. More Vaccines are not the answer, but contribute to the medical problems of those that receive them. Thomas Braun RPh N2E+ for Life Health Edu. Institute

Hitting the baby with IDTP while their blood brain barrier is immature or "leaky" is at best very irresponsible and at worst down right evil.

If only the FDA, EPA, USDA, product safety commission and FFRDCs, among probably hundreds of other alphabet agencies that add to our unbelievable and ever increasing debt (God only knows how much the military and Pentagon spend on human experimentation in its many forms (including torture and its justification) Would consider just jobbing out truth seeking to the EU, where most of our unbiased safety testing is done... Big Pharma, and, well, every giant source of political influence pays heavily to keep the truth from Americans. Right down to hoping we will forget the Hippocratic oath and any other positive influence on our health systems. Their own 'Paper Persons' instruction sheet tells them "Profit is All" and they must follow their hard programming to the last dot. This is all about Eugenics and the reduction of planetary population. H. Kissinger suggested a 70% reduction. some more, some slightly less. And our government is owned, since before Citizens United, by these Paper Persons and those who run them.

Jeffrey Smith - Institute of Responsible Technology is going to be putting out another documentary. ... - Genetic Roulette is the first movie the Institute of Responsible Technology has put forth. This movie is titled Secret Ingredients and highlights real people who have regained their health by goning off GMO's (and probably vaccines too because I am reading that some ingredients of vaccines are now genetically engineered) I would encourage people to take a look at that. Also Steven Drucker wrote a book on GMOs entitled Altered Genes, Twisted Truth. GMO's were never proven to be GRAS - It is just that an Indiana politician, Vice President Dan Quayle said that GMO's were GRAS. He probably got a big financial donation from Monsanto for that. I am grateful our daughter has seen to NOT be vaccinated in her third trimester and will not vaccinate her daughter - For now The state we live in still has informed consent laws - but . . . even with that - esp. companies who insist their employees get injected with toxins - some people have no rights unless they want to lose their jobs. What insanity.

Our family has experienced several very serious adverse systemic and almost lethal side effects from vaccines. We had to find out the hard way and at our children's health and our financial expense on top of it, to recover from the vaccine damages done and to pay for alternative healing approaches and detoxification protocols to regain some health back again. It was and still is a nightmare to deal with the aftermath on what our sons had to go through and I have serious concerns that now pregnant women are being targeted for vaccination and the toxic ingredients in those shots. I hope NOBODY will have to go through what we and others went through.

If vaccines are so safe then why aren't the ingredients listed - actually ingredients are secret, aren't they?

What about all the kids born to addict mothers and the severe impact on these babes seen at birth. How can anyone not correlate how dangerous it is to have toxins intentionally absorbed into the bloodstream one way or another via vaccination route. I agree with the commenter Lisa, as we are at a paradigm shift of consciousness in these next ten years, but it is so scary and feels so helpless. We have to share our views with others and open the eyes to the insanity, one small piece at a time.

Decisions that are not made from loving kindness, seeking the best for everyone, are wrong-minded, destructive and in the end cause more pain and suffering... I find United States to be hypocritical in that as we point the finger to other countries and call them murderers for the outrageous acts of destruction based on ideologies that can not be proven one way or another... yet here we are raging the same war against our own but with a needle... to me it is even more sinister because we do our murdering using the veil of medicine.. rather then shooting people with bullets... we shoot our people with vaccines and prescription drugs... But then again remember what the Nazi's did under the veil of medicine... We have medical tyranny ruling our lives... in the United States of America...

I agree with everything that Barbara Loe Fisher said. Transparency should be required of the CDC and FDA: all ingredients, all testing done,, all results (especially negative outcomes). This should be made readily available to the public.

All I've been hearing lately is how the FDA is fast tracking every proposed vaccine coming down the pike. This reeks of greed and corruption. We know the pharmaceutical companies can get away with murder, because they aren't accountable to the American people for their actions.The cost for vaccine injury compensation is paid for by us. Where are the safety trials and how about an independent research team running them for once? We know all about their rigged studies and any evidence that doesn't support their cause is destroyed. Where is the outrage? How many more politicians will they buy before we stand up for truth and demand transparency? Where is the outrage for Big Pharma's reckless actions that have ruined people's lives? Medical tyranny is right!

If there are no incentives to develop a safe vaccine (if such a thing can exist) because of the National Childhood Vaccine Injury Act, then fast tracking them makes sense. You can use humans as your test subjects since they have no recourse upon injury. You do your testing while making a profit. The best of all worlds to the manufacturers.

The Government will continue to poison us, and our children as long as consumers continue to allow it, and doctors will continue to be part of the problem because they either receive funds from big pharma to do so, or they never do the independent research to learn the truth. Mothers that want to avoid the dangers medicine will impose on them should get back to using traditional home birth midwives. They will not impose vaccines, unnecessary testing, scheduled induction (which almost always leads to c-section), and they don't have the maternal/fetal mortality/morbidity rates that we see increasing every year in this country. It is up to us to control the health care we receive, nobody else is looking out for us. Just say no. It may be inconvenient to home school if you live in a state that requires full vaccination for your child to attend school, your insurance may not pay for alternative health care to see a midwife, homeopath, ect., but if enough people get on that band wagon, change will come eventually. When we continue to treat doctors as gods, and rely on our government agencies to keep us safe we are going to follow the heard over the cliff.

In a sick way I am cheering on the FDA with this plan as a wonderful idea. The more crap Pharma and the FDA cram down people's throats (or into their arms), the more people will have adverse reactions. And then the truth gets out more and more and maybe that will fast track the people revolting against this medical tyranny. It's already happening where I live with the flu shot this year. WAY fewer people are getting it this year and it is advertised everywhere on every type of media. Bring on the poison.

Glen, Well,it continues to be the Primary Driver of the FDA and CDC is running interference for Big Pharma. The Bobbsey Twins(FDA/CDC) will throw the Truly Informed a bone from time to time but are asleep at the switch & refuse to execute Their Original PRIMARY RESPONSIBILITY of protecting us from Big Pharma's quest for bigger market shares. The revolving door of these two agencies where high-level employees leave the service of "protecting the public" only to go to work for the enemy at MUCH HIGHER SALARIES IS SICK.

I cannot conceive of vaccinating newborns and causing their deaths is anything but murder.

Just say NO to this nonsense and insanity!

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FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

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FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

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