Varicella (Chickenpox) Vaccine
April 10, 2012 -- In May 2011, the Food and Drug Administration (FDA) approved an extended period for administering VariZIG™. The period after exposure to varicella zoster virus during which a patient may receive VariZIG™, which had been 96 hours (4 days), is now 10 days. VariZIG™ should be administered as soon as possible after exposure. The article was published in the FDA Approval of an Extended Period for Administering VariZIG™ for Postexposure Prophylaxis of Varicella; Morbidity and Mortality Weekly Report (MMWR), March 30, 2012 / 61(12);212-212. Additional information on the process for obtaining VariZIG™ under the investigational new drug (IND) application expanded access protocol, use of antiviral therapy if varicella occurs after administration of VariZIG™, and the interval between administration of VariZIG™ and varicella vaccine once the patient becomes eligible is reviewed in the A New Product (VariZIG™) for Postexposure Prophylaxis of Varicella Available Under an Investigational New Drug Application Expanded Access Protocol; MMWR, March 3, 2006 55(08);209-210.
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 (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 -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.
Advisory Committee on Immunization Practices (ACIP) Recommendations for the Use of Varicella Vaccine
April 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.
May 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;1-12). 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:
- The routinely recommended ages for measles, mumps, rubella and varicella vaccination continue to be 12 to 15 months of age for the first dose and 4 to 6 years of age for the second dose.
- For the first dose of measles, mumps, rubella, and varicella vaccines at 12 to 47 months of age, either measles, mumps, and rubella (MMR) vaccine and varicella vaccine or MMRV vaccine may be used. Providers who are considering administering MMRV vaccine should discuss the benefits and risks of both vaccination options with the parents or caregivers. Unless the parent or caregiver expresses a preference for MMRV vaccine, the CDC recommends that MMR vaccine and varicella vaccine should be administered for the first dose in this age group.
- For the second dose of measles, mumps, rubella, and varicella vaccines at any age (15 months to 12 years) and for the first dose at greater than 48 months of age, use of MMRV vaccine generally is preferred over separate injections of its equivalent component vaccines (i.e., MMR vaccine and varicella vaccine). Considerations should include provider assessment, patient preference, and the potential for adverse events.
- A personal or family (i.e., sibling or parent) history of seizures of any etiology is a precaution for MMRV vaccination. Children with a personal or family history of seizures of any etiology generally should be vaccinated with MMR vaccine and varicella 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/.
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