Shingrix FDA Approval History

FDA Approved: Yes (First approved October 20, 2017)
Brand name: Shingrix
Generic name: zoster vaccine recombinant, adjuvanted
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Herpes Zoster, Prophylaxis

Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles).

Shingrix is indicated for prevention of herpes zoster (HZ):
- in adults aged 50 years and older.
- in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
Shingrix is not indicated for prevention of primary varicella infection (chickenpox).

Development timeline for Shingrix

Date	Article
Jul 17, 2025	Approval US FDA Approves GSK’s Shingrix in a Prefilled Syringe Presentation
Jul 26, 2021	Approval Shingrix Approved in the US for Prevention of Shingles in Immunocompromised Adults
Oct 20, 2017	Approval Shingrix (zoster vaccine recombinant, adjuvanted) Approved in the U.S. for Prevention of Shingles
Sep 13, 2017	FDA Advisory Committee Votes Unanimously for Shingrix (HZ/su) in the US for Prevention of Herpes Zoster (Shingles) in Adults Ages 50 and Over
Jun 21, 2017	GSK Presents Positive Results from Phase III Revaccination Study of its Candidate Shingles Vaccine Shingrix at CDC’s Advisory Meeting

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Shingrix FDA Approval History

Development timeline for Shingrix

See also

Further information