Herpes Zoster (Shingles) Vaccine
IMPORTANT! Varivax® and Zostavax® - Shipping Insert and Transport Information
July 7, 2011 -- The vaccine manufacturer, Merck, released the following important information regarding Varivax® and Zostavax® shipping and transport.
Merck, the manufacturer of Varivax® and Zostavax® has recently changed the shipment packaging for these frozen vaccines and issued new Food and Drug Administration (FDA) approved guidance regarding caution in the use of dry ice for storage of frozen vaccines. New shipment packaging became effective June 6, 2011.
Merck no longer ships these vaccines to customers on dry ice. Gel packs are now utilized. The quantity of gel packs placed in the container is based on carefully determined guidelines that are designed to maintain proper temperatures for three days from the shipment date located on the packing list. It also takes into account the maximum temperature to which the container will be exposed, the time in transit, and the need to keep the vaccine at the appropriate temperature during shipping.
If the container is received after the three-day shipping time period, the provider should contact the Merck Order Management Center immediately for replacement instructions at
Shipments now contain shipper inserts in brightly distinguishable colors that inform the recipient of the new pack-out, storage of vaccine and diluent as well as reporting and replacement instructions if there is a question regarding the shipment. This shipper insert is also available at www.merckvaccines.com.
The vaccine is located in the lower compartment of the shipping box. Providers should immediately open the container and store the vaccine in the freezer. To maintain potency the vaccine must be stored frozen between -58°F and +5°F (-50°C to -15°C). The diluent is located in the top compartment of the shipping box underneath the cardboard cap. On arrival, the diluent should be stored in a refrigerator (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F).
The Centers for Disease Control and Prevention (CDC) and the vaccine manufacturer do not recommend transport of frozen vaccine. However, we understand that under certain circumstances (emergencies, power outages, etc.) frozen vaccine may need to be transported. The manufacturer does not recommend reuse of shipping materials, including gel packs and shipping containers, to further transport vaccine products. Improper re-packaging using these materials and improper transportation could negatively impact the vaccine. If frozen vaccines must be transported, the CDC recommends transport with a portable freezer that maintains a temperature between -58°F and +5°F (-50°C and -15°C).
In addition, according to the manufacturer's Prescribing Information, Varivax® and Zostavax® may be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 continuous hours prior to reconstitution. If transporting frozen vaccine under refrigerated conditions, document EXPLICITLY: 1) time refrigerator storage began; 2) time refrigerator storage ended; and 3) storage temperatures under which the vaccine was kept for this period of time.
The manufacturer should be called before discarding frozen vaccine that has been kept under refrigerated storage conditions. Questions regarding vaccine shipments should be directed to the manufacturer at the number listed above.
The CDC is currently working with Merck, the vaccine manufacturer of Varivax® and Zostavax®, to respond to questions generated by the new shipment packing for frozen vaccines and the manufacturer's advisement that dry ice should not be used for storage of these frozen vaccines.
Update: FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age
April 19, 2011 -- The Food and Drug Administration (FDA) approved the use of Zostavax (Zoster Vaccine Live), a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age on March 24, 2011.
Zostavax is already approved for use in individuals 60 years of age and older. The FDA press release and the full prescribing information is available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm248390.htm and www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ ApprovedProducts/UCM132831.pdf.
The Bureau of Immunization will send an update when the Advisory Committee on Immunization Practices (ACIP) publishes their recommendations in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR). An updated Vaccine Information Statement (VIS) should be published at that time as well. The current ACIP recommendations can be accessed at www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm?.s_cid =rr5705a1_e.
Please note that Zostavax is on back-order in some areas. The following Merck Vaccines link provides updated information on the vaccine supply: www.merckvaccines.com/Order-Vaccines/Pages/supply-status.aspx.
Vaccine Information Statement Updates
October 12, 2009 -- The Bureau of Immunization is pleased to highlight recent updates to three Vaccine Information Statements (VIS): pneumococcal (PPSV), rabies, and zoster (shingles). Existing stocks may be used up, but be prepared to explain the changes to patients when appropriate.
