This message is from Dr. Susan M. Lett, Medical Director, MDPH Immunization Program.

CDC has published an article on errors associated with administration of the new Shingrix vaccine in the Morbidity and Mortality Weekly Report on May 25, 2018. These errors were reported to the Vaccine Adverse Event Reporting System (VAERS) during the first four months of Shingrix monitoring.

Summary
There were 155 reports to the VAERS system, of which 13 (8%) documented vaccine administration errors. In addition, CDC has received calls about Shingrix administration errors or how to avoid them. The following errors/problems were described:
1) Wrong route. Shingrix given SC. (Shingrix should be administered via the IM route.)
2) Wrong vaccine. Shingrix given instead of varicella.
3) Wrong storage. Shingrix improperly frozen and then administered. (Shingrix antigen and adjuvant should be stored in the refrigerator between 2⁰C and 8⁰C [36⁰F and 46⁰F]).
4) Wrong age. Shingrix was administered to someone 39 and 48 years of age. (Shingrix is approved for use in those 50 years of ageand older);
5) Wrong Schedule. Shingrix given at the wrong intervals or only 1 dose given. Shingrix is a 2-dose series administered 2 to 6 months apart); AND
6) Reconstitution problems. Failure to reconstitute the vaccine and administration of only 1 component of the vaccine occurred. (RZV glycoprotein E lyophilized antigen must be reconstituted with the accompanying ASO1B liquid adjuvant).

Please note that Shingrix administered through the appropriate IM route is associated with high rates of local and systemic reactions. However, erroneous SQ injection can increase the likelihood of these episodes.

Highlights and lessons learned include:
· The new shingles vaccine Shingrix has different storage and administration requirements than Zostavax.
· When new vaccines are introduced, it takes time for providers to adjust their storage and handling and administration procedures, especially when a new vaccine requires different techniques from one that was already in use.
· Providers should counsel patients should about expected local site reactions and side effects that could disrupt regular activities for a few days. They should still be encouraged to receive their second vaccination dose as recommended.
· Providers using Shingrix should pay close attention to the storage and handling requirements, should ensure that the vaccine is reconstituted correctly, administered via the IM route, and should continue to report any adverse events as and administration errors as described below.

Some of the resources available to help providers avoid vaccination errors include:
· Information on Shingrix: https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/index.html
· CDC Infographic about Shingrix: https://www.cdc.gov/vaccines/hcp/infographics/call-the-shots-Shingrix-P_508.pdf
· American Pharmacists Association. Zoster Vaccines – Key Points to Be Aware of Regarding Differences between Zoster Vaccines: http://www.pharmacist.com/sites/default/files/files/2018ZosterVaccinesChartv9Final.pdf
· Immunization Action Coalition's "Ask The Experts", Shingles: http://www.immunize.org/askexperts/experts_zos.asp

Reporting
· Report all vaccine adverse events to VAERS at vaers.hhs.gov or (800) 822-7967.
· Report vaccine administration errors (e.g., wrong route, wrong dose, and wrong age) to the Institute for Safe Medication Practices (ISMP) via the Vaccine Error Reporting Program (VERP) website http://ismp.org. Vaccine administration errors should also be reported to VAERS (as described above), and MUST be reported if they resulted in an adverse event.

We hope this information helpful.

If you have questions about Shingrix recommendations, please call the Immunization Program at 617-983-6800 and ask to speak to an immunization epidemiologist or nurse.

This report highlights your jurisdiction's HPV–associated cancer burden in addition to distribution data for all CDC and non-CDC distributed Gardasil 9 vaccines for 2017. The graph on the front page of the HPV Vaccination Report indicates your jurisdiction's progress towards a "Goal" of distributing enough HPV vaccine to immunize the estimated total number of 11-year-olds in your jurisdiction. The 2015 US Census and American Community Survey were used to obtain the population estimate of 11-year-olds in your jurisdiction. Based on this estimate, we were able to calculate the number of doses needed to immunize this cohort in your state or city with 2 doses of vaccine. Historically in the United States, 20% of annual HPV vaccine doses have been distributed in the first quarter, 20% in the second quarter, 35% in the third quarter, and 25% in the fourth quarter. These are the benchmarks we used to measure your jurisdiction's progress each quarter. The gold arrow indicates your jurisdiction's ordering trend last year and its progress towards distributing100% of its estimated HPV vaccine doses in 2017. Data presented in this report includes all CDC and non-CDC HPV vaccine orders. Although we're estimating the number of doses needed to vaccinate your 11-year-old cohort, doses that were distributed in 2017 may have been administered to individuals between the ages of 9 and 26 years.

