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Vaccine Administration Errors Involving Recombinant Zoster Vaccine--United States, 2017-2018.

Two vaccines for the prevention of herpes zoster (shingles) are licensed for use in the United States and recommended by the Advisory Committee on Immunization Practices (ACIP). Zoster vaccine live (ZVL; Zostavax, Merck), licensed in 2006, * is a live attenuated virus vaccine administered as a single subcutaneous (SQ) dose. Although the Food and Drug Administration (FDA) approved ZVL for adults aged [greater than or equal to] 50 years, ACIP recommends ZVL for immunocompetent adults aged [greater than or equal to] 60 years (1). Recombinant zoster vaccine (RZV; Shingrix, GlaxoSmithKline), licensed October 2017, ([dagger]) is also approved by the FDA for adults aged [greater than or equal to] 50 years and is recommended by ACIP for immunocompetent adults aged [greater than or equal to] 50 years (2). RZV is administered as a 2-dose intramuscular (IM) series, with the second dose given anytime from 2 to 6 months after the first. RZV is preferentially recommended by ACIP over ZVL (2). Furthermore, ACIP recommends that persons previously vaccinated with ZVL receive the full 2-dose RZV series (2).

RZV and ZVL differ with regard to vaccine type, dose, and schedule; ACIP recommendation; route of administration; and storage requirements (Table). Prior experience indicates that administration errors are reported most frequently shortly after vaccine licensure and publication of recommendations, likely because of lack of vaccine provider familiarity with the new vaccine (3).

During the first 4 months of RZV monitoring (October 20, 2017-February 20, 2018), the Vaccine Adverse Event Reporting System (VAERS) (4) received 155 reports involving RZV, 13 (8%) of which documented an administration error, including some reports documenting more than one error. Among these reports, nine involved RZV given by the SQ route rather than the IM route; injection site reactions (e.g., pain, erythema, and pruritus) were described in eight of these nine reports. One of the nine reports describing errors in the route of administration also described vaccination of a person aged 48 years (inappropriate age), and two described patients receiving the vaccine information statement for ZVL instead of RZV and not being instructed to return for the second RZV dose. The remaining four reports included 1) administration of RZV instead of the intended varicella (Varivax) vaccine to a person of unreported age, 2) administration of RZV after incorrect frozen storage, 3) administration of RZV to a person aged 39 years, and 4) administration of only the adjuvant component without reconstitution with the vaccine antigen. Vaccine administration errors occurred in a pharmacy (nine reports), a health care provider's office (two), and unknown sites (two). CDC also received 13 public inquiries concerning RZV administration errors or questions asked to avoid errors. Topics included SQ administration (five), reconstitution (five), incorrect interval or schedule (two), and administration of previously frozen vaccine (one).

Although data from passive reporting to VAERS and inquiries submitted to CDC limit the ability to draw conclusions regarding the cause of the administration errors, early monitoring indicates that vaccine providers might confuse administration procedures and storage requirements of the older ZVL and the newer RZV. Failure to reconstitute the vaccine and administration of only one component of RZV also appears to be occurring, similar to errors observed for other vaccines that require mixing (5). Whereas RZV administered through the appropriate IM route is associated with high rates of local and systemic reactions (2), erroneous SQ injection can increase the likelihood of these episodes (6). In addition, some errors could potentially affect vaccine effectiveness. To prevent RZV administration errors, vaccine providers should be aware of prescribing information, storage requirements, preparation guidelines, and ACIP recommendations for herpes zoster vaccines (1,2).

Conflict of Interest

No conflicts of interest were reported.

Tom T. Shimabukuro, MD [1]; Elaine R. Miller, MPH [1]; Raymond A. Strikas, MD [2]; Beth F. Hibbs, MPH [1]; Kathleen Dooling, MD [3]; Ravi Goud, MD [4]; Maria V. Cano, MD [1]

[1] Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC; [2] Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC; [3] Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, CDC; [4] Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

Corresponding author: Elaine R. Miller, emiller@cdc.gov, 404-498-0662.

References

(1.) Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008; 57(No. RR-5).

