Haemophilus influenzae Type B (Hib) Vaccine Archive-- Superseded Information -- HISTORICAL USE ONLY -- See Current Information --
Invasive Haemophilus influenzae Type B Disease in Young Children and Importance for All Young Children to Receive 3-Dose Primary Series with Available Hib-Containing Vaccine
March 18, 2009 -- The information below regarding the Haemophilus influenzae type b (Hib) vaccine shortage was published by the Centers for Disease Control and Prevention (CDC) Health Advisory via the Health Alert Network.
Background of the Hib Vaccine Shortage
Healthcare providers must be vigilant about ensuring all young children are appropriately vaccinated with the 3-dose primary series of Hib vaccine. A nationwide shortage of Hib vaccine began in December 2007 and is ongoing. The recall of certain lots of the two Hib-containing vaccines produced by Merck & Co., Inc., and cessation of production of both vaccines, has left only one manufacturer of Hib vaccine in the United States (Sanofi Pasteur). The shortage resulted in a recommendation by the CDC to defer the Hib booster (routinely recommended at 12 through 15 months) for children who are NOT at high risk of Hib infection temporarily, until supplies are restored. This recommendation is still in effect.
Temporary deferral of the booster dose at 12 through 15 months of age for non-high-risk children may have resulted in increased Hib carriage and transmission in non-symptomatic children. There is potential to see increases in cases of Hib disease at the local level. During 2008 in Minnesota, five children aged 5 months through 3 years were reported with invasive Hib disease; one died. Three patients had received no vaccinations because of parent or guardian deferral or refusal. One child was aged 5 months and had received 2 doses of Hib PRP-TT vaccine, in accordance with the primary series schedule. Another child had received 2 doses of Hib PRP-OMP vaccine, but no booster dose, per the CDC's recommendations during the shortage. Subsequent to Hib infection, this child was diagnosed with hypogammaglobulinemia. The five cases in 2008 were the most reported for one year from Minnesota since 1992, when 10 cases were reported.
There is enough Hib-containing vaccine for all U.S. children to receive the primary series. All children should complete the primary series by 7 months of age; high-risk children should continue to receive the full primary series and the booster dose. Completion of the primary series with currently available vaccine products (manufactured by Sanofi Pasteur) requires a total of 3 doses of Hib-containing vaccine (2, 4, and 6 months of age). Although there is enough Hib-containing vaccine nationally to support these recommendations, there may be times when practitioners do not have an adequate supply of vaccine to meet local demand. If Hib vaccine is not available in the office at the time of a visit, children who are unable to receive one of the primary series doses should be tracked and recalled to schedule an appointment to receive their dose as soon as vaccine becomes available in the office.
In addition, using available Hib-containing vaccines has presented challenges associated with switching from the Merck to Sanofi products for some providers.
There are indications these challenges have led to lower completion of the primary series. Preliminary information comes from sentinel immunization information systems (registries) in select states, which have indicated up to 10% lower coverage with the third Hib dose in the primary series, compared to other vaccines (DTaP, PCV7) commonly administered at the same visit. In the scenario of booster dose deferral, it is even more important that all children receive the complete primary series.
Specifically, some of the challenges in using the currently available Hib-containing vaccines have included provider reluctance to switch inventory and schedules, misunderstanding regarding what constitutes primary versus booster doses, determining a catch-up schedule in the setting of the deferred booster, and provider and parent concerns about over-vaccination, resulting from switching to the Sanofi Pasteur Hib-containing vaccine. Despite these challenges, healthcare providers need to ensure that all children are appropriately vaccinated with the primary series. For example, if Pentacel (DTaP-IPV/Hib) is the only Hib-containing vaccine available, this combination product should be used to complete the primary series, even if doing so results in receipt of additional doses of other antigens (e.g., DTaP, IPV). The Hib-containing vaccine products that are available may not be what providers used previously in their practice; however, the potential for increased transmission of Hib makes it more important than ever that every child is adequately protected.
The following non-high-risk children should be scheduled to receive the primary series of Hib vaccine, as outlined below:
- If the child is at least 6 weeks but less than 12 months of age and has received 0, 1, or 2 doses of Hib vaccine, schedule him/her for the first or next dose(s) immediately with a minimum of 4 weeks between the doses. These children will need 1 booster dose when the Hib vaccine shortage is over.
