2007 Immunization News ArchiveImmunization Guidelines for Florida Schools, Child Care Facilities, and Family Day Care Homes Effective March 2007 Available at State Distribution CenterDecember 2007 -- The Bureau of Immunization is pleased to announce that the revised Immunization Guidelines for Florida Schools, Child Care Facilities, and Family Day Care Homes, effective March 2007, are now available in packages of 5 at the State Distribution Center. Follow the simple steps below to order:
Department of Health staff should follow internal procedures and contact the Distribution Center to order the guidelines. A small quantity of the guidelines was shipped directly to all county health departments, all Bureau of Immunization Field Staff, the Department of Education (DOE), and Children's Medical Services. The Department of Children and Families (DCF) received guidelines for distribution to all licensed childcare providers in Florida. The revised Immunization Guidelines are also available online at: http://www.doh.state.fl.us/disease_ctrl/immune/schoolguide.pdf [PDF 989 KB]. Temporary Medical Exemptions for Children in Childcare Facilities, Family Daycare Homes and PrekindergartenDecember 31, 2007 -- This is in follow-up to the announcement regarding the short-term disruption to the Haemophilus influenzae Type b (Hib) vaccine supply and the recommendation to temporarily defer the Hib vaccine booster dose administered at 12 to 15 months of age to non-risk children as, detailed below. This temporary deferment of the booster dose has allowed Sanofi Pasteur to predict that its supply would cover demand through June (http://www.iht.com/articles/ap/2007/12/21/america/Vaccine-Recall.php). This temporary deferment will impact Hib requirements for childcare. Please note: Temporary Medical Exemptions (TMEs) can/should be extended 6 months for children 12 to 15 months of age who are attending/entering child care as the Certification of Immunization (DH Form 680) is issued or expires. Continue to keep track of children given TME extensions in order to recall them when vaccine supplies allow. Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB® and Comvax®)December 21, 2007 -- On December 13, 2007, a pharmaceutical manufacturer announced a voluntary recall of certain lots of two Haemophilus influenzae type b (Hib) conjugate vaccines, which is expected to result in short-term disruption to the Hib vaccine supply in the United States. A Centers for Disease Control and Prevention (CDC) Dispatch, issued on December 19, 2007 in the Morbidity and Mortality Weekly Report (MMWR), Vol. 56, provides additional details on the expected shortage and interim recommendations for the use of Hib-containing vaccines. You may access the full recommendation at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d1219a1.htm?s_cid=mm56d1219a1_e. The recommended vaccination schedule for all available Hib-containing vaccines consists of a primary series (consisting of 2 or 3 doses, depending on the formulation) administered beginning at 2 months of age and a booster dose at 12 to 15 months of age. Because of the short-term reduction in available doses of Hib-containing vaccines, the CDC, in consultation with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics, recommends that providers temporarily defer administering the routine Hib vaccine booster dose administered at 12 to 15 months of age, except to children in specific groups at high risk, which include:
The CDC recommends that providers continue to vaccinate AI/AN children with available Hib conjugate vaccines according to the routinely recommended schedules, including the 12 to 15 months of age booster dose. The CDC recommends that providers continue to vaccinate close contacts according to published guidelines. PedvaxHIB® (if available), ActHIB®, and TriHIBit® may be used for the booster doses for these children during this shortage. TriHIBit® is only licensed to be administered at the 12 to 15 months of age visit. Hib vaccines also are recommended for use in prophylaxis for susceptible close contacts of patients with Hib disease. AI/AN children not in AI/AN communities or who already receive Polyribosylribotol Phosphate-Tetanus Toxoid (PRP-TT) conjugate vaccines should continue to be vaccinated with available vaccines according to the routinely recommended schedules, including the 12 to 15 months of age booster dose. Providers should register and track children for whom the booster dose is deferred to facilitate recalling them for vaccination when supply improves. The ACIP recommends that public health practitioners conduct thorough and timely investigations of all cases of Hib disease. To maximize the amount of available vaccine, providers should order only the number of doses of vaccine required to meet immediate needs (i.e., a supply for up to four weeks) and should refrain from attempting to build an inventory of Hib vaccine. The Bureau of Immunization, CDC, ACIP, and other partners will continue to monitor the supply of available Hib vaccines and the epidemiology of Hib disease and provide updates when available. The CDC maintains a web-page with the latest national information about vaccine supplies and provides guidance to healthcare providers who are facing vaccine shortages or delays at: http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm. Important Notice: Merck Recalls Hib VaccinesDecember 13, 2007 -- Merck & Co., Inc. ("Merck") has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate)]. The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck.
