國家疫苗傷害賠償計劃：將孕婦推薦的疫苗類別添加到疫苗傷害表中
該公眾評論是代表非營利性國家疫苗信息中心的20多萬名支持者提交的，該中心是由DPT疫苗接種兒童的父母於1982年成立的慈善機構，旨在通過公共教育預防疫苗傷害和死亡。 1 我是20世紀80年代早期與國會合作的父母聯合創始人之一，以確保1986年國家兒童疫苗傷害法案中的通報，記錄，報告和研究條款，並製定疫苗傷害賠償計劃的疫苗傷害表（VICP）由國會根據該歷史法創建。 2 3 4 有關法律的信息可以在NVIC.org找到 。
我們今天在這裡，因為在2016年，國會修改了1986年法案，將疾病預防控制中心建議的疫苗添加到孕婦接種疫苗傷害表中。如果沒有 衛生和人類服務部的大力支持，該修正案將不會被納入21世紀治愈法案5，該部門自2013年以來一直倡導這一修正案 。 6 7 國會採取行動是必要的，因為1986年的法案不是針對在子宮內發育的成人或未出生嬰兒推薦的疫苗。
正如1982年至1986年多次國會聽證會所述，國會制定了“國家兒童疫苗傷害法”，其目的之一是：保護聯邦政府推薦的疫苗，為國家規定的入學兒童提供疫苗。 8 9 DHHS和司法部反對1986年法案，因為它保留了生產DPT，脊髓灰質炎和MMR疫苗的四家製藥公司的產品責任，這是當時為兒童推薦和授權的七種疫苗（Wyeth，Lederle，Connaught和默克公司）。 10 11 今天，有10家公司銷售16種疫苗，CDC現在推薦這些疫苗，並規定兒童參加日托和學校的任務（輝瑞，葛蘭素史克，默克，惠氏，賽諾菲，Seqiris，蛋白質科學，MedImmune，Dynavax，諾華）。 12 13
1993年，DHHS遊說該法案的修正案，該法案幾乎將所有權力從國會移交給DHHS，以便在疫苗傷害表中添加新疫苗，並修訂授予聯邦補償的指導方針。 14 15 16 2011年，DHHS和DOJ都加入了疫苗生產商，並要求美國最高法院做國會在1986年沒做的事情，並最終切斷了聯邦政府推薦的公司和美國國家規定的兒童疫苗的所有產品責任。 17 18 19 20
雖然這個NPRM要求公眾就如何在疫苗傷害表格中添加這種新的母體疫苗接種類別 進行評論[ 21]，由於知識差距，公眾因為知識缺口而無法做出明智的評論，而不僅僅是關於懷孕期間免疫功能的複雜性， 22 23 ，但對安全性和管理疫苗對孕婦和潛在的負面健康結果對胎兒在子宮內發展，包括出生後接種受損的免疫應答的有效性。 24 25 26 27 28 29 30 31 儘管DHHS部分遵守1986年法案中的疫苗安全研究規定，委託國家科學院任命委員會評估和發布兒童疫苗不良反應的報告，但重要的是要注意醫學研究所發表的報告。 1991年至2013年間多次表示，關於疫苗傷害和死亡的生物學機制的基礎科學知識存在長期存在的差距，個體更容易受到疫苗接種的傷害。 32 33 34 35 36 37
DHHS尚未採取行動填補跨越二十多年的IOM報告中概述的基本疫苗科學知識缺口。關於繼續缺乏科學的理解如何和為什麼疫苗不能保護 38 39 或傷害和殺害無預警，以及為什麼有些人是生物和環境風險較高的患害， 40 也是如此百日咳含Tdap的疫苗和流感疫苗建議所有女性在每次懷孕期間使用。Tdap和流感疫苗從未經過測試或許可用於孕婦，並被標記為妊娠B類或C類產品。 41 42 這些疫苗的各種包裝插頁包含警告，例如“尚未進行動物繁殖研究;”和“不知道疫苗在給孕婦服用時是否會造成胎兒傷害或影響生殖能力;”和“有沒有對孕婦進行充分和良好對照的研究;“和”疫苗’尚未評估其致癌或誘變潛力;“和”孕婦疫苗的現有數據不足以告知孕婦疫苗相關風險;“並且“只有在明確需要時才應給予孕婦疫苗。” 43