- If the child is between 12 and 14 months of age and has not had any doses of Hib vaccine, schedule appointments for 2 doses, 8 weeks apart.
- If the child is between 12 and 14 months of age and has received Hib vaccine, but did not complete the primary series before they turned 1 year of age (i.e., had 1 dose of the Merck product OR 1-2 doses of the Sanofi product), schedule an appointment for 1 additional dose, a minimum of 8 weeks from the last dose.
- If the child is at least 15 months of age, but less than 5 years of age, and has not received any doses of Hib vaccine OR has not completed the primary series (i.e., had 1 dose of the Merck product OR 1-2 doses of the Sanofi product), schedule an appointment for 1 dose.
- If the child is 5 years old or older and hasn't received any Hib vaccine, Hib vaccine is not necessary.
Certain children are at increased risk for Hib disease, including children with asplenia, sickle cell disease, human immunodeficiency virus infection and certain other immunodeficiency syndromes, and malignant neoplasms. The CDC recommends that providers continue to vaccinate these children with available Hib conjugate vaccines according to the routinely recommended schedules, including the 12- through 15-month booster dose. Providers who serve predominantly American Indian/Alaska Native (AI/AN) children living in AI/AN communities should continue to stock and use PRP-OMP- containing Hib vaccines (Merck product) and vaccinate according to the routinely recommended schedule, which includes the 2-dose primary series (2 and 4 months of age) and a 12- through 15-month booster dose. This product is available from the VFC Pediatric Vaccine Stockpile, through their state immunization programs.
For more information about Hib disease and vaccination, contact your state or local county health department, the Bueau of Immunization at (850) 245-4342, or the CDC at 1 (800) 232-4636 [(800) CDC-INFO] or on the web at: www.cdc.gov/vaccines/about/contact/nipinfo_contact_form.htm. Information about current vaccine shortages and delays can be found at http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm.
Additional Sources of Information
- CDC. Invasive Haemophilus influenzae Type B Disease in Five Young Children - Minnesota, 2008.MMWR 2009:58(03);58-60.
- CDC. Continued shortage of Haemophilus influenzae Type B (Hib) Conjugate Vaccines and Potential Implications for Hib Surveillance - United States, 2008. MMWR 2008;57(46):1252-1255.
- CDC. 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). MMWR 2007; 56(50):1318-1320.
August 6, 2008 -- We are entering the 9th month of the Haemophilus influenzae type b (Hib) vaccine shortage that was initiated by Merck's recall of their Hib-containing vaccines. We continue to hear that Merck's Hib-containing vaccines will be available during the fourth quarter of this year. Once that happens, the vaccine allocation system that we are currently using will change and more options will be possible.
As a result of the recall, Sanofi Pasteur is currently the only supplier of Hib-containing vaccine for the Nation. While the licensure of the combination vaccine, Pentacel®, has enhanced the supply of Hib-containing vaccine, this addition is not sufficient to resume the booster dose of Hib vaccine.
The Florida Department of Health, Bureau Immunization will continue to receive a limited supply of ActHib®. However, the addition of the newly licensed Pentacel® should assure our continued ability to provide infants with the first 3 doses of Hib-containing vaccine.
It is important to note that the bureau will only be able to supply a limited amount of monovalent Hib vaccine until Merck resumes distribution of their Hib-containing product. Practices are encouraged to order Pentacel® to supplant their monovalent Hib vaccine supply to assure infants receive the first 3 doses of Hib during this temporary shortage.
Incorporating Pentacel® into the Immunization Schedule
For practices using single-antigen vaccines, transition to Pentacel® is relatively straightforward. These practices could begin using Pentacel® as the first dose in the primary series for their 2-month-olds. Infants who have begun the Hib series with single-antigen vaccines can complete the series with separately administered DTaP, IPV, and Hib vaccines. An alternative is to switch all infants to Pentacel®. See below for these options for single-antigen practices.
For practices using Pediarix® (DTaP/IPV/HepB), the situation will be more challenging. Confusion and administration errors may result when both Pediarix® and Pentacel® are in use simultaneously in the same practice. These two combination vaccines both include DTaP and IPV. However, Pediarix® contains HepB and no Hib, and Pentacel® contains Hib, and no HepB.
For practices incorporating Pentacel®, it is easiest to begin with administration of Pentacel® to their newborns, while infants already started on Pediarix® should complete the series with Pediarix®.
