Vaccine Administration Errors Involving Recombinant Zoster Vaccine-United States 2017-18
On May 25, 2018 the CDC published data on vaccine administration errors involving Recombinant Zoster Vaccine (RZV).
RZV and ZVL differ with regard to vaccine type, dose, and schedule; ACIP recommendation; route of administration; and storage requirements. 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.
During the first 4 months of RZV monitoring (October 20, 2017-February 20, 2018), the Vaccine Adverse Event Reporting System (VAERS) received 155 reports involving RZV. Errors included:
- Wrong route (vaccine was given SQ instead of IM)
- Vaccine given at inappropriate ages (age 39 and 48)
- VIS for Zoster Vaccine Live (ZVL) given instead of RZV and not being instructed to return for 2nd dose
- Administration of RZV instead of the intended Varicella
- Administration after improper storage in the freezer
- Administration of the adjuvant only
CDC also received 13 public inquiries concerning RZV administration errors or questions asked to avoid errors. Topics included SQ administration, reconstitution, incorrect interval or schedule, and administration of previously frozen vaccine.
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. Whereas RZV administered through the appropriate IM route is associated with high rates of local and systemic reactions, erroneous SQ injection can increase the likelihood of these episodes. 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.
Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4)-United States, 2018-19 Influenza Season:
On June 8, 2018 the CDC published updated Advisory Committee on Immunization Practices (ACIP) recommendations for the use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) for the 2018-19 flu season in the MMWR. Recommendations of the ACIP are as follows:
For the 2018–19 U.S. influenza season, providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, recombinant influenza vaccine [RIV], or LAIV4). LAIV4 is an option for those for whom it is otherwise appropriate. No preference is expressed for any influenza vaccine product. ACIP will continue to review data concerning the effectiveness of LAIV4 as they become available. Providers should be aware that the effectiveness of the updated LAIV4 containing A/Slovenia/2903/2015 against currently circulating influenza A(H1N1)pdm09-like viruses is not yet known.
Update: Influenza Activity in the United States During the 2017-18 Season and Composition of the 2018-19 Influenza Vaccine:
On June 8, 2018 the CDC published an update on the 2017-18 influenza activity in the United States and the recommended composition for the 2018-19 influenza vaccine.
The United States 2017–18 influenza season (October 1, 2017–May 19, 2018) was a high severity season with high levels of outpatient clinic and emergency department visits for influenza-like illness (ILI), high influenza-related hospitalization rates, and elevated and geographically widespread influenza activity across the country for an extended period. Nationally, ILI activity began increasing in November, reaching an extended period of high activity during January–February, and remaining elevated through March. Influenza A(H3N2) viruses predominated through February and were predominant overall for the season; influenza B viruses predominated from March onward. This report summarizes U.S. influenza activity during October 1, 2017–May 19, 2018.
The Food and Drug Administration’s Vaccines and Related Biologic Products Advisory Committee recommended that the 2018-19 trivalent vaccine to be used in the United States Contain:
- A/Michigan/45/2015 A(H1N1)pdm09-like virus
- A/Singapore/INFIMH-16-0019/2016 A(H3N2)-like virus
- B/Colorado/06/2017-like (B/Victoria lineage) virus
The quadrivalent vaccine recommendation included the trivalent vaccine viruses listed above as well as a:
- B/Phuket/3073/2013-like (B/Yamagata lineage) virus
Vaccine recommendations were based on factors including: global influenza, virologic and epidemiologic surveillance, genetic characterization, antigenic characterization, and the candidate viruses that are available for production.
NEW CDC Storage and Handling Video titled, “Keys to Storing and Handling Your Vaccine Supply-2018”
CDC has made available a new video on the storing and handling of vaccine. “Keys to Storing and Handling Your Vaccine Supply-2018,” is presented as a web-on-demand video.
One of the most important safeguards for the nation's vaccine supply is proper storage and handling. This video is designed to decrease vaccine storage and handling errors by demonstrating recommended best practices and addressing frequently asked questions. It is a great educational resource. The video is just over 50 minutes and includes the opportunity for Continuing Education (CE) credit, which is available until April 18, 2020!
Direct link: https://www2.cdc.gov/vaccines/ed/shvideo/