FDA approves meningitis vaccine

French drugmaker Sanofi-Aventis has won U.S. approval to sell a new vaccine designed to give longer protection against meningitis, a potentially fatal bacterial infection.

The Food and Drug Administration, in a statement posted on the agency’s Web site, said it cleared the vaccine, called Menactra, on Friday for immunizing people ages 11 to 55.

The vaccine is expected to last longer than an older Sanofi-Aventis shot called Menomune, which wears off after three to five years, the company has said.

Menactra’s effectiveness can be strengthened with booster shots.

The vaccine was made with new technology so that it will shield adolescents through their college years, the time meningitis often hits, the manufacturer has said.

A spokesman for Aventis Pasteur, the company’s vaccine unit, confirmed Menactra’s approval on Saturday but declined further comment until the firm announced the FDA clearance.

Menactra protects against one of three types of meningitis bacteria that strike the fluids surrounding the brain and spinal cord. The infection can cause seizures, brain damage and memory loss, and can even kill otherwise healthy people in less than 48 hours.

The strain Menactra targets infects up to 3,000 Americans each year, according to estimates from the Centers for Disease Control and Prevention. Ten percent of people infected with the strain die from the disease despite treatment with antibiotics.

Meningitis can occur in young children but frequently crops up among older teenagers and young adults living in close quarters, such as college students or military recruits.

Sanofi-Aventis plans to apply next month for approval to market Menactra for vaccinating children ages 2 through 11, according to the FDA’s letter.

In September, an FDA advisory committee ruled Menactra was as safe and effective as Menomune but called for longer studies of the new vaccine after approval. The studies the advisory committee and the FDA reviewed lasted three years.

In a letter to the company announcing the approval, the FDA asked the firm to do a follow-up study tracking immunity levels five to 10 years after vaccination. Sanofi-Aventis has said it has research ongoing to determine how long Menactra works.

The FDA also asked for further studies of possible side effects. The most common reactions reported in research so far were pain, headaches and fatigue. Most cases were mild.

Provided by ArmMed Media
Revision date: June 20, 2011
Last revised: by Dave R. Roger, M.D.