Inventory management will be challenging in a practice that uses both Pediarix® and Pentacel®, and may result in vaccine wastage if inventories are not monitored closely. The risk of children missing a dose of hepatitis B or Hib vaccine increases when both products are available.
May 5, 2008 -- The Florida Department of Health, Bureau of Immunization would like to remind providers that the Haemophilus influenzae type b (Hib) vaccine booster dose administered at 12 to 15 months of age should continue to be deferred, except for specific high-risk groups described below and in the Morbidity and Mortality Weekly Report (MMWR).
The basic interim recommendations are as follows:
- Do not give the Hib vaccine booster to healthy children 12 to 15 months of age. Defer administering the routine Hib vaccine booster administered at 12 to 15 months of age, except for specified high-risk groups. Stocking vaccine to give the booster dose during the shortage can take away from providers who are struggling to provide the primary series.
- Continue to give booster to high-risk children with asplenia, sickle cell disease, HIV, other immune syndromes, or those who are Alaskan or Native American.
- Plan for when the shortage is over. Utilize best practice/recall-reminder systems and review the catch-up schedule at: http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.
Temporary Medical Exemptions (TMEs) can/should be extended for children 12 to 15 months of age who are attending/entering child care as the Florida 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.
Please ensure that providers are reminded of the interim recommendations and that everything is done to follow them.
Please provide this information to colleagues, members, coalitions, and partners with an interest in the supply, distribution, management, and administration of Hib conjugate vaccines.
For questions regarding vaccine supply, contact the bureau at 850-245-4342.
Please remember that revised Hib recommendations are NOT office-specificâthese affect the whole country.
Following are some Centers for Disease Control and Prevention (CDC) resources related to the Hib vaccine shortage:
March 6, 2008 -- The Florida Department of Health, Bureau of Immunization reminds providers that the Haemophilus influenzae type b (Hib) Conjugate vaccine booster dose administered at 12 to 15 months of age should be deferred, except for specific high-risk groups described below and in the Morbidity and Mortality Weekly Report (MMWR). At this time, there are no immediate plans to change the interim recommendations. A cooperative effort for the appropriate use of a valuable resource currently in limited supply will work towards an equitable and appropriate public health use of the vaccine. 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®) were posted on December 19, as an MMWR Dispatch. Merck has suspended production of its Hib conjugate vaccines and does not expect to resume distribution of these vaccines until the fourth quarter of 2008. The recall of PedvaxHIB® and Comvax® and suspension of production are expected to result in short-term disruption to the Hib vaccine supply in the United States.
The basic interim recommendations are as follows:
- Defer administering the routine Hib vaccine booster administered at 12 to 15 months of age, except for specified high-risk groups.
- Certain children at increased risk for Hib disease, including children with asplenia, sickle cell disease, human immunodeficiency virus infection, and certain other immunodeficiency syndromes, and malignant neoplasms should continue to receive the full routinely recommended schedule, including the 12- to 15-month booster dose.
- American Indian/Alaska Native (AI/AN) children should also continue to receive the full routinely recommended schedule, including the 12- to 15-month booster dose. Providers who currently use PRP-OMP-containing Hib vaccines (PedvaxHib® and Comvax®) to serve predominantly AI/AN children in AI/AN communities should continue to use only PRP-OMP-containing Hib vaccines.
The original MMWR is available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5650a4.htm
The CDC shortage web-site can be found at: http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm.
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.
Temporary Medical Exemptions for Children in Childcare Facilities, Family Daycare Homes and Prekindergarten
December 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. This temporary deferment will impact Hib requirements for childcare.
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:
- American Indian/Alaska Native (AI/AN) children
- Children with asplenia
- Children with sickle cell disease
- Children with human immunodeficiency virus infection
- Children with certain other immunodeficiency syndromes
- Children with malignant neoplasms
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.
December 13, 2007 -- Merck & Co., Inc. ("Merck") has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type b (Hib) vaccine, PEDVAXHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Hib/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.
- Letter from Merck includes information on returning any vaccines listed.
- Q & A sheet to assist with communication with staff and any parents who may call.
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]
NDC 0006-4897-00 and 0006-4898-00
DATE RECALL INITIATED:
December 11, 2007
|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|
Merck & Co., Inc.
West Point, PA
These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility.
- 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.
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.
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. 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 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