What is the Shingrix (recombinant zoster vaccine)?

From the Guidelines

Shingrix is a highly effective vaccine recommended for adults 50 years and older to prevent shingles (herpes zoster) and its complications, with a preference for its use over Zostavax due to its higher efficacy and longer duration of protection 1. The vaccine is administered as a two-dose series, with the second dose given 2-6 months after the first. Shingrix is a non-live, recombinant vaccine that stimulates the immune system to produce a strong response against the varicella-zoster virus, which causes both chickenpox and shingles. Some key points to consider when recommending Shingrix include:

• It is over 90% effective at preventing shingles and postherpetic neuralgia (a painful complication of shingles) 1.
• The vaccine is particularly important for older adults because the risk of developing shingles increases with age as the immune system naturally weakens.
• Common side effects include pain, redness, and swelling at the injection site, as well as muscle pain, fatigue, headache, and fever, which typically resolve within 2-3 days.
• Shingrix is recommended even for those who have previously received the older Zostavax vaccine or have already had shingles, as it provides superior protection against recurrence 1. The Centers for Disease Control and Prevention (CDC) and other health organizations recommend the use of Shingrix for the prevention of herpes zoster and related complications in immunocompetent adults aged 50 years or older 1.

From the FDA Drug Label

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): • 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.

The Shingrix vaccine is indicated for the prevention of herpes zoster (shingles) in:

• Adults aged 50 years and older
• Adults aged 18 years and older who are at increased risk of HZ due to immunodeficiency or immunosuppression 2

From the Research

Shingrix Vaccine Overview

• The Shingrix vaccine is an adjuvanted recombinant herpes zoster vaccine approved by the Food and Drug Administration for the prevention of herpes zoster in adults 50 years of age and older 3.
• It has been shown to significantly reduce the risk of developing herpes zoster by more than 90% compared to placebo 3.
• The vaccine is administered in two doses, given 2-6 months apart, and has a comparable adverse effect profile to placebo, with common local adverse events including injection site pain, redness, and swelling, and common systemic adverse events including myalgia, fatigue, and headache 3.

Efficacy and Safety

• Clinical trials have demonstrated the efficacy and safety of the Shingrix vaccine, with a vaccine effectiveness of 70.1% for two doses and 56.9% for one dose 4.
• The vaccine has been shown to be effective in preventing postherpetic neuralgia, with a two-dose vaccine effectiveness of 76.0% 4.
• The safety profile of the vaccine has been evaluated in several studies, with no significant safety concerns identified 3, 4, 5.

Administration and Recommendations

• The Advisory Committee on Immunization Practices (ACIP) recommends the routine use of the Shingrix vaccine as the preferred vaccine for the prevention of herpes zoster in immunocompetent adults 50 years of age and older 3, 6.
• The vaccine can be administered at intervals of 2,6, or 12 months, with non-inferiority of immune responses demonstrated for the 0,6-month schedule compared to the 0,2-month schedule 5.
• The vaccine is also effective in individuals with autoimmune or immunosuppressive conditions, and in those aged 80 years and older 4.