Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib)
- "Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib)" with MMWR attachment is also available as in Portable Document Format (PDF, 204KB, 5pg.)
| December 26, 2007 | |
| To: | Hospitals, Providers, Local Health Departments |
| From: | New York State Department of Health Bureau of Communicable Disease Control, Immunization Program |
Health Advisory:
- Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall; and
- Recommendations for Increased Surveillance for Vaccine-Associated Bacillus cereus Infections
Please distribute to staff in the Departments of Primary Care, Pediatrics, Family Medicine, Pharmacy, Infection Control, Infectious Disease and Laboratory Medicine
The New York State Department of Health (NYSDOH) has been notified of a voluntary recall by Merck & Co. of ten lot numbers of PedvaxHIB® and two lot numbers of COMVAX®. The NYSDOH is providing the information below to providers on the interim recommendations for the use of Hib conjugate vaccines, as the recall is expected to result in short-term disruption to the Hib vaccine supply in the United States. In addition, as part of comprehensive vaccine safety monitoring, the NYSDOH asks that health care providers and clinical laboratories enhance surveillance for vaccine-associated Bacillus cereus infections.
1) Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall
Merck & Co. has issued a voluntary recall of ten lots of its Pedvax HIB (monovalent Hib vaccine) and two lots of COMVAX (Hib/hepatitis B vaccine) due to concerns about the company's ability to assure sterility for certain specific vaccine lots. Through routine testing of manufacturing equipment, Merck identified the presence of the bacteria Bacillus cereus (B. cereus). Providers who have received affected lots should follow the procedures outlined in the Health Advisory released December 13, 2007. An 11th lot of PedvaxHIB® was also recalled, but it was only used in China. No other U.S. lots of PedvaxHIB® or COMVAX® and no other Merck products are affected by this recall.
- Two other Hib conjugate vaccines manufactured by Sanofi Pasteur, ActHIB® (monovalent Hib vaccine) and TriHIBit® (diphtheria and tetanus toxoids and acellular pertussis [DTaP]/Hib vaccine), are unaffected by the recall and currently available for use in the United States.
- The vaccines affected by the recall, PedvaxHIB and Comvax, contain Hib capsular polysaccharide (i.e., polyribosylribitol phosphate[PRP]) covalently linked to a meningococcal outer membrane protein (OMP) carrier. PedvaxHIB and Comvax are recommended as a 2-dose primary series at ages 2 and 4 months. PedvaxHIB is also licensed for the 12-15 month booster dose.
- The two unaffected vaccines, ActHIB and TriHIBit, are polyribosylribitol phosphate-tetanus toxoid (PRP-TT) conjugate Hib vaccines. ActHIB is recommended as a 3-dose primary series at ages 2, 4, and 6 months, and is also licensed for the 12-15 month booster dose. TriHIBit is licensed only for the 12-15 month booster dose.
- Children who are not at increased risk for Hib disease (described below) and who received PRP-OMP vaccines for only the first or second dose of their routine primary series may be administered PRP-TT to complete the primary series. In these children, a total of 3 doses will complete the primary series. Children who are behind schedule should complete the primary series according to age-appropriate recommendations.
- Because of the short-term reduction in available doses of Hib-containing vaccines, the Centers for Disease Control and Prevention (CDC), in consultation with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics, recommend that providers temporarily defer administering the routine Hib vaccine booster dose administered at age 12-15 months except to children in specific groups at high risk, which are described below. Short-term deferral of the booster dose among children aged 12-15 months is not likely to result in an increased risk for Hib disease.
- Providers should register and track children for whom the booster dose is deferred to facilitate recalling them for vaccination when supplies improve.
- Children at increased risk for Hib disease include children with asplenia, sickle cell disease, human immunodeficiency virus infection and certain other immunodeficiency syndromes, and malignant neoplasms. CDC recommends that providers continue to vaccinate these children with available Hib conjugate vaccines according to the routinely recommended schedules, including the 12-15 month booster dose. PedvaxHIB (if available), ActHIB, and TriHIBit may be used for the booster doses for these children during this shortage.
- Hib vaccines also are recommended for use in prophylaxis for susceptible close contacts of patients with Hib disease. CDC recommends that providers continue to vaccinate close contacts according to published guidelines.
- American Indian/Alaska Native (AI/AN) children also are at increased risk for Hib disease, particularly in the first 6 months of life. Compared with PRP-TT conjugate vaccines, the administration of PRP-OMP vaccines leads to a more rapid seroconversion to protective antibody concentrations within the first 6 months of life. Failure to use PRP-OMP vaccines for the first dose is associated with excess cases of Hib disease in AI/AN infants living in communities where Hib transmission is ongoing and exposure to colonized persons is likely. CDC recommends that providers who currently use PRP-OMP--containing Hib vaccines (PedvaxHIB and Comvax) to serve predominantly AI/AN children in AI/AN communities continue to stock and use only PRP-OMP-- containing Hib vaccines not affected by the recall and vaccinate according to the routinely recommended schedules, including the 12--15 month booster dose.
- Limitations of the vaccine supply underscore the importance of surveillance for Hib disease in children and serotyping of H. influenzae isolates. 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 4 weeks) and should refrain from attempting to build an inventory of Hib vaccine.
2) Recommendations for Increased Surveillance for Vaccine-Associated Bacillus cereus Infections
B. cereus is a common cause of food poisoning. Nongastrointestinal B. cereus infections (including wound infections, sepsis, meningoencephalitis, endocarditis, and pneumonia) can occur in persons with compromised immunity or skin barriers. Rarely, cutaneous B. cereus infections have been reported in immunocompetent persons. As of December 20, 2007, no cases have been reported to the Vaccine Adverse Event Reporting System (VAERS) of local or disseminated B. cereus infections among children who received vaccines from the affected lots.
As part of comprehensive safety monitoring, CDC and the Food and Drug Administration (FDA) are conducting enhanced surveillance for vaccine-associated B. cereus infections.
- All suspect cases of vaccine-associated B. cereus infection should be reported to the local health department (LHD). LHDs should report suspect cases to their NYSDOH Regional Office Immunization Representative.
- A suspect case is defined as infection in any child, aged <6 years, vaccinated in the United States, who:
- had isolation of B.cereus from specimens other than feces or vomitus after any vaccination, and
- had been vaccinated with any vaccine after March 31, 2007.
- All B. cereus isolates from suspected cases should be submitted to the NYSDOH Wadsworth Center.
If you have any questions, please contact your local health department or the NYSDOH Immunization Program at (518) 473-4437.
