Shingrix (Zoster Vaccine Recombinant, Adjuvanted) is a recombinant varicella-zoster virus (VZV) glycoprotein E (gE) antigen that is reconstituted at the time of use with AS01B suspension, a proprietary adjuvant containing QS-21 and MPL with liposomes.
Shingrix is a vaccine for the prevention of shingles (herpes zoster) in adults 50 years and older.
Shingrix is not used to prevent primary varicella infection (chickenpox).
Shingrix is a suspension for intramuscular injection only. It is supplied in 2 vials that must be combined prior to administration.
Use only the supplied adjuvant suspension component (liquid) for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid.
Two doses are necessary to provide strong protection, up to 90%, the first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
Due to the limited supply, the CDC has stated: If more than 6 months have elapsed since the 1st Shingrix dose, administer the 2nd dose as soon as possible. Do not restart the Shingrix vaccine series.
October 20, 2017, the Food and Drug Administration approved Shingrix to introduce or deliver for introduction into interstate commerce.
May 22, 2019, China’s National Medical Product Administration (NMPA) announced the ‘conditional approval’ for Shingrix.
Shingrix' Clinical Trial numbers: NCT00434577, NCT00492648, NCT00802464, NCT00920218, NCT01086449, NCT01165177, NCT01165203, NCT01165229, NCT01295320, NCT01751165, NCT01777321, NCT01827839, NCT01954251 and NCT02075515