FDA approves MCV4 for younger population

November 2007

The FDA has now expanded the approved age range for the meningococcal conjugate vaccine to include children aged between 2 and 10 years.

About 2,600 Americans become ill from bacterial meningitis each year, according to a press release. Nearly 10% die of the infection and approximately 15% experience brain damage or limb amputation.

The FDA originally approved Menactra, (MCV4, Sanofi Pasteur) in January 2005 for people aged between 11 and 55 years. Previously, the meningococcal polysaccharide vaccine (Menomune, Sanofi Pasteur) was the only meningococcal vaccine for use in children aged 2 years and older available in the United States. Both vaccines offer protection against four groups of Neisseria meningitides.

The Advisory Committee on Immunization Practices currently recommends meningococcal vaccination for children aged 2 to 10 years who are at increased risk for developing meningococcal disease, including those who have had their spleen removed or whose spleen is not functioning.

It is also recommended in children with a medical condition called terminal complement component deficiency, which makes it difficult to fight infection, and for those who expect to travel to areas outside of the United States where the disease is common.

The vaccine is also used to control outbreaks of bacterial meningitis.

Researchers examined the effectiveness of MCV4 in clinical trials that included people aged between 2 and 55 years. The vaccine produced an immune response one month after vaccination.

Vaccine safety was evaluated in eight clinical studies; participants were assigned to receive vaccination with either MCV4 (n=10,057) or the meningococcal polysaccharide vaccine (n=5,266). The most common adverse events reported were irritability and injection site pain. Diarrhea, drowsiness and decreased appetite also were also common.

Although not observed in these particular clinical trials, Guillain-Barré syndrome was reported to be a possible but unproven risk in some teenagers aged 15 to 19, although the data are limited.

As a precaution, it is recommended that people previously diagnosed with Guillain-Barré syndrome should not receive MCV4.

The FDA and the CDC will continue to monitor MCV4’s safety through their jointly administered Vaccine Adverse Event Reporting System, according to a press release.

Editorial board reaction

Infectious Diseases in Children editorial board members Stan L. Block, MD, and Richard Lander, MD, commented on the age range expansion at the 20th Annual Infectious Diseases in Children Symposium, held in New York recently.

“It’s an invaluable vaccine,” Block, professor of clinical pediatrics at the University of Louisville and the University of Kentucky and president of the Kentucky Pediatric Research Institute, said in an interview.

“A child may come into the office because he has a fever, and the next day the child could be dead or devastated because of this bacterial illness. Pediatricians need this [vaccine] because it will hopefully cut down on the number of rare terrifying cases that occur annually.”

“I’ll start it at 2 years. It’s wonderful,” said Lander, who is a clinical assistant professor of pediatrics at the University of Medicine and Dentistry and chair for the section on administration and practice management for the AAP. “I’ve seen and lost patients to meningococcocemia years ago, so I’ll do anything to prevent it.”