Accelerated approval for Hiberix, a Haemophilus b Conjugate Vaccine, has been granted by the U.S. Food and Drug Administration, drug maker GlaxoSmithKline said Wednesday.
Hiberix was approved as a booster dose for use in children ages 15 months to 4 years old in order to protect them from invasive disease caused by Haemophilus influenzae type b (Hib), RTTNews reported.
Hib disease is an often serious and potentially deadly bacterial infection that can cause meningitis.
The FDA's accelerated approval is meant to help deal with a shortage in the United States of a vaccine to protect infants from Hib. GlaxoSmithKline said the vaccine should be available within several weeks, RTTNews reported.