Key points
- Hib disease is a serious illness caused by the bacteria Haemophilus influenzae type b (Hib).
- There are vaccines that can protect against Hib disease.
Available vaccines & manufacturer package inserts
Single antigen Hib vaccines
Only contain Hib vaccine.
- The FDA approved PedvaxHIB® in 1989. PedvaxHIB is usually given to children who are 2 through 15 months old.
- FDA approved ActHIB® in 1993. ActHIB is usually given to children who are 2 through 15 months old.
- FDA approved Hiberix® in 2009. Hiberix is usually given to children who are 2 through 15 months old.
Combination vaccines with Hib
Contain Hib vaccine plus other vaccines, combined into a single dose.
- FDA approved Pentacel® in 2008. Pentacel is usually given to children who are 2 through 18 months old to protect against Hib disease, diphtheria, tetanus, pertussis (whooping cough), and polio.
- FDA approved VaxelisTM in 2018. Vaxelis is usually given to children who are 2 through 6 months old to protect against Hib disease, diphtheria, tetanus, pertussis (whooping cough), polio, and hepatitis B.
Who should & should not get the vaccine
CDC recommends Hib vaccination for all children younger than 5 years old. Children need multiple (3 or 4) shots of a Hib vaccine. Older children and adults usually do not need a Hib vaccine. However, CDC recommends Hib vaccination for people with certain medical conditions.
Common side effects
- Redness, warmth, or swelling at the site of injection.
- Fever.
- Irritability.
When to call 911
Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.
Hib vaccine is safe and effective at preventing Hib disease. Vaccines, like any medicine, can have side effects. The most common side effects are usually mild and go away on their own.
A closer look at the safety data
Findings from vaccine safety monitoring systems and scientific studies have shown that Hib vaccines have a favorable safety profile—the body of scientific evidence overwhelmingly supports their safety.
- A study of the safety of Hib vaccines (PedvaxHIB, ActHIB, Hiberix, Pentacel) in VAERS did not find any new or unexpected safety concerns and reconfirmed the safety of Hib vaccines.1
- An observational study using Vaccine Safety Datalink records did not find an increased risk for seizures, meningitis/encephalitis/myelitis, allergic reactions, or fever among children younger than 1 year old.2
Hib vaccine recall in 2007
Recall summary
In 2010, CDC published a report summarizing the findings of a safety assessment after the 2007 Hib vaccine recall. The report, Summary of Safety Assessment of Recalled Haemophilus influenzae type be (Hib) conjugate vaccines–United States, 2007-2008, was a collaborative effort involving the Food and Drug Administration (FDA) and CDC vaccine and laboratory experts.
In response to concerns about potential contamination, the Vaccine Adverse Event Reporting System (VAERS) and the Epidemic Information Exchange (Epi-X) were used to rapidly conduct post-recall safety surveillance for vaccine associated B cereus infections. Based on a review of reports to VAERS and Epi-X, this assessment found no evidence of B. cereus infection in recipients of recalled Hib vaccines.
Findings
- No evidence of B. cereus infection was found in people who received recalled Hib vaccines.
- Routine testing identified B. cereus in the vaccine manufacturing process equipment, but not in individual vaccine lots.
- B. cereus can cause food poisoning, and can rarely cause serious non-gastrointestinal infections in persons with compromised immune systems resulting in sepsis, endocarditis, meningitis, pneumonia, osteomeylitis, or wound infections.
- VAERS received 75 reports involving recalled Hib vaccines from April 2007 through February 2008. Experts searched the VAERS database for "Bacillus" or "cereus" to identify potential reports of infection. The reports were analyzed by seriousness and adverse event patterns. There were 5 reports of death. Before the recall, no B. cereus infection that occurred after vaccination had been reported to VAERS.
- A CDC medical officer reviewed medical records of all serious reports involving recalled Hib vaccines. For each death report, autopsy results, in conjunction with state health departments, local medical examiners, and CDC's Infectious Disease Pathology Branch, sought evidence of B. cereus infections. Tissue specimens were obtained for 4 or the 5 deaths; none of these specimens revealed evidence of B. cereus infection.
- In December 2007, CDC's Epi-X was used to collect information from among thousands of public health professionals and infectious disease specialists for vaccine-associated B. cereus infection. One report of vaccine-associated B. cereus infection was found in a child who received a non-recalled Hib vaccine from the same manufacturer. The patient's B. cereus isolate did not have the same genotype ("fingerprints") as the B. cereus isolated from the manufacturing equipment.
How CDC monitors vaccine safety
CDC and FDA are committed to monitoring the safety of vaccines. Once vaccines are licensed or authorized by FDA for use in the United States, CDC, FDA, and other federal agencies work together to monitor them using several safety systems.
Resources
- Moro, P. L., Jankosky, C., Menschik, D., Lewis, P., Duffy, J., Stewart, B., & Shimabukuro, T. T. (2015). Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013. The Journal of pediatrics, 166(4), 992–997. https://doi.org/10.1016/j.jpeds.2014.12.014
- Nelson, J. C., Yu, O., Dominguez-Islas, C. P., Cook, A. J., Peterson, D., Greene, S. K., Yih, W. K., Daley, M. F., Jacobsen, S. J., Klein, N. P., Weintraub, E. S., Broder, K. R., & Jackson, L. A. (2013). Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety study. American journal of epidemiology, 177(2), 131–141. https://doi.org/10.1093/aje/kws317
- Fritzell B, Plotkin S. Efficacy and safety of a Haemophilus influenzae type b capsular polysaccharide-tetanus protein conjugate vaccine. J Pediatr. 1992 Sep;121(3):355-62.
- Decker MD, Edwards KM, Bradley R, Palmer P. Comparative trial in infants of four conjugate Haemophilus influenzae type b vaccines. J Pediatr. 1992 Feb;120(2 Pt 1):184-9.
- Holmes SJ, Fritzell B, Guito KP, Esbenshade JF, Blatter MM, Reisinger KS, et al. Immunogenicity of Haemophilus influenzae type b polysaccharide-tetanus toxoid conjugate vaccine in infants. Am J Dis Child. 1993 Aug;147(8):832-6.
- Davis RL, Black S, Shinefield H, Mahoney L, Zavitkovsky A, Lewis E, et al. Post-marketing evaluation of the short term safety of COMVAX. Vaccine. 2004 Jan 2;22(3-4):536-43.
- Black S, Greenberg DP. A combined diphtheria, tetanus, five-component acellular pertussis, poliovirus, and Haemophilus influenzae type b vaccine. Expert Rev Vaccines 2005 Dec;4(6):793-805.
- Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR. Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: A randomized, clinical trial. Pediatrics. 2009 Jan;123(1):301-12.
- CDC. Prevention and Control of Haemophilus influenzae type b Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2014;63(No. RR-1):1-14.
- Rinderknecht S, Bryant KA, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, et al. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11.
- Nelson JC, Yu O, Dominguez-Islas CP, Cook AJ, Peterson D, Greene SK. Adapting group sequential methods to observational postlicensure vaccine safety surveillance: Results of a pentavalent combination DTaP-IPV-Hib vaccine safety study. Am J Epidemiol. 2013 Jan 15;177(2):131-41.
- Moro PL, Jankosky C, Menschik D, Lewis P, Duffy J, Stewart B, et al. Adverse events following Haemophilus influenzae type b (Hib) vaccines in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. J Pediatr. 2015 Apr;166(4):992-7.
- Oliver SE, Moore KL. Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants. MMWR Morb Mortal Wkly Rep. 2020 Feb 7;69:136-139.