ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.
Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.
ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:
• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.
• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.
• Infants in a defined risk group for a community or institutional outbreak.
• Infants with HIV, if another indication for vaccination exists.
The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.
"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."
ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.
The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.
"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.
The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.
In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.
In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.
The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.
"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.
Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.
The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.
Current immunization schedules are available at the CDC website.
As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.