GlaxoSmithKline’s (NYSE: GSK) vaccine that protects children as young as six weeks against two potentially deadly bacterial infections has won approval from U.S. health regulators.
It’s the first such vaccine.
The Food and Drug Administration approved Menhibrix, a combination vaccine for infants and babies that prevents meningococcal disease and haemophilus influenza. Those bacteria can cause potentially deadly illness, or lead to blindness, mental retardation and amputation.
The FDA said the diseases are difficult to spot because their symptoms are similar to the common cold.
“All of us at GSK Vaccines look at today’s approval as a good day for infants, toddlers and healthcare providers,” said Leonard Friedland, head of Clinical and Medical Affairs for North America Vaccine Development at GSK Vaccines. “MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers.”
GSK won approval based on clinical trials conducted in the United States and several other countries over seven years.
The vaccine is given in a four-dose regimen beginning as early as six weeks of age. The fourth dose can be given as late as 18 months of age.
The vaccine is manufactured at facilities in Belgium.
GSK operates its U.S. headquarters in RTP.
[GSK ARCHIVE: Check out a decade of GSK stories as reported in WRAL Tech Wire.