FDA approves expanded use of GSK Hib vaccine from booster dose to full series

15 January 2016

Issued: Philadelphia

GSK [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration approved an expanded age indication for HIBERIX® [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)].  HIBERIX® is now indicated for the immunization of children aged six weeks through four years (prior to 5th birthday) against invasive disease caused by Haemophilus influenzae type b (Hib). Hib infection is a serious disease caused by bacteria usually affecting children under the age of five, and Hib vaccination for appropriate children is routinely recommended. 

"With this approval, GSK can now offer patients, physicians, and the public health community a more comprehensive pediatric vaccines portfolio in the U.S. for infants up to 18 months," said Patrick Desbiens, Senior Vice President and head of U.S. Vaccines, GSK. "While we were pleased that HIBERIX® was first approved as a booster dose to address a supply challenge in the U.S., now with the full series approved, we complete that chapter."

The evaluation of the effectiveness of HIBERIX® was based on immune responses in children using serological endpoints that predict protection from invasive disease due to Hib. Across clinical trials, common solicited adverse events (³20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. No clinical data are available from controlled studies comparing booster immunization with HIBERIX® and a US-licensed Hib conjugate vaccine. 

"Hib is a serious, invasive bacterial disease that is preventable by vaccination," said Dr. Leonard Friedland, Vice President/Director, Scientific Affairs & Public Health, GSK Vaccines, North America. "HIBERIX® provides another Hib option to healthcare providers and patients to receive protection against a serious childhood infectious disease."

In 2009, health authorities and GSK worked together to bring HIBERIX® to the U.S. as a booster dose to fill a supply shortage, and it was used until supply levels for the complete series returned to normal. The U.S. Centers for Disease Control and Prevention (CDC) recommends the following schedule for Hib vaccination:

• First dose: 2 months of age
• Second dose: 4 months of age
• Third dose: 6 months of age (if needed, depending on vaccine type)
• Final booster dose: 12-15 months of age (*Note, HIBERIX's indication for the booster dose is 15-18 months)

HIBERIX® was initially licensed outside the U.S. in 1996 and is approved in 78 countries around the world.  To date, GSK has delivered approximately 210 million doses of HIBERIX® worldwide.  The full U.S. Prescribing Information for the expanded indication of HIBERIX® will available on  https://www.gsksource.com/hiberix in several days. An electronic copy is available upon request.

About Hib[1]

Haemophilus influenzae type b (Hib) infection is a serious disease caused by bacteria.  It usually affects children under the age of 5.  The bacteria are spread person-to-person and if they reach the lungs or the bloodstream, then the bacteria become invasive and can cause serious problems such as bacterial meningitis.  Meningitis is an infection of the lining of the brain or spinal cord, which can lead to brain damage or deafness.

Before Hib vaccine was introduced in 1985, Hib was the leading cause of bacterial meningitis in children under the age of 5 in the U.S.  Approximately 20,000 children in the U.S. under the age of 5 acquired Hib disease each year and approximately 3-6% of them died. Since the introduction of Hib vaccine, the number of cases of invasive Hib disease has decreased by more than 99%.

Indication and Important Safety Information for HIBERIX

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).

No clinical data are available from controlled studies comparing booster immunization with HIBERIX and a US-licensed Haemophilus b Conjugate Vaccine.

• A severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b-  or tetanus toxoid-containing vaccine or any component of HIBERIX is a contraindication to administration of HIBERIX

• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give HIBERIX should be based on consideration of the potential benefits and possible risks

• Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

• Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination

• In clinical studies, adverse events in children receiving HIBERIX included pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness

• Vaccination with HIBERIX may not result in protection in all vaccine recipients

GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.