We are here today because in 2016, Congress amended the 1986 National Childhood Vaccine Injury Act to add vaccines recommended by the CDC for routine administration to pregnant women to the Vaccine Injury Table. 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. Although this NPRM requests public comment on how the addition of this new maternal vaccination category should be formatted on the Vaccine Injury Table, the public is hampered from making informed comments because of knowledge gaps about the safety and effectiveness of administering vaccines to pregnant women and potential negative health outcomes for the unborn child developing in the womb. Various package inserts for these vaccines contain warnings such as “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 “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.” 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.

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