Novartis' new meningitis vaccine appears safe for infants

Here is a reason to smile for the multinational pharmaceutical company Novartis AG. In a latest study, the Swiss drug maker’s new type of meningitis vaccine proved effective in protecting newborns against meningococcal disease, a major cause of meningitis.

The vaccine, called Menveo, is aimed at four of the most common strains of meningococcal meningitis. Manufactured by Basel, Switzerland based- Novartis, the Menveo vaccine promises to be well-tolerated and boosted the immunity of infants as young as six months, showed the new data.

The vaccine, which is not yet licensed in the United States, generated high levels of immunogenicity in infants against meningococcal serogroups A, C, W-135 and Y, offering a potential new weapon against meningococcal meningitis, a potentially fatal bacterial disease involving inflammation of membranes around the brain and spinal cord.

"This vaccine offers the hope that the number of young children experiencing this devastating illness can be dramatically reduced," said lead author Matthew D. Snape, F.R.A.C.P., of the Oxford Vaccine Group, University of Oxford, England.

To reach their findings, Snape and colleagues conducted a randomized controlled study and examined the safety and effectiveness of the new vaccine, called MenACWY, in 421 healthy infants in the United Kingdom and Canada.

All the infants in the study received one of three different dosing schedules of MenACWY, or a monovalent vaccine targeting only meningitis C. The researchers noticed that the vaccine boosted immunity to all four strains in the three different dosing groups, but the less frequent dosing groups had less protection against serogroup A.

"In this study, we have demonstrated that a primary immunization course of the novel tetravalent meningococcal glycoconjugate vaccine MenACWY was well tolerated and immunogenic for serogroups A, C, W-135, and Y when given to healthy infants at either two, three, and four months or two, four, and six months of age," the researchers said.

However, the study showed the Menveo vaccine boosted immunity in infancy, but the effect was not large enough to prove that the vaccine was safe, researchers said.

The Menveo vaccine is currently in several late-stage trials and Novartis has said it intends to make regulatory submissions in 2008.

If Novartis’ experimental vaccine succeeds in winning the FDA approval for sale in the United States, it would compete against Sanofi-Aventis’ similar vaccine called Menactra, which was approved by the U.S. regulators in October for children aged 2-10.