Vaccine Law/Smallpox Materials

General Vaccine Provisions of the Homeland Security Act

These provisions deal with attempts to circumvent the National Childhood Vaccine Injury Act (NCVIA) by lawsuits claiming that the preservatives in vaccines cause injuries such as autism. (See Statement on National Vaccine Injury Compensation Program.) The Homeland Security Act amends the NCVIA to include all components on the label of the vaccine under the provisions of the Act. This will reduce the ability of anti-vaccine litigation to undermine the provisions of the NCVIA and imperil the U.S. vaccine supplies.

SEC. 1714. CLARIFICATION OF DEFINITION OF MANUFACTURER.

Section 2133(3) of the Public Health Service Act (42 U.S.C. 300aa-33(3)) is amended--

(1) in the first sentence, by striking `under its label any vaccine set forth in the Vaccine Injury Table' and inserting `any vaccine set forth in the Vaccine Injury table, including any component or ingredient of any such vaccine'; and

(2) in the second sentence, by inserting `including any component or ingredient of any such vaccine' before the period.

SEC. 1715. CLARIFICATION OF DEFINITION OF VACCINE-RELATED INJURY OR DEATH.

Section 2133(5) of the Public Health Service Act (42 U.S.C. 300aa-33(5)) is amended by adding at the end the following: `For purposes of the preceding sentence, an adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label.'.

SEC. 1716. CLARIFICATION OF DEFINITION OF VACCINE.

Section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33) is amended by adding at the end the following:

`(7) The term `vaccine' means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccines's product license application and product label.'.