Barbara Loe Fisher Food Headline Medicine Watch vaccines for pregnant women

Vaccine Safety Untested on Pregnant Women, But Big Pharma Not Liable for Vaccine Injuries to Unborn Children and Pregnant Mothers


by Barbara Loe Fisher
Co-founder & President
Nationwide Vaccine Info Middle (NVIC)



Nationwide Vaccine Damage Compensation Program: Including the Class of Vaccines Advisable for Pregnant Ladies to the Vaccine Damage Desk

This public remark is being submitted on behalf of greater than 200,000 supporters of the nonprofit Nationwide Vaccine Info Middle, a charity based in 1982 by mother and father of DPT vaccine injured youngsters to forestall vaccine accidents and deaths by means of public schooling. 1

I used to be among the many mother or father co-founders who labored with Congress within the early 1980s to safe informing, recording, reporting and analysis provisions within the Nationwide Childhood Vaccine Damage Act of 1986, and to develop a Vaccine Damage Desk for the Vaccine Damage Compensation Program (VICP) created by Congress underneath that historic regulation. 2 Three four

Details about the regulation might be discovered at


We’re right here as we speak as a result of in 2016, Congress amended the 1986 Act to add vaccines really helpful by the CDC for routine administration to pregnant ladies to the Vaccine Damage Desk. That modification wouldn’t have been included within the 21st Century Cures Act 5 with out the robust help of the Division of Well being and Human Providers, which has been advocating since 2013 for this addition. 67

Congressional motion was required to do it as a result of the 1986 Act was not about vaccines advisable for adults or unborn infants creating within the womb.

As said in a number of congressional hearings between 1982 and 1986, the Nationwide Childhood Vaccine Damage Act was created by Congress for one function: to shield the supply and decrease the prices of federally really helpful vaccines for youngsters which are state mandated for faculty attendance. eight 9

DHHS and the Division of Justice opposed the 1986 Act as a result of it preserved product legal responsibility for the 4 pharmaceutical corporations producing DPT, polio and MMR vaccines, the seven vaccines that have been advisable and mandated for youngsters at the moment (Wyeth, Lederle, Connaught and Merck).  10 11

In the present day, there are 10 corporations advertising 16 vaccines that the CDC now recommends and states mandate for youngsters to attend daycare and faculty (Pfizer, GlaxoSmithKline, Merck, Wyeth, Sanofi, Seqiris, Protein Sciences, MedImmune, Dynavax, Novartis). 12 13

In 1993, DHHS lobbied for amendments to the Act that transferred virtually all authority from Congress to DHHS to add new vaccines to the Vaccine Damage Desk and revise tips for awarding federal compensation. 14 15 16

In 2011, each DHHS and DOJ joined with vaccine producers and requested the U.S. Supreme Courtroom to do what Congress didn’t do in 1986 and lastly minimize off all product legal responsibility for corporations advertising federally really helpful and state mandated vaccines for youngsters within the U.S. 17 18 19 20


Though this NPRM requests public remark on how the addition of this new maternal vaccination class ought to be formatted on the Vaccine Damage Desk, 21 the general public is hampered from making knowledgeable remark due to information gaps, not solely concerning the complexity of immune perform throughout being pregnant, 22 23 however concerning the security and effectiveness of administering vaccines to pregnant ladies and potential unfavorable well being outcomes for the unborn youngster creating within the womb, together with impaired immune responses to vaccination after start. 24 25 26 27 28 29 30 31

Though DHHS partially complied with vaccine security analysis provisions included within the 1986 Act by commissioning the Nationwide Academy of Sciences to appoint committees to consider and publish stories on the hostile results of childhood vaccines, it is necessary to observe that reviews revealed by the Institute of Drugs between 1991 and 2013 repeatedly said that there have been lengthy standing gaps in primary science information concerning the organic mechanisms of vaccine damage and demise and which people are extra vulnerable to hurt from vaccination. 32 33 34 35 36 37

DHHS has not taken motion to fill in primary vaccine science information gaps outlined in IOM reviews spanning greater than 20 years.

The persevering with lack of scientific understanding about how and why vaccines fail to shield 38 39 or injure and kill with out warning, and why some people are biologically and environmentally at larger danger for struggling hurt, 40 can also be true for pertussis containing Tdap vaccine and influenza vaccines beneficial for all ladies throughout each being pregnant.

