Shingrix (Zoster Vaccine Recombinant, Adjuvanted)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2017

Specific Treatments:

herpes zoster (shingles)

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General Information

Shingrix is a recombinant, adjuvanted vaccine against the virus that causes shingles.

Shingrix is specifically indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

Shingrix is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component which must be reconstituted for intramuscular injection. After reconstitution, administer Shingrix immediately. The recommended dose schedule is two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. 

Clinical Results

FDA Approval

The FDA approval of Shingrix was based on a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. The primary efficacy analysis population (referred to as the modified Total Vaccinated Cohort [mTVC]) included 14,759 subjects aged 50 years and older who received 2 doses (0 and 2 months) of either Shingrix (n = 7,344) or placebo (n = 7,415) and did not develop a confirmed case of HZ within 1 month after the second dose. Compared with placebo, Shingrix significantly reduced the risk of developing HZ by 97.2% (95% CI: 93.7, 99.0) in subjects 50 years and older.

Side Effects

Adverse effects associated with the use of Shingrix may include, but are not limited to, the following:

  • pain
  • redness
  • swelling
  • myalgia
  • fatigue
  • headache
  • shivering
  • fever
  • gastrointestinal symptoms

Mechanism of Action

Shingrix (Zoster Vaccine Recombinant, Adjuvanted) combines gE, a protein found on the virus that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunological response. Shingrix was shown to boost VZV-specific immune response, which is thought to be the mechanism by which it protects against zoster disease.

Additional Information

For additional information regarding Shingrix or the prevention of herpes zoster, please visit https://www.shingrix.com/