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National Vaccine Injury Compensation Program:
Addition of Pneumococcal Conjugate Vaccines to the Vaccine
Injury Table
AGENCY: Health
Resources and Services Administration, HHS.
ACTION: Notice.
SUMMARY: Through this notice, the Secretary announces that
pneumococcal conjugate vaccines are now covered vaccines under the National
Vaccine Injury Compensation Program (VICP), which provides a system of no-fault
compensation for certain individuals who have been injured by covered childhood
vaccines. This notice serves to include
pneumococcal conjugate vaccines under Category XIII (new vaccines) of the
Vaccine Injury Table (Table), which lists the vaccines covered under the
VICP. This notice ensures that
petitioners may file petitions relating to pneumococcal conjugate vaccines with
the VICP even before such vaccines are added as a separate and distinct
category to the Table through rulemaking.
DATES: This Notice is effective on [INSERT DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, Medical Director, Division of Vaccine Injury
Compensation, BHPr, HRSA, Parklawn Building, Room 8A-46, 5600 Fishers Lane,
Rockville, Maryland 20857; telephone number (301) 443-4198.
SUPPLEMENTARY INFORMATION: The statute authorizing the VICP provides for the inclusion of
additional vaccines in the VICP when they are recommended by the CDC to the
Secretary for routine administration to children. (See section 2114(e)(2) of the Public Health Service (PHS) Act,
42 U.S.C. 300aa-14(e)(2).) Consistent with section 13632(a)(3) of Pub.
L. 103-66, the regulations governing the VICP provide that such vaccines will
be included in the Table as of the effective date of an excise tax to provide
funds for the payment of compensation with respect to such vaccines. (42 CFR 100.3©(4)).
The two prerequisites for adding pneumococcal conjugate
vaccines to the VICP as covered vaccines as well as to the Table have been
satisfied. First, on December 17, 1999,
the excise tax for pneumococcal conjugate vaccines was enacted by Pub. L.
106-170, the Ticket to Work and Work Incentives Improvement Act of 1999, with
an effective date of December 18, 1999.
Section 523 of this Act provides that all conjugate vaccines against streptococcus
pneumoniae (pneumococcus) are added to section 4132(a)(1) of the Internal
Revenue Code of 1986, which defines all taxable vaccines. Second, the CDC published its recommendation
that pneumococcal conjugate vaccines be routinely administered to children up
to 23 months of age in the October 6, 2000, issue of the Morbidity and
Mortality Weekly Report.
Under the regulations governing the VICP, Item XIII of the
Table specifies that “[a]ny new vaccine recommended by the [CDC] for routine
administration to children, after publication by the Secretary of a notice of
coverage” is a covered vaccine under the Table. (42 CFR 100.3(a), Item XIII.)
As explained above, CDC’s recommendation has been made. This Notice serves to satisfy the regulation’s
publication requirement. Through this
notice, pneumococcal conjugate vaccines are now included as covered vaccines
under Category XIII of the Table.
Because the CDC only recommended pneumococcal conjugate vaccines to the
Secretary for routine administration to children, polysaccharide-type
pneumococcal vaccines are not covered under the VICP or included on the Table.
Under section 2114(e) of the PHS Act, as amended by
section 13632(a) of the Omnibus Budget Reconciliation Act of 1993, a revision
to the Table adding a vaccine recommended by the CDC for routine administration
to children shall take effect upon the effective date of the tax enacted to
provide funds for compensation with respect to the vaccine added to the Table. Thus, pneumococcal conjugate vaccines are
included in the Table under Category XIII with an effective date of December
18, 1999. Petitioners may file petitions
related to pneumococcal conjugate vaccines as of [INSERT DATE OF PUBLICATION IN
THE FEDERAL REGISTER].
The Secretary plans to amend the Table through the
rulemaking process by including pneumococcal conjugate vaccines as a separate
category of vaccines in the Table.
December 18, 1999, will remain the applicable effective date when the
Secretary makes a corresponding amendment to add pneumococcal conjugate
vaccines as a separate category on the Table through rulemaking.
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INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
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VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.