Approval for a children’s vaccine is expected to help make up for a national shortage
The Food and Drug Administration today gave accelerated approval to GlaxoSmithKline’s booster shot for a vaccine that prevents meningitis, pneumonia and other infections. The Hib shot protects children from the bacteria Haemophilus influenzae type b, which infects the brain and spinal cord.
Infants usually receive a series of Hib vaccinations, but there has been a nationwide shortage of booster shots after Merck recalled two Hib vaccines in 2007. They were recalled because of possible contamination. The FDA accelerated approval of GlaxoSmithKline’s shot, Hiberix, to speed the catch-up period as the Hib vaccine supply returns to normal.
The shot is used in dozens of other countries, and clinical studies in 1000 children demonstrated the safety of the shot. GlaxoSmithKline will conduct follow-up studies on the safety and efficacy of the vaccine after it has been administered to children, the FDA said in a statement.