FDA Recall: Certain Lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
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| PRODUCT DESCRIPTION | LOT # | EXP. DATE |
|---|---|---|
| PedvaxHIB® | 0677U | 11 January 2010 |
| PedvaxHIB® | 0820U | 12 January 2010 |
| PedvaxHIB® | 0995U | 16 January 2010 |
| PedvaxHIB® | 1164U | 18 January 2010 |
| PedvaxHIB® | 0259U | 17 October 2009 |
| PedvaxHIB® | 0435U | 18 October 2009 |
| PedvaxHIB® | 0436U | 19 October 2009 |
| PedvaxHIB® | 0437U | 19 October 2009 |
| PedvaxHIB® | 0819U | 09 January 2010 |
| PedvaxHIB® | 1167U | 10 January 2010 |
| PedvaxHIB® | J2438 | 24 October 2009 |
| COMVAX® | 0376U | 05 January 2010 |
| COMVAX® | 0377U | 08 January 2010 |
MANUFACTURER:
Merck & Co., Inc.
West Point, PA
REASON:
These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility.
Please note:
- Merck has not identified potency concerns for these vaccine lots.
- Children who received vaccine from the affected lots do not need to be revaccinated
The Vaccines for Children (VFC) Program has submitted a list of VFC providers who received the recalled vaccines to Merck. Merck will be mailing a Business Reply Card and Packing Slip to these providers. See Important notice: Hib recall of eleven lot numbers [PDF 205 KB] for further information on using the return cards and returning VFC vaccines.
Recommendation from the Advisory Committee on Immunization Practices Regarding Quadrivalent Meningococcal Conjugate Vaccine
December 7, 2007 -- The Bureau of Immunization is pleased to announce the release of the Centers for Disease Control and Prevention (CDC) notice, Recommendation from the Advisory Committee on Immunization Practices (ACIP) for Use of Quadrivalent Meningococcal Conjugate Vaccine (MCV4) in Children Aged 2--10 Years at Increased Risk for Invasive Meningococcal Disease, issued on December 7, 2007 in the Morbidity and Mortality Weekly Report (MMWR). (Meningococcal Conjugate Recommendations)
National Influenza Vaccination Week
November 26 - December 2, 2007
The Bureau of Immunization is pleased to announce that National Influenza Vaccination Week (NIVW) will be celebrated November 26 to December 2, 2007. The Centers for Disease Control and Prevention (CDC) designates the week after Thanksgiving as National Influenza Vaccination Week. This event is designed to raise awareness of the importance of continuing influenza (flu) vaccination, and encourage use of flu vaccine through the months of November, December, and beyond. The CDC recommends that people take this opportunity to be vaccinated and asks that flu vaccine providers use this time to schedule additional flu vaccine clinics; extend clinic hours; and plan mass vaccination at retail locations.This year, Tuesday, November 27, 2007, is set aside as Children's Flu Vaccination Day, with focus on vaccinating high-risk children. Each year, over 20,000 children are hospitalized as a result of influenza. This day will help raise awareness about the value of vaccinating children, especially high-risk children and their close contacts.
The Bureau of Immunization has materials available commemorating National Influenza Vaccination Week and promoting the importance of flu vaccination at: http://www.doh.state.fl.us/disease_ctrl/immune/qi_clinical/publications.htm or http://www.doh.state.fl.us/disease_ctrl/immune/flu/index.htm.
The CDC will have resources available for National Influenza Vaccination Week in November at: http://www.cdc.gov/flu/nivw07.htm
Update on Supply of Merck & Co., Inc. Vaccines
November 16, 2007 -- The Centers for Disease Control and Prevention (CDC) maintains a webpage with the latest national information about vaccine supplies and provides guidance to healthcare providers who are facing vaccine shortages or delays at: http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm.
Varicella
Merck is continuing to experience a vaccine supply interruption and shipping delays of 6 to 8 weeks for varicella orders. While there is no change in the routine recommendation, provision of Temporary Medical Exemptions may still be necessary. Please see the letter from Merck & Co., Inc. regarding their current vaccine supply status at: http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/var-shortage-12-5-07.pdf [PDF 74 KB].
