Novartis AG said an experimental meningitis B vaccine met the goals of a late-stage clinical study.
The vaccine, called 4CMenB, achieved a “robust immune response” in the study of more than 3,600 infants, the Basel, Switzerland-based company said today in an e-mailed statement. The drug also had “an acceptable” side-effect profile, the company said.
Novartis expects the results of additional clinical trials over the next few months and plans to seek European regulatory approval for the vaccine by the end of 2010. The compound may be used in different age groups and alongside other vaccines, the Swiss drugmaker said. Infants are particularly vulnerable to the meningitis B virus which can kill within 48 hours of the first symptoms appearing, according to Novartis.
“Meningitis B can be devastating for affected families and is a major concern for pediatricians who care for children with this serious illness,” said Andrew Pollard, Professor of Pediatric Infection and Immunity at the University of Oxford. “Many cases of meningitis are prevented today by the vaccines we give to our children, but the more complex meningitis B remains as a major threat.”
Novartis pioneered the technology known as “reverse vaccinology’’ to develop the shot after decoding the genetic makeup of a pathogenic meningitis strain.