Vaccine TopicsVaricella (Chickenpox) VaccineIMPORTANT! Varivax and Zostavax - Shipping Insert and Transport InformationJuly 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 (800) 637-2579. Such requests for replacements must be received by Merck within 15 days of the original shipment date. 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 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 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. Advisory Committee on Immunization Practices (ACIP) Recommendations for the Use of Varicella VaccineApril 14, 2011 -- The Bureau of Immunization would like to take this opportunity to remind providers about the Advisory Committee on Immunization Practices (ACIP) recommendations for the use of varicella vaccine and Florida’s immunization requirements for daycare and school attendance. The one-dose varicella requirement for attendance in Florida schools, daycares, and family daycare homes was implemented in the 2001-2002 school year. Beginning with the 2008-2009 school year, children entering kindergarten were required to provide proof of two doses of varicella vaccine with the requirement extending to the next highest grade every year thereafter. For the upcoming 2011-2012 school year, two doses of varicella vaccine will be required for students entering or attending kindergarten, first, second, and third grades. The ACIP recommends routine vaccination with two doses of varicella for all children 12 months of age and older and adults with no evidence of immunity. Though not required for seventh grade entry, providers are encouraged to offer the second dose of varicella vaccine along with other required and recommended vaccines during adolescent visits. As part of comprehensive health services for all adolescents, the ACIP, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend a health maintenance visit at 11 to 12 years of age. This visit should also serve as an immunization visit to evaluate vaccination status and administer necessary vaccinations. Physicians should use this and other routine visits to ensure that all children without evidence of varicella immunity have received two doses of varicella vaccine to ensure adequate protection against this commonly occurring vaccine-preventable disease. The full ACIP recommendation can be viewed at www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm. Florida Immunization Guidelines for Florida Schools, Childcare Facilities, and Family Daycare Homes can be found on the Bureau of Immunization website at: www.immunizeflorida.org/publications/misc.htm. 2011-2012 immunization requirement flyers for daycare and school attendance can be found at www.immunizeflorida.org/publications/flyers.htm. ACIP Recommendations for Use of Combination Measles-Mumps-Rubella-Varicella VaccineMay 13, 2010 -- The Bureau of Immunization is pleased to bring to your attention an important report published by the Centers for Disease Control and Prevention (CDC) on May 7, 2010, in the Morbidity and Mortality Weekly Report (MMWR Weekly / Vol. 59 / No. RR3). The report, Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine - Recommendations of the Advisory Committee on Immunization Practices (ACIP) (page 1 - 12), presents the recommendations and use of the combination measles-mumps- rubella-varicella vaccine (MMRV, ProQuad, Merck & Co., Inc.). We encourage providers to read these recommendations and guidance carefully, since we include only excerpts here. In June 2009, the CDC's Advisory Committee on Immunization Practices (ACIP) adopted new recommendations regarding use of the combination MMRV vaccine. MMRV vaccine was licensed in the U.S. in September 2005 and may be used instead of measles-mumps-rubella vaccine (MMR, M-M-RII, Merck & Co., Inc.) and varicella vaccine (VARIVAX, Merck & Co., Inc.) to implement the recommended 2-dose vaccine schedule for prevention of measles, mumps, rubella, and varicella among children 12 months through 12 years of age. At the time of its licensure, use of MMRV vaccine was preferred for both the first and second doses over separate injections of equivalent component vaccines (MMR vaccine and varicella vaccine), which was consistent with the ACIP's 2006 general recommendations on use of combination vaccines (CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55;[No. RR-15]). Since July 2007, supplies of MMRV vaccine have been temporarily unavailable as a result of manufacturing constraints unrelated to efficacy or safety. MMRV vaccine is now available in the U.S. again. After consideration of the postlicensure data and other evidence, the ACIP adopted the following summized new recommendations regarding use of MMRV vaccine for the first and second doses and identified a personal or family (i.e., sibling or parent) history of seizure as a precaution for use of MMRV vaccine:
MMRV vaccine may be administered simultaneously with other vaccines recommended for children 12 to 15 months of age and 4 to 6 years of age. If simultaneous administration is not possible, MMRV vaccine may be administered at any time before or after an inactivated vaccine but at least 28 days before or after another live, attenuated vaccine, except varicella vaccine, for which a minimum interval of 3 months is recommended. Effective Monday, May 10, 2010, Merck ProQuad, MMR-V, NDC 00006-4999-00, 10-pack single dose vial became available for ordering through the Vaccines for Children (VFC) Program. A separate Vaccine Information Statement (VIS) for MMRV is in draft form and is expected to be available later this year. Both MMR and varicella VISs include information about MMRV and are available at: http://www.cdc.gov/vaccines/pubs/vis/. -- View Varicella Archives -- |
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