Quiero saber acerca de...

lotter on DSK11XQN23PROD with RULES1

Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations number and sources of the comments are as follows: 44 from individuals, two from pharmaceutical companies, and two from organizations, with one stating it represents 12 other entities. In addition, HRSA held a public hearing on the NPRM on September 17, 2018, and a national organization and two individuals presented oral comments.
While the Secretary only sought public comment on how best to implement the statutory amendment to add vaccines recommended by the CDC
for routine administration in pregnant women to the Table, many commenters offered comments beyond the scope of the request. Nevertheless, the Secretary carefully considered all 51 comments received in the development of this final rule. Below is a summary of the comments and the Secretarys response to them.
Comment: Several comments supported the addition of vaccines recommended for routine administration in pregnant women to the Table, stating that maternal immunization will improve the health of the mother, her unborn child, newborns, and the overall health of the nation.
Response: Based on existing evidence and data trends, the Secretary agrees that the eradication and reduction of vaccine-preventable diseases through immunization has directly increased life expectancy by reducing mortality.
Pregnant women are at risk for vaccinepreventable diseaserelated 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 likely provides direct fetal and infant benefit through passive immunity transplacental transfer of maternal vaccine-induced antibodies. Among the vaccines recommended by the CDC for adults, currently, two are specifically recommended for routine administration during pregnancy, and hepatitis A, hepatitis B, meningococcal ACWY, and meningococcal B are recommended in pregnancy based on additional risk factors.
Comment: A comment supporting the proposed changes in the NPRM suggests that the recommendations of the CDC
should be included as additional language on the Table, supporting the safe administration of vaccines in pregnant women.
Response: The Table does not include language about the safe administration of vaccines, as the purpose of the Table is to list and explain injuries and/or conditions that are presumed to be
VerDate Sep<11>2014

16:00 Dec 01, 2021

Jkt 256001

caused by covered vaccines, unless another cause is proven, for potential compensation under the VICP.
However, CDC develops best practice guidance for the safe administration of vaccines that can be found at https
www.cdc.gov/vaccines/hcp/acip-recs/
index.html.
Comment: Comments supporting the proposed changes in the NPRM
indicated that the CDC
recommendations for the administration of routine vaccination to pregnant women would result in increased communication and knowledge around vaccines recommended for pregnant women, leading to increased informed consent and facilitate decision-making regarding immunizations. In addition, this may result in the development of new vaccines for pregnant women.
Response: Recommendations for the routine use of vaccines in pregnant women are issued by the CDC and are harmonized to the greatest extent possible with recommendations made by the American College of Gynecologists and Obstetricians, the American Academy of Family Physicians, and the American College of Physicians. The Advisory Committee on Immunization Practices, established in 1964 by the Surgeon General of the United States, is chartered as a Federal advisory committee to provide expert external advice and guidance to the Director of the CDC on the use of vaccines in the civilian population. The Advisory Committee on Immunization Practices makes recommendations to the Director of the CDC for vaccines authorized or licensed by the Food and Drug Administration for the prevention of diseases. Providing information regarding whether these recommendations increase communication and knowledge around vaccines recommended for pregnant women, and facilitating decisionmaking regarding immunizations, is beyond the scope of this final rule.
Comment: Some comments supporting the proposed changes in the NPRM suggested that adding the category of pregnant women to the Table would allow the VICP to function more efficiently and pregnant women would have recourse should an alleged injury occur.
Response: The Secretary agrees that the addition of the category of vaccines recommended for routine administration in pregnant women to the Table will make the VICP function more efficiently. The addition of such vaccines to Item XVII of the Table will allow any new vaccines that in the future are recommended by the CDC for routine administration in pregnant
PO 00000

Frm 00037

Fmt 4700

Sfmt 4700

68425

women and subject to an excise tax to be covered under the VICP after the Secretary issues a notice of coverage, without requiring further rulemaking.
In addition, the Table lists covered vaccines and associated injuries, making it easier for some people to get compensation. The Table lists and explains injuries and/or conditions that are presumed to be caused by vaccines unless another cause is proven. The Tables Qualification and Aids to Interpretation define some of the injuries and/or conditions listed on the Table. The Table also lists periods in which the first symptom of these injuries and/or conditions must occur after receiving the vaccine to receive the Tables presumption of causation. If the first symptom of an injury and/or condition listed on the Table occurs within the listed time, and any associated definitions included in the Qualification and Aids to Interpretation are satisfied, it is presumed that the vaccine was the cause of the injury or condition unless another cause is proven.
Comment: Several comments opposed the proposed changes in the NPRM
because they stated that the administration of vaccines to pregnant women and their unborn children causes injuries, such as miscarriages, pre-eclampsia, cancer, autism, neurodevelopmental disorders of infants, and learning disabilities. Some opposed the addition of the category of pregnant women to the Table because they believe that there is a lack of vaccine safety testing and studies, especially regarding the administration of vaccines in pregnant women. Some comments suggested there is no scientific evidence that vaccinating pregnant women is safe or advantageous and that there are limited benefits and increased risks for vaccinating pregnant women. In addition, some adamantly opposed all vaccinations.
Response: As noted in the NPRM, a recent amendment to the Vaccine Act requires that the Secretary 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.
Moreover, the United States has a long-standing vaccine safety program that closely and constantly monitors the safety of vaccines. A critical part of the vaccine safety program is the CDCs Immunization Safety Office, which identifies possible vaccine side effects and conducts studies to determine whether health problems are caused by vaccines. Information regarding vaccine
E:FRFM02DER1.SGM

02DER1