Encourage the development of vaccines to prevent, treat, or mitigate opioid, cocaine, methamphetamine, or alcohol use disorder, to…

Section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended by adding at the end the following:

If a request is submitted under paragraph (1) for a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder, such vaccine is deemed to be a breakthrough therapy.

Subparagraph (A) shall cease to be effective on the date that is 10 years after the date of enactment of this paragraph.

Section 506(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(b)) is amended by adding at the end the following:

If a request is submitted under paragraph (1) for a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder, such vaccine is deemed to be a fast track product.

Subparagraph (A) shall cease to be effective on the date that is 10 years after the date of enactment of this paragraph.

The Secretary of Health and Human Services shall give priority review to any application for a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder that is submitted under—

(A) section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or

(B) section 351 of the Public Health Service Act (42 U.S.C. 262).

Paragraph (1) shall cease to be effective on the date that is 10 years after the date of enactment of this subsection.

In this section, the term eligible new drug sponsor means the sponsor of a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder that—

(1) is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or is licensed under section 351 of the Public Health Service Act (42 U.S.C. 262); and

(2) is mass-produced.

An eligible new drug sponsor may submit to the Secretary of Health and Human Services an application for an award, to be known as the Vaccine X–Prize.

Subject to subsection (d), if the Secretary of Health and Human Services determines that an eligible new drug sponsor has submitted an application under subsection (b), the Secretary shall, subject to the availability of appropriations, pay the eligible new drug sponsor $1,000,000,000.

The Secretary of Health and Human Services may not award more than 1 Vaccine X–Prize.