Barbara Loe Fisher
Co-founder & President
National Vaccine Information Center (NVIC)
Public Comment - NPRM Hearing
Health Resources and Services Administration (HRSA)
U.S. Department of Health and Human Services (DHHS)
Sept. 17, 2018
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National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
This public comment is being submitted on behalf of more than 200,000 supporters of the nonprofit National Vaccine Information Center, a charity founded in 1982 by parents of DPT vaccine injured children to prevent vaccine injuries and deaths through public education. 1 I was among the parent co-founders who worked with Congress in the early 1980s to secure informing, recording, reporting and research provisions in the National Childhood Vaccine Injury Act of 1986, and to develop a Vaccine Injury Table for the Vaccine Injury Compensation Program (VICP) created by Congress under that historic law. 2 3 4 Information about the law can be found at NVIC.org.
We are here today because in 2016, Congress amended the 1986 Act to add vaccines recommended by the CDC for routine administration to pregnant women to the Vaccine Injury Table. That amendment would not have been included in the 21st Century Cures Act 5 without the strong support of the Department of Health and Human Services, which has been advocating since 2013 for this addition. 6 7 Congressional action was required to do it because the 1986 Act was not about vaccines recommended for adults or unborn babies developing in the womb.
As stated in multiple congressional hearings between 1982 and 1986, the National Childhood Vaccine Injury Act was created by Congress for one purpose: to protect the availability and lower the costs of federally recommended vaccines for children that are state mandated for school attendance. 8 9 DHHS and the Department of Justice opposed the 1986 Act because it preserved product liability for the four pharmaceutical companies producing DPT, polio and MMR vaccines, the seven vaccines that were recommended and mandated for children at that time (Wyeth, Lederle, Connaught and Merck). 10 11 Today, there are 10 companies marketing 16 vaccines that the CDC now recommends and states mandate for children to attend daycare and school (Pfizer, GlaxoSmithKline, Merck, Wyeth, Sanofi, Seqiris, Protein Sciences, MedImmune, Dynavax, Novartis). 12 13
In 1993, DHHS lobbied for amendments to the Act that transferred almost all authority from Congress to DHHS to add new vaccines to the Vaccine Injury Table and revise guidelines for awarding federal compensation. 14 15 16 In 2011, both DHHS and DOJ joined with vaccine manufacturers and asked the U.S. Supreme Court to do what Congress did not do in 1986 and finally cut off all product liability for companies marketing federally recommended and state mandated vaccines for children in the U.S. 17 18 19 20
Although this NPRM requests public comment on how the addition of this new maternal vaccination category should be formatted on the Vaccine Injury Table, 21 the public is hampered from making informed comment because of knowledge gaps, not only about the complexity of immune function during pregnancy, 22 23 but about the safety and effectiveness of administering vaccines to pregnant women and potential negative health outcomes for the unborn child developing in the womb, including impaired immune responses to vaccination after birth. 24 25 26 27 28 29 30 31 Although DHHS partially complied with vaccine safety research provisions included in the 1986 Act by commissioning the National Academy of Sciences to appoint committees to evaluate and publish reports on the adverse effects of childhood vaccines, it is important to note that reports published by the Institute of Medicine between 1991 and 2013 repeatedly stated that there have been long standing gaps in basic science knowledge about the biological mechanisms of vaccine injury and death and which individuals are more susceptible to harm from vaccination. 32 33 34 35 36 37
DHHS has not taken action to fill in basic vaccine science knowledge gaps outlined in IOM reports spanning more than two decades. The continuing lack of scientific understanding about how and why vaccines fail to protect 38 39 or injure and kill without warning, and why some individuals are biologically and environmentally at higher risk for suffering harm, 40 is also true for pertussis containing Tdap vaccine and influenza vaccines recommended for all women during every pregnancy. Tdap and influenza vaccines were never tested or licensed for use in pregnant women and are labeled as either Pregnancy Category B or C products. 41 42 Various package inserts for these vaccines contain warnings such as “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 policy has preceded the science.
Now, with the addition of vaccines recommended for pregnant women to the Vaccine Injury Table, the 12 other vaccines the CDC currently recommends for children become candidates for a future maternal use recommendation by CDC 44 because the manufacturers of those vaccines are now protected from liability when a pregnant woman and/or her unborn baby born alive is harmed in the womb by vaccination, although there is less clarity about whether DHHS will offer compensation when maternal vaccinations cause a miscarriage or stillbirth. In addition, the manufacturers of two new experimental vaccines specifically targeting pregnant women – RSV 45 and strep B 46 – will be shielded from liability, as will manufacturers of other new vaccines the CDC recommends for use by all pregnant women. 47 This is a stunning expansion of vaccine product liability protection for the pharmaceutical industry in a 1986 tort reform Act that created a federal compensation program option for children injured by government recommended and mandated vaccines that was never intended to cover adults or be an exclusive remedy. 48
Currently, pertussis containing and influenza vaccines account for the majority of federal compensation awards, although two out of three vaccine injury claims are denied. 49 These vaccines contain adjuvants and other ingredients known to be neurotoxic 50 51 52 53 54 but have not been evaluated for neurotoxic, genotoxic, 55 or adventitious agent 56 effects or stimulation of intrauterine inflammation in the pregnant woman or her fetus that may cause miscarriage or brain injury or otherwise damage the health of the baby after birth. In this regard, there have been two signals, one for miscarriage and one for clinical chorioamnionitis associated with vaccines given to pregnant women. 57 58 59 These two adverse outcomes should be added to the Vaccine Injury Table for maternal vaccines, in addition to the serious complications of encephalitis/encephalopathy and Guillain Barre syndrome already listed for these vaccines on the Table.
Of particular concern is evidence published in the medical literature indicating that chronic inflammation in a pregnant women or developing fetus frequently leads to poor health outcomes in children, including neurodevelopmental delays. 60 61 62 The fact that vaccination provokes an inflammatory response in the body to stimulate the production of artificial immunity, an inflammatory response that can become chronic in some individuals, should not be ignored. Evidence of intrauterine inflammation and elevated concentrations of cytokines in the umbilical cord or plasma of newborns, whose mothers were vaccinated during pregnancy, should be considered when those children later develop neurodevelopmental delays and neurodevelopmental delays should be added to the Vaccine Injury Table. 63 64
Emerging scientific evidence confirms that not only is there a fundamental lack of scientific understanding about how infectious diseases and vaccines stimulate natural or artificial immunity in the body at the cellular and molecular level, but there are basic science knowledge gaps about how infections and vaccines cause complications leading to injury and death. 65 Future genetically engineered vaccines recommended for pregnant women will contain new ingredients to which pregnant women and unborn babies have never been exposed. 66 It is urgent that this federal agency responsible for protecting the public health fully comply with the vaccine safety research provisions in the 1986 law 67 by funding independent research to develop pathological profiles based on cellular, molecular and other biological evidence for the purpose of creating vaccine contraindications that will prevent harm, and to facilitate the awarding of vaccine injury compensation when there is evidence of harm.
Finally, between 2014 and 2016 and recently in a public comment to the FDA concerning including pregnant women in clinical trials, the National Vaccine Information Center has asked for DHHS officials to affirm the ethical principle of informed consent to medical risk taking, which includes vaccine risk taking. 68697071 There is no single vaccine-related issue of more concern to Americans than protection of this internationally recognized human right for pregnant women, parents of minor children and adults of all ages, who are too often being threatened and sanctioned if they do not agree to receive all government recommended and mandated vaccines for which the pharmaceutical industry has had no product liability since 2011. 7273
Thank you for your consideration of this public comment.
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