Here is the December 2017 HPV vaccination report. The December report highlights HPV vaccination coverage estimates for your jurisdiction from the 2016 National Immunization Survey-Teen. More HPV-related material and resources can be found on our HPV Portal. For more information on HPV-associated cancers, visit here. If you have any questions, please contact hpvquarterlyreport@cdc.gov.

This message is from Dr. Susan M. Lett, Medical Director, MDPH Immunization Program.

The Advisory Committee on Immunization Practices recommendations for the newly licensed recombinant zoster vaccine (RZV), Shingrix, by GlaxoSmithKline for the prevention were published in the MMWR on January 26, 2018. Shingrix is a 2-dose vaccine containing recombinant glycoprotein E and an adjuvant (AS01B).  RZV is approved for use in those >50 years for the prevention of shingles and its complications.  Initial clinical trials of RZV show higher vaccine efficacy across all age groups compared to zoster vaccine live (ZVL), Zostavax.  Please see the attached recommendations for detailed clinical guidance

Recommendations

  • Recombinant zoster vaccine (RZV) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults ≥50 years.
  • RZV is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received zoster vaccine live (ZVL).
  • RZV is preferred over ZVL for the prevention of herpes zoster and related complications (see p 105 of the recommendations for rationale).

Clinical Guidance

  • Please Note:  Care should be taken not to confuse the two different zoster vaccine formulations. RZV (Shingrix) is stored in the refrigerator and administered intramuscularly (IM). ZVL (Zostavax) is stored in the freezer and administered subcutaneously (SC).
  • Reconstitution. Shingrix consists of a lyophilized vaccine which needs to be reconstituted with the liquid adjuvant.
  • Schedule.  2 doses should be administeredIM at 0 and 2-6 months.  The vaccine series need not be restarted if more than 6 months have elapsed since the first dose.  The minimum interval between doses is 4 weeks and doses given at shorter intervals should be repeated.

Shingrix can be given regardless of: 1) prior receipt of varicella vaccine; 2) prior receipt of ZVL; and 3) prior history of herpes zoster.  Do not screen for a history of varicella (verbally or via laboratory serology).

  • Timing of RZV for persons previously vaccinated with ZVL.  Age and time since receipt of ZVL may be considered to determine when to vaccinate with RZV.  Studies examined the safety and immunogenicity of RZV vaccination administered ≥5 years after ZV); shorter intervals have not been studied. However, there are no data or theoretical concerns to indicate that RZV would be less safe or less effective when administered at an interval of <5 years.  Clinical trials indicated lower efficacy of ZVL in adults aged ≥70 years; therefore, a shorter interval may be considered based on the recipient’s age when ZVL was administered.  Based on expert opinion, RZV should not be given <2 months after receipt of ZVL.
  • Coadministration with Other Vaccines.  CDC’s general best practice guidelines for immunization advise that recombinant and adjuvanted vaccines, such as RZV, can be administered concomitantly, at different anatomic sites, with other adult vaccines.  Administration of RZV and adjuvanted influenza vaccine (Fluad), either concomitantly or at other intervals, has not yet been evaluated.
  • Reactions.  Studies show Shingrix is safe.  Shingrix contains an adjuvant to improve immune response, so it can be associated with more temporary side effects than some other vaccines.  About 16% of those vaccinated reported reactions that might prevent them from doing regular activities. Local reactions were reported in about 9% of recipients and systemic reactions in 11%, which included fatigue, fever, nausea, vomiting, diarrhea, shivering.  The most common symptoms were pain (78%), myalgia (45%) and fatigue (45%).  However, they resolve in 2-3 days.
  • Counseling for Reactogenicity.Before vaccination, providers should counsel RZV recipients about expected systemic and local reactogenicity. Reactions to the first dose did not strongly predict reactions to the second dose; vaccine recipients should be encouraged to complete the series even if they experienced a reaction to the first dose of RZV.

