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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
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this policy change is seemingly at odds with the actions undertaken by HHS to expand liability protections for administrators under authorities granted in the PREP Act.
Response: The Department appreciates the desire to quickly add vaccines to the Table. However Congress in 42 U.S.C. 300aa14
specified the procedures that must be followed to amend the Table. In addition, an excise tax would have to be imposed. During the effective period of the Secretarys COVID19 PREP Act declaration, Covered Persons are already immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of FDA-approved or FDAlicensed COVID19 vaccines unless they engage in willful misconduct that causes death or serious physical injury.
See 42 U.S.C. 247d6d.
Section VIII: Miscellaneous Comments Comment: A commenter asked that the license for the Hepatitis B Vaccine be revoked until further safety studies are done.
Response: This is beyond the scope of this final rule. For more information on the safety of this vaccine, see https
www.cdc.gov/hepatitis/hbv/
bfaq.htmbFAQd04; https
www.cdc.gov/vaccines/hcp/vis/visstatements/hep-b.html.
Comment: Some commenters believe that all vaccines should be automatically added to the VICP. Other commenters asked for specific vaccines to be added to the Table immediately.
Response: In 42 U.S.C. 300aa14c d, Congress specified procedures that the Department must follow to add vaccines to the Table. In revising the Table, the Department must follow these procedures. The Department notes, though, that if a vaccine is in a category of vaccines that is already covered by the VICP, then the new vaccine product is already covered even before the date of licensure. For example, hepatitis B
vaccines are covered under the Program under Category VIII of the Vaccine Injury Table. If a new hepatitis B
vaccine is licensed in the U.S., it is already automatically covered under the VICP. Adding specific vaccines to the Table in this final rule is likely impermissible under the Administrative Procedure Act and the logical outgrowth doctrine. Such vaccines could be added in a separate rulemaking.
Comment: Many commenters stressed that vaccines should be changed so they do not need to be administered with a shot.

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Response: This is beyond the scope of this final rule.
Comment: Some commenters believed that any and all mandatory vaccines should be covered. Specifically, a commenter expressed her anger over a mandatory TD shot to travel out of the country.
Response: There are no vaccination requirements for visitors to the United States, and U.S. residents traveling abroad do not need any vaccines to reenter the United States. Many vaccines are recommend by the CDC
and primary care doctors when travelling outside the United States, but they are not mandatory under federal law.33
Comment: One commenter said it was unfair that the Table does not include heart conditions, because they were diagnosed with Pericarditis 24 hours after receiving the DMMR vaccine.
Response: To gain entitlement to compensation under the VICP, a petitioner must establish that a vaccinerelated injury or death has occurred, either by proving that a vaccine actually caused or significantly aggravated an injury causation-in-fact or by demonstrating what is referred to as a Table injury. That is, a petitioner may show that the vaccine recipient 1
received a vaccine covered under the Act; 2 suffered an injury of the type enumerated in the regulations at 42 CFR
100.3the Tablecorresponding to the vaccination in question; and 3 that the onset of such injury took place within the time period specified in the Table. If so, the injury is presumed to have been caused by the vaccine, and the petitioner is entitled to compensation assuming that other requirements are satisfied, unless the respondent affirmatively shows that the injury was caused by some factor unrelated to the vaccination see 42
U.S.C. 300aa11c1Ci, 300aa 13a1B, and 300aa14a. Whether to add heart conditions to the Table is beyond the scope of this final rule.
Comment: A commenter expressed concern that CDC guidelines for vaccine administration are not followed, which is leading to SIRVA and vasovagal syncope. Some commenters believe that pharmacies should not be allowed to administer vaccines if injuries such as SIRVA and Vasovagal Syncope are occurring.
33 For more information on Vaccines recommended for international travel: https
wwwnc.cdc.gov/travel/destinations/traveler/none/
united-states::text=There%20are%20no%
20vaccination%20requirements, reenter%20the%20United%20States. last viewed Jan. 2021.

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Response: The Department is grateful for the many health care professionals and pharmacists who improve public health by vaccinating the American public, and does not believe they would intentionally administer a vaccine in an improper manner, but the Department also wants to incentivize those who administer vaccines to do so properly.
Doing so will improve public confidence in vaccinations. Removing SIRVA from the Table further incentivizes learning proper administration technique. The Department agrees that proper vaccine administration is critical to ensure that vaccination is safe and effective. CDC
provides recommendations on vaccine administration technique, many of which can be found at https
www.cdc.gov/vaccines/hcp/admin/
admin-protocols.html. Whether pharmacists should be allowed to vaccinate is beyond the scope of this final rule.
Comment: One commenter believed that instead of removing SIRVA and vasovagal syncope from the Table, a new department should be created to deal exclusively with injuries caused by vaccine administration.
Response: Only Congress, not the Department, has the authority to create a new department to deal exclusively with injuries caused by vaccine administration.
Comment: One commenter suggested that vaccine companies should be mandated to set apart part of their profits to help fund the National Vaccine Injury Compensation Program VICP.
Response: The source of funding for the VICP is the Vaccine Injury Compensation Trust Fund Trust Fund.
The Trust Fund is already funded by an excise tax on each dose of vaccines recommended by the CDC for routine administration to children. To the extent that the commenter is proposing a change to the funding mechanism for the VICP, effectuating such a change is beyond the scope of this final rule.
Comment: Some commenters believed that all those injured should be able to go to their local court and file claims.
Response: Under 42 U.S.C. 300aa 11a2, no person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccinerelated injury or death associated with the administration of a vaccine after October 1, 1988, and no such court may award damages in an amount greater than $1,000 in a civil action for damages for such a vaccine-related injury or
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