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FDA Committee Votes to Broaden PCV13 Indication to Adults 50 and Older
If FDA Approves, ACIP Likely to Recommend, Says FP Expert
By Matt Brown
That approval, says a statement (1-page PDF; About PDFs) from the vaccine's manufacturer, Pfizer Inc., could come as early as January 2012.
A scientific analyst for AAFP since 2006 who also served as the Academy's liaison to the ACIP for a number of years before joining the committee, Campos-Outcalt told AAFP News Now that an expanded age indication would be beneficial in these older patients, given that current data suggest PCV13 is superior to the only pneumococcal vaccine option now available for this age group -- the 23-valent nonconjugated pneumococcal polysaccharide vaccine marketed as Pneumovax.
Campos-Outcalt acknowledged, however, that additional steps must be taken before the vaccine becomes a routine part of the annual adult immunization schedule (4-page PDF; About PDFs). "The FDA needs to formally approve (the vaccine) first; then, the ACIP will make a recommendation," he said. "I think both will happen within six months."
ACIP recommendations are considered provisional until they have been approved by the CDC director and HHS and published in Morbidity and Mortality Weekly Report. Only after that step has occurred would the recommendation be formally reviewed by the Subcommittee on Clinical Preventive Services of the AAFP Commission on Health of the Public and Science.