Confusing the shingles vaccines may cause storage and administration errors

CDC report highlights need for more provider training with new vaccine

 

In the May 25 Morbidity and Mortality Weekly Report, CDC published a brief overview of vaccine administration errors involving recombinant zoster vaccine ([RZV] Shingrix—GlaxoSmithKline) as reported voluntarily to the Vaccine Adverse Event Reporting System (VAERS). The errors included wrong route of administration, incorrect storage, administration to patients in the wrong age group, and administration of only the adjuvant component without reconstitution of the vaccine antigen. Two of the reports noted that patients had received the information about zoster vaccine live ([ZVL] Zostavax—Merck) instead of RZV.

 

“[E]arly monitoring indicates that vaccine providers might confuse administration procedures and storage requirements of the older ZVL and the newer RZV,” the authors state.

 

Since its October 2017 entrance into the market, RZV has made a splash because of its effectiveness and its recommendation by the Advisory Committee on Immunization Practices (ACIP). Yet as with any new vaccine or medication, health providers need to get used to it, said Tom T. Shimabukuro, MD, deputy director of CDC’s Immunization Safety Office in Atlanta and lead author of the paper.

 

“Health care provider lack of familiarity with a new vaccine likely contributes to vaccine administration errors and has been seen with other new vaccines once they have been released on the market and recommended by ACIP,” Shimabukuro said. “The important thing is to note is that vaccine administration errors are preventable, regardless of health care setting, with proper training and adherence to established guidelines and protocols for administering vaccines.”

 

Shimabukuro encouraged pharmacists to provide patient education.

 

“Pharmacists should counsel patients about the benefits of RZV in preventing shingles and about the [potential] side effects. Patients can experience pain, redness, or swelling at the injection site. Some patients can also experience systemic symptoms like tiredness, muscle pain, chills, and fever. These conditions will go away on their own and are not a reason to skip the second dose,” Shimabukuro said.

 

For the full article, please visit www.pharmacytoday.org for the August 2018 issue of Pharmacy Today.

 

 

Recommended storage, use, and administration of currently licensed herpes zoster (shingles) vaccines—United States, 2018

Characteristic

Brand name (manufacturer)

Shingrix (GSK)

Zostavax (Merck)

Vaccine type

Recombinant adjuvanted (RZV, licensed 2017)*

Live attenuated virus (ZVL, licensed 2006)†

Packaging

Supplied as 2 components: 1) single-dose vial of lyophilized varicella zoster virus glycoprotein E antigen, and 2) a single-dose vial of AS01B adjuvant suspension

Single-dose vial of lyophilized vaccine and a vial of sterile water diluent

Storage

Antigen and adjuvant should be stored refrigerated between 2°C and 8°C (36°F and 46°F); discard antigen or adjuvant components if frozen; discard reconstituted vaccine if frozen

Vaccine should be stored frozen between -50°C and -15°C (-58°F and +5°F),§ diluent should be stored separately at room temperature or refrigerated between 2°C and 8°C (36°F and 46°F); do not freeze reconstituted vaccine

Reconstitution

Reconstitute the lyophilized varicella zoster virus glycoprotein E antigen component with the accompanying AS01B adjuvant suspension component (single reconstituted dose is 0.5 mL)

Reconstitute lyophilized vaccine with the supplied diluent (single reconstituted dose is 0.65 mL)

Use

Administer immediately after reconstitution or refrigerate and use within 6 hours; discard reconstituted vaccine if not used within 6 hours

Reconstitute immediately upon removal of vaccine from the freezer and administer immediately after reconstitution; discard reconstituted vaccine if not used within 30 minutes

Route

Intramuscular injection

Subcutaneous injection

Dose/Schedule

2 doses; second dose 2–6 months after the first dose

1 dose

Indication

Prevention of herpes zoster in adults aged ≥50 years

Prevention of herpes zoster in adults aged ≥50 years

ACIP recommendation

Immunocompetent adults aged ≥50 years, including those who previously received ZVL,¶ RZV is preferred over ZVL for the prevention of herpes zoster and related complications¶

Immunocompetent adults aged ≥60 years**

 

Abbreviations used: ACIP = Advisory Committee on Immunization Practices; GSK = GlaxoSmithKline; RZV = recombinant zoster vaccine; ZVL = zoster vaccine live.
* Shingrix (zoster vaccine recombinant, adjuvanted) package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf.
† Zostavax package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.
§ ZVL (Zostavax) may be stored or transported at refrigerator temperature between 2°C to 8°C (36°F and 46°F) for up to 72 continuous hours before reconstitution; vaccine stored between 2°C to 8°C (36°F and 46°F) that is not used within 72 hours of removal from -15°C (+5°F) storage should be discarded.
¶ Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm?s_cid = mm6703a5_w.
** Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/mmwr/PDF/rr/rr5705.pdf.

 

 

Reprinted from Morb Mortal Wkly Rep. 2018 May 25;67(20):585-586. doi: 10.15585/mmwr.mm6720a4., https://www.cdc.gov/mmwr/volumes/67/wr/mm6720a4.htm