Storage and Handling
Shingrix should be stored in the refrigerator at 2-8⁰C (not in the freezer).  After reconstitution, it must be used within 6 hours or be discarded. 

Resources for Healthcare Professionals and Patients
CDC has updated its shingles vaccination websites to reflect the new recommendations:  

The Immunization Program launched our new website this week! We hope that the website will be more user-friendly, searchable, and informative. You can find it here.
Please familiarize yourself with the new organization and update bookmarks accordingly. While things are redirected from the old website for now, those redirects will be taken away in the future.

Immunization Updates webinars
This is a reminder that the continuing education credits affiliated with the Immunization Updates recorded webinars will be removed on December 31, 2017. Please note that this only applies to people who have not watch the recorded webinars and were planning on doing so for continuing education credit(s).

There are currently four webinars available that you can find here.

  1. VFC Compliance/Storage and Handling
  2. Epidemiology of Vaccine Preventable Disease/Vaccine Confidence/School Immunization Data
  3. Massachusetts Immunization Information System (MIIS) Update
  4. Immunization Schedule Updates

VFC Compliance Training Certificates associated with the VFC Compliance/Storage and Handling webinar will continue to be awarded

On January 1, 2018 we will be removing all of the recorded webinars, except for the VFC Compliance/Storage and Handling webinar. The VFC Compliance/Storage and Handling webinar will be available through end of March 2018. At that point, registration for the 2018 Immunization Update in-person and webinar events will open.

You can find information on Immunization Program events and programs here.

If you have questions about the annual VFC Compliance Training, please contact the Assessment Unit at 617-983-4330 or immassessmentunit@state.ma.us.

CDC has released the General Best Practice Guidelines for Immunization as an online report, and it is available on the Advisory Committee on Immunization Practices (ACIP) web page (https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html). The General Best Practice Guidelines for Immunization replace the General Recommendations on Immunization, last published in the Morbidity and Mortality Weekly Report (MMWR) in 2011.

The General Best Practice Guidelines for Immunization goes beyond vaccination recommendations to give providers guidelines on vaccination practice. The document will help vaccination providers to assess vaccine benefits and risks, use recommended administration practices, understand the most effective strategies for ensuring that vaccination coverage in the population remains high, and communicate the importance of vaccination to reduce the effects of vaccine-preventable disease.

By releasing the General Best Practice Guidelines for Immunization as an online report, ACIP will be able to update the document more quickly, giving vaccination providers the most up-to-date guidance on vaccination practice. 

We encourage you to share General Best Practice Guidelines for Immunization with your partners and health care professionals. Attached is a sample announcement you can modify to post online or share through a newsletter, as well as sample tweets.

The updated guidelines include:

1.       Confirmation that if a patient is not acutely, moderately, or severely ill, vaccination during hospitalization is a best practice;

2.       New information on simultaneous vaccination and febrile seizures;

3.       Enhancement of the definition of “precaution” to include any condition that might confuse diagnostic accuracy;

4.        More descriptive characterization of anaphylactic allergy;

5.       Incorporation of protocols for management of anaphylactic allergy;

6.        Allowances for alternate route (subcutaneous instead of intramuscular) for hepatitis A vaccination;

7.        An age cutoff of 12 years through 17 years for validating a dose of intradermal influenza vaccine;

8.       Deletion of much of the storage and handling content, including information on storage units, temperature monitoring, and expiration dates (this content is now contained and continually updated in CDC’s Vaccine Storage and Handling Toolkit, available at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html);

9.        Incorporation of the Infectious Diseases Society of America guidance on vaccination of persons with altered immunocompetence;

10.    Timing of intramuscular administration in patients with bleeding disorders;

11.   Updated data on vaccination record policy;

12.   Additional impacts of the Affordable Care Act on adult vaccination; and

13.    Updated programmatic contact information on source material for vaccine information.

Continuing education (CE) credit is available for the General Best Practice Guidelines for Immunization.

To receive updates on this and other ACIP recommendations and guidelines, sign up at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.


If you have questions regarding immunization practice, please send them to NIPinfo@cdc.gov. As always, if you have questions about immunizations please call the MDPH Immunization Program at 617-983-6800 and ask to speak to an immunization epidemiologist.