The U.S. Food and Drug Administration (FDA) has granted a license to Sanofi to expand the indication for its meningococcal conjugate vaccine, Menactra(R) to include children 2 years through 10 years of age.
The Menactra vaccine, licensed in the U.S. for the prevention of meningococcal disease, treats a rare, serious bacterial infection that often causes meningitis or sepsis.
Dr. Michael Pichichero, professor of microbiology/immunology, pediatrics and medicine, at University of Rochester Medical Center said in a press release, "About half of the cases in children 2 years through 5 years, and two-thirds in those 6 years through 11 years can potentially be prevented through vaccination in the United States."
"We have been waiting for this expansion of use of Menactra(R) to younger children, since they too are at risk and may benefit from the vaccine. Meningococcal disease is serious and no healthy child should have to risk permanent disability, or even death, from this vaccine-preventable disease," he added.
Data from the studies indicated that the vaccine was safe and immunogenic for children 2 years through 10 years of age. Menactra(R) vaccine resulted in longer-term persistence of bactericidal antibody, production of high avidity antibody, and the establishment of immune memory.
No clinically significant adverse events were identified after a six-month controlled follow-up, the press release said.
The vaccine is made by Sanofi Pasteur, which is Sanofi-Aventis' vaccines unit. Sanofi-aventis is listed in Paris and in New York.
