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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
safety and current research are available by conducting literature reviews.
Pregnant women are at risk for vaccine-preventable disease-related morbidity and mortality and adverse pregnancy outcomes, including congenital anomalies, spontaneous abortion, preterm birth, and low birth weight. In addition to providing direct maternal benefit, vaccination during pregnancy may provide direct fetal and infant benefit through passive immunity transplacental transfer of maternal vaccine-induced antibodies.
Existing evidence and data trends indicate that the eradication and reduction of vaccine-preventable diseases through immunization has directly increased life expectancy by reducing mortality. In addition, numerous published and peer-reviewed scientific studies have found that neither vaccines nor vaccine ingredients cause the neurodevelopmental disorders of autism, Attention-Deficit/
Hyperactivity Disorder, or speech or language delay.
Comment: Some comments opposing the proposed changes in the NPRM
stated that pregnant women are often coerced or forced to be vaccinated without being given information about possible vaccine side effects to themselves and/or their unborn child/
children.
Response: This final rule does not require vaccines for pregnant women.
However, the CDC and the American Academy of Pediatrics, as well as other medical organizations, publish information regarding the safety of recommended vaccines. In addition, Vaccine Information Statements, which are information sheets produced by the CDC that explain both the benefits and risks of VICP-covered vaccines, are required to be provided to all individuals, or their legal representatives, before receiving such vaccines. However, the decision to ultimately be vaccinated rests with the individual or legal representative.
Comment: Some comments opposing the NPRM stated that by recommending vaccines to pregnant women, liability protection is conferred upon vaccine manufacturers and that this creates a disincentive to conduct safety research on vaccines. Some stated a belief that the addition of pregnant women will now eliminate the pregnant womans right to sue for damages.
Response: The Vaccine Act created the VICP, a no-fault alternative to the traditional tort system. It provides compensation to people thought to be injured by vaccines recommended by the CDC for routine administration to children and now pregnant women.

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When a vaccine is added to the Vaccine Injury Table, it is covered under the VICP. To help ensure a stable vaccine supply, the VICP generally provides liability protection for vaccine manufacturers and health care providers for injuries caused by VICP-covered vaccines. Claims alleging injuries or death from certain vaccines generally must be filed with the VICP before a lawsuit can be filed in civil court.
Comment: Some comments opposed the addition of the category of vaccines recommended for routine administration in pregnant women to the Table, as this would provide vaccine manufacturers the ability to increase revenue by having a new population to target with their products.
Response: As noted previously, the Secretary is required by statute to revise the Table to include vaccines recommended by the CDC for routine administration in pregnant women and subject to an excise tax by Federal law.
See 42 U.S.C. 300aa14e3.
Comment: Some comments opposing the change proposed in the NPRM
suggested that the VICP be eliminated.
Response: The Vaccine Act established the VICP, and Congress would need to enact legislation to eliminate the VICP. Eliminating the Program is beyond the scope of this final rule.
Comment: Some comments supporting and opposing the changes proposed in the NPRM suggested additional changes to the Table, such as adding injuries to the Table.
Commenters opposing changes proposed in the rule stated that vaccines cause miscarriages and other conditions, such as chorioamnionitis, encephalitis/
encephalopathy, Guillain-Barre Syndrome, and neurodevelopmental disorders, and can negatively affect the offspring of pregnant women who have undiagnosed genetic disorders. Some commenters requested that the Table be revised or expanded to include all vaccines that could be recommended in pregnancy and their potential complications, and vaccines contraindicated during pregnancy, including statistics of complications.
Response: Consistent with the statutory requirement, the Secretary is revising the Table to include new vaccines recommended by the CDC for routine administration in pregnant women. The Secretary is implementing this change by amending the existing language in Item XVII of the Table to include and/or pregnant women after children. This will add to that general category of the Table, any new vaccine recommended by the CDC for routine administration in pregnant women, after
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imposition of an excise tax and publication of a notice of coverage by the Secretary.
As explained above, in its 2012
Report, Adverse Effects of Vaccines:
Evidence and Causality, the Institute of Medicine considered SIRVA and vasovagal syncope as mechanistic injuries resulting from the injection of a vaccine and not from the contents of a particular formulation of a vaccine.
Thus, these conditions are listed as Table injuries for any new vaccine recommended by the CDC for routine administration to children or pregnant women after the imposition of an excise tax and publication by the Secretary of a notice of coverage to account for any new injected vaccines that potentially may lead to SIRVA or vasovagal syncope. In the future, when specific vaccines recommended for routine administration in pregnant women are added to the Table, the Secretary will review the literature to determine if other injuries should be added to the Table for those new vaccines.
Comment: Comments supporting and opposing the proposed change in the NPRM speculated that there is the potential for increased compensation for adverse reactions resulting from increased injury claims, as both the mother and her unborn child are now eligible to file a claim for a vaccine related injury. Commenters expressed concern with possible abuse in reporting and compensation, compounded by the addition of SIRVA
and vasovagal syncope as injuries to the Table.
Response: The Secretary is required by statute to revise the Table to include vaccines recommended by the CDC for routine administration in pregnant women and subject to an excise tax by Federal law. See 42 U.S.C. 300aa 14e3. Additionally, with respect to vaccination of pregnant women, the Cures Act permits two VICP petitions to be filed: One on behalf of a woman who was pregnant when vaccinated and one on behalf of her live-born child whose injurys was allegedly sustained in utero. See 42 U.S.C. 300aa11b2.
Comment: A commenter questioned who would be the proper petitioner in the context of maternal immunization i.e., would the petitioner be the pregnant woman, the child born after his/her pregnant mother was vaccinated, or both?.
Response: The Cures Act amended the Vaccine Act to permit VICP claims filed on behalf of live-born children for injuries allegedly sustained in utero as a result of maternal immunizations with respect to covered vaccines. See 42

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