STEPS

New Drug Reviews

Recombinant Zoster Vaccine (Shingrix) for the Prevention of Shingles

 

Am Fam Physician. 2018 Oct 15;98(8):539-540.

Recombinant zoster vaccine (Shingrix) is a two-dose intramuscular vaccine labeled for the prevention of herpes zoster virus (shingles) in adults 50 years and older. It is not indicated for the prevention of primary varicella infection (chickenpox).1

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DrugDosageDose formCost*

Recombinant zoster vaccine (Shingrix)

Two injections given separately two to six months apart

0.5-mL vial for intramuscular injection

$175 for two vials


*—Estimated retail price of one course of treatment based on information obtained at https://www.goodrx.com (accessed September 6, 2018).

DrugDosageDose formCost*

Recombinant zoster vaccine (Shingrix)

Two injections given separately two to six months apart

0.5-mL vial for intramuscular injection

$175 for two vials


*—Estimated retail price of one course of treatment based on information obtained at https://www.goodrx.com (accessed September 6, 2018).

Safety

In clinical trials, serious adverse events, defined as “an undesirable experience associated with the vaccine that results in death, hospitalization, disability or requires medical or surgical intervention to prevent a serious outcome,” occurred at a similar rate with the recombinant zoster vaccine and a saline placebo (approximately 2% at 30 days postvaccination).1,2 In two clinical trials involving 29,305 patients, one patient experienced lymphadenitis, and another developed a fever greater than 102.2°F (39°C). The rate of adverse effects was less than 0.01% for both outcomes.1

Tolerability

Local reactions are common following administration, with pain (78%), redness (38%), and swelling (26%) being the most prevalent, especially in patients younger than 69 years. Reactions following administration have been shown to resolve after one to three days. Systemic adverse effects may also occur; myalgia (45%), fatigue (45%), and headache (38%) are the most common.1 In clinical trials, more than 95% of participants completed the two-dose series.3

Effectiveness

Recombinant zoster vaccine will prevent shingles in 96% of persons 50 to 59 years of age, 97% of persons 60 to 69 years of age, and 91% of persons 70 years and older for at least three years (number needed to treat = 33).14 It is 91% effective at preventing postherpetic neuralgia in patients 50 to 69 years of age and 89% effective in those 70 years and older.2,4 In co

Author disclosure: No relevant financial affiliations.

Address correspondence to Leena Deshpande, PharmD, BCACP, at lvajaria@uic.edu. Reprints are not available from the author.

References

show all references

1. U.S. National Library of Medicine. Daily Med. Drug label information: Shingrix—ge recombinant varicella zoster virus (vzv) glycoprotein e. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0280849d-5c78-4a9d-8941-4eab429f6bd8. Accessed March 2, 2018....

2. Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep. 2018;67(3):103–108.

3. Lal H, Cunningham AL, Godeaux O, et al.; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087–2096.

4. Cunningham AL, Lal H, Kovac M, et al.; ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019–1032.

5. Centers for Disease Control and Prevention. Vaccines and preventable diseases. What everyone should know about Zostavax. https://www.cdc.gov/vaccines/vpd/shingles/public/zostavax/index.html. Accessed September 17, 2018.

6. U.S. National Library of Medicine. DailyMed. Drug label information: Zostavax—zoster vaccine live injection, powder, lyophilized, for suspension. Sterile diluent—sterile water injection. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30a0464e-e012-4c16-bc05-88f07e412203. Accessed March 29, 2018.

7. Centers for Disease Control and Prevention. Vaccines and preventable diseases. Administering Shingrix. https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/administering-vaccine.html. Accessed September 13, 2018.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Assistant Medical Editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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