Meningococcal Vaccine Gets FDA Nod for Booster Immunization

September 9, 2014
Katie Eder, Senior Editor

The FDA has approved the use of Sanofi's Menactra vaccine as a booster immunization against meningococcal disease in patients at continued risk.

The FDA has approved the use of Sanofi’s Menactra vaccine as a booster immunization against meningococcal disease in patients at continued risk.

Although meningococcal disease is rare, the condition can result in permanent disabilities and death. As a result, the US Centers for Disease Control and Prevention (CDC) currently recommends that adolescents receive 1 dose of meningococcal conjugate vaccine at age 11 or 12, followed by a booster vaccination at age 16. With its expanded approval, Menactra can now fulfill both of those guidelines.

“The FDA’s approval of the Menactra booster vaccination gives health care providers the option to use a meningococcal conjugate vaccine that is approved for both primary and booster immunization, which aligns with the CDC’s recommendations for preventing cases of meningococcal meningitis,” said David P. Greenberg, MD, Vice President of US Scientific and Medical Affairs at Sanofi Pasteur, in a statement. “With this approval, we hope health care providers are reminded to talk to their teen patients and their parents about the CDC’s recommendations, ultimately helping to improve booster immunization rates for teens across the country.”

The FDA originally approved Menactra in January 2005 as an active immunization against meningococcal disease caused by the A, C, Y, and W-135 serogroups. According to Sanofi, the vaccine’s expanded approval as a booster immunization in patients aged 15 to 55 years was based on an open-label trial that evaluated the safety and immunogenicity of a booster dose among individuals who received Menactra 4 to 6 years earlier.

Following the booster dose, the most common adverse events reported in the study were injection-site pain and myalgia.