Hepatitis A
Merck & Co., Inc., is experiencing production delays for Pediatric and Adult hepatitis A vaccine (Pediatric & Adult VAQTA®), resulting in backorders for these products. Merck has temporarily discontinued accepting orders for Pediatric VAQTA® and Adult VAQTA® in the vial formulation. Based on current information, it is estimated that VAQTA® will be available in late first quarter 2008, but actual timing will be confirmed when more is known. There is no change in the routine recommendation. Please see the letter from Merck & Co., Inc. regarding its current vaccine supply status at the link above. GSK production and supply of its Pediatric and Adult hepatitis A vaccine (Pediatric & Adult Havrix®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) are currently in good supply to meet demand. GSK has initiated plans to increase production of Havrix® and Twinrix®, to help ensure uninterrupted supply for the U.S. market.
Haemophilus influenzae Type B (Hib)
Merck & Co., Inc. has reported that PedvaxHIB® is unavailable for shipment. Based on the latest information, Merck expects PedvaxHIB® (PRP-OMP) to be available sometime in the first quarter of 2008. Merck reports that the exact timing is dependent upon resolution of a manufacturing issue. There is no change in the routine recommendation. Please see the letter from CDC regarding its current vaccine supply status at: http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-shortage-11-7-07.pdf [PDF 37 KB]. If it becomes necessary to complete a Hib series that was started with PedvaxHib, the following guidelines may be followed:
- If the first 2 doses of PedvaxHIB® were administered as the primary series, any Haemophilus influenzae b conjugate vaccine including ActHIB (PRP-T) may be administered for the dose 3 booster at 12 to 15 months of age.
- If only one dose of PedvaxHIB® has been administered, the primary series may be completed with 2 additional doses of ActHIB. There should be a minimum interval of 4 weeks between all doses of the primary series, followed by a 4th dose as a booster at 12 to 15 months of age.
- Please consult the Catch-Up Immunization Schedule for the timing of doses for those who start late or are more than one month behind: http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2007/child-schedule-color-print.pdf [PDF 333 KB].
Please be assured that the Florida Vaccines for Children (VFC) Program has sufficient Haemophilus influenzae type B, Varicella, and Hepatitis A vaccine available. The bureau will provide vaccine supply updates as indicated.
Prevention of Hepatitis A After Exposure to Hepatitis A Virus and in International Travelers.
Updated Recommendations of the Advisory Committee on Immunization Practices
October 29, 2007 -- This report details updated recommendations, made by the Advisory Committee on Immunization Practices (ACIP) in June 2007, for prevention of hepatitis A after exposure to hepatitis A virus (HAV), and in departing international travelers, and incorporates existing ACIP recommendations for prevention of hepatitis A. Persons who recently have been exposed to HAV, and who previously have not received hepatitis A vaccine, should be administered a single dose of single-antigen vaccine or immune globulin (IG) (0.02 mL/kg) as soon as possible. For healthy persons 12 months to 40 years of age, single-antigen hepatitis A vaccine at the age-appropriate dose is preferred to IG because of vaccine advantages that include long-term protection and ease of administration. For persons aged greater than 40 years, IG is preferred because of the absence of information regarding vaccine performance and the more severe manifestations of hepatitis A in this age group; vaccine can be used if IG cannot be obtained. IG should be used for children less than 12 months of age, immunocompromised persons, persons who have had chronic liver disease diagnosed, and persons for whom vaccine is contraindicated.
Persons administered IG for whom hepatitis A vaccine also is recommended for other reasons, should receive a dose of vaccine simultaneously with IG. The updated recommendations for use of hepatitis A vaccine alone for postexposure prophylaxis do not apply to the combination hepatitis A/hepatitis B vaccine. Please review the full recommendation online at: http://www.cdc.gov/mmwr/pdf/wk/mm56d1219.pdf [PDF 71 KB].
Update on Supply of Vaccines Containing Varicella-Zoster Virus
October 29, 2007 -- We are continuing to experience extended delivery timelines for vaccines containing varicella-zoster virus. Shipments of varicella vaccines are anticipated to be delivered within 30 to 35 business days, or six to seven calendar weeks. However, there is no change in the routine recommendation for vaccines containing varicella-zoster virus. Providers should plan on recalling any children or adolescents who have been given temporary medical exemptions as soon as the vaccine supply is sufficient.