孕產婦疫苗接種政策先於科學。
現在，通過向疫苗傷害表中添加推薦用於孕婦的疫苗，疾病預防控制中心目前為兒童推薦的其他12種疫苗成為CDC 44未來產婦使用建議的候選者， 因為這些疫苗的製造商現在免於承擔責任。懷孕婦女和/或她出生的未出生嬰兒在接種疫苗時會在子宮內受到傷害，儘管當母親接種疫苗導致流產或死產時，DHHS是否會提供補償的清晰度較低。另外，兩種新型實驗疫苗的製造商專門針對孕婦 – RSV 45 和鏈球菌B 46 – 將免除責任，CDC建議所有孕婦使用的其他新疫苗的製造商也將免於承擔責任。 47 這是1986年侵權改革法案對製藥行業疫苗產品責任保護的驚人擴展，該法案為受政府推薦和授權疫苗傷害的兒童制定了聯邦補償計劃選項，這些疫苗從未打算涵蓋成年人或是專屬補救措施。48
目前，含有百日咳的疫苗和流感疫苗佔聯邦賠償金的大多數，儘管有三分之二的疫苗傷害索賠被拒絕。 49 這些疫苗含有佐劑和已知具有神經毒性的其他成分 50 51 52 53 54， 但尚未評估 孕婦或其胎兒可能導致流產的神經毒性，遺傳毒性， 55 或外來因子 56的作用或刺激宮內炎症。出生後腦損傷或以其他方式損害嬰兒的健康。在這方面，有兩個信號，一個用於流產，另一個用於與孕婦接種疫苗相關的臨床絨毛膜羊膜炎。 57 58 59 除了表中列出的這些疫苗的腦炎/腦病和格林巴利綜合徵的嚴重並發症外，這兩種不良後果應加入孕產婦疫苗疫苗傷害表中。
特別值得關注的是醫學文獻中發表的證據表明，孕婦或發育中的胎兒的慢性炎症經常導致兒童的健康狀況不佳，包括神經發育遲緩。 60 61 62 疫苗接種引起體內炎症反應以刺激人工免疫的產生這一事實不應該被忽視，人工免疫是一種可能在某些個體中變成慢性的炎症反應。當這些兒童發生神經發育遲緩並且應在疫苗損傷表中加入神經發育遲緩時，應考慮胎兒炎症和新生兒臍帶或血漿中細胞因子濃度升高的證據，這些新生兒的母親在懷孕期間接種疫苗。 63 64
新出現的科學證據證實，在細胞和分子水平上，傳染病和疫苗如何在體內刺激自然或人工免疫方面存在根本缺乏科學認識，但關於感染和疫苗如何引起並發症存在基本的科學知識差距。導致傷亡。 65 為孕婦推薦的未來基因工程疫苗將含有孕婦和未出生嬰兒從未接觸過的新成分。 66 這個負責保護公共衛生的聯邦機構迫切需要完全遵守1986年法律中的疫苗安全研究規定 67 通過資助獨立研究，開發基於細胞，分子和其他生物學證據的病理學概況，目的是製定預防傷害的疫苗禁忌症，並在有傷害證據時促進疫苗傷害賠償的授予。
最後，在2014年至2016年之間以及最近向FDA提出的關於將孕婦納入臨床試驗的公眾意見中，國家疫苗信息中心要求DHHS官員確認醫療風險知情同意的道德原則，其中包括疫苗風險服用。 68 6970 71 對於美國人來說，沒有任何單一的疫苗相關問題比保護這種國際公認的孕婦，未成年子女的父母和所有年齡段的成年人的人權更受關注，如果他們這樣做，他們往往受到威脅和製裁不同意接收自2011年以來製藥行業沒有產品責任的所有政府推薦和強制疫苗 .72 73
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