PPSV: The paragraph on pregnancy under section 5 has received a minor update. In the previous edition, the term "is not recommended" was used in a way that could be misinterpreted to mean "should never be given." In fact, while PPSV is not routinely recommended for pregnant women, it may be given under some circumstances. This VIS is available at http://www.cdc.gov/vaccines/pubs/vis/default.htm#ppv23.
Rabies: This update incorporates the new 4-dose post-exposure regimen and makes minor updates throughout. This VIS is available at http://www.cdc.gov/vaccines/pubs/vis/default.htm#rabies.
Zoster: This change removes active, untreated tuberculosis as a contraindication, which had been erroneously included in the previous editions. Several minor changes were also made. These involve changes in numbers (number of annual cases, age over which the disease is more common, and duration of rash) to make the VIS more consistent with other published materials. The edition date has not changed. This VIS is available at http://www.cdc.gov/vaccines/pubs/vis/default.htm#shingles.
Healthcare providers should periodically access VISs electronically and print out a supply for routine distribution. If necessary, bureau staff can fax copies to providers without internet access. Please contact the bureau by calling 850-245-4342.
For the latest information concerning VIS updates, visit the CDC's VIS News website. Many VIS forms are available in other languages. As new editions are translated, they are posted on the Immunization Action Coalition's website.
Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices
June 13, 2008 -- The Florida Department of Health, Bureau of Immunization announces publication of the Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 2008; volume June 6, 2008 / 57);1-30 concerning the prevention of herpes zoster through vaccination. A Continuing Education Activity has been approved for this report and is included in the print and electronic format on June 06, 2008, in Vol. 57, No. RR-5. The credits awarded are as follows: CME, 2.75; CNE, 2.75; CEU, .25; and CHES, 3.0.
These recommendations represent the first statement by the Advisory Committee on Immunization Practices (ACIP) on the use of a live attenuated vaccine for the prevention of herpes zoster (zoster) (i.e., shingles) and its sequelae, which was licensed by the U.S. Food and Drug Administration (FDA) on May 25, 2006. This report summarizes the epidemiology of zoster and its sequelae, describes the zoster vaccine, and provides recommendations for its use among adults older than 60 years of age in the United States.
The CDC's Shingles (Herpes Zoster) webpage provides additional information.
CDC's Advisory Committee Recommends "Shingles" Vaccination
The ACIP to the Centers for Disease Control and Prevention (CDC) voted Wednesday, October 25, 2006, to recommend a newly licensed zoster vaccine, Zostavax manufactured by Merck, to protect against shingles be given to all people age 60 and older, including those who have had a previous episode of shingles.
http://www.cdc.gov/media/pressrel/r061026.htm
Shingles (Herpes Zoster) Vaccine Information Statement (VIS)
The Bureau of Immunization is pleased to announce the release of an interim Shingles (zoster) Vaccine Information Statement (VIS) dated 9/11/06. The Food and Drug Administration (FDA) licensed a new vaccine to reduce the risk of shingles (herpes zoster), Zostavax, on May 25, 2006. A single dose of shingles vaccine is indicated for adults 60 years of age and older. When the Advisory Committee on Immunization Practices (ACIP) votes and releases their recommendations, a final VIS edition will be published. Once a VIS is available it should be used effective immediately. The VIS can be viewed online at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-shingles.pdf and http://www.cdc.gov/vaccines/pubs/vis/default.htm.
VISs are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VISs be handed out whenever (before each dose) certain vaccinations are given.
For more details about VISs, access the CDC and Immunization Action Coalition (IAC) VIS web pages at: http://www.cdc.gov/vaccines/pubs/vis/default.htm and http://www.immunize.org/vis/.
Please note: The shingles vaccine is not distributed by the Florida Vaccines for Children (VFC) program.