Questions regarding the supply of these Merck products should be addressed to Merck's National Service Center at (800) 637-2590. Updates on vaccine shortages and delays are available from the Centers for Disease Control and Prevention (CDC) at: http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm. We will continue to provide updates about the supply of varicella-zoster-containing vaccines as new information becomes available.
For further information regarding adult immunization recommendations, prevention of hepatitis A after exposure, or the supply of vaccines containing varicella-zoster virus, please contact the Bureau of Immunization at (850) 245-4342.
Recommended Adult Immunization Schedule United States, October 2007–September 2008
October 29, 2007 -- The Advisory Committee on Immunization Practices (ACIP) annually reviews the recommended Adult Immunization Schedule to ensure that the schedule reflects current recommendations for the use of licensed vaccines. In June 2007, the ACIP approved the Adult Immunization Schedule for October 2007-September 2008. This schedule has also been approved by the American Academy of Family Physicians, the American College of Physicians, and the American College of Obstetricians and Gynecologists. Please review the new schedule and changes to the Age-Based Schedule, Medical/Other Indications Schedule, and the Footnotes online at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5641a7.htm?s_cid=mm5641a7_e.
You may access the schedule online at: http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm.
Expansion of Age-Range for Menactra
October 18, 2007 -- On October 18, the Food and Drug Administration (FDA) issued a press release announcing that it approved the use of Menactra bacterial meningitis vaccine (Sanofi Pasteur) to include children 2 to 10 years of age. (Menactra Age-range)
National Adult Immunization Awareness Week 2007
National Adult Immunization Awareness Week (NAIAW) 2007 is September 23-29, 2007. This year marks the twentieth consecutive observance of NAIAW, and provides an excellent opportunity for individuals and organizations to promote the importance of adult and adolescent immunization. "Adult Immunization: It's Your Best Shot" is the theme for National Adult Immunization Awareness Week 2007. For more information visit: http://www.cdc.gov/vaccines/events/naiaw/default.htm.
Vaccines are safe and offer protection from infectious diseases. By staying up-to-date on the recommended vaccinations, individuals can protect themselves, their families, and their communities from serious or even life-threatening diseases such as tetanus, diphtheria, hepatitis A & B, measles, mumps, rubella and chickenpox. This week is also an appropriate time to make arrangements for an annual flu vaccination.
According to the Centers for Disease Control and Prevention (CDC), as many as 50,000 adults in the U.S. die each year from vaccine-preventable diseases. Influenza (or flu) also contributes to more than 100,000 people being hospitalized and an average of 36,000 deaths each year in the U.S.
The Department of Health, Bureau of Immunization encourages Floridians to contact their primary healthcare provider or the local county health department to schedule appointments for vaccinations and assure immunizations are up-to-date.
Additional immunization information is available at the bureau's Adult Immunization Web-page and the Flu & Pneumococcal Website. Florida-specific printed materials are available for download on our publications page.
The recommended adult and adolescent immunization schedules are located at: http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm
Revised Recommendations of the Advisory Committee on Immunization Practices Regarding Meningococcal Conjugate Vaccine
The Centers for Disease Control and Prevention (CDC) published the Revised Recommendations of the Advisory Committee on Immunization Practices (ACIP) to Vaccinate All Persons Aged 11--18 Years with Meningococcal Conjugate Vaccine on August 10, 2007, in the Morbidity and Mortality Weekly Report (MMWR) Series, Vol 56, #31. (Meningococcal Conjugate Vaccine)
Food and Drug Administration Approval of an Alternate Dosing Schedule for Twinrix®
April 2007 -- In April 2007, GlaxoSmithKline Vaccine Division (GlaxoSmithKline Biologicals) received approval from the Food and Drug Administration (FDA) for an alternate schedule for Twinrix® (http://www.fda.gov/cber/label/hahbgsk032807lb.pdf [PDF 115 KB]), a combined hepatitis A and hepatitis B vaccine. Twinrix® was first licensed in 2001 as a 3-dose schedule (0, 1, and 6 months) for vaccination of persons 18 years of age and older. For routine immunization purposes, providers should continue to follow the 3-dose schedule. The alternate 4-dose schedule will accelerate protection when needed for travel and/or other potential exposures.
