Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Page 20460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-07368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-3446]


Notice of Approval of Product Under Voucher: Rare Pediatric 
Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus 
Vaccine, Adjuvanted)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
approval of a product redeeming a rare pediatric disease priority 
review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
authorizes FDA to award priority review vouchers to sponsors of 
approved rare pediatric disease product applications that meet certain 
criteria. FDA is required to publish notice of the issuance of rare 
pediatric disease priority review vouchers as well as the approval of 
products redeeming vouchers. FDA has determined that AREXVY 
(Respiratory Syncytial Virus Vaccine, Adjuvanted), BLA supplement 
approved June 7, 2024, meets the criteria for redeeming a priority 
review voucher.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 
industry.biologics@fda.hhs.gov, 240-402-7911.

SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product 
redeeming a rare pediatric disease priority review voucher. Under 
section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will report the 
issuance of rare pediatric disease priority review vouchers and the 
approval of products for which a voucher was redeemed. FDA has 
determined that AREXVY (Respiratory Syncytial Virus Vaccine, 
Adjuvanted) meets the redemption criteria.
    For further information about the Rare Pediatric Disease Priority 
Review Voucher Program and for a link to the full text of section 529 
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about AREXVY (Respiratory Syncytial Virus Vaccine, 
Adjuvanted), go to the Center for Biologics Evaluation and Research 
Approved Products website at https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07368 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P