Tdap and influenza vaccines have been by no means examined or licensed for use in pregnant ladies and are labeled as both Being pregnant Class B or C merchandise. 41 42

Numerous package deal inserts for these vaccines include warnings similar to “animal reproduction studies have not been conducted;” and “it is not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity;” and “there are no adequate and well controlled studies in pregnant women;” and “the vaccine’ has not been evaluated for carcinogenic or mutagenic potential;“ and “available data on the vaccine administered to pregnant women are insufficient to inform vaccine associated risks in pregnant women;” and “the vaccine should be given to pregnant women only if clearly needed.” 43


Maternal vaccination coverage has preceded the science.

Now, with the addition of vaccines advisable for pregnant ladies to the Vaccine Damage Desk, the 12 different vaccines the CDC at present recommends for youngsters turn out to be candidates for a future maternal use suggestion by CDC 44 as a result of the producers of these vaccines at the moment are shielded from legal responsibility when a pregnant lady and/or her unborn child born alive is harmed within the womb by vaccination, though there’s much less readability about whether or not DHHS will supply compensation when maternal vaccinations trigger a miscarriage or stillbirth.

As well as, the producers of two new experimental vaccines particularly concentrating on pregnant ladies – RSV 45 and strep B 46 – shall be shielded from legal responsibility, as will producers of different new vaccines the CDC recommends for use by all pregnant ladies. 47

This can be a beautiful enlargement of vaccine product legal responsibility safety for the pharmaceutical business in a 1986 tort reform Act that created a federal compensation program choice for youngsters injured by authorities advisable and mandated vaccines that was by no means meant to cowl adults or be an unique treatment. 48

At present, pertussis containing and influenza vaccines account for nearly all of federal compensation awards, though two out of three vaccine damage claims are denied. 49

These vaccines include adjuvants and different elements recognized to be neurotoxic 50 51 52 53 54 however haven’t been evaluated for neurotoxic, genotoxic, 55 or adventitious agent 56 results or stimulation of intrauterine irritation within the pregnant lady or her fetus which will trigger miscarriage or mind damage or in any other case injury the well being of the child after delivery.

On this regard, there have been two alerts, one for miscarriage and one for medical chorioamnionitis related to vaccines given to pregnant ladies. 57 58 59

These two antagonistic outcomes must be added to the Vaccine Damage Desk for maternal vaccines, as well as to the intense problems of encephalitis/encephalopathy and Guillain Barre syndrome already listed for these vaccines on the Desk.

Of specific concern is proof revealed within the medical literature indicating that persistent irritation in a pregnant ladies or creating fetus steadily leads to poor well being outcomes in youngsters, together with neurodevelopmental delays. 60 61 62

The truth that vaccination provokes an inflammatory response within the physique to stimulate the manufacturing of synthetic immunity, an inflammatory response that may turn out to be persistent in some people, shouldn’t be ignored.

Proof of intrauterine irritation and elevated concentrations of cytokines within the umbilical twine or plasma of newborns, whose moms have been vaccinated throughout being pregnant, ought to be thought-about when these youngsters later develop neurodevelopmental delays and neurodevelopmental delays ought to be added to the Vaccine Damage Desk. 63 64


Rising scientific proof confirms that not solely is there a elementary lack of scientific understanding about how infectious illnesses and vaccines stimulate pure or synthetic immunity within the physique on the mobile and molecular degree, however there are primary science information gaps about how infections and vaccines trigger problems main to damage and dying. 65

Future genetically engineered vaccines beneficial for pregnant ladies will include new components to which pregnant ladies and unborn infants have by no means been uncovered. 66

It’s pressing that this federal company accountable for defending the general public well being absolutely adjust to the vaccine security analysis provisions within the 1986 regulation 67 by funding unbiased analysis to develop pathological profiles based mostly on mobile, molecular and different organic proof for the aim of making vaccine contraindications that may forestall hurt, and to facilitate the awarding of vaccine damage compensation when there’s proof of hurt.

Lastly, between 2014 and 2016 and just lately in a public remark to the FDA regarding together with pregnant ladies in medical trials, the Nationwide Vaccine Info Middle has requested for DHHS officers to affirm the moral precept of knowledgeable consent to medical danger taking, which incorporates vaccine danger taking. 68 69 70 71

There isn’t a single vaccine-related difficulty of extra concern to People than safety of this internationally acknowledged human proper for pregnant ladies, mother and father of minor youngsters and adults of all ages, who’re too typically being threatened and sanctioned if they don’t agree to obtain all authorities advisable and mandated vaccines for which the pharmaceutical business has had no product legal responsibility since 2011. 72 73

Thanks for your consideration of this public remark.

Learn the complete article at

Remark on this text at

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73 Nationwide Vaccine Info Middle. Cry for Vaccine Freedom Wall. 

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Revealed on September 21, 2018

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