Using the newly licensed, alternate 4-dose schedule, doses can be administered at 0, 7, and 21-30 days, followed by a dose at 12 months. More information on the FDA approval of an alternate dosing schedule can be found in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5640a5.htm?s_cid=mm5640a5_e.
Pre-teen Vaccination Campaign
The Bureau of Immunization is pleased to announce the Pre-teen Vaccination Campaign, sponsored by the Centers for Disease Control and Prevention (CDC). (Pre-teen Vaccination)
Vaccine Packaging Update for Sanofi Pasteur Products
The Bureau of Immunization provides this important notice to alert you regarding packaging changes to two Sanofi Pasteur vaccine products: DAPTACEL® - (DTaP) Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (licensed for children up to age 7 years); and ADACEL® - (Tdap) Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (licensed for persons 11 through 64 years). These changes will help avoid confusion in the marketplace between the two vaccines. Please see the packaging document [PDF 44 KB] from Sanofi Pasteur Inc. for more details.
Please Note: The Bureau of lmmunization will continue to provide DAPTACEL® and ADACEL® vaccines to all Vaccines for Children (VFC)-eligible children for whom the vaccine is indicated. More information is available at: http://www.sanofipasteur.us.
If you have any questions concerning recommendations for the Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, please contact Phyllis Yambor, R.N., Bureau of lmmunization, at (850) 245-4342. For information regarding the VFC vaccine supply, contact Robert Griffin at (850) 245-4342.
August is recognized as National Immunization Awareness Month (NIAM). The goal of NIAM is to increase awareness about immunizations across the life span, from infants to adults and the elderly. (National Immunization Awareness Month)
Immunization Requirements
The Bureau of Immunization is pleased to announce the release of the revised Immunization Guidelines for Florida Schools, Child Care Facilities, and Family Day Care Homes, effective March 2007 and incorporated by reference in amended Rule 64D-3.046, Florida Administrative Code, which became effective July 15, 2007. (Immunization Requirements)National Infant Immunization Week
April 21-28, 2007
National Infant Immunization Week (NIIW) is an annual observance to promote the benefits of immunizations and to focus on the importance of immunizing infants against vaccine-preventable diseases by age two. This year, NIIW will again be held in conjunction with the Pan American Health Organization's Vaccination Week in the Americas (VWA), April 21-28, 2007. (National Infant Immunization Week)
Bureau of Immunization Website Merges with www.ImmunizeFlorida.org
We have moved all content from the www.ImmunizeFlorida.org website to our site contained within the Department of Health website. You can still use www.ImmunizeFlorida.org to reach our site; only the look and specific page links have changed. There is now more information regarding adolescent and adult immunizations available through www.ImmunizeFlorida.org. Your links to www.doh.state.fl.us/disease_ctrl/immune will still work. If you are having any problems finding your information, please use our Site Map to find your way.
The 2007 Florida Statewide Immunization Summit
This year's summit took place April 24-25, 2007 in Orlando, Florida at The Florida Hotel & Conference Center at the Florida
Mall. This event, hosted by Central Florida Central Florida Area Health Education Center (AHEC), Inc., with the Florida Department of
Health's Bureau of Immunization,
focused on updating the state's public and private providers on immunizations and assisting practitioners with reaching the goal of achieving 90 percent coverage of Florida's two-year-olds by July 2007.
CDC Reaffirms Vaccine Policy Recommendations to Routinely Vaccinate U.S. Infants With Rotavirus Vaccine
The Bureau of Immunization is pleased to announce the release of the Centers for Disease Control and Prevention (CDC) report, Postmarketing Monitoring of Intussusception After RotaTeq™ Vaccination --- United States, February 1, 2006--February 15, 2007, issued on March 16, 2007 in the Morbidity and Mortality Weekly Report (MMWR). (Rotavirus Recommendations)
Introducing Vaccine Topics
This new page will contain links to information about new vaccines and immunization issues (Vaccine Topics).
Revised Human Papillomavirus (HPV) Vaccine Information Statement and Update on Vaccines for Children Program HPV Vaccine Availability
The Bureau of Immunization is providing this important update to the Advisory Committee On Immunization Practices (ACIP) recommendations regarding HPV vaccine that were distributed on December 1, 2006. (HPV Update)