Shingrix® (zoster vaccine recombinant, adjuvanted), developed by GlaxoSmithKline

Shingrix® (zoster vaccine recombinant, adjuvanted), developed by GlaxoSmithKline
Kaity Kuske, Pharm.D., Smiley’s Family Medicine Clinic

Indication: On October 20, 2017, the Federal Drug Administration (FDA) approved the zoster recombinant adjuvanted vaccine for prevention of herpes zoster (shingles) in adults aged 50 years and older.

Mechanism of Action: The recombinant zoster vaccine contains varicella zoster virus glycoprotein E antigen and an adjuvant to induce an active immune response to the varicella-zoster virus.

Dosage and Administration:  The vaccine powder product will require reconstitution with a supplied adjuvant suspension prior to administration.  Each injection is 0.5 ml, given intramuscularly.  This vaccine is a two dose regimen with the two doses given two to six months apart, different than the previous one dose live attenuated zoster vaccine (Zostavax®).  

Effectiveness: The recombinant zoster vaccine has proven to be effective in patients 50 to 70 years of age and in patients greater than 70 years of age by reducing the incidence of herpes zoster by approximately 97% and 91%, respectively.  When compared to the live attenuated vaccine, the recombinant zoster has better efficacy data.  The live attenuated vaccine reduced the incidence of herpes zoster by approximately 70%, 64%, 41% and 18% in patient ages 50 to 59, 60-69, 70-79 and 80 or older, respectively.  

Additionally, patients 70 years of age or older who previously had herpes zoster (shingles) and then received the recombinant zoster vaccine had an approximate 89% reduction in post-herpetic neuralgia.  The duration of efficacy remained at approximately 85-93% after 4 years.  This vaccine is not intended as treatment for herpes zoster active infection, nor is it indicated for varicella infections.

Safety: As with any intramuscular injection, pain, erythema or swelling at the injection site is possible.  Patients should be monitored for anaphylaxis and syncope for 15 minutes following administration.  The FDA has acknowledged the commitment of GlaxoSmithKline to conduct future studies assessing long term efficacy, immunogenicity and safety of the zoster recombinant adjuvanted vaccine.

Place in Therapy: The Advisory Committee on Immunization Practices (ACIP) voted to recommend the recombinant adjuvanted zoster vaccine for 1) the prevention of herpes zoster and related complications for healthy adults age 50 years and older, 2) for adults who previously received the live attenuated shingles vaccine, and 3) as the preferred vaccine for shingles prevention.  This third recommendation of preference for the recombinant adjuvanted zoster vaccine over the previous live attenuated zoster vaccine narrowly passed by one vote whereas the other recommendations were very clearly determined. These recommendations will become official policy once approved by the CDC director and published in the Morbidity and Mortality Weekly Report.  The recommendations will be included in the 2018 adult immunization schedule.  Product availability is anticipated in quarter four of 2017 and the AWP is $168.00 for one vial.

References:

  1. Center for Disease Control and Prevention. Shingles (Herpes Zoster). https://www.cdc.gov/shingles/vaccination.html. Reviewed October 17, 2017. Updated October 27, 2017.  Accessed November 14, 2017.

  2. Shingrix [package insert]. Research Triangle Park, NC: GlaxoSmithKline; October 2017. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF. Accessed November 14, 2017.

  3. Crawford C. American Academy of Family Physicians. ACIP Recommends New Herpes Zoster Subunit Vaccine. http://www.aafp.org/news/health-of-the-public/20171031acipmeeting.html. Published October 31, 2017. Accessed November 14, 2017.

  4. Lexi-comp. Hudson, OH, USA: Wolters Kluwer Clinical Drug Information, Inc; 2017. Accessed November 14, 2017.