01-12808. 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 May 22, 2001.

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 [phone].

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(c)(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 May 22, 2001.

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.

Dated: May 15, 2001.

Elizabeth James Duke,

Acting Administrator.