Thursday, June 16, 2011

Novartis seeks vaccine approval for infants

By Michelle Lang

The U.S. Food and Drug Administration is reviewing a vaccine for invasive meningococcal disease developed by Novartis Vaccines and Diagnostics, the Cambridge division of Switzerland-based Novartis, for accepted use in infants and toddlers from two months to two years old. The immunization, called Menveo, is already approved in the U.S. for two to 55-year-olds.

Novartis noted in a press release today that meningococcal disease, a bacterial infection of the bloodstream, can lead to brain damage, learning disabilities, hearing loss, limb loss, or potentially death. The company said the first seven months of a baby’s life are the most vulnerable to contracting meningococcal disease.

The supplemental Biologics License Application submitted to the FDA by Novartis includes data on 6,000 infants and toddlers, with 100 percent of the infants and toddlers gaining full immune protection after the four-dose vaccination, beginning at two months and concluding at up to 16 months.

Menveo just received FDA approval in January for children two to 10 years old. In the European Union, the vaccine is approved for people from age 11 and up, with Novartis seeking European Medicines Agency approval for infants and children soon, the company said.