Haemophilus influenzae type b (Hib) Vaccine Safety

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 Vaxelis^TM 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.

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 the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Resources