FDA Committee Votes to Broaden PCV13 Indication to Adults 50 and Older

If FDA Approves, ACIP Likely to Recommend, Says FP Expert

December 02, 2011 10:55 pm Matt Brown

The 13-valent pneumococcal conjugate vaccine, or PCV13, which is marketed as Prevnar 13, most likely will receive an expanded age indication -- and, possibly, a CDC recommendation -- by the middle of 2012. That's according to one family physician who currently sits on the CDC's Advisory Committee on Immunization Practices, or ACIP.

[Stock photo of scattered empty syringes]

ACIP member Doug Campos-Outcalt, M.D., M.P.A., of Phoenix, who also is associate chair for the department of family and community medicine at the University of Arizona College of Medicine, said that last month's recommendation from the FDA's Vaccines and Related Biologics Advisory Committee to expand the indication for PCV13 to include adults 50 and older should pave the way for final FDA approval of the change.

That approval, says a statement(www.pfizer.com) 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.

Currently, PCV13 is recommended(5 page PDF) solely for children ages 6 weeks to 5 years.

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). "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.