(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; 67:103-8. https://doi. org/10.15585/mmwr.mm6703a5

(3.) Hibbs BF, Moro PL, Lewis P, Miller ER, Shimabukuro TT. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013. Vaccine 2015; 33:3171-8. https://doi. org/10.1016/j.vaccine.2015.05.006

(4.) Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine 2015; 33:4398-405. https://doi.org/10.1016/j.vaccine.2015.07.035

(5.) Su JR, Miller ER, Duffy J, Baer BM, Cano MV. Notes from the field: administration error involving a meningococcal conjugate vaccine--United States, March 1, 2010-September 22, 2015. MMWR Morb Mortal Wkly Rep 2016; 65:161-2. https://doi.org/10.15585/mmwr. mm6506a4

(6.) Vink P, Shiramoto M, Ogawa M, et al. Safety and immunogenicity of a herpes zoster subunit vaccine in Japanese population aged [greater than or equal to] 50 years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother 2017; 13:574-8. https://doi.org/10.1080/21645515.2016.1232787

* Zostavax (zoster vaccine live) package insert. https://www.fda.gov/downloads/ BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.

([dagger]) Shingrix (zoster vaccine recombinant, adjuvanted) package insert. https://www. fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ UCM581605.pdf.
TABLE. 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            Live attenuated
                 adjuvanted (RZV,       virus (ZVL, licensed
                 licensed 2017) *       2006) ([dagger])

Packaging        Supplied as 2          Single-dose vial of
                 components: 1)         lyophilized vaccine
                 single-dose vial of    and a vial of
                 lyophilized            sterile water
                 varicella zoster       diluent
                 virus glycoprotein E
                 antigen and 2) a
                 single-dose vial of
                 [AS01.sub.B]
                 adjuvant suspension

Storage          Antigen and adjuvant   Vaccine should be
                 should be stored       stored frozen
                 refrigerated between   between
                 2[degrees]C and        -50[degrees]C and
                 8[degrees]C            -15[degrees]C
                 (36[degrees]F and      (-58[degrees]F and
                 46[degrees]F);         +5[degrees]F),
                 discard antigen or     ([section]) diluent
                 adjuvant components    should be stored
                 if frozen; discard     separately at room
                 reconstituted          temperature or
                 vaccine if frozen      refrigerated between
                                        2[degrees] and
                                        8[degrees]C
                                        (36[degrees]F and
                                        46[degrees]F); do
                                        not freeze
                                        reconstituted
                                        vaccine

Reconstitution   Reconstitute the       Reconstitute
                 lyophilized            lyophilized vaccine
                 varicella zoster       with the supplied
                 virus glycoprotein E   diluent (single
                 antigen component      reconstituted dose
                 with the               is 0.65 mL)
                 accompanying
                 [AS01.sub.B]
                 adjuvant suspension
                 component (single
                 reconstituted dose
                 is 0.5 mL)

Use              Administer             Reconstitute
                 immediately after      immediately upon
                 reconstitution or      removal of vaccine
                 refrigerate and use    from the freezer and
                 within 6 hours;        administer
                 discard                immediately after
                 reconstituted          reconstitution;
                 vaccine if not used    discard
                 within 6 hours         reconstituted
                                        vaccine if not used
                                        within 30 minutes

Route            Intramuscular (IM)     Subcutaneous (SQ)
                 injection              injection

Dose/Schedule    2 doses; second dose   1 dose
                 2-6 months after the
                 first dose

Indication       Prevention of herpes   Prevention of herpes
                 zoster in adults       zoster in adults
                 aged [greater than     aged [greater than
                 or equal to] 50        or equal to] 50
                 years                  years

ACIP             Immunocompetent        Immunocompetent
recommendation   adults aged [greater   adults aged [greater
                 than or equal to] 50   than or equal to] 60
                 years, including       years **
                 those who previously
                 received ZVL,
                 ([paragraph]) RZV is
                 preferred over ZVL
                 for the prevention
                 of herpes zoster and
                 related
                 complications
                 ([paragraph])

Abbreviations: 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.

([dagger]) Zostavax package insert.
https://www.fda.gov/downloads/BiologicsBloodVaccines
/Vaccines/ApprovedProducts/UCM132831.pdf.

([section]) ZVL (Zostavax) may be stored or transported at
refrigerator temperature between 2[degrees]C to 8[degrees]C
(36[degrees]F and 46[degrees]F) for up to 72 continuous hours before
reconstitution; vaccine stored between 2[degrees]C to 8[degrees]C
(36[degrees]F and 46[degrees]F) that is not used within 72 hours of
removal from -15[degrees]C (+5[degrees]F) storage should be
discarded.

([paragraph]) 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.
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Article Details
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Title Annotation:Notes from the Field
Author:Shimabukuro, Tom T.; Miller, Elaine R.; Strikas, Raymond A.; Hibbs, Beth F.; Dooling, Kathleen; Goud
Publication:Morbidity and Mortality Weekly Report
Geographic Code:1U5MD
Date:May 25, 2018
Words:1484
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