FDA green-lights GSK's MenHibrix

After asking for more information back in June 2010, two years later the FDA has green-lighted MenHibrix, GlaxoSmithKline's ($GSK) combination meningitis vaccine for the U.S. market. This targets infections with Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B, and is given as four doses between 6 weeks and 18 months of age. Both of these infections can cause meningitis.

This vaccine has a couple of advantages over its competitors--it is the only meningitis vaccine that can be given to children as young as 6 weeks old, Leonard Friedland, vice president of clinical and medical affairs in North America for GSK Vaccines, told FierceBiotech. It also doesn't add to the vaccination burden for these young children. "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," Freidland said.

- read the press release from the FDA
- see GSK's release
- check out the FierceBiotech article