What is the Shingrix (recombinant zoster vaccine)?

From the Guidelines

Shingrix is the preferred vaccine for preventing shingles and its complications in adults 50 years and older, due to its high efficacy and safety profile, as demonstrated in the most recent study 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 administering Shingrix include:

• It is over 90% effective at preventing shingles and postherpetic neuralgia, a painful long-term complication, as shown in the ZOE-50 and ZOE-70 trials 1.
• Shingrix is recommended even for those who previously received the older Zostavax vaccine or have already had shingles, as it provides superior protection 1.
• Common side effects include pain and swelling at the injection site, muscle pain, fatigue, and headache, which typically resolve within 2-3 days, indicating that the immune system is responding to the vaccine 1.
• Most insurance plans, including Medicare Part D, cover Shingrix, though copayments may vary 1.
• The vaccine is particularly important because nearly one in three people will develop shingles in their lifetime, and the risk increases with age due to natural decline in immune function 1. Key benefits of Shingrix include:
• High efficacy in preventing shingles and postherpetic neuralgia
• Safety profile with no significant increase in serious adverse events
• Recommendation for use in adults 50 years and older, including those with immunodeficiency or immunosuppression
• Coverage by most insurance plans, including Medicare Part D.

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 a recombinant 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 been found to be effective in preventing herpes zoster and postherpetic neuralgia 4, 5.

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 found to be well-tolerated, with common adverse events including injection site pain, redness, and swelling, as well as systemic adverse events such as myalgia, fatigue, and headache 3, 4.
• 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.

Real-World Effectiveness

• Real-world studies have confirmed the effectiveness of the Shingrix vaccine in preventing herpes zoster and postherpetic neuralgia 4, 5.
• A study of Medicare Part D beneficiaries found that the vaccine effectiveness was 70.1% for two doses and 56.9% for one dose, with no significant difference in effectiveness among beneficiaries aged 80 years or older 4.
• Another study found that the vaccine was effective in preventing herpes zoster and postherpetic neuralgia in adults with autoimmune or immunosuppressive conditions 5.

Vaccination Uptake

• A study of shingles vaccination uptake in Massachusetts adults aged 50 years and older found that physician recommendation and influenza vaccination were associated with increased shingles vaccination uptake 6.
• The study also found that awareness of the shingles vaccine and perception of shingles risk were important factors in determining vaccination uptake 6.